A disturbing prediction on cervical cancer deaths ...

Today's New York Times has an article summarizing the disturbing results of a new study looking at trends in cervical cancer morbidity and mortality in Latin America.

In an era in which most cases of cervical cancer can be prevented or detected early and treated, the study – sponsored by the Sabin Vaccine Institute, the Pan American Health Organization, and the US CDC, among others – concluded that cervical cancer-related deaths are likely to double in Latin America in the next 20 years. Fewer than five per cent of women in Africa, Asia and Latin America are screened for cervical cancer, as compared to 70% of women in North America and Europe. Most of these women also lack access to newly-approved HPV vaccines.

Does this truly have to be the case? Must we continue to needlessly condemn 250,000 poor women to death every year? Even if we accept the argument that current screening and treatment technologies – Pap smears and the HPV vaccine – are too costly to be used widely in resource-poor countries like Haiti and Nicaragua, what about lower cost screening technologies like VIA (visual inspection of the cervix using acetic acid)?

For almost a decade, it has been known that clinicians, usually nurse-midwives, who wiped a patient's cervix with acetic acid (white vinegar) can be trained to accurately detect more than three-fourths of pre-cancerous and cancerous cervical lesions. That this method is not more widely used, particularly in light of a recent Lancet study showing that VIA is as effective as traditional screening methods in India, is shameful.

It's time to wake up and smell the vinegar ...

Hear WBP founder Kathryn Hinsch in person

If you live in or near Maricopa County, Arizona, don't miss this chance to hear WBP founding director and board president Kathryn Hinsch speak on women and bioethics at the YWCA's Empowering Women Lecture on Tuesday, September 16, at the Orpheum Theatre. More on the YWCA and its goals from the Arizona Republic here.

Happy 3rd Birthday to our blog!

Please join me in wishing the Women's Bioethics Blog a very happy Birthday -- it's been three years this month since we started this endeavor and we're still going (and growing) strong...Thank you to all of our wonderful bloggers and loyal readers!

Bionic Athletes stepping out of the debate and in to action

I've been fascinated with the growth in public awareness recently regarding bionic athletes. It's very interesting to watch something go from fringe and then mainstream. Almost a year ago, an article by Jamais Casico made me take a real look at what it is to be bionic when he talked about getting hearing aids in The Accidental Cyborg. Since then, I've had a heightened awareness and intrigue for the topic. Last month my husband's ESPN came in, I am admittedly not a reader of this particular magazine, but the cover was beautiful. It had bionic Little Leaguer Anthony Burruto on the cover preparing for the pitch and the debate: Bionic Athletes Is Baseball Ready for This Guy? Are You? I had to read it immediately and highlight profusely the interesting comments, while my husband watched and let it slide that I had both read and defamed his magazine before he had even cracked the issue.

The comments inside were intriguing: "...he [Hugh Herr] doesn't want his human legs back because soon they'll be archaic", "Technology...is quickly outpacing evolution, and few know how to respond", "Others will fret that some athletes might cut off a limb to gain a prosthetic advantage." This last quote has been a debate between a close friend and I for months now. I think this is a probability in the future, people are very competitive and those who were not born to compete may pay to be able to do so at any cost. She, only the other hand, is appalled at the idea, she is very open-minded about things, but this one crosses her line of what people would subject themselves to. The difference in opinions is understandable, we come from different experience and backgrounds, she had a mother who had to have her legs amputated for medical reasons and saw firsthand what life is like without limbs. Me I only know from what I read and imagine. We therefore amicably agree to disagree.

My other favorite quote however, and the one I saw on American Gladiators this week, was, "Shed a tear for the 'disabled' today. Tomorrow they might pity you." I wish I would've written this. I thought of it Monday evening when I was watching American Gladiators. This is a requirement in my home, my son is enamored with the Gladiators as any almost 9 year old should be. They showed the next competitors and who did they have...a leg amputee...a bionic athlete, John Siciliano.

My first thoughts were good for him, and my second was good for NBC or whoever in the company selected him to compete. The show, with it's overly muscular Gladitors, typically has competitors that are also overly muscular and look as if they're training for, well, to take on a Gladiator. This guy, however, was different. He wasn't overly muscular, he was a Para-Olympian Gold Medalist, he had endurance and a great determination took to take them all on. I watched and rooted for him. He didn't win, but it wasn't without a fight. The last challenge was tough and I must be honest, it was a bit sad and disheartening. No matter what his determination was, his leg was not outfitted for the Eliminator. The water challenge made the leg wet, the leg was the J-shaped Flex Foot version not good for ropes, tight-rope walking or going down the pipe, also not good with the wet leg. When it came to the end, he fought hard while the crowd cheered, he finished with pride.

Honesty again, this made me tear up, seeing him and knowing that he won't be the first, hoping others out there built like a Gladiator will want to compete also, as an equal to the Gladiators and to show up the first bionic competitor. Except the next time, they will be outfitted with prosthetics to take on the ropes, water, and the evil travelator. Bionic athletes are not going away any time soon,and as was mentioned in ESPN magazine, "Thousands of vets will return to the U.S. without limbs, and they will want the best replacements...and those vets will take their prosthetics to the blacktop and the field. Disabled athletes will get only more competitive."

So I say, good luck to the next competitor and welcome to the mainstream. We're going to be seeing a lot more of you in the future and I hope that we will all benefit from your determination and continual drive for best technologies.

Smart advice re genetic testing

Today's Newsday includes this fantastic op-ed by Wylie Burke, an ethicist and medical geneticist at the University of Washington, and H. Gilbert Welch, a primary care doc and researcher at Dartmouth. (Full disclosure: I work with Wylie and think the world of her. Read the editorial, and you'll have an inkling of why that is.)

Dr. Welch is also the author of a wonderful book, Should I Be Tested for Cancer? Maybe Not and Here's Why that provides lots more information about the ways in which "predictive" testing and population-level screening can create problems for patients.

Is Life A Gift?

[Cross posted with permission from the IEET site]

By Michael LaTorra

Harvard's Michael Sandel argues in his book The Case Against Perfection: Ethics in the Age of Genetic Engineering that life is a gift and that we should accept the unbidden nature of this gift, working toward acceptance and solidarity with others rather than seeking unbridled mastery over human biology.

But is life properly viewed as a gift?

The claim that life is a gift automatically entails a responsibility on the part of the recipient of that gift to respond with gratitude and without taking issue with the precise attributes and characteristics of what has been given and received. One is supposed to live by the aphorism "Don't look a gift horse in the mouth" (or you might see a lot of rotten teeth). So to accept Sandel's premise that life is a gift is also to accept that one is obliged to respond in a certain way and without closely scrutinizing the actual conditions of what has been received.

But is life a gift at all? The alleged giftedness of life is not inherent in life itself. Something can be given and received without that something being a gift. Communicable diseases are given and received, yet we do not usually consider diseases to be gifts. In some cases, some individuals will say that they learned valuable lessons from their struggle with a disease. In that sense, perhaps we could deem a disease to be a gift. A better term for such an event, however, would be a test.

A test is given and received, just like a gift. However, a test may properly be viewed as fair or unfair, depending on whether the test is appropriate to the skill and knowledge level of the person being tested, and whether the test is free from trickery or deception. We are not expected to have any sense of social obligation to be grateful for being tested. We are not expected to overlook unfairness, bias or deception in the test itself. Indeed, we have a duty to evaluate the fairness of the test so that neither we nor other test-takers should be badly affected by an unfair, biased, deceptive or inappropriate testing instrument.

Life as we currently live it has many undesirable features, such as sickness, old age, too-short duration, painful death, and other limitations. To represent life as a gift without recognizing these negative attributes is to bias the discussion of how life might be improved. If life were merely a gift, one would have to wonder about the motives or competence of whomever chose to give such a gift. If you were shopping for the perfect gift to give someone you loved, would you give them spinal bifida and Huntington's disease?

Life is not always or only a gift. Life is also a test. A crucial element of this test is how life itself might be improved so as to lessen suffering, improve capacity, enhance abilities, and extend the duration of every desirable aspect of life itself. This is the lesson of life. This is how the test is well-met. The true gift of life is to make it better than it was when first received.

Worth the read today...

From Wired's Science Blog: "The First Genetically Modified Human Embryo: Advance or Abomination?

Scientists have created the first genetically modified human embryo.

What does this mean to you?

Led by Nikica Zaninovic, researchers at Cornell University added a green fluorescent protein to an embryo left over from assisted reproduction. They destroyed the embryo five days later. It is believed to be the first documented genetic modification of a human embryo." Rest of the article can be accessed here.

Image: Five-day-old (unmodified) human embryo, courtesy of the Wellcome Trust. They provide information about the UK's proposed Human Fertilisation and Embryology Bill here.

What do you see in this picture?

I'm fascinated by how pop culture shapes, and is shaped by, our society's view of bioethical issues. Here's the Mother's Day cover of the New Yorker.

It shows a woman peering gooily into a shop window, mooning over a warm and wriggling litter of--wait for it--not puppies, but diapered babies. Meanwhile, her male companion tries to drag her away from the window, eyes rolled heavenward in the universal male posture of "Not this again!"

There's a lot to unpack here, beginning with the idea that women view motherhood the same way they view a new pair of shoes; that men view women's desires to become mothers with the same exasperation as they view the shoe-buying habits some of us have; that babies are like puppies (warm, fuzzy, commodities)....

You can play too! What other assumptions and analogies are implied here?

Happy Mother's Day from the WBP

You don't have to have a child to feel like a mother, or be motherly, or motherlike or maternal. We can be mothers to our ideas, our passions, to our pets, to our extended families -- being a mom can also be about being a nurturing caregiver, a protector of life and liberty, a guardian of the weak and the fragile, and a steward of the earth and all of its living creatures.


So, from all of us at the Women's Bioethics Project, we wish you a Happy and Joyful Mother's Day!

Dude, Where's my artificial womb?

A couple of our bloggers (Terry Tomsick and Jennifer Bard) have written articles on ectogenesis (aka the artificial womb or the uterine replicator), which is a fascinating area, considering all the ethical, legal, and social implications. And just in time for Mother's Day bioGeek and blogger Terry Johnson also speaks to this issue at the IO9 website:

"Whether you'd prefer a new and improved reproductive system installed as a replacement for your own or external to yourself (say, next to the washing machine), there are a few recent advancements bringing it a step closer to reality. An emulsified liquid blood substitute called perflubron has had some success used as a replacement for amniotic fluid for premature babies in respiratory distress. It's not a complete replacement for the complex stew of hormones, lipids, and proteins normally present in the amniotic fluid, it is at least a promising way to get oxygen into developing lungs."

He concludes, "we're still many decades away from a safe, human uterine replicator that can bring an embryo from conception to zeroeth birthday party. Even once we've sorted out the technical aspects of the womb itself, we'll have to deal with what the rest of the mother's body contributes to development. Hormones have already been mentioned, but baby also borrows mommy's disease-fighting machinery. Our replicator will require nearly complete endocrine and immune systems, too.

All in all, I'd take a serious look at adoption."

Full article accessible here.

Conference May 23rd in NYC: New Dilemmas in Medicine

Conference: New Dilemmas in Medicine, co-hosted by the IHEU-Appignani Bioethics Center & Bioethics International

Where: 777 United Nations Plaza, 2nd Fl., New York, NY

When: May 23, 2008 9. 30 am-7. 00 pm

To Have the Best Child Possible: The Coming Age of “Procreative Beneficence?”

Genetic science has the potential to provide prospective parents with unprecedented control over their unborn child’s characteristics and attributes. In vitro fertilization and pre-implantation genetic diagnosis allow couples to sort out “good” from “bad” embryos prior to the start of pregnancy. Although these technologies are almost exclusively employed to detect genetic and/or chromosomal abnormalities among embryos, their use for selection of other medical and non-medical traits is conceivable. Tomorrow’s couples may have the opportunity to select embryos that will not only be the least susceptible to disease but which also have particular hair colors, skin tones, temperaments, or other personal attributes. Advocates of these eugenic initiatives have argued that future couples will have a moral obligation to pursue these technologies whenever possible to achieve the greatest benefit for their children, a principle known as “procreative beneficence.” Still, secular and non-secular critics alike argue that use of such technologies is immoral and may be potentially devastating to children and the structure of society.

. Arthur Cooper, M.D., Director of Trauma & Pediatric Surgical Services, Columbia University- Harlem Hospital Center

· Jennifer Kimball, Executive Director Culture of Life Foundation

· Eva Kittay, Ph.D. SUNY Stony Brook

· Barbara Katz Rothman, Ph.D. CUNY Baruch College

· Udo Schuklenk, Ph.D. Queen's University, Canada

· Panel Moderator: TBD

Ethics and Pharmaceutical R&D: Who Should Be Responsible for Tomorrow’s Drugs?

The vast majority of prescription medications are developed and sold by private pharmaceutical companies. Under the current market-based system, however, some critics argue that pharmaceutical companies have financial incentives to support R&D that will yield the biggest return but which may not be in the best interests of improving the health of patients worldwide. They claim, for example, that pharmaceutical companies are far more interested in producing Viagra than vaccines, and call for change in paradigm of drug design and provision. Others point to the high costs of R&D and the critical importance of blockbuster drugs to the future development of less profitable vaccines and antibiotics; without the former, they argue, there could be no breakthroughs.

· Angela Ballantyne, Ph.D.,Yale University Interdisciplinary Center for Bioethics, Visiting Scholar

· Chalmers C. Clark, Ph.D., Associate Professor, Department of Philosophy, Union College

· Paul Howard, Ph.D., Director of the Manhattan Institute's Center for Medical Progress

· Wilmot James, Ph.D., Executive Director of the Africa Genome Education Institute

· Jason L. Schwartz, Ph.D., Researcher, University of Pennsylvania Center for Bioethics

· Panel Moderator: Jason Lott, M.D., University of Pennsylvania School of Medicine

Saying “No” to Patients: Medical Professionals as Conscientious Objectors

Central to the professional and ethical mandate of physicians, pharmacists, and other healthcare personnel is the provision of medical care consistent with the best interests of their patients. However, news of healthcare professionals refusing to provide certain types of care to their patients under the auspices of “conscientious objection” have raised questions about the role of professionals’ personal beliefs in fulfillment of their purported obligations and duties. Examples include doctors refusing to terminate pregnancies, pharmacists refusing to dispense emergency contraception, certain Catholic hospitals receiving public funds refusing to issue morning-after birth control to rape victims, and others.

• Robert Baker, Ph.D. Director & Professor of Bioethics, The Union Graduate College-Mount Sinai School of Medicine
• Thomas Berg, L.C., Ph.D., Executive Director, Westchester Institute for Ethics & the Human Person
• Laura Katzive, Deputy Director, International Legal Program, Center for Reproductive Rights
• Mark Mercurio, M.D., M.A., Yale University School of Medicine, Director of the Yale Pediatric Ethics Program, and Co-Chair of the Hospital Ethics Committee
• Rosamond Rhodes, Ph.D., Professor & Director Medical Education, Bioethics Education, Mount Sinai School of Medicine
• Girija Nandan Singh , Ph.D., University Professor & Head of Geography at R. D. & D. J. College Munger, Bihar, India
• Panel Moderator: Austin Dacey, Ph.D., Center for Inquiry, NYC

****************************************************************

Following the conference there will be a cocktail reception featuring an Argentinean Tango performance by Laura Real.  This will be from 7:00 PM to 9:30 PM at the Consulate General of Romania, located nearby at 200 East 38th Street @ Third Ave

Registration Fees (includes cocktail reception):
General Public - $65
Students - $30

One can attend the cocktail reception only for $30.

Pay at the door, or send your check to:
IHEU-Appignani Center for Bioethics
P.O. Box 4104
Grand Central Station
New York, NY 10162

Contact person: Ana Lita: (212) 687-3324 AnaLita@iheu.org

Girls & sports & character

Not a bioethics story, but I can't resist sharing this one.

Albany Medical Center Prize Awarded to Two Female Biomedical Researchers

For the first time since its inception, the Albany Medical Center Prize, (the largest prize for medicine in the United States, and second world-wide only to the Nobel), was awarded to two women.

Dr. Joan Steitz of Yale University does research that has improved the lives of people suffering from a variety of auto-immune diseases, while Dr. Elizabeth Blackburn of UCSF discovered the enzyme telomerase, which repair telomeres on chromosomes (and many believe may be linked to aging).

The women will share the $500,000 prize.

Wanted: Women to Eat Chocolate

What woman wouldn't want to sign up for this clinical trial? From across the pond:

"Researchers in Norwich have set themselves an easy challenge: finding 150 women prepared to eat a bar of chocolate a day.

The chocolate is free, and made specially for the trial by a Belgian chocolatier. The intention is to see whether it improves the women’s health." To see the rest of the article, click here.

Iron Man: Not So Far From Reality

Iron Man, the upcoming summer blockbuster, has captured the attention of kids and comic book aficionados everywhere -- Isn't this every kid's dream? To be super strong, and a superhero? Well, it's not as far out in the future as you may think -- Although I've written about the ELSI (Ethical, Legal, and Social Implications) of future Augmented Cognition (sorry about the shameless plug), the first step, the Augmented Human Robotics System is already here. Too cool for words, this system not only has military applications, but promises to replace wheelchairs and crutches for those patients suffering with mobility disorders. Check out a prototype here:




Ooooh, I want one of these...(oh, for my nephews and nieces, of course).

More on Malaria -- It really is a preventable disease.

One of the places I teach is at the University of Sciences in Philadelphia, in the Department of Biomedical Writing. The Chair of Biomedical Writing is Susanna Dodgson and she is an amazing woman -- you can see her talking about her program at Pharmed Out, an independent, publicly funded project that empowers physicians to identify and counter inappropriate pharmaceutical promotion practices, and who we just added to our blogroll.

In addition to teaching and being the department chair, she is the Editor-in-Chief of the Medical Journal of Therapeutics Africa, and she has recently taken on the cause of eradicating malaria. She went on location in Lagos, Nigeria and produced, with the help of faculty and students of the Biomedical Writing program, this great video why malaria should be and continue to be a major world health concern and just how malaria can be prevented:



We had posted earlier about World Malaria Day and Blackout for Malaria on Facebook, but Susanna's video is a reminder that one day isn't enough. Go, Susanna!

The “third tier” in US health care?

It’s a sickening situation. Physicians’ incomes are under attack: think lower reimbursements, higher costs for malpractice premiums and the like, greater business costs, claims processing hassles, and deadbeats.

What’s a poor doctor to do? One possible cure is the concept of Concierge Care.

Concierge Care (or Boutique Medicine, or Platinum Practices, one name hasn’t stuck) could offer a patient such privileges as 24-hour phone or pager access to the doctor, house calls, and guarantee of an appointment with your chosen doctor the same day you call.

The cost: a fixed annual fee that could range beyond $20,000 a year, depending on the services provided, and the patient’s age and health.

I’m not quite old enough to remember the days when doctors offered all the above and a lot more to everyone, for a lot less.

So there it is: to the other tiered services available in the US (UPS for the rich, the post office for everyone else; private schools for the rich, public schools for everyone else) we can now add a three-tiered “health” care system: no coverage at all for 45 million people, inadequate medical services for most of the rest of us, and Concierge Care for the lucky, wealthy few.

The God Squad Redux?

There has been a simple problem with organ transplants, for as long as it has been technologically possible to do so: there are never, ever enough organs. And that leads to the simple, painful, difficult question of how you decide who receives a organ, and who is consigned to death that could have been prevented. And perhaps most importantly, how do you make that decision ethically?

For better or worse, much of the debate on who gets to play god has centered in and around the medical facilities in Seattle. Almost everyone knows the history of Dr. Belding Scriber and the hemodialysis God Squad, with the now-infamous headline “They Decide Who Shall Live and Who Shall Die.” And their criteria for choosing who did receive dialysis is almost painful to consider these days: a married Christian white man with children? Worthy member of society, should be saved! Single convict? Let 'im die.

It's a well-known history, in bioethics and Seattle proper. So it was with some surprise that I read, in the morning's news cycle, that the University of Washington was back in the news with accusations that their transplant committee was playing god. Only this time, they're second-guessing other medical professionals in the process.

The situation itself is simple: a man in need of a liver transplant was prescribed medical marijuana use by his physician to control pain, alleviate nausea, and stimulate his appetite.

The marijuana use, according to a doctor at Harborview Medical Center, would prohibit his paperwork for transplanting being processed. He would have to abstain for six months - a ruling eventually dropped in favour of an offer to reconsider after completion of a 60 day substance abuse program. Sixty days that the patient didn't have. On appeal, the University of Washington Medical Center agreed to consider the case again, and a week ago rejected the man from transplant consideration for a second time.

Medical use of marijuana was approved by Washington voters back in 1998, yet use of illicit substances is often grounds for rejecting someone's place on the transplant list. UNOS leaves the specific criteria to each individual hospital, and the information coming out of Seattle seems to suggest that UW's policy is not automatic rejection, but instructions to abstain for six months to then be reconsidered. (And of course, the medical center itself is not commenting on this case, save to say a range of factors play into every decision made regarding transplant cases).

The problem with this is hopefully simple: if a patient is using marijuana under medical supervision, why should it be considered problematic? Or any more problematic than the use of any other addictive substance (such as most pain medications).

The other problem is less simple. Physicians trying to do right by their patients, trying to alleviate pain and suffering (something that is often difficult to even motivate physicians to do, as continued coverage of the dearth of chronic pain management indicates), are inadvertently creating a situation where their patients are actually being denied further medical treatment based on their current treatment.

Peggy Stewart, a clinical social worker in the UCLA liver transplant center, has a simple solution: create a national eligibility criteria, so that everyone is on the same page, and aware of what will and will not increase their chances at actually being placed on the list.

Or, if I may be so bold as to point out the obvious, don't penalize a patient for following the medical advice of a fully licensed physician.
-Kelly Hills

Random Acts of Mindfulness

Grrl Scientist posts about a Lakewood, WA police officer who stopped traffic so a duck and her family could finish crossing a highway. (silent video included in post)

While superficially this is an act of kindness by someone in a position of authority or simply a removal of a potential traffic hazard, on a higher level, this story demonstrates a mindfulness about the parts of Nature that we cannot control, the aspects that will keep living and doing regardless of our own engagements. And we all have a choice to ignore those aspects, or we can spare a bit of the immense power we have to embrace something as fundamental as helping a family in the course of its life.

As May dawns and brings with it the rigorous flush of new life, I urge everyone to consider a random act of mindfulness that appreciates the living world around us.

Kudos go out to Officer Carrell and to the drivers for taking a moment to appreciate life.

(This story was so heartwarming I just had to share it)

Cochlear Implant Manufacturer Facing Multi-Million Dollar Fine

As a quick search on this blog for the word deaf shows, I am a pretty vocal advocate of Deaf rights, and quite anti-cochlear implant for d/Deaf children. Because of the nature of the procedure, and its permanence, I do believe it's a choice that an autonomous agent should consent to rather than have pushed onto them. And this article from the LA Times just adds to that belief: the FDA wants to fine cochlear implant manufacturer Advanced Bionics $2.2 million for apparent manufacturing violations that actually put patients at risk for additional hearing loss, electrical shocks, and other issues. (Frankly, those two are enough, as far as I'm concerned.)

As for my other objections, they are relatively simple from a technological standpoint. Unless technology has rapidly changed in the last few years, one of the major drawbacks of cochlear implants is that they do destroy any residual hearing. This is why many doctors suggest only implanting one ear, in case a better technological or biological solution comes along later down the line. So you are wedded to the device implants, and that technological level, for the remainder of your life.

Stop and think about this for a minute. Go dig around in your junk drawer and take a look at your cell phone from three or four years ago. Or better yet, go find a computer from the 1980s.

How would you like to have that technology (in all it's now unsupported glory) embedded as a part of you that you are reliant upon for the remainder of your life, regardless of whether or not people continue to support that level of technology?

From a purely technological, I spent too long in the software industry, standpoint (and leaving out all notions of Deaf culture), it's simply a bad idea.

This Advanced Bionics lawsuit is just another in a long list of reasons cochlear implantation is a decision that should be made only by competent adult agents.
-Kelly Hills

No wrongful-dismissal verdict for creationist postdoc

From The Scientist (free subscription may be required) comes this report of the outcome of Nathaniel Abraham's lawsuit against the Woods Hole Oceanographic Institution. Abraham claimed that he was fired from his postdoc position because he told his supervisor, Mark Hahn, that he believes in the literal truth of the Bible and considers evolution to be a theory, not a fact. Abraham, who had been working in evolutionary biology, sued and asked for $500,000 in damages for violation of his civil rights. (There's an NPR report on the lawsuit here.)

Over at the Panda's Thumb, blogger Timothy Sandefur explains that the case was thrown out on a pair of technicalities: Abraham failed to file his complaint within the required time period of a notice from the EEOC, and he couldn't personally sue Hahn under applicable law. It could well be that this will be appealed--and that Abraham will be the new poster child for Ben Stein's creationist campaign. Stay tuned.

The FDA blows it ... again.

Despite all of the recent, largely negative press that the US Food and Drug Administration has received, one of their biggest screw-ups has so far slipped under the radar.

In yesterday's Federal Register, the FDA published its amended rule for accepting for regulatory review data collected from in foreign clinical trials not performed under an IND.

I'm thrilled that the FDA wants all trials submitted to it for review to be conducted in accordance with Good Clinical Practice (GCP) guidelines, including review and approval by an independent ethics committee such as an IRB or a REC. In doing so, however, the FDA removed from its regulations all reference to the Declaration of Helsinki.

Many of us in the advocacy arena have been arguing against this proposed change for years, suggesting instead that the FDA should work towards harmonizing the substantive requirements of GCP with the ethical aspirations of the Declaration of Helsinki. But the Agency chose to ignore us, leaving many of us to wonder if this is just another example of the FDA kowtowing to corporate business interests ... particularly their oft-stated opposition to Paragraph 30 of the Declaration:

"At the conclusion of the study, every patient entered into the study should be assured of access to thebest proven prophylactic, diagnostic and therapeutic methods identified by the study."

Sex selection in India ...

It took then-US President Ronald Reagan several years to even mention the word "AIDS," by which time thousands had died and tens of thousands more were infected.

Much in the same way, it has taken Manmohan Singh four years as Prime Minister to finally denounce the wide-spread practice of in utero sex determination and selective abortion of female fetuses in India.

The Lancet once estimated that as many as 10 million female fetuses had been selectively aborted in India between 1986 and 2006. So, we can conservatively guesstimate that approximately 2 million such abortions have occurred since Mr. Singh's election as Prime Minister.

Hopefully the next words out of his mouth will be a clear order to Indian law enforcement agencies to actively implement already existing laws that make the practice of selectively aborting female fetuses illegal, instead of just paying lip-service.

The Boycott to Help Global Warming

Living in Vermont, I get to meet really interesting people sometimes -- and this weekend, I had the serendipitous fortune to meet a woman who decided she, one person, was going to try and make a difference in the battle against global warming. She has launched a one-women show, The Boycott Play, based on the 2400-year-old Greek sex comedy Aristophanes’ "Lysistrata", where the First Lady leads the women of the world to go on a sex strike to pressure political leaders (the fictional self-absorbed President, in particular) into taking action. As one reviewer put it, "If the planet gets hot, the men will get naught."

Here's one of her clips from Youtube:




What a nice reminder that one person can make a difference! You go, girl!

Reversal in life expectancy for some Americans

Ok, ok, I'll spare you the suspense: it's poor women, mainly.

According to a study published last week in PLoS Medicine, available here, life expectancy for some people--and particularly women in the Deep South and Appalachia--has actually decreased since the 1980s. According to the lead author, Dr. Majid Ezzati, "The finding that 4 percent of the male population and 19 percent of the female population experienced either decline or stagnation is a major public health concern." Yeah, you could say that. The main culprits are identified as chronic diseases related to smoking, overweight and obesity, and high blood pressure.

Life expectancy has long been regarded as an indicator of the effectiveness of a country's health and social systems. The fact that we seem to be moving backward, particularly in poor parts of the country, is bad news. You can read more at the NYT.

And because I can't help it on a Monday, here's a big fat helping of irony for you: Linda's link to Art Caplan's commentary on the ethics of extending life (ie, there's nothing wrong with us "haves" choosing to extend our lives) and this MSNBC feature, on the crazy things some women are doing to their faces in hopes of looking younger (having outlived their dewy complexions, presumably).

Social justice, anyone?








Photo credit: Shelby Lee Adams for the NYT