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Author Archive: Bioethics Today

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03/28/2018

The Biology Behind the Fertility Clinic Meltdown

*This blog was first published at DNA Science Blog at Public Library of Science*

The spindle apparatus is among the most elegant structures in a cell, quickly self-assembling from microtubules and grabbing and aligning chromosomes so that equal sets separate into the two daughter cells that result from a division. But can spindles in cells held at the brink of division in the suspended animation of the deep freeze at a fertility clinic survive being ripped from their slumber off-protocol, as happened the weekend of March 4 at the Pacific Fertility Clinic in San Francisco and University Hospitals Fertility Center in Cleveland?

The tragic events sent me back to developmental biology courses in grad school, and I read a bunch of technical papers and polled a few nerd friends. The experiments from the 1950s onward were controlled, and so my thoughts on the damage done in early March are hypothetical. I can’t help but wonder what, exactly, happened to those eggs and embryos?It was a stunning coincidence impacting the eggs or embryos of 500 couples on the west coast and 700 using the Ohio clinic. Liquid nitrogen ran low in a cryogenic device in San Francisco, and temperature fluctuations reportedly plagued the Cleveland facility.

The Media and the Damage Done

A news conference from one legal firm filing a class action lawsuit against the clinics was long on emotion and short on details. Here’s a lawsuit from a different firm that provides a timeline of what the donors went through.

Media coverage lacked biological details too. WaPo mentions “damage to tissue” with a video proclaiming “the only way to tell the viability of the egg is to thaw and implant it.” Really? Law firm websites parroted WaPo, not scientists (many experts in reproductive biology are PhDs, not MDs).

The New York Post and other outlets shared the sad story of Amber and Elliott Ash, who froze two embryos in 2003 after his cancer diagnosis. “The medical community calls it tissue. I like to think of it as my children,” Amber said.

Carl Herbert, MD, head of the San Francisco clinic, was curiously optimistic on NPR. “The good news is, we have viable embryos — we’ve proven that from that tank.” Viable enough to transfer?

Of Oocytes and Embryos

Technically speaking, there’s no such thing as an egg or ovum. Feminism aside, our gametes are oocytes until a sperm enters one and it magically then becomes a fertilized ovum. That’s why scientific reports and reproductive health guidelines use “oocyte.” Lawyers stick to the familiar. “Has a freezer failure compromised your frozen eggs or embryos?”


When a cell isn’t dividing, spindles break down. But as one cell splits to become 2, and then 2 become 4, and 4 become 8 as the cleavage divisions of the early embryo ensue, spindles form and vanish and reform to properly distribute the chromosomes. This time, in non-sex (somatic) cells, it’s mitosis, not meiosis.An oocyte packs in maximal nutrients through two divisions of meiosis. Before birth, a female has about a million oocytes stalled in the first meiotic division. Then, starting at puberty, a few oocytes awaken each month and continue meiosis, halting just before completion until a sperm comes along. If no sperm enters, the oocyte never finishes meiosis and leaves in the menstrual flow. If the oocyte is fertilized, its spindle apparatus ensures that the resulting fertilized egg has the right number of chromosomes from the female; similar division happened as the sperm formed.

Because spindles are sensitive to temperature, the unexpected fertility clinic meltdowns are worrisome.

A Brief History of Cryopreservation

Efforts to freeze – or cryopreserve – eggs, sperm, and embryos have been ongoing for decades. The main challenge is to avoid formation of ice crystals, which can slice up cellular interiors.

Sperm freeze easiest because they have little fluid – they’re not much more than a bulbous DNA-stuffed head with a tail and a ring of empowering mitochondria. Sperm were first frozen in 1938, with the first human birth resulting in 1954.

Experiments unfurled on eggs a little later, using glycerol in the 1950s and the solvent DMSO (dimethyl sulfoxide) in the 1970s, in sea urchins, mice, hamsters, rabbits, sheep, and monkeys. Early efforts at gradual cooling wrecked the spindles of mouse, hamster, and rabbit eggs, leading to the wrong number of chromosomes (aneuploidy). The nuclei of some eggs even glommed together, ending up as “polyploidy digynics,” a form of parthenogenesis that doubles the female genome in a gamete. Might such developmental disasters appear “viable” if simply eyeballed, the chromosomes uncharted? Embryo pickers have told me, though, that they can tell a good embryo from an ill-fated one just by looking.

Various sugars, solvents, and antifreezes (glycerol, propylene glycol and ethylene glycol) have been used in egg and embryo preservation as “cryoprotectants.” They displace water while countering ice crystal formation and strengthening membranes, preserving fragile cellular insides and keeping the outsides intact as a freezing agent, like liquid nitrogen, is applied.

These chemicals have different roles. Sugars stay outside cells, drawing the water out of them by osmosis, while glycerol and ethylene glycol enter and prevent the cell from shriveling. In this way cells can dehydrate but maintain their three-dimensional shapes. It works because eggs and embryos are small; it wouldn’t work so well on a spleen, for example.

Slow cryopreservation, over two to three hours, with the cryoprotectants added one at a time as the cells gradually cooled, gave way to the much faster vitrifaction, which uses higher concentrations of cryoprotectants. It’s so fast that a glass-like consistency forms, not ice. Vitrification uses liquid nitrogen, plunging the temperature to -320.8 degrees Fahrenheit (-196 degrees Celsius).

(Theatrical asides: Han Solo in The Empire Strikes Backwas flash-frozen in carbonite, which my husband Larry the chemist says does not exist. Larry brought liquid nitrogen home for our kids’ parties – when poured on the floor it evaporates into an entertaining eerie steam. And famed baseball player Ted Williams’ head is reportedly frozen at a cryogenics lab in Scottsdale, Arizona.)

Warming is precise and delicate. “It’s basically the reverse process. The key factors that must be achieved on thawing are rehydration of the cell without blowing it up,” embryo expert Barry Behr, PhD, told Scientific American in 2005. The cryoprotectants are gradually diluted out as the temperature slowly rises, and after a few hours at body temp, embryos can be implanted if they look okay – they’ve refilled the fluid-filled space at their centers and the cells are clear and not dark.

The first baby to develop from a frozen embryo was born in 1984. Births from vitrified human eggs that were then fertilized came in 1999. (A great review is here.) Usually 20 to 30 eggs are frozen, with 6 to 8 thawed for each IVF attempt.

From Medical Need to Lifestyle Choice

As with other assisted reproductive technologies, like IVF and preimplantation genetic diagnosis (PGD), the reasons for freezing eggs have evolved from medical need to lifestyle choice.


In 2014 the American College of Obstetricians and Gynecologists (ACOG) published support of the 2013 statement.In 2013, the American Society for Reproductive Medicine and the Society for Assisted Reproductive Technology published Mature Oocyte Cryopreservation: A Guideline,which stated “there are not yet sufficient data to recommend oocyte cryopreservation for the sole purpose of circumventing reproductive aging in healthy women because there are no data to support the safety, efficacy, ethics, emotional risks, and cost-effectiveness of oocyte cryopreservation for this indication.”

At that time, egg freezing was being considered for women undergoing damaging treatments like chemo; had conditions like fragile X or XO (Turner’s) syndrome that can include ovarian insufficiency; or who had their ovaries removed to prevent BRCA-related cancers. But by 2016, when ACOG declared egg cryopreservation “no longer considered experimental,” the candidate pool expanded. And a vast economic opportunity presented itself to the egg and embryo freezers.

I perused a few relevant websites.

UCLA’s Egg Freezing website first lists medical reasons and then “fertility preservation for social or personal reasons to delay childbearing.”

The language at the Mayo Clinic website is uncharacteristically condescending: “Your doctor can help you understand how egg freezing works,” and then helpfully points out that freezing eggs doesn’t require sperm. But the first entry in the list of reasons is: “Egg freezing might be an option if you’re not ready to become pregnant now but want to try to ensure your ability to get pregnant or have a biological child in the future.”

It isn’t cheap. Egg freezing at Pacific Fertility costs $8,345 for the first retrieval and a year of storage; a second cycle is $6,995. And that’s not counting charges for drugs, new patient consultations, lab tests, and continuing storage fees.Prelude Fertility, which runs the facility in San Francisco, makes matters clear under a photo of a smiling, multiracial woman: “Find that right person. Focus on your career. Finish your education. The age of your eggs (not you) is the number one cause of infertility. Freeze your eggs to preserve your option to build a family when you’re ready.”

Back to the Spindle

A paper from 2005 in Human Reproduction raises hope – after freezing and thawing, a spindle can reform. It’s possible, because the tubulin protein pairs that build the microtubules that build the spindle naturally self-assemble.

For the study, conducted at the University of Bologna, 18 patients donated 110 oocytes. The cells were slowly cryopreserved using propylene glycol and sucrose, then thawed, as the researchers watched, capturing images with polarized light microscopy. Over the course of five hours, spindles reappeared in about three-quarters of the oocytes.

But tracking the return of the spindle, however elegantly, didn’t go far enough. Does the spindle apportion a complete set of 23 chromosomes into the maturing egg? If not, a miscarriage or birth of a child with an extra or missing chromosome could result.

Emotions and lawsuits are running high right now, but I hope an opportunity to learn something about early development from the dual disasters isn’t lost. Here’s how.

Collect data!

Pacific Fertility’s website claims “the egg recovery rate after vitrification and later thawing is 83 percent, and fertilization rate is 84 percent.” Is that so for the damaged material? How about constructing karyotypes (chromosome charts, which destroy the cell) for some of the retrieved eggs and embryos from patients who’ve stored several, leaving some aside in case things look good. If more eggs have other than 23 chromosomes, and more embryo cells have other than 46, compared to the numbers predicted based on the age of the mother when the cells were collected, then damage has indeed been done.

Perhaps what’s learned can be used to improve the process of preserving eggs and embryos.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and a Graduate Certificate in Clinical Ethics. For more information on AMBI's online graduate programs, please visit our website.

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03/12/2018

The Color of Bioethics

I would like to take you through a thought exercise. More often than not, we are reflecting on more sober, serious topics but I would like to invite you think about a different question today: what is the color of bioethics? To some this may seem like a silly question and maybe it is. However, as we move towards an increased professional presence we need to reflect on our image, including color. We reflect on how we present ourselves in body language, communication, and writing but why not color as well?

In the professional marketing world, a lot of thought is given to color.  As professionals, we are sometimes trained to wear certain colors during interviews, presentations, or even a meeting.  Wear bright bold colors like red when trying to make a bold assertive statement. Wear lighter colors such as blue when you have to say bad news.  We worry about the color of power point slides.  Organizations spend hours analyzing the color of their logo and even time deciding what color to paint their office walls. Advertisers carefully construct commercials based on color appeal and businesses market products through color.

Color is a consideration and creates meaning.  It can represent organizations or even disease awareness. Red is the color of organizations like the American Red Cross and diseases like HIV/AIDs or heart cancer. Purple is for domestic violence.  Pink represents breast cancer.  We attempt to make waiting rooms comforting by having warm colors such as pale yellow and pink.  White represents physicians and hospital walls.  Each color has a meaning and evokes an emotion. We associate colors with emotions.  Red with blood, love, and anger and blue with sadness and tears.  Color has different meanings in different cultures.  For example, in the United States white is a traditional bride color while in India it is red. Black is the color of mourning in the United States while it is white in India.

So, what is the color of bioethics? A diverse profession that strives to appreciate culture as part of its discipline. Is there a color that adequately captures all that we do? We can look to professional logos for guidance but that may not be as helpful in an individual setting. In order to truly answer this question, we must first answer: what is at the heart of bioethics? What do we want the world to perceive about our profession? This is a message we can send through a color but what should that color be? Many people talk about ethics as dealing in shades of gray. Okay which gray? A cloudy storm sky gray or a soft gray kitten?

I myself do not know if there is a real answer. And some of you may still be convinced that this is not a serious question to be contemplating. In either event, take a second to think about this question, take a breather, even if it just for the fun of it.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and a Graduate Certificate in Clinical Ethics. For more information on AMBI's online graduate programs, please visit our website.

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01/26/2018

A Reflection on Two-Physician Consent

In a recent series of clinical ethics consultations, some physicians expressed concerns over the possible unilateral nation of using two-physician consent for medical decisions for patients without capacity. This concern comes many physicians for a wide range of treatment decisions, a concern of acting without express consent.

Like many states, New York State Family Health Care Decisions Act authorizes two physicians to make medical decisions in the event that no one can be identified to act on behalf of a patient without capacity. It is a safety mechanism to ensure that even those who do not have anyone in their lives will have someone to make medical decisions on their behalf. Some states may use a different mechanism, such as an ethics committee or a surrogate decision-making committee, but the underlying goal is the same. The “unbefriend” patients are arguably one of the most vulnerable population of patients. They lack an advocate, someone to voice their preferences or to consider their best interests. At least in New York, it then becomes the moral responsibility of physicians to decide what is in the best interest of the patient.

For those who distrust the medical profession in general, mechanisms like two-physician consent may seem like a scary option, but then who else should be making these decisions? It is scary to think that maybe one day we will be alone with no family and friends but it is an unfortunate reality. Physicians have years of medical training that can guide a determination in the patient’s best interest. In addition, physicians have taken an oath to uphold a patient’s best interest and practice the standard of care. Physicians are ethically obligated to provide care that benefits and prevents harm to the patient. People who chose to practice medicine tend to have an inherent goodness as they are joining a profession that helps people. These individuals are committed to ensuring a patient’s best interest.

Yes, depending on the gravity of the medical decision and the potential impact it may have on the patient’s quality of life, making medical decisions is a burden. What is also important to note about the New York’s mechanism is it always two physician consent, one physician does not make the decision in isolation. Though there are concerns that the concurring physician will not disagree with his/her colleague.

I empathize with the physicians who express concern in making these decisions but I also think some of these physicians are too focused on the hypothetical legal consequences. This authority to make such decisions is codified in a law and is ethically supported by ancient notions of beneficence.  Maybe we have become too comfortable with the notion of autonomy and without an expression of autonomy, we become uncomfortable. We are forgetting the rest of medical ethics. This is why we have a best interest’s standard in healthcare decision-making and established standards of care.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and a Graduate Certificate in Clinical Ethics. For more information on AMBI's online graduate programs, please visit our website.

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11/16/2017

Enhancing Pediatric Decision-Making: Australian Law Allows Children to Complete Advanced Directives

It always interesting to see how different countries handle pediatric decision-making in health care. For example, Australia now has shifted more towards respecting minors’ autonomy with its recent legislation. I first heard about this law during the Legal Update at the American Society of Bioethics and Humanities Annual Meeting this past October. The new law in Victoria, Australia coming into effect in March 2018 will require physicians to honor advanced directives written by children. Any child with capacity will be allowed to write their own advanced directives. There is no age limit as for who can write an advanced directive. The advanced directives must still be signed and witnessed, like adult advanced directives, and one of the witnesses must be a medical practitioner who must certify the person appears to have decision-making capacity and understands the effect of statements made.

This law will in essence create a situation where substituted judgment standard of decision making may become applicable. Traditionally, we use best interests’ standard for decision making in children because they are presumed to lack capacity and therefore can not make valid past preferences. However, if an advanced directive written by a child is valid, then we would have valid preferences and some evidence in order to navigate substituted judgment on behalf on the child patient. This will expand decision-making standards for children as well as avoid concerns of parents not having best interests of the child in mind.

This law will also call into question the practice of using assent verse consent for minors. The law is giving weight and value to a written stated preference but yet, we may not be honoring the verbal preferences of those same individuals. For example, a 15-year-old could write an advanced directive that would be valid but verbal consent for that same 15-year-old may not be valid if we are operating under the same traditional parental authority/ child assent model. It reinforces the age-old presumption that a written preference is more valid than a verbal preference, simply because it can last the trial of time and is an easier form of evidence to prove. Granted, the design of advanced directives is to govern in the future when the individual loses capacity. However, advanced directives also operate under the premise that the individual completing them have capacity to do so, implicitly also the capacity to consent to treatment. This new law gives children some authority for their future selves but no authority around their current selves.

For those in favor of including children in the health care decision making process, this seems like a great idea. This may also seem like a great idea for proponents of increasing advanced health care planning. However, it some ways this exacerbates the issues raised both in considering pediatric decision-making and honoring advanced directives. For example, should an adolescent patient make decisions for their future adult self (the unresolvable question of how much control the present self should have over the future self)? This seems more applicable to the pediatric population as developmentally adolescents are changing so much over a short period of time (in comparison to a lifespan). Having such a law makes sense for terminally-ill mature minors with capacity who may not live for a full lifespan, assuming of course they have contemplated, understand, and appreciate their medical circumstances. What a child may want one day may dramatically change the next. It is a step forward to properly enhancing children in health care decision making but it should be a cautionary step forward. Overall, this raises the question of how much autonomy is truly necessary for healthcare decision making. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and a Graduate Certificate in Clinical Ethics. For more information on AMBI's online graduate programs, please visit our website.

 

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11/10/2017

Can we talk about gun violence in America?

A report in the New York Times shows the connection between the prevalence of guns in the United States and mass shootings. No country in the world can match the United States in the total number of guns owned by citizens. To put this in context, “Americans make up about 4.4 percent of the global population but own 42 percent of the world’s guns.” There are about 270 million guns in circulation in the United States and between 1966 to 2012 there were 90 mass shooters, no other country in the world has more than 48, million guns in circulation or 18 mass shooters. In short, the problem of mass shootings is basically an American problem because we have so many guns available for some people to use in very harmful ways.

Critics may cite other variables that could explain the inordinately high rate of mass shootings in the United States. Trump recently said of the recent mass shooting in Sutherland Springs, Texas:

“Mental health is your problem here. This was a very, based on preliminary reports, this was a very deranged individual, a lot of problems over a long period of time. We have a lot of mental health problems in our country, as do other countries."

As is often the case with his statements, the facts do not support it. About 18% of the population have mental health problems and the vast majority are not violent and are not involved in mass shoots, though a few are. Other possible variables, such as time spent playing video games, the level of racial diversity, immigration, and even crime rate, also can be ruled out statistically as being a significant factor in mass shootings—there is no statistical evidence that any of these variables account for the high prevalence of mass shootings, as well as homicides, in the United States. For example, we learn that a New Yorker is as likely as a Londoner to be robbed, but a New Yorker is over 50 times likely to be killed in the process.

There simply are no other variables other than the number of guns in circulation that would account for the uniquely high frequency of these horrific mass shootings, with which we have become all too familiar. As the report from the New York Times states:

“More gun ownership corresponds with more gun murders across virtually every axis: among developed countries, among American states, among American towns and cities and when controlling for crime rates.”

If it is the case that is there is a correlation between the number of guns available to citizens in a society and the number of mass shootings that injure and kill innocent people every year, as a matter of common sense, it seems to follow that the solution would be to reduce the number of guns in circulation. In fact this common sense perspective has been borne out by empirical research as stated in the New York Times report:

…(G)un control legislation tends to reduce gun murders, according to a recent analysis of 130 studies from 10 countries.

 The facts seem relatively clear both about the root cause of the problem and how to ameliorate it. So why aren’t people—including citizen voters and politicians—paying attention and responding? This question gets us into a whole other topic, which I don’t want to explore in any depth now. But I will say it seems clear that since the 1980s a powerful gun culture in America cultivated primarily by the zealotry, funds, and organization, of the National Rifle Association (NRA). This culture has been successful in inspiring its followers to take an expansive view of the 2nd Amendment, to see the government as a potential threat to its fundamental right of gun ownership, and live in perpetual fear that politicians will take away their guns and their right to own them. Because of the intense advocacy that puts critical pressure on key politicians, in America the NRA gun culture representing a minority view can bully its way to keeping in place laws that ensure easy access to guns, including deadly assault weapons and large clip magazines.

The fact that most Americans, including many members of the NRA, are thwarted in their desire to see sensible solutions to gun regulation is what is most concerning. According to a Pew Research report, 89% of both gun and non-gun owners favor the mentally ill from purchasing guns—which makes Trump’s repeal of a rule that blocks gun sales to certain mentally ill people, especially in light of his recent statements, all the more troublesome. Moreover, even on issues like barring gun purchases for people on no-fly or watch lists, creating a federal data base to track gun sales, banning assault-style weapons and high capacity magazines, receive two-thirds support from the public. Sadly, in America currently majority views about this and other vitally important public policy issues don’t translate into change in policy.

What is the solution? It seems evident that the majority of people in America with sensible views that are not being heard must take to necessary measures to make themselves heard. Given the trajectory of violence from mass shootings and the urgency of protecting innocent lives, it’s time for new culture of resistance to the NRA and the politicians that support them to find reasonable ways to regulate guns in America.

 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and a Graduate Certificate in Clinical Ethics. For more information on AMBI's online graduate programs, please visit our website.  

 

 

 

 

Full Article

This entry was posted in Health Care, Politics and tagged , , , . Posted by Bioethics Today. Bookmark the permalink.

11/10/2017

Can we talk about gun violence in America?

A report in the New York Times shows the connection between the prevalence of guns in the United States and mass shootings. No country in the world can match the United States in the total number of guns owned by citizens. To put this in context, “Americans make up about 4.4 percent of the global population but own 42 percent of the world’s guns.” There are about 270 million guns in circulation in the United States and between 1966 to 2012 there were 90 mass shooters, no other country in the world has more than 48, million guns in circulation or 18 mass shooters. In short, the problem of mass shootings is basically an American problem because we have so many guns available for some people to use in very harmful ways.

Critics may cite other variables that could explain the inordinately high rate of mass shootings in the United States. Trump recently said of the recent mass shooting in Sutherland Springs, Texas:

“Mental health is your problem here. This was a very, based on preliminary reports, this was a very deranged individual, a lot of problems over a long period of time. We have a lot of mental health problems in our country, as do other countries."

As is often the case with his statements, the facts do not support it. About 18% of the population have mental health problems and the vast majority are not violent and are not involved in mass shoots, though a few are. Other possible variables, such as time spent playing video games, the level of racial diversity, immigration, and even crime rate, also can be ruled out statistically as being a significant factor in mass shootings—there is no statistical evidence that any of these variables account for the high prevalence of mass shootings, as well as homicides, in the United States. For example, we learn that a New Yorker is as likely as a Londoner to be robbed, but a New Yorker is over 50 times likely to be killed in the process.

There simply are no other variables other than the number of guns in circulation that would account for the uniquely high frequency of these horrific mass shootings, with which we have become all too familiar. As the report from the New York Times states:

“More gun ownership corresponds with more gun murders across virtually every axis: among developed countries, among American states, among American towns and cities and when controlling for crime rates.”

If it is the case that is there is a correlation between the number of guns available to citizens in a society and the number of mass shootings that injure and kill innocent people every year, as a matter of common sense, it seems to follow that the solution would be to reduce the number of guns in circulation. In fact this common sense perspective has been borne out by empirical research as stated in the New York Times report:

…(G)un control legislation tends to reduce gun murders, according to a recent analysis of 130 studies from 10 countries.

 The facts seem relatively clear both about the root cause of the problem and how to ameliorate it. So why aren’t people—including citizen voters and politicians—paying attention and responding? This question gets us into a whole other topic, which I don’t want to explore in any depth now. But I will say it seems clear that since the 1980s a powerful gun culture in America cultivated primarily by the zealotry, funds, and organization, of the National Rifle Association (NRA). This culture has been successful in inspiring its followers to take an expansive view of the 2nd Amendment, to see the government as a potential threat to its fundamental right of gun ownership, and live in perpetual fear that politicians will take away their guns and their right to own them. Because of the intense advocacy that puts critical pressure on key politicians, in America the NRA gun culture representing a minority view can bully its way to keeping in place laws that ensure easy access to guns, including deadly assault weapons and large clip magazines.

The fact that most Americans, including many members of the NRA, are thwarted in their desire to see sensible solutions to gun regulation is what is most concerning. According to a Pew Research report, 89% of both gun and non-gun owners favor the mentally ill from purchasing guns—which makes Trump’s repeal of a rule that blocks gun sales to certain mentally ill people, especially in light of his recent statements, all the more troublesome. Moreover, even on issues like barring gun purchases for people on no-fly or watch lists, creating a federal data base to track gun sales, banning assault-style weapons and high capacity magazines, receive two-thirds support from the public. Sadly, in America currently majority views about this and other vitally important public policy issues don’t translate into change in policy.

What is the solution? It seems evident that the majority of people in America with sensible views that are not being heard must take to necessary measures to make themselves heard. Given the trajectory of violence from mass shootings and the urgency of protecting innocent lives, it’s time for new culture of resistance to the NRA and the politicians that support them to find reasonable ways to regulate guns in America.

 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and a Graduate Certificate in Clinical Ethics. For more information on AMBI's online graduate programs, please visit our website.  

 

 

 

 

Full Article

This entry was posted in Health Care, Politics and tagged , , , . Posted by Bioethics Today. Bookmark the permalink.

09/22/2017

Ethics As An Evolving Activity: The Need To Remain Vigilant

Working as an ethicist in a professional work environment, you quickly realize that any ethical advice worth giving to practitioners must always be relevant to real problematic, human situations. Ethics must make a difference. Elucidating one’s obligations in particular problematic situations enhances insight and confidence in working through troubling value-laden dilemmas both in individual circumstances, as in clinical ethics, and also with regard to larger social problems at the macro policy level. Most ethical solutions are provisional recommendations, i.e. always amenable to revision based on new data, based on ethical reasoning in light of the particularities of each case that may ameliorate an impasse and often helps decrease suffering: Ethics helps make the little corner of the world with which it deals a little better off.

Though I am laying out a pragmatic ethical framework, I want to be clear that ethical principles are essential to ethical problem solving. Following Kant but with a pragmatic twist, the foundation of ethics is the duty to treat each individual human being with respect and, as much as possible, to be fair to everyone. This duty reflects the two fundamental moral principles of respect for autonomy and justice. In the application of the principle of individual autonomy, respect is expressed toward human individuals in concrete situations. For the principle of justice, respect is expressed toward a community or society or connected individuals. Elucidating the pragmatic approach further, ethical principles are not viewed as absolute, quasi-religious truths that exist independent of human experience but rather grounded in human experience.

Ethical principles from this perspective are repositories of wisdom gained through reforms primarily in the democratic process of extending the moral community by recognizing more individuals as full moral agents and guaranteeing them the rights of full citizenship. Thus, the way one thinks about ethics today in contemporary America is deeply connected to, and in a real sense grows out of, the historical process of democratic politics. Just think of the bedrock principle of medical ethics, respect for autonomy and how this notion evolved historically within the legal process and the key court cases on informed consent for the past 100 years or more. Think of the political reform movements in civil, feminist, and consumer rights, etc. movements during the 1960’s. Think of the lessons learned from the abuses of human subjects research that came to light after WWII the Nuremberg Trials. Finally, think of the violations of human research described by Henry Beecher in 1966 in an article from the New England Journal of Medicine, which led to the creation of greater protection of human subjects in research. All of these and other historical events helped to give rise to a full-blown concept of individual autonomy as well as the rights of all patients and subjects to voluntary informed consent. To reiterate, ethical principles emerge historically from real human experience, not from out of the blue sky above, based on meaningful progress in the respectful and fair treatment of all human beings as full moral agents.

The larger point I am getting to is that the ethical and moral life of humans as individuals cannot be separated from the life of humans as they struggle together in community, in groups, pursuing their own interests within the political process over and against the interests of others within a legal and political process. The moral options available for individuals are always framed within the confines of a certain collective or institutional order. From this pragmatic perspective, it follows that the very integrity of ethics as an essential dimension of human life that is dependent on the integrity of the political order. Does it treat all people fairly or does it attempt to exclude and deny certain individuals their basic rights to participate in the democratic process? Think of the current commission on voter fraud investigating non-existent problems in the election process, which may result in tighter voting restrictions that will greatly impact populations not likely to vote for the current administration. Is there a commitment to truth (with a little “t”), as in empirical truth, the institution of scientific research as the principal arbiter of scientific claims, and in general to relate facts of ordinary experience? Think about the denial of the claims from climate science research or the claim made by a presidential candidate that he saw Muslims cheering at the dreadful site of 9/11. Is there commitment to treat each other with a basic respect in our interactions and dealings on the public stage? Think of all the name-calling, derogatory comments, and incitements to violence during the last presidential campaign, which has continued up to the present in the current administration. I could go on, but you hopefully get the point.

Those of us who work in areas of applied ethics must be deeply concerned about state and direction of our political process and collective life as a society. This way of thinking about ethics should cause us considerable pause as we witness the current pattern of political events in our country. Up to the present we should be grateful for the ethical framework that has emerged in the tradition that we have inherited. But there is no guarantee that we will remain so lucky. We cannot allow ourselves to reach the point, as past philosophical ethics has done, to think of ethics as an isolated, academic enterprise. It is not. It is a practical, living, and evolving, historically contingent institution of which we must be responsible stewards. That means it is important that ethicists and all concerned citizens vigilant of what is happening in politics and the larger society. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and a Graduate Certificate in Clinical Ethics. For more information on AMBI's online graduate programs, please visit our website.  

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09/14/2017

Perceived Ethical Dilemmas from Labels

Ever hear the expression it’s all in your head? In witnessing a pattern of ethics consults, I have been wondering lately how much of ethical dilemmas are truly perceived dilemmas and not really dilemmas at all. We are our own worst enemies in many ways and health care providers are no exceptions to the flaws of humanity. We perceive a conflict and therefore a conflict arises. Then comes the need for an ethics consultant. Perceptions drive much of society, including ethical dilemmas. 

A physician will hear a label, whether it is ‘drug-addict,’ ‘Christian,’ ‘illiterate,’ ‘difficult,’ ‘noncompliant,’ and he/she will assume all the characteristics that go with that label. This will then create a perceived conflict between the provider and patient based on the presumed characteristics. These labels could have attached to the patient years prior to the current admission but yet, they remain in a patient’s record as past medical history. The classic example is ‘wanting everything done’ when it comes to end-of-life care. Many jump to the conclusion based on particular faiths (or even just hearing that the patient is religious) that patients and families want everything done and will not be open to a conversation about comfort care and hospice. They assume based on a label, that may not be true. A perceived conflict has emerged. These assumptions change how the conversation will go, whether the physician realizes it or not, because the physician is preparing for a challenge. A simple question or inquiry by a family or friend about the medical information may then seem like push-back, since that is what the physician is expecting, when in reality it is just a question. 

I joke that it’s part of the ethics magic of just appearing in a room and problems are solved, but yet, there is more to it. Many would argue that it is the comforting and supporting presence just in case something goes wrong in conversations with patients and families. The presence being the ethics consultant. Much of it is facing the perceived dilemma only to realize there is no conflict at all. This is also the role of the ethics consultant, to face the conflict with the provider and to show that nothing’s wrong. There has many family meetings where providers have asked for an ethics consultant for a variety of reasons and it turns out that the providers could handle the conversation without any assistance. Some may say this is a good provider because the physician is recognizing his/her own limits and asking for help. And maybe it is but maybe labeling it as a conflict is not the best approach either. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and a Graduate Certificate in Clinical Ethics. For more information on AMBI's online graduate programs, please visit our website.  

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08/29/2017

Memo To White Nationalists From A Geneticist: Why White Purity Is A Terrible Idea

On August 14th, UCLA researchers Aaron Panofsky and Joan Donovan presented findings of their study,  “When Genetics Challenges a Racist’s Identity: Genetic Ancestry Testing among White Nationalists,” at a sociology conference in Montreal. They’d analyzed 3,070 comments organized into 70 threads publicly posted to the (sometimes difficult to access) “social movement online community”  Stormfront.

Former KKK Grand Wizard Don Black launched Stormfront on March 27, 1995. Posts exceed 12 million, ramping up since the 2016 election season. Panofsky and Donovan’s report has a lot of sociology speak, such as “scholars of whiteness” and “affiliative self-fashioning,” amid some quite alarming posts – yet also reveals a sophisticated understanding of genetics from some contributors.

A WHITE NATIONALIST ONLINE MEET-UP: STORMFRONT

“We are the voice of the new, embattled White minority!”proclaims the bold, blood-tinged-hued message on the opening page of Stormfront, the “community of racial realists and idealists.” It’s a site for white nationalists, who are a little less extreme than white supremacists, who want to dominate the world from their pinnacle of a perceived racial hierarchy. The Stormfronters seem more concerned with establishing their white purity – defined as “non-Jewish people of wholly European descent.”

Yet the lines between white nationalist and supremacist blur, as Stormfront states, “If Blacks or Mexicans become a majority, then they will not be able to maintain the White man’s social, cultural and economic systems because they do not have to (sic) minds needed to do so.”

The idea of white rights is rather new, catalyzed by the revolts of the truly marginalized, murdered, abused, ignored, and enslaved. In the past, whiteness was equated to lack of race, much as I thought as a child of vanilla as a lack of chocolate. Use of genetic ancestry testing to confirm one’s concept of pure whiteness is also somewhat new, a subversion of technology that is disturbing to this geneticist whose grandparents escaped the pogroms of eastern Europe.

Of the 153 folks on Stormfront brave enough to post their genetic ancestry test results, 53 were relieved. “Pretty much what I expected but it was good to get it confirmed,” proclaimed one. A participant named Sloth found out he has “pretty damn pure blood” from Scandinavia, the British Isles, and Iceland, prompting him to plan a getaway to Iceland and get a Thor’s hammer tattoo. Another relieved Stormfronter, worried that “Their (sic) might be American indian or jew in the mix because I tan really easily,” was happy to learn he’s “100% white! HURRAY!”

The other 100 genetic test-takers weren’t so thrilled with their results, seeking excuses. My favorite: “These companies are quite liberal about ensuring every white person gets a little sprinkling of non-white DNA (we know who owns and runs these companies).” ErikTheWhite helpfully added that the genetic testing company 23andMe is deploying Jewish DNA to create bioweapons to kill pure whites as if the DNA replication machinery checks in with the religion of the person.

But an impressive 1260 posts were about the science, several debating what DNA ancestry tests can and cannot do. I agree that the tests provide partial information that may, in fact, be trumped by a look in the mirror or a chat with great-grandma. Deep ancestry testing only provides partial glimpses of parts of the world where some ancestors may have come from. I have a map of my own roots – just what my grandmother told me.

GENETIC ANCESTRY TESTING IS NOT A FINAL ANSWER

DNA-based ancestry testing, from companies such as FamilyTreeDNA23andMe, and Ancestry.com compare parts of the genome that vary in DNA sequence among individuals from people living in different geographical areas, say Charlottesville and Kenya. In addition, mapping sequential changes in gene variant frequencies with places reveals ancient migration routes, which often jibe with historical knowledge.

Results seem overly simplistic. A “Genetic Ethnicity Summary” from Ancestry.com, for example, “reveals where your ancestors lived hundreds-perhaps even thousands of years ago”to be 57% Scandinavian, 32% British Aisles, 8% Eastern European, and 3% Uncertain. Many Stormfronters are disturbed by the uncertainty. The Jewish sprinkles?

The maps and diagrams the testing companies provide aren’t overtly racist, at least compared to the 1890 Census categories of mulatto (half black and half white), quadro (one-fourth black), or octaroon (one-eighth black).

The genomic points of comparison include autosomal swaths, but covering only parts of the non-sex-chromosomes – the autosomes – offers just signpoints, and are a far cry from comparing complete genome sequences. Mitochondrial and Y chromosome DNA sequences are considered too but must be interpreted in context, and with the proverbial grain of salt.

Mitochondrial DNA passes only from mothers, to all offspring, and is used to trace maternal lineage. Groups of linked genes (haplogroups) on the dinky Y are used to trace the paternal lineage. Mt and Y DNA can trace ancient migrations and the echoes of history, like stretches of Genghis Khan’s Y that today are in 1 in every 200 males (~16 million!) living between Afghanistan and northeast of China, reflecting waves of rapes by Genghis and his male descendants since the 13th century.

It’s easier to see that Y and mtDNA represent only a few of thousands of ancestors with a diagram. (DNAeXplained)

But there’s a hitch: mitochondrial and Y DNA comprise <1% of a genome and are only a tiny two of thousands of lineages contributing to the genome of a person living today.

Other problems lurk behind the pretty pie charts and percentages of ancestry test results:

• Tests don’t include all parts of the world.
• A new mutation could place a person in the wrong population group.
• Companies compare clients’ DNA to their own proprietary databases, and so white nationalists can shop around, seeking acceptable findings. It’s a little like my daughter’s elementary school approach to misspelled words on quizzes: “I just won’t ever use those words, mommy!”
• DNA ancestry testing projects current databases of population genetic variability back in time, assuming gene variant patterns were the same.
• Databases may not include people who’ve died young from a genetic disease.

SHARED AFRICAN ORIGINS AREN’T DETECTED BECAUSE THEY DON’T VARY!

That we all came from Africa is written into our genomes, represented by stretches of DNA so common, so much the same in all of us, that it would be nonsensical to include them in tests meant to detect varying DNA sequences. Even the most powerful KKK Imperial Wizard, if he understood genetics, couldn’t whitewash the reality of our African origins. Yet a Stormfront post comforted a man who was distraught that his Genetic Ethnic Summary included Senegal with “… you are simply related to some White fool who left some of his DNA with the locals in what is now Senegal.”

One post revealed a bizarrely accurate take on Mendelian inheritance. AngryGoy follows only mtDNA and Y chromosome information, despite their representation of <1% of the genome, because they are “pure.” His reasoning: Y chromosome DNA is transmitted entirely and unchanged from male to male and mtDNA is transmitted entirely and unchanged from female to all offspring. But autosomal DNA is halved at each generation as the two copies of each chromosome separate into different eggs or sperm.

He goes a step farther: a bi-racial female with a white mother or bi-racial male with a white father are “the lesser of two evils” because at least the mtDNA and Y DNA are untainted. This logic escaped me when I wrote the sections on mtDNA and Y DNA in my genetics books.

Stormfront considers the mtDNA and Y argument to be a version of the one-drop rule. Which leads me to the oft-evoked metaphor of blood for genetic ancestry, which isn’t even accurate because the red blood cells that impart the characteristic color do not even have any DNA!

BLOOD AS A SURROGATE FOR GENETICS

Claims Stormfront: “In a nutshell, the problem with humanity is not so much one of ideology – this or that religious, political, social, or economic doctrine – but rather one of blood. That is, that a great deal (possibly 90% or more) of a person’s intelligence and character is determined by their DNA, which determines the structure of their brain before they are born.”

The statement reeks of genetic determinism, the idea that our traits arise predominantly if not entirely from our genes. The 90% suggests a reference to heritability, which for intelligence ranges from 50% to 80%, depending upon the study consulted. But heritability isn’t the genetic contribution to a trait. Rather, it’s the genetic contribution to the VARIABILITY of a trait.

Writings from Nazi Germany mention “good blood” and “pure blood,” with a lone drop enough to confer non-purity. I’m reminded of the episode of All in the Family in which bigot Archie Bunker is horrified to learn he’s about to receive a transfusion from a black, female, West Indian physician who shares his rare blood type. “Not to worry,” she cautions him with a grin, “when you come out (of) the anesthetic, you might have a strange craving for watermelon.”

The Nazis quest for pure Aryan blood entailed both positive and negative eugenics. The Lebensborn program, begun in 1935, took the children from “unwed mothers” knocked up by the SS and placed them in good Aryan homes, and also placed appropriately blue-eyed, blond orphans in homes, while murdering millions who didn’t fit the Aryan definition of Nordic people from England, Germany, Denmark, Sweden, or Norway. Excluded whites were Roma, ethnic Poles, Slavics, and of course Jews, all deemed subhuman by the self-appointed master race.

The Nazi “Law for the Prevention of Hereditarily Diseased Offspring” provided a list. While hereditary blindness and deafness and “Hereditary chorea” are single-gene conditions, “Congenital Mental Deficiency, Schizophrenia, Manic-Depressive Insanity, Hereditary Epilepsy,” and “any severe hereditary deformity” are not. Yet Genetic Health Courts ruled on who should be sterilized to halt transmission of faulty genes.

REPRODUCTION: RESTRICTING GENE POOLS IS COUNTERINTUITIVE

Some people on Stormfront ask what to do after learning their genetic ancestry is not what they expected. Most answers are polite, but some are variations on “If you do care about the White race, don’t breed with any White women, therefore not polluting our gene pool.”

Intentionally restricting a gene pool (a term that describes a population, not a person or family) to promote a perceived superiority is a real headscratcher to anyone who knows any biology whatsoever.

Survival stems from genetic diversity – not sameness. That’s why sexual reproduction has been so successful: A plague can’t wipe out a population if some members are resistant to the pathogen thanks to gene variants. Conversely, a field of genetically identical anything is vulnerable to change. So Craig Cobb, the white nationalist who inspired Panofsky and Donovan’s project when he was mortified onstage when confronted with genetic ancestry test results indicating he’s 14% African, should instead be thankful that he’s not 100% white.

The idea is straightforward. Members of the same ancestral population having children together increases the chance that mutations inherited from recently shared ancestors will show up in a child. The close relationships amplify the distribution of mutations, and incidence of certain single-gene diseases increases.

The phrase “Jewish genetic diseases” isn’t prejudicial; it states a biological fact. The mass murders of Jews throughout history have strangled their genetic diversity, creating serial population bottlenecks that have concentrated certain disease-causing mutations that made it through the pogroms and Holocaust. And so we have Canavan disease, Tay-Sachs disease, familial dysautonomia, and some two dozen other illnesses that strike other families too, but us with higher frequency

The Amish and Mennonites too have much higher incidence of several single-gene diseases that they brought in from Europe. For example, maple syrup urine disease affects 1 in 400 newborns in these groups, but only 1 in 225,000 in the general population.

But wait! The Amish brought those bad genes in from Switzerland and the Mennonites from the Netherlands, and they’re certainly not Jewish. Pure white Europeans can have mutations???

Yup.

Consider cystic fibrosis. DNA in teeth discovered in a graveyard in Austria along the Danube left there between 544 and 255 BC yielded the most common CF mutation. (See Discovery of the Principal Cystic Fibrosis Mutation (F508del) in Ancient DNA from Iron Age Europeans).

Isn’t Austria more or less the epicenter of white purity?

Going from the population to the molecular level, new evidence has shown that if two people are carriers of certain CF mutations that affect opposite ends of the gene, the genes can complement, encoding correctly-folded proteins that function, so that their children don’t actually face the 25% risk of inheriting the disease. The best way to have parents carrying different mutations is for them to have come from different population groups.

Genetic diversity can protect; genetic sameness empowers mutations. I guess the Nazi list of Hereditarily Diseased Offspring missed the genetic diseases of European whites. It is selective pseudoscience.

And so scientifically, the white nationalists, white supremacists, and neo-Nazis have it all wrong. For DNA doesn’t discriminate – it just assorts itself in sync to our patterns of procreation.

A WHITER SHADE OF PALE

To a geneticist, the idea of supremacy, intellectual or otherwise, based on minimal distribution of a pigment molecule in skin is meaningless, if not outright idiotic. Yet it has dictated so much of our history, fueled so much senseless hatred. So I’ll end with an explanation of human skin color, from my human genetics textbook:

“The definition of race based largely on skin color is more a social construct than a biological concept, because skin color is only one of thousands of traits whose frequencies vary in different populations. We may classify people by skin color because it is an obvious visible way to distinguish individuals, but this trait is not a reliable indicator of ancestry. The concept of race based on skin color falls apart when considering many genes. That is, two people with very dark skin may be less alike than either is to another person with very light skin. Overall, 93% of varying inherited traits are no more common in people of one skin color than any other.”

Skin color arises as melanin molecules are produced and packaged into sacs called melanosomes in cells called melanocytes. The pigment-packed melanocytes snake between the tile-like epidermal cells, releasing melanin granules that are broken into bits and pushed upward as the skin cells divide below. The bits of color darken the skin, protecting it from ultraviolet radiation.

Several genes control melanin production and dispersal, and we vary in skin color. Having more melanin is an adaptation, not a liability! So where did white people come from? The prevailing hypothesis has been that white skin captures more sunshine, making it possible to produce vitamin D and keeping bones strong. A study from David Reich’s lab at Harvard identified 3 genes that brought white skin to Europe.

People who left Africa for Europe about 40,000 years ago had dark skin. Then about 8500 years ago, hunter-gatherers from Spain, Luxembourg, and Hungary brought in variants of the genes SLC24A5 and SLC45A2, which impair the ability to make and distribute melanin. Farther north, where the lower light would have made white skin even more advantageous, evidence from southern Sweden shows contribution from the third gene, HERC2/OCA2, which conferred not only pale skin but blue eyes and blond hair too. Finally, farmers from the Near East also brought in gene variants for white skin. Amid all this mixing, natural selection and perhaps human behavior favored whiteness. Completely wiping out these genes causes albinism, so if anyone could be called mutant, it’s white people, not the brown and black.

Could one type of pigment molecule, controlled by just 3 of our 20,633 genes, fuel so much bigotry?

A FINAL THOUGHT

I applaud Panofsky and Donovan’s revelation of the twisting of genetic ancestry testing to validate white nationalism and its slippery slope to white supremacy. The technology has been helpful in many ways: solving crimes, reuniting families dispersed by slavery, and finding relatives after disasters. Let’s hope that the taking of genetic testing to the dark side of white supremacy backfires, bringing a greater appreciation of our essential biological diversity.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and a Graduate Certificate in Clinical Ethics. For more information on AMBI's online graduate programs, please visit our website.  

 

 

 

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08/10/2017

Topsy-Turvy Brand Name Drug Pricing?

On August 7, 2017, The New York Times with ProPublica (an independent, non-profit investigative new agency) reported that some drug companies have struck deals with insurers to require that prescriptions be dispensed for the more expensive brand name drug rather than the less expensive generic alternative! Has the world turned upside down? What has happened? Perhaps one could respond: Follow the money.

Pharmaceutical companies have apparently cut a deal with health insurance companies and pharmacy benefits managers for some drug products so that middle men pay prices that are very competitive, at least as competitive as the generic equivalents. In one arrangement for a particular drug – Shire’s Adderall XR, used to treat attention deficit hyperactivity disorder (ADHD) – UnitedHealthcare insured patients were provided a discount coupon which lowered the cost of the brand name considerably, but a patient’s family still payed about $50 more a month than for the generic. Consumers clearly are bearing the increased costs.

A spokesman for United Healthcare defended the program: “By providing access to these drugs at lower cost, we are able to improve affordability for our customers and members.” Of course, the statement is true, but it is a poor justification because in this instance have no choice in the matter. Even if patients’ physicians write for the generic equivalent, the doctors are told that they “had to specify that patients required brand-name versions of the drug.” This may or may not be true depending on the health insurers’ and pharmacy benefits managers’ formulary requirements; but it may be a moot point if the band name drug is the only one available, or unless the patient wants to pay full price for a drug product that is not listed in the formulary.

Regardless, it appears as if the drug companies and the health insurers and pharmacy benefits managers have conspired or colluded in some way to maintain unique market shares when generics are a reasonable option at consumers’ expense. It seems anti-competitive. It undercuts the foundation for providing for generics in the first place. It doesn’t make sense because it’s so counter-intuitive.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and a Graduate Certificate in Clinical Ethics. For more information on AMBI's online graduate programs, please visit our website.  

 

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