Early Age Gender Crisis

At age 2 Kathryn began vehemently insisting that she was a boy.  No amount of persuasion could convince her otherwise and even her mother Jean’s best efforts to show Kathryn that she biologically was female failed to convince Kathryn who simply replied, “When did you change me?”  Kathryn was so insistent on her status as a boy that Jean and her husband finally began to do some research into the topic of transgender children.  After listening to Kathryn constantly claiming that she was a boy in a girl’s body for years her parents finally took her to a psychologist who specialized in treating the transgendered.  The psychologists recommended that Kathryn’s parents allow her to live as a boy, which they ultimately did. 

Now Kathryn is referred to as a he, is called Tyler and is publicly a boy in every way.  The family has told their relatives, the school their daughter/son attends and their church and Tyler now is happily living as a boy.  Tyler’s transgender lifestyle does pose some problems however.  In five years when Tyler is ten, Tyler’s parents will have to decide whether or not to put Tyler onto puberty blockers and later when Tyler is 15 or 16 Tyler’s parents will have to decide whether, if Tyler want to, to allow Tyler to begin hormone injections. 

Great controversy has arisen over to what extent parents should allow their gender-dysphoric children to undergo gender-changing procedures.  Because of the difference in the nature of each procedure different rules of ethicality apply: parents should ethically be permitted to put their children on puberty blockers but, should not allow their children to begin early hormone treatments because of the difference in permanency between the two procedures. 

Puberty blockers taken by children at the correct age prevent children’s body from maturing and, in the case of girls, menstruating.  The decision to give a child puberty blockers is a difficult one but puberty blockers differs dramatically from hormone injections in that the effects are reversible if the puberty blockers are halted.  Parents should allow their children access to puberty blockers if their children want them as a way of increasing their child’s happiness. 

Parents should not however allow 15 to 16 year old to begin hormone injections that will make them grow the characteristics of the opposite biological sex because with hormone injections the effects are not reversible.  Hormone treatments, though they make sex-change surgery less painful and expensive for adults later down the line, cause the recipients to become infertile.  Taking hormone injections can make the lives of transgendered individuals easier down the road but it is still unethical for a parent to allow a child to take permanent infertility drugs at the age of 15 or 16.  According to transgender counselor, Edgardo Menvielle, about 80 percent of transgender kids end up switching back to their own biology but about 20 percent remain transgender as they transition to adulthood.  The high percentage of kids that revert back to their original gender identity is much to high for parents to allow their children to make such a radical permanent decision at such a young age.  Though parents should try to make their children happy and do what’s best for their child gender-dysphoric kids should be given the maximum amount of time to decide on their identity before they take irreversible infertility-causing hormone injections.  

http://www.washingtonpost.com/local/transgender-at-five/2012/05/19/gIQABfFkbU_story_4.html

Side Effects Include... Nevermind.

Negative thinking might really be bad for your health. An recent article in the American Journal of Bioethics by bioethics Rebecca Erwin Wellsa & Ted J. Kaptchuk describe the “nocebo” effect. The article cites extensive research which shows that physicians who stress possible negative side effects of treatment to their patients may cause their patients to feel those side effects more intensely – the nocebo effect. Physicians are, among other standards, abide by the principles of informed consent and nonmaleficence. If informing a patient of negative side effects may worsen side effects, then these two principles find themselves in contradict. The question then is which principal prevails? Wellsa and Kaptchuck stay on the fence of the issue. They argue that physician ought to provide “contextualized informed consent,” meaning physician should stay away from simply bombarding patients with lists of negative side effects but instead should tailor their discussion on a case-by-case basis. I think there’s a problem here – for both the patient and the doctor. A physician may choose to leave out or understate a certain side effect because it seems insignificant and yet the side effect in question may have implications important to the patient. On the other side of the coin, it puts a lot of responsibility and liability on the physician. If a patient experiences a severe side effect that was not outlined by his or her physician, accusations of malpractice may ensue. There doesn’t seem to be a clear cut solution to this issue, but in light of the problems just presented, the answer Wellsa and Kaptchuk provide leaves much to be desired. It is therefore important to continue to discuss the issue in hopes of creating a set of guidelines that will protect physicians and patients alike from the “nocebo effect.”

http://www.tandfonline.com/doi/full/10.1080/15265161.2011.652798

Not the present, but maybe the future?: a look at female sterilization in Uzbekistan

A recent article on the BBC website said that Uzbekistan doctors have been sterilizing female patients without their knowledge as part of a secret government initiative. Doctors were given quotas to sterilize as many as 8 women per month, a practice that is simple to implement because of the abundance of births by Cesarean section. Some doctors have taken the tact of manipulating poor patients into sterilizations, saying that it fewer children will benefit her health, but some cut out the middle man and perform the operation in secret during the cesarean section. The idea behind the program was to decrease infant mortality rates and control the size of the population, as many of the problems of developing countries are severely hampered by very high birth rates. This secret program is clearly a fundamental violation of human rights, and the secrecy surrounding it seems unnecessary, but the rationale behind such a directive raises an interesting question. Is an aggressive population control program a legitimate next step for developing countries? The benefits are clear: with a less explosive birth rate, public services and infrastructural problems become more affordable to fix. In addition, fewer children per family would lead to better overall care, and thus fewer health problems for both the mother and her children. There were human rights violations, but with revisions that prevented the secrecy and obligatory nature of the Uzbekistani doctor, this could be a legitimate way to improve the average quality of life of your country’s citizens.

http://www.bbc.co.uk/news/magazine-17612550

150 Half-Siblings with No Father – A Look at the Limits of Sperm Donation

Cynthia Daily has only one son, but that son has 149 half-siblings.

Ms. Daily, a social worker from Washington, conceived via artificial insemination. Using the identification number on the sperm sample she received and a website called the Donor Sibling Registry, she was able to track down 149 other children who had been conceived from the same sperm donor. “It’s wild when we see them all together — they all look alike,” she says.

The United States does not limit the number of children that may be born from a single donor. The American Society for Reproductive Medicine suggests that one donor be have no more than 25 children per 800,000 people in a given area, but sperm banks are under no obligation to follow this recommendation. Issues of donor restriction are further complicated by the fact that many sperm banks distribute over large areas, often nationwide. Additionally, sperm donors may give to many different banks, often under conditions of anonymity.

There are significant reasons to be concerned about overdonation. Especially in small communities, there is a very real chance that two children of the same donor could meet and enter into a potentially incestuous relationship. Unsuspected incest aside, there is also the risk of propagating otherwise rare genetic defects.

Other countries, including Britain and France, limit the number of children that can be conceived from one donor’s sperm. France even does this while still preserving the donor’s right to anonymity, a potentially thorny issue. There is no good reason that a similar limit could not work in the United States.

Because of the risks involved to the children produced from artificial insemination, the United States should limit the number of children that can be produced from any one donor’s sperm.

Sources:

Mroz, Jaqueline. “One Sperm Donor, 150 Sons and Daughters.” The New York Times

Frith, Lucy. “Gamete Donation and Anonymity.” Oxford Journals

It's what the crowd wants: are current publishing practices unethical?

About a month ago, Stuart Rennie wrote a blog entitled, “Research Ethics as a Sideshow,” which can be found http://globalbioethics.blogspot.com/. In the blog, Rennie reports on a disturbing, growing trend in the realm of research publication. Apparently, it is becoming commonplace for journals to publish ethically questionable studies, as long as they are interesting, and alongside them publish multiple editorials which point out the subtle to glaring violations of ethical conduct that can be found in the studies. He gives the example of a recent tuberculosis treatment study which was published in the International Journal of Tuberculosis and Lung Disease despite not having any method of obtaining informed consent from the participants of the study. It was published alongside two editorials that rejected the reasons for skipping informed consent given by the researchers. Rennie addresses the possibilities of simply not publishing the articles, or retracting them after they have been published. However, he concludes that it is unlikely either will occur.

            How can we allow this to continue? The whole point of ethics codes is to protect people from being exploited and abused in experiments and trials. This practice of publishing unethical goes against the concept entirely. To be fair, each of the studies that was published had already been approved by an ethics review board. However, the multiple steps in the research and publication process should serve as checks and balances for this sort of thing, otherwise there is no point to peer review. To me it seems like a chain reaction is starting, one that should not happen. If publishers become accustomed to accepting unethical trials as long as they add on editorials that say as much, then IRBs may become more willing to approve questionable trials, if for no other reason than the existence of many precedents. We cannot stand by and watch all of our current ethical safeguards fall apart. Journals should not be allowed to publish trials that are obviously ethically unsound, regardless of how “entertaining” they may be.

http://globalbioethics.blogspot.com/

Saving the world, one genome at a time.

    The solution to global warming and environmental issues is not just increased environmental awareness. No, the real solution is genetically engineering children to help the environment.

Wait, what?

    Yes, according to a recently published paper, NYU and Oxford Bioethicists Matthew Liao, Anders Sandberg and Rebecca Roache. The paper proposes human engineering as a potential solution to climate change since existing solutions are ineffective and alternative solutions, such as geoengineering, are incredibly risky.

    In the modern world, most solutions to climate change fall under one of three categories: market solutions, behavioral solutions, or geoengineering. Social solutions involve increasing social awareness of efforts such as recycling and reducing driving. Market solutions rely on regulation and economic factors – such as carbon taxation – to reduce effects on the environment. Geoengineering generally involves much larger solutions ranging from reforestation to space-based mirrors to seeding the ocean to increase carbon absorption. Human engineering would involve biomedical modification of humans to mitigate climate change.

    The paper suggests a few potential benefits for human engineering. The first is to induce meat intolerance in humans. The reason for this is that cows and grazing animals appear to have significant environmental effects, so reducing meat consumption could reduce their numbers and thus reduce these effects. Their second suggestion is simply to make humans smaller. This would reduce the amount of food we consume and also allow for a similar reduction in food consumption and its accompanying environmental benefits. Their last suggestion is to lower birth-rates through cognitive enhancement (genetic, pharmaceutical, and education). While this may not seem to be the most obvious solution, they suggest that such enhancements would increase altruism and empathy, thus making a person more likely to care for the environment. One last proposal is a child-per-family quota based on size rather than on numbers. Such a policy, they argue, would maintain personal freedom by allowing parents to make decisions on how they wanted their children enhanced (Would you like two small children or one basketball player)?

     So, perhaps these are not the most natural solutions to climate change, but they do raise some interesting issues. There are countless arguments for and against enhancement in general, and this proposal probably falls into the bounds of enhancement and genetic engineering for the good of society versus individuals. Additionally, the idea of human engineering may be more realistic than extreme – and potentially extremely dangerous – proposals in geoengineering. So while it may seem absurd now, I think that it is an idea that deserves more thought. Human engineering may seem crazy and unlikely, but perhaps it may turn out to not be so bizarre and unrealistic in the long run.

http://www.bioedge.org/index.php/bioethics/bioethics_article/9986

http://www.smatthewliao.com/wp-content/uploads/2012/02/HEandClimateChange.pdf

Big Brother: Can the fMRI Undermine Privacy?

Researchers at Dartmouth recently conducted a study in which they were able to predict future behavior of the participants based on fMRI scans of the brain. Yes, that’s right; it is now possible to make a pretty good guess as to how disposed an individual is to certain types of behavior.

I will summarize briefly. The researchers showed each subject a series of images while measuring activity in the pleasure center of the participant’s brain. These images — varying from the sexually arousing to the culinarily intriguing — and the degree of increased brain activity associated with each image could accurately predict the behavior of the participant in the future. For example, if a participant showed a particularly acute reaction to a picture of a cake, the researchers hypothesized that the individual would tend to gain weight. After conducting a survey of all participants some months after the experiment (and weighing them before and after), these hypotheses were deemed statistically valid.

So, while this experiment did not attempt to predict thoughts and immediate actions, it did demonstrate the ability to “mind-read” — to accurately gauge an individual’s mental proclivities. Consider what might happen if such fMRI scans became routine in law enforcement: just as we are finger-printed and blood-typed now after a run-in with the police, perhaps in the future we might be brain-scanned for future capacity for criminal behavior.

The problem here is that, while we are guaranteed the right not to self-incriminate, brain-scans don’t lie. If subjected to such a scan, the law could force a person’s psyche into the open — not in any great detail, but enough to be able to judge future behavior. And this is bad; bad for the person in question, and bad for society as a whole. The reason is that, despite the best intentions of the law — protecting the general welfare, for instance — when the law can “steal” information and make significant decisions based on that information (decisions like whether or not to release a minor criminal), that threatens the privacy of everyone. What is to stop the government from extending such a program to try and identify potential criminals before they commit a crime. Sound familiar? 

That’s pretty much the same function as the Thought Police in 1984, and I think that’s where our society — if we were to use brain scans in law enforcement — might end up. If we agree to compromise the individual’s privacy for the sake of general safety, we give up what makes our individual lives worth living; we sacrifice the individual to the aggregate. And while it might not be for the same reasons or have the same manipulative character of the government in 1984, the effects on society would be the same: demoralization and dehumanization, turning the spontaneous and free into the homogenous and mechanical. It’s all well and good to study the brain and learn how it works, but when we can read each other’s minds — and the research cited is a far cry from that — we should be worried.

(1) http://www.popsci.com/technology/article/2012-04/brain-scans-can-reliably-predict-your-future-insatiable-appetites

Extra Lettuce Please, and Hold the Capitalism.

“When you can buy 2000 calories for under $10 at your neighborhood McDonalds, but have trouble getting your hands on an apple, it’s difficult to justify trying to shame anyone into skinniness.” -Dhruv Khullar of the Yale School of Medicine and Harvard Kennedy School. 

           

            Khullar is right. While everyone is responsibility for his or her own health, when people who are willing to eat healthily struggle to do so because of their external environment, it is not the individual who should feel shamed, but the environment.

            Nearly three quarters of Americans are overweight. Statistics about obesity are thrown around left and right, but take a second to appreciate this figure. These figures are off the charts when compared to the rates of fifty years ago, and the trends show no signs of the increase leveling off. So are Americans just getting more undisciplined? It’s unlikely. What’s more likely it that our food chain, from the seed to the grocery shelf store, has been poisoned by the free market. Food companies are to blame: they spend $2 billion dollars a year advertising food that has been stripped of any sort of nutrition, they impose farmers to extract as much of their product as they can, disregarding the consequences of over producing, and they sent their lobbyists to Washington to ensure that their nutrition-depleted food, if you can even call it that, gets to stores shelves at a lower price than fairly  and organically grown real foods. This isn’t news to many. So what’s the solution?

            Let’s get the free market out of the food industry. It’s radical, it’s huge, and with the two so deeply intertwined and so many people making huge profits, it’s much easier said than done, but why not? The US is currently joining the rest of the developing world in creating a universal health care system. The idea behind government run health care is that every human being should have a right to health care. This is a right that countries with national health care systems deem important enough to protect by keeping in public hands and out of hands of profit-driven corporations. I think these countries have the right idea.

            If a country values its citizens’ health enough to ensure access to medical treatment through government run health care, why would it be so bizarre for a country to protect its citizens’ health by ensuring  had access to healthy food by creating government run food companies. That way, governments wouldn’t only play a role in treating disease, but preventing disease. The goal of these companies would be to offer nutritious food untainted by cost-cutting measures associated with private and profit-driven companies. Of course, it’s unlikely a government could meet all the food demands of a population, and so there would still be room for the private sector – so people wouldn’t be deprived of choice, but they would have more healthy choices and less unhealthy ones.

            It’s a big idea, too big to contain within a small blog post, but an idea worth thinking about – Some food for thought.

http://www.thehastingscenter.org/Bioethicsforum/Post.aspx?id=5796&blogid=140

What Would You Do?

Yesterday, one of my friends mentioned in passing that she and her twin were “test tube” babies—nothing unusual in this day and age (though in vitro fertilization faces harsher restrictions in Europe). As an afterthought, she told me that her mom was once interviewed on CNN. Why? She was one of few women who remained undecided as to what to do with her fertilized eggs that were not implanted. These eggs are normally discarded or, very recently, given to stem cell research. But her mom wasn’t comfortable with either option, opting instead to have them stored in a lab until she is able to make a decision.

The story highlighted the difference between making policy decisions on a macro, impersonal level and making personal decisions on a micro level. Yes, I believe that embryos that comprise of only a few cells might as well be used in stem cell research. But the idea that you can hold something that shares a significant amount of your DNA, and that has the potential to develop into another whole person makes you stop to think. Especially because two of those eggs did eventually develop into two bundles of joy, I found myself surprisingly sympathetic to my friend’s mom’s decision. Even though she is progressive, in favor of abortion and stem cell research, she found it hard to just discard such a tiny part of her, not because she adhered to the conviction that life begins at conception, but because, well, wouldn’t you?

This gut reaction often underlies many objections to bioengineering and medical practices in general. The mother’s support of embryonic stem cell research but reluctance to forfeit her own eggs to the cause may seem irreconcilable, but if we are careful to distinguish macro polices and micro decisions, the issue becomes clearer. Objectively, life is not (yet) legally defined as beginning with conception, and so it is acceptable to donate un-developed fertilized eggs to research. There is no ethical problem with a legal policy that allows such donations. However, there would be something problematic about a legal policy that forced such donations. This is not currently the case, which is why my friend’s mom is free to store the eggs until she is ready to let them go (or make some other decision). This is where subjective gut reactions can come into play—if you, as an individual, are uncomfortable with a certain practice, there is no reason for you to partake in it. For every woman out there who doesn’t want to discard her potential babies, there is probably another who is perfectly happy donating her unused zygotic cells to science. An ethical law in this case is one that ensures that both women are allowed to make their own decision.

More about the IVF controversy:

http://www.cbsnews.com/8301-504763_162-57413777-10391704/fertility-treatment-bans-in-europe-raise-controversy-questions/

http://www.cbsnews.com/8301-504763_162-57357715-10391704/ivf-study-shows-one-or-two-embryos-is-enough/

http://topics.cnn.com/topics/in_vitro_fertilization

HIV transmission in Africa: A plea for fairness

 In developed countries around the world HIV transmission from mother to infant has effectively been curtailed through the AIDS Clinical Trial Group Protocol 076 (ACTG 076).  However, this protocol is extremely extensive, and it requires the pregnant mother to take a lengthy oral regimen and get intravenous injections of the relatively expensive drug zidovudine, among other things.  Because of this, undeveloped regions of the world, such as parts of Africa, can neither afford this protocol nor do they have the proper facilities and personnel to implement it.  As a result, in most parts of Africa, HIV positive mothers don’t have access to any treatment or medications to stop the transmission of HIV to their children, and this is becoming an increasingly large problem.

 In response to this need, researchers from the World Health Organization are attempting to find cheaper and less intensive treatments (and most probably less effective) which can be implemented in Africa.  Of course, to test the effectiveness of these treatments, researchers have run clinical trials in Africa, and in them they have had one group that undergoes the treatment, and one group that gets a placebo.  This use of placebo control groups have led to great contention around the world, and critics claim that since an alternate, effective treatment (ACTG 076) is available the new treatments should be tested against that, so no one is denied treatment altogether.  This notion can find its roots in the Declaration of Helsinki, which states, “The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods”.

Although this argument is valid in a country where ACTG 076 is available (because then a placebo control group would really be denying people treatment), it is not valid in a region where ACTG 076 is unavailable in the first place, because no one is being denied treatment they would otherwise receive.  In effect, in such a region there is no “best current treatment”, and in such cases, no one denies that a placebo group is ethical. And yet, critics still claim that the trials shouldn’t have a placebo group, and should have an ACTG 076 group instead, so everyone in the trial at least gets some sort of treatment.  But, objectively, this is no different than simply running the trials with a placebo group and then giving certain random people in Africa the ACTG 076 treatment – because either way the rest of the African population gets no treatment, and is, in a sense, a placebo group.  However, these same critics generally do not argue that we should give everyone in Africa ACTG 076. Thus, from this it becomes clear that it is not the placebo group in itself that is troublesome to critics but rather, the trials bring the blatant inequality in the world to the forefront.  The placebo group emphasizes the inequality between the African population and people in developed countries (who would get ACTG 076 rather than a placebo), and consequently people are more emotionally motivated to have an ACTG 076 group rather than a placebo group.

Admittedly, this social and economic inequity is indeed a problem that should be resolved, but it does not intrinsically make the use of a placebo group unethical, all it does is blur the issue.  Because the placebo group makes the inequity ever more visible, people jump to the conclusion that the placebo group is actually exacerbating the problem.  On the contrary, the very purpose of the placebo group is to alleviate the inequity by finding cheaper, more readily accessible treatments for African mothers.  As David Satcher, a researcher, notes, the use of the placebo group will make the trials more efficient and will give more definitive results.  Since the expectation is that the new treatment will be less effective than ACTG 076, if the control group is ACTG 076 then it will be difficult to tell whether the new treatment is better than nothing – further prolonging the development of new treatments, which actually exacerbates the inequity even more.

 Therefore, the use of the placebo group in the case of these clinical trials in Africa will actually help reduce the inequalities between Africa and more developed regions faster and more efficiently than if an ACTG 076 control group is used.  Of course, it would be fantastic if all pregnant women in Africa had access to ACTG 076, but the sad reality is that they don’t.  The sooner critics realize this, the sooner these women will be able to get access to at least some form of treatment. 

Sources

https://blackboard.princeton.edu/@@/664683C27709CA2175BB52BC68E90A1B/courses/1/WRI167_S2012/content/_1289369_1/background.pdf
https://blackboard.princeton.edu/@@/664683C27709CA2175BB52BC68E90A1B/courses/1/WRI167_S2012/content/_1289370_1/Complexities_of_Cond_1F6C72.pdf

Clinical Trials and Tribulations: A Look at Overseas Clinical Trials

Making sure that clinical trials are ethical is a classical problem in the study of bioethics. How do we properly regulate, however, for trials done in foreign countries? This is an increasing problem, as many pharmaceutical companies have shipped their clinical trials almost exclusively overseas, particularly to countries that have less stringent ethical boundaries. One possible benefit of this idea is to check the effectiveness of drugs on variety of racial backgrounds. That being said, this is clearly not what companies are after. With fewer ethical restrictions in place in poorer countries, the companies can pay their test subjects less, and it is easier to gather information if the wellbeing and ethical treatment of a patient is less of a concern. Ideally medical ethics should be applied uniformly regardless of geographic boundaries, but there is an issue; how can we enforce our brand of ethics in countries where the same standards don’t apply? One possible way to check that standard medical procedures are followed in these foreign trials is for the FDA to conduct audits of the companies before allowing their drug to appear on the market. These audits, however, are extremely expensive, and the FDA has been long strapped for cash. One possible solution to this problem (besides somehow finding more governmental funding, which I don’t see happening) is to be less accommodating to the drug companies. For example, rather than just approving drugs with clinical trials that don’t adhere to standard formats, we can force them to standardize, making the databases of clinical data more complete. In addition, attempts to force companies to register their foreign trials would make monitoring for unethical behavior much simpler and more organized. In these extenuating circumstances, this seems to be the best option.

http://www.nytimes.com/2010/06/22/health/research/22trial.html