blog.bioethics.net

Another State Joins the Stem Cell Business

Jim Fossett brought to my attention that yet another state, Maryland, is getting into the stem cell business.

The Bioethics Quilt Project

Karama Neal sent along some great links about the Bioethics Quilt Project by Muhjah Shakir, assistant professor of occupational therapy and senior scholar at the National Center for Bioethics in Research and Health Care at Tuskegee University. Professor Shakir has been working with the female partners of the men in the U.S. Public Health Service Syphilis Study (Tuskegee) to create a quilt and find out the impact the study had on contemporary women in Tuskegee and Macon County, Alabama.

“I had long since wanted to use quilting as a method to engage a group around,” she said. “The community had a long history of quilting, so the quilt project was a great way to engage the community and learn of the impact of the syphilis study.”

This project involves women between the ages of 55 and 96 meeting twice a week to tell their life stories, create a quilt and journal. Each creates a square to depict how they are feeling. This is designed to develop a capacity for reflection in the women.

Shakir said the squares vary in their symbolism and meaning. “Each square tells a particular story from the woman’s own perspective,” she said. “The quilting has become a community narrative of Tuskegee.”

You can also hear both Professor Shakir and Harriet Washington, the author of Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present discuss the history of experimentation on black Americans, as well as how the quilt project heals old wounds via art.
-Kelly Hills [with many thanks to Karama]

HPV Vaccine Culture Wars

For a time, Georgia was poised to become the latest state to require preteen girls to be vaccinated against a virus that causes cervical cancer. A powerful state Republican lawmaker proposed making the vaccine mandatory for girls entering sixth grade, and the governor included $4.3 million in his budget to make it available to some 13,000 girls whose family's insurance policies wouldn't cover it. But state lawmakers nixed the plans after aggressive lobbying by religious conservatives, who argued that vaccinating young girls could promote promiscuity. The human papillomavirus that causes cervical cancer is transmitted through sexual contact.

Similar proposals were introduced in 23 other states and the District of Columbia, but only Virginia has signed such a mandate into law. Proposals in many states died or were watered down to only provide parents with educational materials instead of requiring the vaccine. In Texas, Gov. Rick Perry signed an executive order requiring vaccinations for sixth-grade girls, but the Legislature then passed a bill blocking the order.

Over the past several months, a vaccine that once was hailed as a breakthrough to prevent cancer deaths has become embroiled in some of the nation's most politically charged issues: teen sex, parental control, state mandates, a backlash against vaccines and a suspicion of drug companies.

The politics on HPV are getting interesting— one set of Republicans is getting money from Merck to push a mandate, while another set is worried about encouraging “promiscuity”.
-Jim Fossett

What Counts as Family?

Several people have pointed out an email sent out by Stephen Bennett of Concerned Women for America, which clearly says that what matters in parent/child relationships is not actually the relationship, but the biology involved. Talking about Mary Cheney, her partner Heather Poe, and their child, Samuel David, Bennett says

Fact is Mary Cheney, the Vice President's daughter - in one way or another - received a male's sperm. She is the biological mother, parent number one, and some man, somewhere out there, is Samuel David's real biological father, parent number two.

Heather Poe is Mary Cheney's live-in lesbian lover. She may act like a parent, she may treat the baby as a parent, she may love this baby with all of her heart, but in this reality we all live in, Heather Poe is NOT the baby's real parent. She has NO biological connection to the child whatsoever. Some man, the baby's real Daddy, is the child's other REAL parent.

Early on in the emailed press release, Concerned Women for America attempt to separate out a very specific set of adopted children and parents: those who are adopted by the spouse of a second marriage, implying that there is still at least one biological connection present. But what about kids completely adopted into a family, through either closed or open adoptions in the United States, or overseas adoptions? How about kids who are created through assisted reproductive technologies, who might have the genetic material of one woman, carried by a second, and raised by a third? What about families where one parent cannot contribute genetic material? Are they suddenly no longer a parent because they are not in this special category of marrying into an already established family where something has "gone wrong"?

There is more than the biological identity of a child. There's the social identity - the years upon years of familial habits that are not genetically encoded into us, but become part of us because it's part of our experience. I don't expect science to ever find a segment of DNA that is responsible for the fact that my grandmother and mother both placed potholders over their purses whenever they turned the oven on, so they would not leave the house without turning the oven off. Yet it's there, and if I ever get back into the habit of cooking, it's probably something I'll do without thinking about it - just like my sister does.

A few years back, Glenn McGee wrote that

one profound miracle of the mapping of the genome is that it is now more clear than ever that we share so much of our genes with every human being that to select a child on the basis of a few inherited susceptibilities or traits is to overestimate the power of individual genes to make us human, to make families, or to link us together.

Science has allowed us to change the rules of biology, and DNA is becoming a tool, not a definition. Likewise, family is a constantly changing concept, fluid with both social and technological advances. What matters is not the genetic code tying us together, but the social construct that allows us to feel tied together at all.
-Kelly Hills

California's Supreme Court Clears Way for CIRM

The California Supreme Court cleared the way for the state's stem cell research agency to distribute billions of dollars in grants Wednesday when it turned back a last-ditch legal challenge by abortion foes and other critics.

The state's high court declined to review a lower court ruling that upheld the constitutionality of the California Institute for Regenerative Medicine. The litigation had prevented the agency from doling out $3 billion in research grants.

"Today's action by the California Supreme Court is a victory for our state because potentially life-saving science can continue without a shadow of legal doubt," said Gov. Arnold Schwarzenegger.

The stem cell dollars are now flowing. They've already awarded over $100 million from the governor's loan, and the rest will soon be available. Of course, that means tons of work needing to be done - stat - to meet the regulations!
-David Magnus

Stem Cells - Should It Be the Feds or Is It Still the States?

China's Food & Drug Chief Sentenced To Death

China's former top drug regulator was sentenced to death Tuesday in an unusually harsh punishment for taking bribes to approve substandard medicines, including an antibiotic blamed for at least 10 deaths.

The sentence was unusually heavy even for China, which is believed to carry out more court-ordered executions than all other nations combined - and likely indicates the leadership's determination to deal with the recent scares involving unsafe food and drugs.

Well this is one way to insure vigorous oversight of the pharmaceutical and device industries. Certainly would silence the critics who worry about FDA being in cahoots with the industry it regulates!




-Art Caplan

You Don’t “Beat” Cancer in Mere Months

The only claim more medically ridiculous than a Lindsay Lohan or a Britney Spears announcing defeat over substance abuse after a month-long stint in rehab is the claim of a Farrah Fawcett, Sheryl Crow, or Melissa Etheridge that she has “beaten” cancer after a few months of treatment. “Three months after being declared cancer-free, she copes with the unexpected return of her illness”, rang out the June 4 People magazine, referring to the unfortunate former Charlie’s Angel, Fawcett. I doubt any oncologist would have made that statement.

Five-Year Survival
Even the 5-year survival statistic used by the National Cancer Institute that seems to have eluded the cancer celebrities ignores the micrometastases that can persist, no matter how targeted or toxic the treatment or how dramatically symptoms have abated. My mother passed the magical 5-year mark, yet her breast cancer returned at year 17. I had thyroid cancer in 1993, and I know it isn’t and never really will be entirely gone. Even people whose leukemia appears to have vanished following treatment with Gleevec – the closest thing to a “miracle” drug I’ve ever heard of – can still have, at the RNA level, traces of something not quite right. They can feel fine, their blood can look normal, even their telltale mixed up chromosomes can be undetectable, yet the errant oncoprotein that lies behind the disease is, sometimes, still there. That’s why when people go off Gleevec, such as to become pregnant, a supposedly vanquished cancer can return.

Five-year survival rates assess the deadliness of a cancer on a population level. By “survival”, the definition means anyone still alive, whether or not symptoms and/or treatment are ongoing. Such a population statistic should not be applied to an individual case. Yet I just received a phone call from a Red Cross representative seeking a donation. When I declined, explaining my cancer history, to my utter astonishment she asked me if it had been more than 5 years since my diagnosis. Not wishing to launch into a spirited discussion of the concept of micrometastases, I politely declined, explaining that I would sooner donate bovine blood than mine, in which a cancer cell or two is bound to lurk.

With thoughts of the Red Cross and poor Farrah in my mind, I checked out the Red Cross website. Lo and behold, as of their May 24 update of the eligibility guidelines, besides the obvious blood-borne cancers, “Other types of cancer are acceptable, if the cancer has been treated successfully, and it has been at least 5 years since treatment was completed and there has been no cancer recurrence in this time.”

Enter Gene Expression Profiling
Whoa! Hasn’t anyone at the Red Cross heard about MammaPrint, the test that the FDA approved earlier this year (Buyse 2006)? It’s the first test that detects a gene expression signature – rather than mutations – that is correlated with risk of recurrence 5 to 10 years from diagnosis! It’s based on 70 genes and has been marketed in Amsterdam, where it was developed, since 2005.

Do the math: If MammaPrint predicts increased risk of cancer resurfacing after 5 years, why is the Red Cross accepting blood from people who’ve had cancer just because they have passed the 5-year population-based mark? I understand that individual donation decisions are made at the collection sites based on a person’s detailed family history, but if there’s still doubt – and in science there always is – why risk letting cancer cells get into the blood supply?

The idea that tumors can return isn’t new. In 1889 English surgeon Stephen Paget meticulously traced the spread of disease from the breast to secondary organs in 735 women, calling the original tumor the “seed” and the site of spread the “soil” (Paget 1889, Fidler 2003). The new twist today, akin to a crystal ball, is the gene expression profiling that is the basis of MammaPrint – the first genetic peek into Paget’s timeless seed and soil hypothesis. Still in development are a 5-gene signature that predicts survival in non-small-cell lung cancer (Chen 2007), and another that foretells whether breast cancer will spread to the lung or bone (Gupta 2007).

Many such prognostic tests are in the works. And so cancer diagnosis circa 2015, or even sooner, will come with predictions not only of where and when the disease is most likely to spread, but also which drugs will be most effective, with the fewest side effects. The ability of gene expression profiling to highlight molecular derangements not apparent at the cellular level will take cancer diagnosis and prognosis to a new level.

But back to practicality and stars who miraculously beat cancer in weeks. I prefer Elizabeth Edwards’ stoic recognition of her cancer as a chronic, treatable condition than the giddily premature proclamations of having escaped the oncobullet.

It takes time to come to terms with cancer. You learn to live with the vestige of the disease, for it may remain, even if you are in perfect health. Perhaps most micrometastases never translate into clinical recurrences. We outlive our cancers. I read somewhere that having cancer divides time, so that your remaining days, whether they are few or many, are different. It’s trite, but oh so true.

I’m not trying to throw cold water on all the people who have fought so bravely and endured the indescribable fear of knowing that cells are dividing out-of-control in the body. I had only a tiny taste of that terror. But what bothers me about the celebrities who claim to have “beaten” cancer after a few months of treatment, besides raising false hopes, is the implication or outright claim -- often the fault of the media -- that they “did everything right”.

What does that say about the rest of us, like me, who avoided tobacco and sunburns, stuffed ourselves with broccoli, exercised like crazy, and got cancer anyway? Alas, for many of us, cancer just happens. It is a consequence of somatic mutations, which are a consequence of occasionally faulty DNA replication and repair.

So Farrah, Sheryl, and Melissa, I love you all, I wish you well, but please be careful not to proclaim your triumph over the devil that is cancer after only a few months. Unfortunately, millions of us know better.

- Contributing Editor Ricki Lewis

Buyse, M., et al. 2006. Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer. Journal of the National Cancer Institute 98:1183-1192.

Tasteless and Unethical? Sounds Like Reality TV to Me!

In a display of truly questionable ethics that I would only expect from American reality television, a Dutch reality TV show is set to premier - one that has three families competing to win a dying woman's kidney. The show producers admit that there's no guarantee that the families will go through this ordeal and receive anything, including a winning kidney - although they hope to skirt Dutch transplant laws by transplanting the kidney while the donor is still alive.

The producers echo the same altruistic motivations any producer of any show that exploits a failing in the medical system (see any number of non-quite-reality-TV airing on American stations right now), that they're doing it to draw attention to the shortage of organs available for transplant, and that their show isn't as bad as the reality of the number of people who die every year waiting for transplant.

No, their show is only show bad that three families will compete, beg, plead and do whatever they can to win the sympathy of the voting public and sway the dying donor, regardless of the fact that Dutch law does not allow post-mortem directed donation, that their family is the most deserving.

A few years ago, I wrote about an ABC show by the name of Miracle Workers, and what I said that that show is equally applicable to BNN's Big Donor Show: when medicine begins competing with television to provide medical services to people in need, when network executives are masquerading as fairy godmothers, we need to ask ourselves: do we want medical care to continue becoming a theatre of entertainment, something we should be lucky to receive? Are you pretty enough, sexy enough, compelling enough to be picked out of a flood of applicants to receive the chance of care? Will your story win the hearts, minds, and most importantly, votes of the viewing public?

-Kelly Hills, with thanks to everyone who sent copies of the story to us!
[It is the ultimate in a TV reality show--organ donation by the dying! American Idol take a back seat to Dying Dutch Decider! -Art Caplan]

New Abortion Bill To Require Fetal Consent

Selective Reduction of a Multiple Pregnancy

Imagine experiencing infertility, and then finding out that you are pregnant -- with triplets! Doctors then recommend that you reduce the pregnancy to twins because of the risk of trying to carry triplets for both mom and the babies. You weigh the potential of losing all three babies to a miscarriage or giving birth to three premature infants vs. intentionally ending the life of one. How do you choose which one?

There are no statistics to know how many women face this "Sophie's Choice" each year; however, the use of assisted reproductive technology (ART), particularly fertility drugs, has increased the number of women faced with this decision. Liza Mundy explores this issue with great sensitivity in the Washington Post Magazine this week and follows up with an on-line chat on the topic. Mark Evans is to be commended for his willingness to discuss this sensitive topic with Mundy.

What Mundy doesn't discuss is why these multiple pregnancies exist in the first place. Yes, she mentions that they are the product of ART, but she doesn't talk about the controversy that exists in the ART community over practicing fertility medicine responsibly. Howard Jones and other outspoken infertility treatment providers have advocated for guidelines to limit the number of embryos transferred to a woman's uterus during IVF treatment. ASRM has recently adopted guidelines, but they still allow for more than two embryos to be transferred. Other countries have taken to fining ART clinics that produce too many multiple births. We also need to work on educating IVF and fertility drug patients that multiples are not a blessing. It's high time that every ART provider lose the cavalier attitude (that I've personally heard) that selective reduction as a simply way to deal with a multiple pregnancy. The risks of multiple pregnancy must be clearly explained to women as part of the consent process for both IVF and the use of fertility drugs. Responsible providers will follow the ASRM guidelines for the number of embryos to transfer and carefully monitor cycles using fertility drugs, canceling those cycles when too many ovarian follicles are developing.

A good follow-up study on the effects of selective reduction on women and families is also needed. It might help infertile couples who think they want a multiple pregnancy understand what responsible providers are trying to avoid.
-Andrea Kalfoglou

Is 2 Hours and 10 Tries Humane?

The AP is reporting that it took 2 hours and 10 jabs before Ohio prison staff were able to insert shunts to deliver a lethal cocktail to inmate Christopher Newton. Botched executions have become almost common now, with multiple states questioning what the most humane method of execution is, and in at least nine states completely suspending lethal injections while the procedure is re-evaluated.

But this case takes a bizarre turn when you start reading the details. Newton laughed and joked with the prison medical staff while they tried to insert the needles, and he was even allowed a bathroom break during the proceedings. But the truly bizarre comes from just how helpful Newton was in his own case, insisting that the only way he would cooperate with investigators is if they sought the death penalty.

Bizarre aspects to the case aside, Ohio is one of the states that had a botched execution last year. Following the extended execution of Joseph Clark, which took close to 90 minutes due to scarred veins from drug use, the state announced it would make several key changes to how it handled lethal injections, designed to prevent any extended execution process in the future. That these changes were in place for Newton's execution continues to raise the question of whether or not lethal injection can ever be the swift and painless death it was originally advertised as being.
-Kelly Hills

FDA Leaves Blood Donation Ban In Place

Despite the criticisms by the Red Cross, America's Blood Centers, the international blood association AABB, and other blood advocate groups, despite the increasing sophistication of tests to detect HIV, despite the appearance of discriminatory practices, despite thoughtful editorials by respected bioethicists, the FDA has reiterated its long-standing ban on gay men donating blood.
-Kelly Hills

Flying East? Don't Forget Your Viagra

Good news for frequent flyers heading east: Viagra appears to offset jetlag. Sadly, it seems to have no effect - at least on jetlag - for those flying west.

After reading the original paper this morning, with several cups of coffee helping to decode the biology, I am left wondering both how Pfizer will pursue this to their best advantage (the risque advertising possibilities seem almost limitless), and less cynically, if it will even work for women at all. As the Women's Bioethics Blog notes, Viagra does work as an arousal aid for at least some women, so in theory it should help some women with eastbound jetlag. But per the norm in scientific studies, the only mice used were male. Followup study, anyone?


-Kelly Hills


[edited at 1pm EST, May 23rd]

Backseat prescriber? Let us open the door for you.

It's no secret that drug companies have been using the prescription records of physicians in order to better "educate" doctors. As you might expect, this backseat prescribing has rubbed a lot of physicians the wrong way. And as the Washington Post reported this week, the frustration has led to proposed legislation in a handful of states. New Hampshire even passed a law prohibiting the practice, but that law was declared unconstitutional on commercial speech grounds by a U.S. District Court last month.

Nevertheless, a recently created organization called the National Physicians Alliance is continuing the fight to close off pharma's access to prescription records. And how about the AMA? From that WaPo piece:

The American Medical Association, a larger and far more established group, makes millions of dollars each year by helping data-mining companies link prescribing data to individual physicians. It does so by licensing access to the AMA Physician Masterfile, a database containing names, birth dates, educational background, specialties and addresses for more than 800,000 doctors.

After complaints from some members, the AMA last year began allowing doctors to "opt out" and shield their individual prescribing information from salespeople, although drug companies can still get it. So far, 7,476 doctors have opted out, AMA officials said.

"That gives the physician the choice," said Jeremy A. Lazarus, a Denver psychiatrist and high-ranking AMA official.

-Greg Dahlmann

Art Caplan on MSNBC: New Machine Keeps 'Heart in a Box' Beating

Over on MSNBC, Art Caplan continues to talk about the tell tale heart-in-a-box machine, noting that although macabre, this advance could bring longer life to donated organs:

One of the greatest short stories ever written is Edgar Allan Poe's "The Tell-Tale Heart." In this 1843 classic, the murderer of an old man is tortured by the sound of his victim's heart continuing to beat, a sound which no one else seems to hear. The relentless beating eventually leads the murderer to confess. That creepy tale certainly kept a 10-year-old Arthur Caplan awake at night.

Now there's a machine that can do what Poe imagined - preserve a beating heart in isolation. And while this might seem to be the yuckiest idea to come down the pike in a long time, it really represents a bold and fascinating advance in trying to save the lives of people with failing hearts.

The "heart in a box" machine, known as the Organ Care System, is made by TransMedics Inc., of Andover, Mass. Doctors in Pittsburgh recently announced that they used the machine to keep hearts beating for hours on their own after being removed from cadavers. Three patients, a 47-year-old man and two women in their 50s, received these hearts and all seem to be doing very well.

The machine will be tested further in the coming year at five transplant centers in the U.S. - the University of Pittsburgh Medical Center, Brigham and Women's Hospital in Boston, UCLA Medical Center in Los Angeles, the University of Chicago Hospitals' Cardiac Center and the Cleveland Clinic. The researchers want to be sure that hearts transplanted out of the box really work as well as those preserved by current methods.

Until now, when a heart was donated upon someone's death, the organ was saturated with preservative fluid and stashed in a thermos-type cooler packed with ice. We've all seen the images of people in white coats running to or from airplanes, cooler in hand, racing against the clock to get an organ to someone in desperate need. Hearts are very fragile and can sometimes be damaged by the current standard method of preserving them on ice.

Inside the new transportable box, a machine pumps blood donor through the heart without requiring cold temperatures or artificial preservative fluids. The company says a heart kept functioning this way can be preserved for at least 24 hours.

If this machine succeeds in keeping hearts beating safely in more trials, then instead of the current six-hour limit that existing preservation techniques allow, hearts could be moved anywhere in the country to where someone needs one without worrying about how long the process is taking. And some hearts that might not be strong enough to last using current techniques might be able to be salvaged and transplanted using this new technology.

There is no denying that, as Poe understood, the image of the beating heart outside the body is macabre. That is until you imagine a family grieving over the loss of a loved one because there was no heart to transplant. That truly nightmarish image is the one this new machine may help prevent.

Coming Soon to a TV Near You: PharmaTV!

If you're European and find yourself jealous of the many options pharma companies have for advertising in the United States, you will be happy to learn that

four of the world's biggest pharmaceutical companies are proposing to launch a television station to tell the public about their drugs, amid strenuous lobbying across Europe by the industry for an end to restrictions aimed at protecting patients. Pharma TV would be a dedicated interactive digital channel funded by the industry with health news and features but, at its heart, would be detailed information from drug companies about their medicines.

Johnson & Johnson, Pfizer, Novartis and Procter & Gamble, are behind the pilot, which they are offering to the European commission as a way to give patients more information. The industry has been lobbying in Europe to be allowed direct access to patients. It argues that lifting restrictions would help its competitiveness and has hinted that companies may relocate to the US, where they can advertise to patients who then demand drugs from their doctors. Profits have soared there as a result.

Of course, pesky things like the detrimental effects to patients and the inaccurate information provided by pharmaceutical industry advertisements, playing down the risks and emphasizing the rewards, are all just part of the fun when proposing a self-regulating, on demand channel of 24/7 advertainment.

-Kelly Hills

Is There a Drug For Broken Credulity?

Did April Fool's come late this year? What other reason could there be for the op ed page of the Boston Globe to publish this patently absurd article on the merits of pharmaceutical companies providing education about drugs to physicians. Look, I am willing to concede that worries about conflicts of interest have in many ways gotten a bit out of hand but, touting big Pharma as an objective source of information on drug use for docs strains credulity well beyond the breaking point. This op ed made me laugh so hard it gave me headache. I wonder which bubbly, attentive, cute, exquisitely coifed and attired one-year-ago-cheerleader-music-major-now drug rep I should have over to my house to lecture me on the physiology of blood flow and nerve structure in the brain as well as the biochemistry of the available nostrums to fix them?

-Art Caplan

A Tell Tale Heart?

University of Pittsburgh Medical Center surgeons successfully performed the first beating heart transplant in the United States, the health system announced today.

The surgery was done April 8 on Richard Jackson, 47, of Portage, Cambria County, who had congestive heart failure. He was released from the hospital on April 30. The donated heart, which came from a 46-year-old man, was kept beating outside the body for almost 3 hours by a machine that is being tested in clinical trials.

Where is Edgar Allen Poe when we need him? Is this the beating of the 'hideous heart'? Actually I dont think so since it will help preserve fragile hearts and save lives. But if you wanted a candidate of the year to pin the needle on the yuk factor scale this is my choice.

- Art Caplan

Robots Are a Soldier's Best Friend

While we have written about a robot code of ethics, the Washington Post has an incredibly touching and illuminating story about soldiers in Iraq and Afghanistan interacting bonding with their robots:

Humans have long displayed an uncanny ability to make emotional connections with their manufactured helpmates. Car owners for generations have named their vehicles. In "Cast Away," Tom Hanks risks his life to save a volleyball named Wilson, who has become his best friend and confidant. Now that our creations display elements of intelligence, however, the bonds humans forge with their machines are even more impressive. Especially when humans credit their bots with saving their lives.

Ted Bogosh recalls one day in Camp Victory, near Baghdad, when he was a Marine master sergeant running the robot repair shop.

That day, an explosive ordnance disposal technician walked through his door. The EODs, as they are known, are the people who -- with their robots -- are charged with disabling Iraq's most virulent scourge, the roadside improvised explosive device. In this fellow's hands was a small box. It contained the remains of his robot. He had named it Scooby-Doo.

"There wasn't a whole lot left of Scooby," Bogosh says. The biggest piece was its 3-by-3-by-4-inch head, containing its video camera. On the side had been painted "its battle list, its track record. This had been a really great robot."

The veteran explosives technician looming over Bogosh was visibly upset. He insisted he did not want a new robot. He wanted Scooby-Doo back.

It's a heartwarming story, although it's actually the introduction, which talks about an Army colonel stopping a test on a centipede-style mine detonation robot because it was "inhumane", that makes me wonder if the entire point of a robot code of ethics misses something intrinsic in our interaction with robots: how we, ourselves, bond to the robot, regardless of just how sentient that robot is.

-Kelly Hills [with a tip of the hat to Art Caplan]

Egg Freezing No Longer Experimental?

Oprah once said she wishes she had frozen her oocytes to keep open the possibility of having a child later in life. Now, for $9,000 to $15,000 per attempt, plus $350 to $500 a year to store the eggs, women in their early 30's can do just that. While scientists developing egg freezing may say they are doing it for cancer patients who may lose their fertility as a result of radiation treatment, they all know the real market for this technology is women in graduate school who want a fertility insurance policy. The market potential motivated Christy Jones, a high-powered Harvard MBA, to start an egg freezing business she calls Extend Fertility Inc. While there are no official figures on how many clinics offer egg-freezing or how many women are using it, a cancer survivor advocacy group, Fertile Hope, recently surveyed 430 clinics and found that 138 were providing the service, up from 58 three years earlier. The clinics reported having done more than 500 egg retrievals for women delaying motherhood. Extend Fertility, which recently expanded to a sixth city, says it has signed up more than 200 women in the past three years.

So why is this an issue? The problem is that this is one more example of a fertility technology being marketed to the public before it's go through clinical trials to assess whether it actually works. Success rates thus far have been pretty poor, but this hasn't stopped many of these clinics from claiming much higher success rates on their websites. Even the American Society for Reproductive Medicine, the fertility medicine's professional society, says that there isn't yet enough evidence to "validate the assumption that if you freeze your eggs now, your chances of a successful pregnancy will be better than your chances using your own fresh eggs at that point." ASRM currently recommends limiting egg-freezing to cancer patients and research studies.

Additionally, even if egg freezing does work, it's only going to be financially feasible for the wealthiest in society. It's a technological fix for social problem. Wouldn't it be better if we had more reasonable family policies that supported women in their desire to have both a career and a family? So ladies, think long and hard before you drop 10 grand to put your eggs on ice. It might buy you the time you need to establish your career or find that elusive partner, but it could also be nothing more than a great marketing ploy to get you to gamble with your hard earned cash.

-Andrea Kalfoglou

When There's a Market...

Just when you thought you'd heard it all. Here's another way to be parted with your hard earned cash ladies. Is you partner complaining about the amount of time it takes for you to have an orgasm? NBC4 reports, that for a mere $1850 every four months, you can have collagen injected into your vagina to "augument your g-spot." Unnamed consumers testify to miraculous results on the provider's website. The California physician who developed the procedure declares he can't keep up with the demand. Before you decide you can't live without a G-shot, keep in mind that this is an "off-labeled" use of collagen and there are no clinical studies to support the effectiveness of this procedure. The website claims that injecting collagen in the vagina should have the same safety profile as collagen injections for urinary incontenence (which has received approval from the FDA). While the website reports that collagen is "natural" -- I suppose because it's collected from other people's bodies -- there are no less than 68 risks listed on the website. Now, if we can just get our health insurance companies to cover it like Viagra!

-Andrea Kalfoglou

Massachusetts Proposes hESC Funding

Massachusetts Governor Deval Patrick unveiled plans, today, for a $1 billion investment in biotechnology and stem cell research, directly attempting to challenge California as the place to be for stem cell research. Like California, Patrick's plan is a 10-year plan that will fund, among other things, a stem cell bank and the nation's first centralized repository of new public and private stem cell lines, which will be overseen by the University of Massachusetts. It will be the world's largest of its kind (according to Patrick's office, anyhow), with Harvard, MIT, Massachusetts General and other hospitals contributing their lines.

Massachusetts might actually be able to give California a run for its money (or talent) here; in addition to being able to learn from CIRM's mistakes, Massachusetts has over 500 life science companies, several major universities, two dozen teaching hospitals, and four medical schools. This is just one of a list of things Patrick has done to undo Republican presidential hopeful and former Massachusetts governor Mitt Romney's time in office; Patrick's proposal requires legislative approval that he is very likely to get. In 2005, both the Senate and House supported a bill to encourage stem cell research that Romney promptly killed.

And continuing to deviate from party line, California Governor Schwarzenegger says he welcomes the competition; the more research being done, the better.

-Kelly Hills

is it time to change the formula, or time to stop using it entirely?

The forensic pathologist who developed the currently used system of lethal injection has told CNN that while there might be new drugs that should cause the injection formulation to be revisited and revised, the procedure itself is medically sound if done by competent people.

While the article talks about Dr. Jay Chapman's motivation for devising this particular method of execution, and his opinion that perhaps we should consider bringing back the guillotine, the option of actually not killing people is nowhere to be found.

-Kelly Hills

Troops at Odds With Ethics Standards

Not only is the Iraq war becoming a quagmire that will set back the well-being of every American and Iraqi, it is taking an enormous toll on our troops who are now stuck in Vietnam war circumstances--no clear mission, no ability to tell who their friends are, undersupplied and with rapidly waning support for the conflict on the home front. Not only is this taking a terrible toll on their mental health but it is undermining core ethics and values in our armed forces.

Iraq is not only a human disaster it is an ethical disaster as well. The neoconservatives who got us into this ill-advised, concocted conflict, who claim to stand for traditional American values, have done more to undermine then in troops and in our civic society than any enemy could have hoped to accomplish. Where is their moral accountability for what they have done?

More than one-third of U.S. soldiers in Iraq surveyed by the Army said they believe torture should be allowed if it helps gather important information about insurgents, the Pentagon disclosed yesterday. Four in 10 said they approve of such illegal abuse if it would save the life of a fellow soldier.

In addition, about two-thirds of Marines and half the Army troops surveyed said they would not report a team member for mistreating a civilian or for destroying civilian property unnecessarily. "Less than half of Soldiers and Marines believed that non-combatants should be treated with dignity and respect," the Army report stated.

About 10 percent of the 1,767 troops in the official survey -- conducted in Iraq last fall -- reported that they had mistreated civilians in Iraq, such as kicking them or needlessly damaging their possessions.

Army researchers "looked under every rock, and what they found was not always easy to look at," said S. Ward Casscells, the assistant secretary of defense for health affairs.

You can read the rest of the article here.

Republican Hopefuls Demonstrate Doublespeak

What exactly, students sometimes ask me, is 'doublespeak'. Now I have a paradigmatic example to show them.

Herewith the wafflings, twistings, turnings and outright mumbo-jumboing of ten wannabe Presidents.The ten GOP presidential candidates held a debate on Thursday evening. Moderator Chris Matthews of MSNBC asked the candidates about stem cell research. Here is that section of the debate transcript.

Moderator: We have to go down the line again. It's always fun to ask these questions down the line. We have Mr. Reagan here. The camera will not focus on her, but I will tell you, it will now focus on you.

Mrs. Reagan wants to expand federal funding of embryonic stem cell research. Will that progress under your administration, Governor?

Romney: It certainly will. Altered nuclear transfer, I think, is perhaps the best source...

Moderator: Embryonic. Embryonic.

Romney: Altered nuclear transfer creates embryo-like cells that can be used for stem cell research. In my view, that's the most promising source. I have a deep concern about curing disease.

I have a wife that has a serious disease that could be affected by stem cell research and others. But I will not -- I will not create new embryos through cloning or through embryo farming, because that will be creating life for the purpose of destroying it.

Moderator: And you won't take any from these fertility clinics to use either?

Romney: I'm happy to allow that to -- or I shouldn't say happy. It's fine for that to be allowed, to be legal. I won't use our government funds for that. Instead, I want our governments to be used on Dr. Hurlbut's method, which is altered nuclear transfer.

Moderator: The same question, embryonic stem cell research with federal funds, sir.

Brownback: It will not, with all due respect to Mrs. Reagan and her desires here. I've studied this matter a great deal. We are curing and healing people with adult stem cells.

Moderator: OK.

Brownback: It is not necessary to kill a human life for us to heal people. And we're doing it with adult stem cell work, and it's getting done.

Moderator: OK. I'm going to have to go yes or no.

Governor Gilmore, for embryonic stem cell federal funding or not?

Gilmore: We can't create people in order to experiment with people.

Moderator: Governor Huckabee?

Huckabee: I would concur. I don't think it's right to create a life to end a life. That's not a good health decision.

Moderator: Congressman?

Hunter: No. I'd like to show Mrs. Reagan the alternatives, which are adult stem cells.

Moderator: Governor Thompson.

Thompson: There's so much research going on, Chris, you cannot answer that question yes or no. There's research currently going on right now at the Weissman Center (ph) in Madison, Wisconsin, that's going to allow for adult stem cells to become pluripotent, which will have the same characteristics of embryonic stem cells, so you do not have to kill an embryo.

Moderator: Senator, embryonic stem cell federal funding.

McCain: I want to thank Mrs. Reagan for the many kindnesses extended to me many -- and my fellow prisoners of war many years ago when we came home to this wonderful state.

I believe that we need to fund this. This is a tough issue for those of us in the pro-life community. I would remind you that these stem cells are either going to be discarded or perpetually frozen.

We need to do what we can to relieve human suffering. It's a tough issue. I support federal funding.

Moderator: That's a yes. Dr. Paul, yes or no on federal funding?

Paul: Programs like this are not authorized under the Constitution.

The trouble with issues like this is, in Washington we either prohibit it or subsidize it. And the market should deal with it, and the states should deal with it.

Moderator: OK. That's a no.

Giuliani: As long as we're not creating life in order to destroy it, as long as we're not having human cloning, and we limit it to that, and there is plenty of opportunity to then use federal funds in those situations where you have limitations.

So I would support it with those limitations, like Senator Coleman's bill in Congress.

Moderator: Mr. Tancredo?

Tancredo: There are billions of dollars going into this research right now. It does not require me taking money from federal -- from taxpayers in the United States to fund it...

Moderator: OK. Thank you.

Tancredo: ... because it is morally, I think, reprehensible in certain ways.

Dilbert Hires the Ethicist

[hat tip: Brian Mooney; click image for full size cartoon]

An Invitation to Join the American Society for Bioethics and Humanities

From the ASBH president, and AJOB associate editor Paul Root Wolpe:

Do you enjoy the kind of probing, cutting edge issues you read on bioethics.net., AJOB, and the blog? Do you have a scholarly interest in bioethics or the medical humanities? Then I would like to invite you to join the American Society of Bioethics and Humanities (ASBH).

The ASBH is a dynamic and wide-ranging professional society made up of clinicians, bioethicists, legal scholars, philosophers, theologians, social scientists, historians, and scholars of the medical humanities, among many, many others. The Annual Meeting will be held this year from October 18-21 in Washington, D.C. The theme, Connecting and Collaborating, is dedicated to the widest participation of people from across the disciplines. We hope those involved in human subject protection will join us and contribute to our always lively Annual Meeting.

In addition to the Annual Meeting, joining ASBH has other benefits. Members receive discounts on ten of the major journals in the field; receive our newsletter, ASBH Exchange, with articles and features; have access to the ASBH website, including access to our large membership directory; can join affinity groups in their areas of interest; and can become members of the premier community of scholars in bioethics and the medical humanities.

In order to give even a bit more incentive, join before June 1, and we can offer a 10% discount on your membership (send in only $60, $85, $100 or $125 from the four categories on the ASBH website ).If you have questions, please call our Executive Director, Amy Claver, at (847) 375-4877.

Paul Root Wolpe, Ph.D.

President, ASBH

Not-so-exquisite corpses

A Code of Ethics for Robots?
Uh, Yes. Please.

The South Korean people really love robots. Industry in South Korea receives millions in government subsidies to develop them. Recently, Park Hye-Young, of the South Korean Ministry of Commerce, Industry, and Energy’s robot team, said in a statement to French Press Agency that the Ministry hoped “to have a robot in every South Korean household between 2015 and 2020,” and predicted that these robots would develop “strong intelligence.”

South Koreans are not the only ones embracing robots. Already iRobot, a company founded by Rodney Brooks, director of the MIT Artificial Intelligence Lab, has sold at least two million Roombas, a little robotic vacuum cleaner. The promise of the robot vacuum and its cousins is that the home robot will become faster, more reliable, and more cost-effective than human domestic work. It has to get this “strong intelligence” part down first. My Roomba is a one-trick pony, sucking dirt while rolling in circles and slapping into the same walls every day as it relearns a 12' x 12' room. This is not Rosie from “The Jetsons.”

But the more important issue regarding today’s domestic robots and the future is not so much about intelligence as it is about ethics. If you ever watched the Roomba-sized robots hack each other to bits on the aptly named BBC-5 television program, “Robot Wars”, you know the fear that lives in the souls of many who will never buy a domestic robot: that their Roomba would one day awaken like the robots of The Terminator. A robot with sinister intentions, without ethics, or adhering dispassionately to a code of ethics where intuition and subtlety is required (remember RoboCop?) has been the fuel of science fiction for decades. Should we require robot makers to program in a code of ethics to domestic products?

Perhaps robots should be afraid of us too; whether or not they dream of electric sheep, the robotic sex toys under development are purveyed as better-than-real-life companions. But they are plastic and metal, not human. As humans build robots that learn what their owners desire, the dilemma of the robots of Blade Runner emerges: What do humans owe “purpose-built” machines who begin to reach awareness, or to so resemble awareness that it becomes a selling point? Should laws be written to protect robots from us, by requiring robot makers to stop short of, say, robosexual devices that learn to be incredibly intimate with humans and yet are owed nothing? If so, do we create such laws in the interest of robots, or to preserve our own human dignity by choosing not to create a new kind of slave, whether or not that slave is fully aware?

The South Korean government has taken a progressively minded step by convening a committee to draw up an ethical code to prevent humans from abusing robots and vice versa. The code draws in part on the work of science-fiction writer Isaac Asimov, and specifically, according to Park, on the three laws Asimov proposed for robot ethics in a 1942 story, “Runaround.” They are: 1) A robot may not injure a human being or, through inaction, allow a human being to come to harm; 2) A robot must obey orders given it by human beings, except where such orders would conflict with the first law; and 3) A robot must protect its own existence as long as such protection does not conflict with the first or second law.

Likewise, a committee of EURON, the European Robotics Research Network, met in Genoa, Italy, in June, 2006 and concluded that a code must be created to deal with the problems of hostility to and from robots, as well as how to avoid accidents, trace robots, ensure the secrecy of their data, and monitor the nature of their intelligence, which one member of the latter commission aptly described as “intelligence of an alien sort.”

It remains to be seen whether robots will become in some sense intelligent androids, capable of interacting as peers with humans and other parts of the world. In the meantime, we are much closer to making robots with “strong intelligence” than we are to creating a code of ethics to guide our stewardship of tin men, or to protecting humanity from misbegotten robotics. Either the effort to create a code of ethics to shape the evolution of robotics will be embraced, or we may reap the consequences. It only remains to be seen who will wake up first.

The Narrow Battle Ground of Late Term Abortion

Over at Poynter Online's Everyday Ethics column, Kelly McBride talks to Art Caplan about the recent Supreme Court ruling on late-term abortions:

Doctors seek to abort these fetuses for three general reasons – if the mother’s health is critical because of a pregnancy-induced condition that cannot be controlled, if the fetus has a deadly infection that could spread to the mother, or if tests reveal the fetus has a fatal deformity that will doom the child to death. In the last scenario, many doctors would prefer to give a woman a choice to end the pregnancy, rather than force her to wait for natural labor to start, which could be months away.

By failing to describe the detail in these scenarios journalists create an environment where we can all believe the worst. If I’m against abortion, I might imagine reckless women aborting perfectly healthy babies at 26-28 weeks, the same gestational age of many babies currently in the neonatal intensive care. If I’m in favor of legal abortion, I might envision women dying, because infection sets in or her blood pressure rises too high.

In fact, neither scenario is likely, Caplan says. Doctors can still end a pregnancy and extract a fetus in these cases. The Supreme Court ruling affirmed a law that says doctors can’t take any action to harm the fetus during the process or after it is out of the womb.

It is still possible to ensure the fetus dies in the womb, Caplan said. Using an ultrasound for guidance, doctors can still inject potassium chloride into the fetus’ blood stream or heart, he said.

“This is about euthanasia, not Roe vs. Wade,” Caplan told me during a phone conversation. “Doctors are saying, 'I can’t do this procedure because I don’t know what to do about the fetus.' ”

Family Planning in China

This may be old news by now, but on April 23rd, NPR reported that dozens of women in China were forced to have abortions of wanted children in southwest China. A family planning official in Baise say these claims have been investigated and were fabricated; however, human rights officials say that, Liang Yage and his wife Wei Linrong reported that Wei was forceable taken to the hospital in Basie city and was injected three times in the abdomen. Sixteen hours later her child was stillborn. She had been seven months pregnant with her second child. He Caigan, an 19 year old unmarried woman days away from delivery, was also forced to have an abortion, which has left her in physical pain and abandoned by her boyfriend. An anonymous eyewithess said he counted 41 occupied beds on just one floor of the maternity hospital in Baise and he believed that none of the women he saw had come to the hospital of their own free will. The NPR reporters speculate that these forced abortions may be a reaction to published population statistics that show the Baise government missed its family planning targets last year.

New and exciting forms of abstinence

Randall Tobias, head of the $15 billion President's Emergency Plan for AIDS Relief (PEPFAR) and administrator of the US Agency of International Development (USAID), resigned last week after he admitted having used a Washington escort service for massage. Tobias stated firmly that he did not pay for, or receive, sexual favors. His plea of innocence -- made while handing in his resignation -- will help the cause of Deborah Jeanne Palfrey, the boss of the escort service, who claims that her business is legal because it involves only the use of costumes, massages, lascivious conversation, and (for example) young women playing Monopoly in the nude.

The irony, of course, is that Mr. Tobias was a strong proponent of 'abstinence only' programs to prevent HIV transmission worldwide, and was also the chief enforcer of the 'Anti-Prostitution pledge', which requires USAID grantees to state their opposition to prostitution in writing and strongly discourages programs that distribute condoms to sex workers. In other words, Randall seems to have very much enjoyed the company of women who, in his professional role, he didn't mind exposing to risks of HIV infection worldwide. And if things were not bad enough, Mr. Tobias is quoted in his ABC interview as saying that he 'invited gals to come over to the condo' to give him a massage, stating a special preference for 'Central American gals.' Did he really say 'gals'? Mr. Tobias is one step away from being the Don Inus of global health.

On the other hand, according to his own account, Mr. Tobias did abstain after all. You might even say that the former 'AIDS Czar' was taking abstinence to a new erotic level, showing the rest of us that abstinence could be very very sexy, albeit without the sex, a way of having your cake and not eating it too. Perhaps it was an exercise in policy experimentation, a bold personal journey beyond the ABC approach to a place where you are not really faithful, not really abstinent, not really using a condom, not really at risk for HIV and not really having sex. (Such behavior may not be for everyone, so he wanted to try it out first.) Then again, maybe it was simply a case of an repressed hypocrite, who was riding his moral high horse last week, and whose name does not even register on the USAID or US Department of State websites this week.

What lessons are to be drawn from this? One possibility is to acknowledge, rather than deny, the pervasive sway that sexuality has over humanity, and try to translate that acknowledgment into science-based and psychologically realistic policies dealing with sexually transmitted diseases around the world. Given the number of lives in the balance in the fight again HIV/AIDS, winning that acknowledgment is far more important than explaining Mr. Tobias' puzzling failure to find a registered massage therapist in the nation's capital.

-Stuart Rennie

Art Caplan on MSNBC: Broken mental-health system puts us at risk

It is not just guns. In all my life I never thought I would write those words after a massacre involving a mass murder with a gun. But a week's worth of intense media coverage of the heinous murders of students and faculty at Virginia Tech and analyses focusing on guns by innumerable experts has left me furious.

I don't think the expert wisdom is even close to understanding what must be done to try and prevent this type of tragedy in the future. It is not just guns. We need to fix a broken, abandoned and pathetic system of mental-health care.

In the same month that Seung-Hui Cho killed and injured scores of people at Virginia Tech, a researcher at the University of Washington was shot to death in her office by a former boyfriend, who then killed himself. Rebecca Griego had gotten a restraining order against Jonathan Rowan. When he showed up at her office he fired five shots into Rebecca. A colleague at the university said it was a "psycho from her past."

In Mandeville, La., a man who had just had a restraining order issued against him by his estranged wife allegedly ambushed her and their three children. Police say James Magee chased his wife's gray Toyota Scion for several blocks, ramming it repeatedly until the car crashed into a tree. As Adrienne Magee tried to get out of the vehicle, James Magee allegedly stepped out of the truck and shot her in the head with a 12-gauge shotgun loaded with buckshot, killing her instantly. He then opened fire on his children as they tried to flee the vehicle, killing his 5-year-old son and striking his 7-year-old daughter in the chest, according to police.

Magee had never gotten any help for previous violent outbursts.

And in Queens, New York, a man killed his mother, a wheelchair-bound man and a home health care worker before shooting himself dead - just minutes after the mother called 911 pleading for help. The mother's surviving sister blamed police for failing to protect her sister from the "mentally ill" son. "My sister was scared!" Annetta Taylor screamed. "She thought this might happen!" Cops outside the house tried to calm her, but she continued. "I blame you!" she said. "She called and nobody would respond!"

The murdered mother, Sonia Taylor, had called police twice Monday during fights with her son Wade Dawkins. The police had been called to the home eight times since last May. During an incident this past October, Taylor told police her son, a drug abuser with no rap sheet, was throwing things around the house and acting violently.

The police brought him to a local hospital for an evaluation. He was quickly sent back to her house.

All of these killings involved not just guns, all involved killers who might have benefited from mental-health treatment. None got the help they needed.

The Virginia Tech murderer was - to be blunt - totally crazy. He fit the dreary profile all too familiar from the shootings at Columbine High School near Denver and the Nickel Mines School in Amish country near Lancaster, Penn. Cho was an angry outcast, preoccupied with thoughts of violence against those whom he saw as bullying, victimizing or just plain ignoring him. From the tapes he made of himself, it is obvious that he was in the grip of paranoia. He had profound social withdrawal, suicidal thinking, destructive fantasies and was a known stalker. He scared people. But he fell through the cracks of university bureaucracy and a hodgepodge mental-health system.

Report after report over the past decade have warned that most public mental-health systems have, to quote one, "all but disintegrated." Such systems, whether local, state or federal, are badly fragmented and ill-equipped to address our nation's mental health in a comprehensive manner.

States have been balancing their budgets on the backs of the mentally ill for years. A recent example is North Carolina, where 33 percent cuts in the state budget have been proposed. Advocates for the mentally ill there say that if the cuts hold, it means that in many towns the mental-health system will simply "collapse."

But you don't really need to read the reports or look at the budgets. Look out your window.

Most of the homeless people wandering around America's cities are mentally ill. Try to get help for your anorexic daughter, alcoholic brother-in-law, suicidal spouse and see what happens. See what happens if someone threatens or harasses you repeatedly in terms of a coordinated police and mental-health response.

Serving in Iraq or Afghanistan with post-traumatic stress disorder or another mental illness? Good luck. The military's mental-health system is overwhelmed and understaffed. The services available to our soldiers' families are just as bad.

I don't buy the line that says "guns don't kill people, people kill people." I think there are too many guns with too much firepower that are too readily available. When the damaged and the deranged amongst us go undiagnosed and untreated in a world of guns, then fatalities result. The guns are not going anywhere. Politically, we lack the will to do anything about that problem.

But that is not the whole problem. It is time to start repairing a mental-health system that serves too few, costs too much, protects too little and cannot even find the means to help those who clearly are in desperate need. Maybe after Virginia Tech we can at least find the will to do that much.

compassion, constitutional rights and Penelope London