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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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08/08/2017

Charlie Gard Post-Mortem: Could He Have Been Saved?

Charlie Gard would have turned one year old tomorrow.

Two days before the British infant died of a mitochondrial disease on July 28, a short article in MIT Technology Review teased that Shoukhrat Mtalipov and his team at Oregon Health & Science University and colleagues had used CRISPR-Cas9 to replace a mutation in human embryos, a titillating heads-up that didn’t actually name the gene or disease.

Yesterday Nature published the details of what the researchers call gene correction, not editing, because it uses natural DNA repair. I covered the news conference, with a bit of perspective, for Genetic Literacy Project.

Might gene editing enable Charlie’s parents, who might themselves develop mild symptoms as they age, to have another child free of the family’s disease? Could anything have saved the baby?

A TRAGIC CASE

The court hearing testimony on the case between Great Ormond Street Hospital (GOSH) and the family, published April 11, chronicles the sad story. The hospital had requested discontinuing life support based on the lack of tested treatment.

Charlie was born August 4, 2016, at full term and of a good weight, but by a few weeks of age, his parents noticed that he could no longer lift his head nor support any part of his body. By the October 2 pediatrician visit, Charlie hadn’t gained any weight, despite frequent breastfeeding. After an MRI and EEG, Charlie had a nasogastric tube inserted to introduce high-caloric nutrition.

By October 11, the baby was lethargic, his breathing shallow. So his parents, Connie Yates and Chris Gard, took him to GOSH. There, physicians noted Charlie’s “persistently elevated lactate.” It was an ominous sign.

Remember Bio 101? When cellular respiration in the mitochondria fails, an alternate pathway releases lactic acid – this is what causes muscle cramps in a sprinter right after a race. It’s what was happening to the thousands of mitochondria in Charlie’s muscle cells; they weren’t extracting enough ATP energy from digested nutrients, and so the baby was limp, unable to reach or react much. His brain was running out of energy too.

Lactic acid buildup in muscles when oxygen is depleted causes cramping. Charlie had persistently elevated lactic acid.

On October 25, a muscle biopsy indicated only 6% of the normal amount of mitochondrial DNA, well below the 35% that indicates a mitochondrial DNA depletion syndrome (MDDS). But which one did Charlie have? Which gene was mutant? That’s important. With a judge discussing “strains” of the syndrome, as if it is a bacterial infection and not a monogenic disease, confusion loomed.

In mid November, sequencing of Charlie’s genome found two mutations in the gene RRM2B, causing “infantile onset encephalomyopathic MDDS.” It affected the brain and muscles – that was obvious – but he was also deaf and had heart and kidney abnormalities. With these findings, the Ethics Committee at GOSH advised against a ventilator.

Charlie’s disease is a “block to the machinery in charge of supplying nucleotide building blocks for mitochondrial DNA synthesis,” Fernando Scaglia, professor of medical and human genetics at Baylor College of Medicine, told me when I picked his brain on whether gene editing might help Charlie’s parents.

(A quasi-technical aside: RRM2B encodes an enzyme [ribonucleotide reductase] that, with three other subunits, removes an oxygen from the sugar part of nucleic acid building blocks, leaving deoxyribose as the sugar rather than ribose, with two phosphates attached. This happens just outside the mitochondria. Once these precursors get into the mitochondria, a third phosphate is added, forming the DNA nucleotide building blocks of the 37 mitochondrial genes. Charlie inherited a RRM2B mutation from each parent – the gene is in the nucleus, but it is essential to supply the mitochondria with nucleotides. RRM2B’s enzyme works only in cells that aren’t dividing – hence the extreme effects on Charlie’s muscles and brain.)

Charlie’s seizures started on December 15 and never let up. Experts began weighing in, including by the end of the month Michio Hirano from Columbia University, who had experience using nucleoside bypass therapy on 18 patients with MDDS due to mutations in a different gene, TK2. A ray of hope?

(Dr. Nakeya Dewaswala, Medicowesome)

Nucleoside bypass therapy provides precursors to the DNA building blocks that have only one of the three phosphates, to circumvent the disabled enzyme, and because the full forms are too highly charged to easily enter cells. But the paper analyzing the strategy, from 2012, clearly showed that it didn’t work in an experimental system for Charlie’s disease – “myotubes,” bits of non-dividing muscle in a dish:

“First we suggest that not only myotubes (post-mitotic cells), but also myoblasts and possibly other dividing cells can show mtDNA depletion in RRM2B deficiency. Second, supplementation with dNMPs, as expected, had no beneficial effect in RRM2B deficiency. Based on the function of this protein supplementation with dNDPs could be tried as an alternative strategy in RRM2B deficiency.” (This isn’t a sentence, albeit the crucial one for the case; it means trying two phosphates instead of one.)

I’m guessing that these three sentences are what catalyzed the parents’ GoFundMe effort and desire to take their baby to the US. But “there’s never been a proper clinical trial for nucleoside therapy,” said Dr. Scaglia, although 18 patients in Spain and Italy with mutations in a different gene, TK2, have so far tolerated it. But that form only affects muscle. The treatment might not have crossed the blood-brain barrier to reach Charlie’s more extensive disease.

Justice Francis knew the limitations of what some in the media called the “pioneering treatment,” if not the difference between a microbe and a gene. “In fact, this type of treatment has not even reached the experimental stage on mice let alone been tried on humans with this particular strain of MDDS,” he wrote.

Charlie’s disease blocks the supply of DNA building blocks to the mitochondria, but his mutant gene is in the nucleus. 
(NHGRI)

From January 9th until the 27th, Charlie had an unrelenting storm of seizures, his EEG erratic even when he wasn’t obviously seizing. This setback caused postponement of an ethics committee meeting and all but Dr. Hirano to give up. Perhaps he thought it a “theoretical possibility” because of that one sentence in the 2012 paper that suggested giving DNA precursors with 2 phosphates instead of one.

For a time, Columbia University considered treating Charlie, with what I don’t know. Meanwhile, nurses noted and then testified that the baby was gaining weight but making no obvious progress, countering the parents’ observations that Charlie felt pain, distress, pleasure, and subtly communicated with them.

Then an EEG from March 30 convinced even Dr. Hirano that an attempt at any treatment would be futile – a term that so dominated the court hearing that Justice Francis defined it: “for the avoidance of any doubt, the word “futile” in this context means pointless or of no effective benefit.” Goals began to focus on preventing suffering.

Yet the Pope and the President weighed in circa July 4, offering to welcome the baby for unspecified treatment to the Vatican or US. What did they know that the English doctors didn’t? And I had to wonder, where are these notables when similar things happen to many other babies born with rare genetic diseases? (See No Ice Buckets or Pink Ribbons for Very Rare Genetic Diseases)

For a time, discussion at the hearing devolved into a UK vs US scenario of the Brits taking a more reasoned approach in denying a futile therapy whereas US docs would try anything if parents could just raise enough money.

As the Pope and President were making their kind offers, pretty much all the experts were reaching agreement that Charlie should be taken off life support. Still, and understandably, the parents grabbed at any hope. “We truly believe that these medicines will work,” the father told the court, although nucleoside bypass was more an untested hypothesis than a medicine. Belief can’t alter biochemistry.

And so Charlie passed away on July 28.

COULD ANYTHING HAVED SAVED CHARLIE?

It was too soon for nucleoside bypass therapy, nor were approaches for other mitochondrial diseases such as cofactor supplementation (which I wrote about here), liver transplant, or stem cell transplant applicable. Nor can a recently-described peptide-like molecule that silences mitochondrial genes help, because Charlie’s mutant genes are in the nucleus. (A mitochondrion only houses 37 genes.)

Gene therapy or gene editing couldn’t have saved Charlie, because the intervention would have to have infiltrated his many muscle and brain cells, damaged beyond repair. But could either approach enable his parents to avoid having another child with two doses of the RRM2B mutation? (Gene therapy introduces a functioning copy of a gene; gene editing can replace it.)

Couples who are carriers of the same recessive condition already have options to avoid passing on the disease: prenatal genetic testing to identify an affected fetus and ending the pregnancy, or preimplantation genetic diagnosis (PGD) following IVF and selecting healthy embryos to continue development in the uterus.

Unfortunately, yesterday’s Nature paper about gene correction of a heart condition doesn’t apply to Charlie’s family. The researchers used CRISPR-Cas9 to snip a dominant mutation from sperm at the brink of fertilizing an egg, jumpstarting a natural DNA repair mechanism that copies a normal version of the gene from the egg to reconstitute two functioning copies — a little like me giving my husband a Women’s March tee-shirt to match mine and replace his Jets tee-shirt. The approach wouldn’t work for a sperm and an egg each bearing a recessive mutation in the same gene, the scenario for Charlie and 1 in 4 of his potential siblings, because there wouldn’t be a healthy gene to copy.

PGD tests one cell of an 8-celled embryo. If all is ok, the remainder is transferred to a woman’s uterus to continue development.

“It’s easier to do PGD and select those embryos that would not have a mutation in the particular gene, as is done for many other conditions,” Dr. Scaglia said. However, editing-out mutations can potentially help older women undergoing PGD by upping the percentage of okay embryos — both the number of eggs and their quality decline precipitously with age. A more pressing problem, Dr. Scaglia added, is controlling the cost of PGD and getting insurance to cover it, rather than pursuing gene editing.

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08/04/2017

How Much Should Your Boss and the U.S. Department of Labor Know About Your Opioid Prescription History?

As the price of health care and uncertainty about health insurance coverage increases, employers are taking more of an interest in their employees’ health. Indeed, this is not a new trend as the United States health insurance system has been employment-based since its creation. However, this trend may seem more justifiable when the federal government also takes an interest in employees’ health.  From a public health perspective, monitoring a society’s health is very important but it must be balanced against the individual’s privacy interest as well as the harms and benefits of that monitoring. There is also the issue of who/what is the most appropriate entity to be doing the monitoring.

On June 27, 2017, the United States Department of Labor announced it will officially be monitoring use of opioid prescriptions by workers under the Federal Employees’ Compensation Act, which is the law surrounding the worker’s compensation system.  The announcement expressed a safety concern based on overdoses and addiction of opioids in the midst of our current opioid crisis.

When an employee files a worker’s compensation claim, the employer must be notified and the employer has access to the health records included in that claim. The employer’s access to health records is limited to whatever is included in the claim and is justified based on the premise that the employer has an interest in the worker’s compensation claim. However, this new monitoring system means that an employer will now have access to its employees’ opioid prescription history, as this is information the U.S. Department of Labor will be monitoring as part of the worker’s compensation process.

This raises ethical concerns about invasion of an employee’s privacy for the benefit of combating the opioid crisis. Yes, we are in a nationally recognized crisis when it comes to the amount of opioid prescriptions and the number of deaths caused by overdoses, but is it truly appropriate for the U.S. Department of Labor to be the ones monitoring and questioning the practice of medicine? This announcement goes on further to state the following requirements to take effect by August 2017:

 

This policy will be administered in two phases, the first of which addresses FECA claims with newly prescribed opioid use (i.e. claims where an opioid has not been prescribed within the past 180 days, if ever). This policy for newly prescribed opioid use will be implemented in August of 2017. After an initial 60 day period of opioid medication, if an injured worker still needs opioid medication, the treating physician must complete a Certification/Letter of Medical Necessity (LMN) form in order for OWCP DFEC to authorize any additional opioid medication. All subsequent prescriptions will require that an LMN be received and reviewed by claims staff before opioid medication is authorized and dispensed.

Please be aware that as part of our new policy to address the safety considerations noted above, authorizations for opioid drug prescriptions will be limited to a maximum of 60 days, with initial fills and refills to be issued in no more than 30-day supplies (however physicians are encouraged to prescribe the shortest duration of opioid medication that will provide appropriate pain relief). Providers should utilize "partial fills" for schedule II and schedule III opioids. Please note that no more than two opioids may be authorized at any given time, and concurrent benzodiazepine prescriptions should be avoided to the extent possible.

This part of the announcement sounds like the practice of medicine or guidelines a health agency would issue, in that it is stating what a physician can and can not prescribe. This medical advice is coming from a federal agency, not a physician. It is also a federal agency that focuses on employment issues, not health. It is limiting the amount of opioids that can be prescribed and added administrative barriers for prescription. Controlled substances already have restrictions but these restrictions come from agencies such as the FDA or state agencies that specialized in issues surrounding drugs.  The U.S. Department of Labor is looking at this health issue from a perspective that may not be ethically appropriate in terms of patient care, i.e. focusing too much on the cost.

As for the privacy concern, employers already get access to health information through other means besides worker compensation process. For example, some employers require health screens, especially if the potential employee works in health care. There has also been an increase in employer-sponsored wellness programs, which involve the disclosure of one’s weight and heart health.  The concern is when the employer uses that information for unethical purposes. Society has already seen the trend of employers choosing not to hire smokers based on their health risk and cost. In 2013, the New England Journal of Medicine reported that 21 states did not have prohibitions against employers from having such restrictions. This article addressed some of the mixed messages a restrictive stance sends to the public when it is a health care institution that has such restrictions.

But when does health monitoring go too far and is it ethically appropriate for one’s employer to have access to this information? Consider the stigma associated with drug abuse in this case. The more pressing question though is whether it is appropriate for the U.S. Department of Labor to be acting in the role of the physician or replacing other agencies that specialize in drugs.  

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07/26/2017

Authorship and Pets

The International Committee of Medical Journal Editors is an influential group that, as expected, takes publication and authorship very seriously.  They have issued the most generally accepted definition of the criteria for authorship of scientific publications. They list these criteria very clearly and unambiguously on their website. These criteria are:

“The ICMJE recommends that authorship be based on the following 4 criteria:

  -Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND

  -Drafting the work or revising it critically for important intellectual content; AN

  -Final approval of the version to be published; AND

  -Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. “

They go on to say “All those designated as authors should meet all four criteria for authorship, and all who meet the four criteria should be identified as authors.” There does not seem to leave much doubt as to their meaning. The practise of guest authorship, including authors with non-substantive contributions by virtue of their position was once common but is now considered inappropriate. However, no simple set of guidelines can address all possible circumstances. Which raises the point I am addressing in this blog: What about pets?

An important paper on atomic behaviour published in Physical Reviews by Jack Hetherington and F.D.C. Willard is the object of this question.

F.D.C. Willard was Jack Hetherington’s Siamese cat Chester. The name represents Felix domesticus Chester Willard.  Willard was Chester’s father also obviously a cat. Chester eventually published a sole author paper, an impressive accomplishment indeed for a cat. Hethrington’s motivation for this offense was the realization that he had used plural terms such as “we” and “our” throughout the manuscript. It was easier to add an author than to edit the entire manuscript.

The pertinent question then is whether F.D.C. Willard met the criteria for authorship. Without going into a lengthy analysis of the likelihood that the criteria were met I am merely going to suggest that I believe it was highly unlikely. In the terminology of research ethics today this would be considered fabrication and falsification, both criteria for research misconduct. So did Jack Hetherington commit research misconduct? The answer, literally, is yes. However, I am going to suggest that he should probably be pardoned for his offense. The reason for this is clear. He was merely making a joke. Science for all its clear value is often a bit humourless. Pranks like this are remembered forty years later in a way that very few actual scientific papers are remembered. After all, F.D.C. Willard has a Wikipedia entry and Jack Hetherington does not. I still do have one concern to address. It is very hard to believe that a cat could actually be a co-author. This would be much more credible if Professor Hetherington had cited his dog.

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

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06/22/2017

Fertility preservation for transgender individuals

The field of oncofertility emerged to preserve the fertility of cancer patients whose treatment might render them as infertile or sterile. Today, the field of fertility preservation has expanded to other patient populations whose medical treatment may affect their fertility. One such population is transgender individuals undergoing gender affirming treatments. Although research on transgender individuals is limited overall and in particular regarding issues surrounding reproduction, transgender individuals are interested in biological reproduction. Because various gender affirming treatments will permanently affect their fertility, such as hormonal treatment and surgical removal of the gonads, it is important for transgender individuals to be offered fertility preservation before they start these treatments.

There are, however, some factors that may make fertility preservation difficult or less attractive of an option for transgender individuals. Healthcare professionals offering fertility preservation should be aware of these factors so they can help mitigate them. Here I will discuss two of them.

First, undergoing fertility preservation treatment can be stressful for both transgender and cisgender people, but there are some unique challenges for transgender individuals. Individuals with gender dysphoria may find it particularly difficult to undergo procedures involving anatomy that is discordant with their identity. For example, transgender women who are asked to retrieve sperm via masturbation may find this request exacerbates their gender dysphoria and may not be possible to do. Transgender men who are asked to undergo vaginal ultrasounds may find this psychologically traumatic. In recognizing how fertility preservation treatment can be particularly difficult for transgender individuals, healthcare professionals should be prepared to find ways to alleviate these difficulties, such as by offering surgical methods of sperm retrieval for transgender women and sedating transgender men during vaginal ultrasounds.

Second, the gametes retrieved and frozen will not match the gender identity of transgender patients (i.e. a transgender woman will bank sperm and a transgender man will bank eggs). This discordance may not matter for some transgender individuals, but it could affect others. At least one older study found that having frozen discordant gametes made it difficult for some transgender individuals to move forward with their lives in their gender identity. More research is needed in this area to understand if and how this discordance affects transgender individuals today. Healthcare professionals should be aware of this potential discordance between gender identity and frozen gametes, but it should not be a reason to deny fertility preservation to transgender patients.

In addition to the two factors I have discussed here, there are other factors at play in fertility preservation for transgender individuals. Fertility preservation is becoming more common for transgender individuals undergoing gender affirming treatment and consequently healthcare professionals treating these individuals should be aware of some of the unique challenges this patient population faces. For more information on this topic, check out the “Proceedings of the Working Group Session on Fertility Preservation for Individuals with Gender and Sex Diversity.”

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

 

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06/19/2017

The Crisis of Our Era: Can we find a way to talk about it?

So much of the fate of our planet, the human race, and all of God’s creatures depends on humans having an objective, causal understanding of the pressing problems we face and then, on that basis, developing some reasonably effective practical means by which those threats can be ameliorated—it’s called, using human intelligence and being connected to reality, at least reality with a small “r”, as in empirical reality. Just think of the causes of threats such as climate change, transmittable diseases and drug resistant viruses, gun violence, drug abuse, hunger, unemployment, poverty, lack of healthcare coverage, and on and on. Without reasonably sound knowledge of the causes of these threat humans are rendered helpless and vulnerable. And even with sound knowledge, without a practical, yes political, means, in the form of sound public policy, of collective action, to ameliorate them, we are cannot take meaningful action, and are still rendered helpless and vulnerable. Currently, in the United States there is vast disagreement not only over how best to formulate policy solutions to some our most pressing problems, there is often no agreement over how to understand the problem or even whether or not a problem exists. Climate change and gun control are two prominent examples. 

The fact that climate change is real and greatly accelerated by human activity is a fact about which there is clear scientific evidence. Practically all scientific societies, science academies, and governmental and intergovernmental agencies, are in complete agreement, which means the evidence for this empirical claim being true is about as compelling as anything we know about the natural phenomena.  So when we see reports on the news about rising sea levels and temperatures, stronger and more intense weather, droughts and heat waves, melting artic ice that is expected to soon be open water, etc. etc. some still say, these effects are simply the result of many natural changes in weather or that there really isn’t a consensus since 2 – 3% of scientists don’t accept the dominant explanation, among many other reasons for these effects. Whereas the vast majority of scientists see these effects as a function of a catastrophic, human caused problem, not an insignificant number of Americans remain either deniers or skeptics. Thus, to the latter group, there really isn’t a problem that can in principle be addressed by humans in the political process. But those against policies to address climate change also include some who accept the claim that human activity is having a deleterious effect on the planet; their objection is that effective policies would require more government regulations, which they see as onerous as the effects of climate change. Human beings on planet earth then left vulnerable to an urgent, mortal threat that is either not perceived or ignored because there is no viable way to address it.

Gun violence is a similar issue in terms of how it is understood in public discourse. In the United States about there are about 93 people killed each day by guns, of which over 30 homicides, 57 are suicides, and about 7 of these deaths are children or teens. There is no other developed country in the world with even remotely similar gun violence numbers. Many of us look at these data and are alarmed; we see the prevalence of gun ownership, especially assault weapons, as concerning and in need of more effective regulation. Others believe the problems can be accounted for by mental illness not the prevalence guns, in spite the evidence to the contrary. 

Moreover, it is common to hear some say after a tragic shooting in which lives were lost: the solution is to make sure more people are armed. As Wayne LaPierre of the NRA said,  “the only way to stop a bad guy with a gun is a good guy with a gun.” Those who study gun ownership know based on scientific research that just owning a gun increasing the risk of death for both the owner and those around him or her—very few gun deaths are from legitimate self-defense, yet “it is telling that through the successful lobbying efforts of the NRA, Congress has blocked further data collection on gun ownership and violence.” More data would elucidate the problem and the apparent solutions, e.g. background checks and eliminating assault weapons. But those who prioritize expansive gun ownership right oppose to such policy changes, and are not willing to allow any evidence to their position to be funded or considered in public policy discussions; it seems clear they would rather continue to live with the current number of gun deaths each year than to face additional gun regulations. Again, we left with a serious threat to our daily lives and no viable, common way either to understand the problem or to address it as a policy matter.

In a democratic setting those of us in bioethics simply cannot critically assess and determine our obligations to each other, our families and communities, and to global wellbeing, without sound empirical evidence of causal relationships and the potential harms and benefits resulting from human actors within their environment, whether it be in the context of global warming or clinical ethics consultation. Unless of course one assumes that ethical obligations are formulated a priori apart from scientific data and human experience. Sadly, in my judgment, this is where we are in the United States and much of the West—a crisis in both how we understand the world through scientific inquiry vs. alternative views such as religion and how we understand our obligations and formulate sound public policy, and indeed, how we understand ethics. This is a crisis that risks rendering ethics literally useless since it is no longer a practical activity, and leaves human beings helpless to find better ways to adapt to our existential threats and challenges. This is the crisis of our era.

How can we foster dialogue between people and groups, from what appears to be, with fundamentally different perceptions and understandings of the world and how we should relate to it? Can we begin new conversations with civility and respect? Can we build bridges and find more common ground? I’m not sure, but we have no choice but to try. 

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

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06/09/2017

Trump’s Attack on Science

Some time ago I began to write a blog about support of science, and the role of science in policy and decision making under the Trump administration. While this would seem to be a straightforward task since all of the evidence is amazingly consistent, in fact, it has been difficult. The reason it has been difficult is that each time I compile the sources and information necessary to write this blog something else happens which illustrates starkly the abandonment of the use of science by this administration. At this time, shortly after Trump’s announcement of the United States withdrawal from the Paris Climate Accord, I am trying to start again. I know it may be futile to expect to cover everything but I am writing anyway. There is no shortage of material. For the purpose of this blog I will focus on the message sent by Trump’s science budget proposals and not seek to be all inclusive. After all, it is the budget proposal which best states the administrations intent. I will also try to touch on the anti-science warriors who have been appointed to high level government positions, including cabinet positions.

While it is attractive to think of science as non-political, science exists in the real world and is, in fact, subject in many ways to political considerations. We have been fortunate that the politicians in Washington including both congress and the executive branch have recognized both the economic and humanitarian benefits of scientific research. They have, with a few exceptions maintained and grown the government’s support of scientific research in both basic and applied fields in both biomedical and other areas of research. This seems now to have changed. Congress fortunately has rescued the 2017 fiscal year science and technology budget from major cuts proposed by the Trump administration. However the administration has proposed draconian cuts for the 2018 fiscal year budget which starts in October 2017. It remains to be seen what that budget looks like when it has been through the Congress.

Trump’s proposed budget includes massive cuts to all federal agencies which support research. He proposes a 22% cut to the National Institutes of Health.  Both the Environmental Protection Agency and the Food and Drug Administration are slated for 30% budget reductions. Other science supporting agencies are expecting cuts of eleven to thirty two per cent. These are huge budget reductions which will cripple labs and institutions conducting science.

Trump has appointed a series of individuals who are most certainly not advocates of science to important science based government positions. This includes climate change denier Scott Pruitt to head the Environmental Protection Agency.  Rick Perry also a climate change skeptic as well as fossil fuel fan is now the head of the Department of Energy. Former CEO of the world’s largest fossil fuel company, Rex Tillerson is now the Secretary of State. Trump consulted with anti-vaccine crusader Robert Kennedy Jr. regarding the establishment of a commission on autism. Eighty five percent of the top science jobs in the federal government lack a Trump nominee.

The role of science as a driver, indeed the driver, of innovation and economic and technological development has been nearly universally acknowledged. We are now moving backward. Our hope lies in the fact that Trump and his cronies cannot kill science. Science is truth and truth will prevail. In the meantime things are pretty much a mess.

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

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