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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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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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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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He’s NOT a Ward of the State: Legal Significance of Words in Clinical Setting

As a lawyer by training and working as a non-lawyer in a clinical setting, I hear legal words of art tossed around without knowledge of their meaning.  In many cases, wrong terminology is the least of the healthcare team’s concerns and it is not an issue.  However, there are times when correct understanding of the legal significance of a phrase resolves an ethical dilemma all on its own.  

The phrase I have been hearing lately in the clinical setting is “ward of the state.”  This phrase has significance for the health care team because it determines who has authority to make decisions for a patient who lacks capacity, such as patients with development disabilities (“DD”). The legal meaning of “ward of the state” means that the patient has a public legal guardian (as opposed to a family member or friend as guardian). For those who do not understand its meaning, those using the term are usually referring to someone who is receiving health care services from a state agency or living in a group home.  The key misunderstanding is that receiving state services does not automatically deem one a “ward of the state” in the eyes of the law. A patient could be receiving services from Office for People with Developmental Disabilities without having a legal guardian. According to the New York Health Care Decisions Act, a 17-A guardian is the one who makes decisions for anyone with an intellectual or developmental disability, including health care decisions.  This is a legal process. It is common for a facility with patients with disabilities to begin a guardianship process for their residents who lack capacity as part of their admission process, but this is not always the case. This difference in understanding becomes an issue when the medical team is looking to make a major medical decision, such withdrawal of care, and no one understands with whom to discuss the plan of care. One may go down a rabbit hole of investigation to find who has guardianship only to learn that there was no public guardian at all. 

Another commonly misunderstood legal word is “proxy.”  Technically, proxy refers to the health care proxy form, a legal document, not the person. However, even lawyers sometimes call the appointed person “proxy,” even though the correct term would be “health care agent.” Proxy and surrogate have different legal meanings; proxy refers to a legal form and surrogate refers to someone who has health care decision making authority based on statute. If someone has health care decision making authority based on a proxy document, it means there was legal paperwork completed and it is evidence of the patient’s preferences. Both a health care agent and surrogate have the same authority; it just comes from a different source. Further, it is harder to remove a named health care agent’s authority than a surrogate’s authority. In order to remove a health care agent, one has to go through a legal proceeding, while removal of a surrogate would be an internal hospital process based on a series of factors, such as who is acting in the patient’s best interests. The difference matters in a clinical setting when there are multiple family members and the medical team is trying to determine who should be the decision maker. A health care agent would trump a surrogate, despite the familial relation. 

Language has meaning. This is not a new revelation.  Language has different meanings in different contexts.  A word in a court room means something very different from the same word in the clinical setting.  However, there are times when the legal meaning of a word has importance in the clinical setting as well. Understanding the legal meaning helps clarify conflict and in these two examples, who is the appropriate decision maker. It is important for health care providers to be precise in their language, as using such terms more carefully may result in better resolution of perceived ethical dilemmas.   

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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A review of Table 19: Reinforcing the dominant cultural narrative that all unintended pregnancies are wonderful and wanted

A friend and I recently watched the movie Table 19 because we were looking for a fun comedy. Unfortunately, the movie was neither fun nor funny. Indeed, the movie did not deliver on a number of fronts, which is why I do not recommend it. I want to focus on a specific plot line that this movie employed—one that is common in movies and books—and that I find problematic. In case you are interested in watching this movie despite my warnings, there are spoilers ahead.

The basic plot is that Eloise McGarry, played by Anna Kendrick, ends up sitting at the table of “rejects” at a wedding. She was originally the maid of honor to the bride, but she and the bride’s brother, Teddy, broke up after two years of dating and she was consequently demoted from the bridesmaids’ table to the “loser” table, Table 19. As the movie progresses, we find out that the reason Eloise and Teddy broke up is because of an argument surrounding an unintended pregnancy. Eloise was upset with Teddy when she told him she was pregnant because he did not immediately respond positively. Instead, he asked her what she wanted to do about the pregnancy. His lack of enthusiasm enraged her and she told him that they would be ridiculous parents, which angered him, causing him to break up with her via text message. Because this is a typical Hollywood movie, it has a happy ending with Eloise and Teddy getting back together and happily welcoming their baby into the world.

Unintended pregnancies account for almost half of all pregnancies in the United States so it is not surprising that they are used as a plot twist in many movies and books. What is problematic is that many movies and books expect both members of the heterosexual couple to respond joyfully to the news of an unintended pregnancy and there is shock and discord if this is not the response. This is precisely what happened in Table 19. While some unintended pregnancies are wanted pregnancies (perhaps they are mistimed or the couple didn’t think they could conceive but they always wanted to), many unintended pregnancies are not wanted pregnancies. Just because a couple is now pregnant does not mean that they automatically switch from not wanting to become pregnant to being thrilled that they are pregnant. The dominant cultural narrative that all pregnancies are wonderful and wanted is harmful to women, men, and couples.

Eloise and Teddy are a couple in their 20s who seem somewhat irresponsible and lacking direction. They are trying to figure out what to do with their lives individually and as a couple. Given their circumstances, it is understandable that they may not be ready for a baby. Their inability to have a mature and reasoned conversation about their unintended pregnancy further buttresses that they might not be ready for a baby. But according to the dominant cultural trope, they are supposed to be able to pull it all together in order to be an intact heterosexual couple who are excited to have a baby. While this is how the movie Table 19 ends, not all stories have happy endings and it is important to recognize that there is a diversity of responses to unintended pregnancies.

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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Rethinking The Obligation To Provide Universal Healthcare Coverage: The need for moral imagination

Healthcare is indeed complicated, in case anyone with a speck of knowledge about it ever thought otherwise. There are many ways to organize a healthcare system, as is evident from all the various ways advanced industrial societies around the globe provide healthcare to their citizens. Questions about the extent to which the private insurance system versus the government is involved brings us back to protracted debates about the legitimate role of government and whether or not citizens have a basic right to healthcare, or should healthcare be assumed to be one more market service which individuals may elect to use or not? Sadly, in the United States these questions often are framed in abstract terms appealing to general ideological values and goals that shape and limit the range of viable policy options. What I want to emphasize in my blog today is the need for moral imagination—what’s it like to be in the shoes of those who are suffering, and often without health insurance, and without a job?  This is a first step we all must take before we can weigh our moral obligations to provide healthcare to everyone.

Before the passage of the Affordable Care Act (ACA) there were over 45 million uninsured Americans who did not have access to a primary care physician. That number has been reduced by about 18 million, but now we at risk of seeing this number rise again with the possibility of a repeal of the ACA and passage of a GOP led alternative. The Congressional Budget Office (CBO), a politically independent agency, estimated that if the American Health Care Act had past would eventually lead to 24 million people loosing their health care insurance by 2026. That means the total number of uninsured citizens will be back close to the 50 million mark. This number is not just a statistic in the abstract—it’s a compelling measure of human suffering. Imagine you, the reader of this blog, become one of those unfortunate souls included in that number, which you and I could? What will that feel like?

Most of us, who have the good fortune of spending our days working in academic medical centers and many other professional settings, have access to not just good healthcare, but to excellent, state of the art, healthcare. Just think about it—have you or members of your family ever been sick or injured and is urgent need of seeing a competent physician? How long did it take you to get your appointment and receive the medical attention you needed? Most of us who have been in situations of need are amazingly fortunate to get what we need reasonably soon, so it is easy for people like us to take healthcare for granted.  Imagine having a troubling medical condition—news from a test, or a worrisome new symptom, or what may be worse, your family, being is serious need and not having health insurance. How would you feel? What would you do? What if you applied for insurance coverage and your premiums were exorbitant, beyond what you could afford, because of a preexisting condition?

Jimmy Kimmel did a remarkably good deed on his show recently by describing the scare he had with his newborn son who required urgent surgery to repair a heart condition. He was among the lucky—to have health insurance but also to be rich. His family’s needs are not at risk of not being met. But he showed moral imagination—empathy for others—when he prompted us to imagine what it would be like to have a baby who needed life saving medical interventions and not have access to medical care. When we ponder healthcare at this level, aren’t we all in agreement, as he said:

“We were brought up to believe that we live in the greatest country in the world, but until a few years ago, millions and millions of us had no access to health insurance at all,” Kimmel said. “If your baby is going to die, and it doesn’t have to, it shouldn’t matter how much money you make. I think that’s something now, whether you’re a Republican or Democrat, or something else, we all agree on that, right?”


 There are many Americans today who have gone without healthcare coverage for years after losing a job that never came back, which mean getting sick or injured puts them a great risk of personal bankruptcy, the number one reason individuals file for bankruptcy. Can you imagine what’s like to be out of job, no money, and have serious healthcare needs for yourself or your family? Sadly too many Americans know first hand exactly what that experience is like. And it is all the sadder because the United States of America is the richest nation on earth and the only advanced nation without universal healthcare. How can a nation be so rich and not provide basic healthcare to all of its citizens?

One barrier seems to be the necessary means by which universal healthcare would be made possible: government involvement. Our lack of moral imagination also limits our options. For decades the so-called conservative mantra has been the demonization of government programs, which perpetuates the myth that government is totally inept to effectuate any important social goal. But there is no other way to provide for the healthcare needs of our population than through government involvement. Individual action, local communities, religious institutions and organizations, NGO’s, etc., etc., alone will never solve this problem. Only the collective action of “we the people”, as an expression of our social and moral goals and values, can accomplish such a mammoth task. So how can we the people start thinking differently about this problem?

We need to be thinking with fresh interest and robust moral imagination about how we are going to fulfill our obligation provide healthcare to all Americans. This starts with first imagining and allowing yourself to feel what it’s like to be sick and without healthcare, and experience your or your family member’s illness getting worse and worse, with the only option at some points to go to a hospital emergency department. If we would not want this for ourselves or for those we care about, we shouldn’t want it for anyone else.

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 

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Increasing Access to Biosimilar Drugs

The development of ‘specialty drugs’ in the health care industry has created legal, ethical, and public policy issues because patients are not able to get access to their prescribed medications based on the expense.  Specialty drugs are usually biologicals, treat serious conditions, and  are very expensive with no cheap alternatives.[1] Although there is debate about how much finances should influence medical decision making, it is a conversation that can not be ignored when patients can not get access to treatment based on ability to pay. There should be increased access to these drugs but how to increase access is up for debate.

One posed solution has been the creation of biosimilar which are the generic version of a specialty drug. A biological medication is different from a traditional drug in molecular make up.[2]  “A biologic drug is ‘a substance that is made from a living organism or its products[,]’”[3]  while a traditional prescription drug is made up of simple molecules.[4]  This difference means that biologicals are scientifically more difficult to produce because a more elaborate research is necessary.[5]  This also means making a generic form, known as a biosimilar, is more expensive and harder to make.[6] Generally, a biological is “twenty times more expensive per patient than traditional small-molecule pharmaceuticals.”[7] There also are patent infringement concerns when making biosimilar.


From ethics perspective, one of the key aspects of justice is ensuring equal access to healthcare or at least fairly allocating available resources. For biosimilar drugs, it truly depends on what insurance company, what insurance plan, and what pharmacy benefit manager the patient has as to whether the patient will even have a chance to get these drugs. One could argue that it is hard to say we have a fair allocation system when it dependent on what backroom deals pharmaceutical companies have with insurance companies. On the other side, fairness includes ensuring that pharmaceutical companies are properly compensated for their time, energies, and resources used to develop these drugs. Yes, they are cheaper than brand name biologics but they are still expensive and arguably unaffordable. Competition has been the suggested method for decreasing prices to ensure better access. However, patents exclusivity and the Food and Drug Administration approval process make competition slow.


On April 27, 2017, The United States Supreme Court heard a case that addresses exactly this issue of access. The Court heard oral arguments in regards to an appeal by Novartis, Swiss pharmaceutical company, requesting the time for biosimilars to be on the market be sped up.[8] Amgen, a California pharmaceutical company who makes the name brand version Neupogen, had challenged the early release. The lower court decision had ruled in favor of Amgen, preventing Novartis from releasing its biosimilar until six months after the Food and Drug Administration approved it. The case revolves around a provision in the Affordable Care Act which aimed at creating an expedited path for approval of biosimilar drugs. The goal was to increase access of new innovations to the public as well as increase competition to decrease price. Zarxio, the biosimilar version of Neupogen, is projected to cost 15 percent less than Neupogen, which is a decrease in cost but not a substantial in cost. Part of the issue is health insurance companies expect biosimilar drugs to work like generic medications and they do not. Biosimilars themselves are still innovation and companies charge for the research and development that goes into innovations. The final decision is due to come in June and this case could determine whether justice will be respected in regards to how quickly consumers can get access to biosimilars.


[1] Joseph J. Hylak-Reinholtz & Jay R. Naftzger, Is it Time to Shed a “Tier” for Four-Tier Prescription Drug Formularies? Specialty Drug Tiers May Violate HIPAA’s Anti-Discrimination Provisions and Statutory Goals, 32 N. Ill. U.L. Rev. 33, 35 ? 36 (2011); Jim Sabin, How the U.S. Rations “Specialty Drugs,” Health Care Org. Ethics (Saturday, April 26, 2008)

[2] Michael Callam, Who Can Afford it?: The Patient Protection and Affordable Care Act’s Failure to Regulate Excessive Cost-Sharing of Prescription Biologic Drugs, 27 J.L. & Health 99, 103 (2014).

[3] Id.

[4] Id.

[5] Id. at 104.

[6] Id.

[7] Callam, supra note 2, at 105.

[8] Andrew Chung, U.S. Top Court Grapples Over Making Copycat Biologics Available Sooner, Reuters (Apr. 26, 2017),


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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When is Non-Existence Better than being Alive?

If bioethics has central or recurring questions, this is surely one of them.  And, of course, the problem, or question, often is restated to: who decides if this life is worth living?  The confounding elephant in the room is that families often have more hope than care providers, and the evidence is mixed on whether either party is particularly accurate in projecting the future.

Hannah Arendt in her book The Human Condition described in detail how humans must make choices without knowing outcomes.  Everyone (except neurologists) loves the stories about people coming out of comas and persistive vegetative states.  Neurologists are not fans because it admits to an inability to predict—even being right 98% of the time isn’t enough. 

Obstetricians face this problem constantly, but with different stakes.  We know fetal heart rate monitoring is far from perfect, but none of us would ignore a bradycardia of several minutes.  Maybe this baby is actually dying, and we aren’t going to take the chance.  When is non-existence acceptable in my specialty?  Only when the pregnant woman has decided it is so.

At both ends of life, non-existence, the ultimate existential question, is left to patient and family values, because there is no cultural/societal consensus.  Inuit tribes expected the elderly and infirm to walk out into the ice when times got tough, and food was scarce.  Our culture rejects this, but medical students often question why we keep alive an individual with no hope of recovery and little or no awareness of their surroundings or condition.

I am not a utilitarian, and I am not defending any of Peter Singer’s views.  But I still wish that we did not prolong suffering, or pour resources into a life without awareness of its own self.  Families struggle with these decisions, and often choose the conservative choice thinking that hope is better than non-existence.  Those of us in medicine tasked with keeping these fragile physiological flames burning often ask ourselves whether we are doing harm or good.  Until we reach (if ever) a societal consensus, we should share with decision makers our moral ambiguity and sense of regret when we support their loved ones against our better judgment.  Is this enough?  Perhaps not, but we are not yet even doing this with consistency.  

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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Fetuses and Full Disclosure

Medicine has a notoriously long history of paternalism, particularly with regards to reproductive health. The past century has seen everything from forced sterilization of people of color and those with intellectual disabilities to nondisclosure of sexually transmitted diseases. Physicians have fought to regain the trust of the community through disclosure of key medical information and shared decision making, both of which are essential underpinnings of the bioethical principle of autonomy. Given the incredible emphasis on these concepts in contemporary medical training, it is surprising that the following law has now passed Texas Senate approval:

SB 25. A cause of action may not arise, and damages may not be awarded, on behalf of any person, based on the claim that but for the act or omission of another, a person would not have been permitted to have been born alive but would have been aborted. (b) This section may not be construed to eliminate any duty of a physician or other health care practitioner under any other applicable law.

In short, there can be no legal penalty against physicians who knowingly choose to withhold information from pregnant patients if the physician thinks it will prevent an abortion. This does not absolve the physician in question from professional consequences, like action from the Texas Medical Board. However, it does set an important precedent – namely, that the belief structure of the physician takes precedence over the rights of the patient. From a bioethical standpoint, this is an inexcusable violation of autonomy. Disclosure of all relevant information is critical to informed decision making, which is the bedrock of autonomy in the complex, jargon-laden world of modern medicine. One of our key roles as clinicians is to promote patient autonomy by translating this jargon into information that can be easily understood by the patients, family members, or anyone with medical power of attorney. Her decisions about the future of her pregnancy hinge on information about fetal status, whether she decides to terminate or simply wants to be able to prepare for the effects of an abnormality. Clearly, allowing one’s own beliefs surrounding abortion to supersede a patient’s right to know about the status of her fetus is an obvious ethical transgression.

Furthermore, legal actions that protect doctors who fail to disclose important information to their patients harm the medical community at large. These laws undermine the trusting relationship between doctor and patient that we continue to build, particularly in vulnerable populations that have historically been ignored or exploited by medical professionals. Trust is especially important in sexual and reproductive healthcare as patients entrust their physicians with some of the most intimate details of their lives when seeking treatment in these matters. SB 25 is akin to codifying mistrust into law. 
Patients’ values may differ drastically from our own and the decisions they make may not reflect what we would do in similar situations. Almost all physicians have had patients make decisions with which they disagree thoroughly. However, it is our duty to behave in an ethically responsible way and to help patients make these decisions in a way that is consistent with their own belief structure, regardless of our own feelings. This means providing all relevant information in a nonjudgmental way and respecting the informed, autonomous decision of the patient. Passing a law exempting physicians from the legal consequences of paternalism doesn’t change what is right. Rather, it serves only to further divide patients from their providers in a way that harms us all. 

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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Dueling BRCA Databases: What About the Patient?

The news release Monday morning grabbed my attention:

“Study finds wide gap in quality of BRCA1/2 variant classification between Myriad Genetics and a common public database.”

Myriad Genetics had been exclusively providing tests, for $3000+ a pop for full BRCA gene sequencing, for 17 years before the Supreme Court invalidated key gene patents back in 2013. Since the ruling a dozen or so competitors have been offering tests for much lower prices. Meanwhile, Myriad has amassed a far deeper database than anyone else, having been in the business so much longer. And it’s proprietary.



Public databases of variants of health-related genes have been around for years too. The best known, ClinVar, collects and curates data from the biomedical literature, expert panels, reports at meetings, testing laboratories, and individual researchers, without access to Myriad’s database. ClinVar uses several standard technical criteria to classify variants as “pathogenic,” “benign,” or “of uncertain significance.” (“Likely pathogenic” and “likely benign” were used more in the past.)

ClinVar lists 5400 variants just for BRCA1. The criteria come from population statistics, how a particular mutation alters the encoded protein, effects on the phenotype (symptoms), and other information. Bioinformatics meets biochemistry to predict susceptibility. The BRCA1 protein acts as a hub of sorts where many other proteins that control DNA repair gather. DNA Science discussed the genes behind breast and ovarian cancers here.

As gene sequences accumulate in the databases and troops of geneticists and genetic counselors annotate them, the proportion of pathogenic and benign entries will increase as that of the unsettling “variants of uncertain significance” — VUS — will decrease. Knowing will outpace not knowing. In the meantime, a woman with a VUS for a gene that confers susceptibility to develop breast and/or ovarian cancer, concerned that her DNA sequence isn’t “normal,” might have her at-risk organs removed. And then she might learn, as the databases grow, that her variant is really benign after all, because while she was being treated for a disease that she didn’t actually have, more patients emerged who have the gene variant but not the related cancers.

The reclassification of a VUS as something more meaningful depends on access to as much information as possible.

How many unnecessary surgeries are happening? Have happened? Myriad estimates hundreds to thousands.


The news release announced a paper from Myriad just published in The Oncologist that compared 4,250 unique BRCA1 and BRCA2 gene variants in the company’s database to entries in ClinVar, and found that 26.7% of the ratings do not fully agree. (ClinVar lists multiple sources for many of the variants, and 14.5% didn’t agree on all counts and 12.3% on only some.) According to Myriad, most of the VUS listings were in ClinVar. In fact, only 0.5% of Myriad’s BRCA1 sequences and 1.1% of their BRCA2 sequences are VUS. They’re clearly ahead of the game.


A breast cancer cell (NHGRI).

The discordance isn’t really news. It echoes earlier reports both from Myriad researchers for the BRCA genes and from a  non-Myriad, multi-center group that also found 26% discordance, but their analysis included several cancer predisposition genes; the most conflicting were CHEK2 and ATM. And another recent study found that about half of women with VUS undergo bilateral mastectomy, concluding that “many surgeons managed patients with BRCA1/2 VUS the same as patients with BRCA1/2 pathogenic mutations.” That’s terrifying. It means that the problem isn’t due just to overanxious patients, but also to surgeons who might not be genetics-savvy.

The news release doesn’t go to the obvious conclusion, that privatization of the database may be fueling inappropriate surgeries, or at least not preventing them, a point that Sharon Begley made elegantly in Stat News. Many of her expert sources countered the implication that variant classifications from ClinVar are just accepted and delivered to patients without further and often intense research and validation by health care providers.


In the news release, William Gradishar, MD, from the Feinberg School of Medicine at Northwestern University and lead author on the new study from Myriad, provided the company view (slightly edited):

“The high degree of discordance seen in this study signals a cautionary note … it means that different labs are providing different results to patients for the same genetic mutation … some patients are receiving incorrect results that may have life-changing or -threatening implications… Although efforts are underway to resolve the quality problems within public databases, it is unlikely the issue will be resolved soon and users of public databases likely will continue to encounter discrepancies. At this time, labs should not use public databases in any way in clinical variant classification.”

Actress and activist Angelina Jolie had her breasts and ovaries removed to lower her risk of BRCA1-associated cancers.

Ron Rogers, spokesperson for Myriad, wrote in an email that the company provides database access for certain scientific collaborations, but then provided the business view:

“Myriad has invested hundreds of millions of dollars to develop our database over two decades, which is used to classify variants as part of the Company’s specific process. We encourage other commercial labs to make their own investments, which are required to offer a quality product. The problem is that some other commercial labs refuse to make the needed investments. Instead, they are trying to short cut the process by relying on inaccurate public databases, which has the potential to deliver inaccurate results and harm real people.”

If anyone remembers the race to sequence the first human genome, which pitted NHGRI and their public database against Celera Genomics and their proprietary one, the battle over BRCA is a little deja vu all over again.

Rogers added that if patients who have had bilateral mastectomies following a report of a VUS had come to Myriad, “we could have provided many of them with definitive answers and helped to prevent a significant number of these life-changing procedures.” About 85% of the BRCA testing market indeed uses Myriads products.

Myriad’s tests as well as their support (genetic counseling) are excellent. The company helped a friend of mine interpret and confirm BRCA1 test results from 23andMe, which her son had taken on a whim but the unexpected finding of a mutation had sent her family into a tailspin. 23andMe, the direct-to-consumer genetic information company, coaxes customers to provide their results for research (“Be part of something bigger”) and charges investigators for access to the data. Like Myriad, 23andMe also suffered a setback in 2013. FDA yanked some of their health-related carrier tests, but the agency reversed the ban on April 6, 2017.

23andMe and Myriad serve different types of individuals. Many of 23andMe’s customers, like my friend’s son, aren’t distraught over cancer, just curious and acting on their own. So here’s another comparison: Is Myriad’s protecting of their data similar to my reaction to people downloading my books for free? No. I’m just losing royalties.

My mother’s lost battle with breast cancer can’t help but influence my view that impeding accurate diagnosis for profit, to protect assets, may make sense in the business world but is not the right thing to do. I have trouble commoditizing patient tests and sequestering information that might help, and the many rock stars of genetics who have joined the Free the Data movement would agree.

Because the entire discussion makes me queasy, I thought instead I’d illustrate the distinction between a harmful mutation and a VUS, by comparing the BRCA1 gene sequence to the English language.


Most genes are thousands of DNA bases long, and therefore can vary in many ways. Gene variants – mutations – can affect health or not depending upon how they disrupt the proteins that they encode.

BRCA1 (the gene) is 125,951 bases long, only 5,589 of which are represented in the protein. Mutations near its ends are more damaging than those in the middle. One of the two Ashkenazi (Jewish) “founder” mutations, 185delAG, removes an A and a G at position 185, near the beginning. Because a gene sequence is read in triplets – every 3 DNA bases encodes an amino acid – adding or deleting a number that isn’t 3 or a multiple of it devastates the protein’s function. 185delAG is, then, a gene variant of very high significance. (My analogy below is not quite on target because the words in a sentence vary in length.)

I entered 125,951 letters into a publishing calculator that translates numbers of alphabet characters into a book of a particular size, and wound up with a 6” by 9” volume of 265 pages. That view of the BRCA1 gene’s enormity corresponds to approximately the length of Margaret Atwood’s dystopian masterpiece “The Handmaid’s Tale.” I’m rereading it, inspired by the “Make Margaret Atwood Fiction Again” signs at the March on Washington January 21.

I took a sentence about as far into the book as the 185delAG mutation is in the BRCA1 gene:

Everything except the wings around my face is red: the color of blood, which defines us.

Removing two adjacent letters – the “ex” in “except” – and then moving the other letters into the word-sizes, clearly disrupts the meaning:

Everything ceptth ewi ngsar oundmy fa ceis re dth: eco lorof bl oodwh ichde finesus

Gibberish, and it would continue to the end of the book. In a gene, the offset sequence would likely lead to a stunted protein, halted when reaching a “stop” signal in the mRNA. And when a BRCA1 gene loses meaning, control of DNA repair falters and other mutations go unchecked. Cancer results.

A VUS would do something less drastic, such as replacing a letter in a way that doesn’t obscure the overall meaning of the sentence (or gene). Substituting the “g” in “everything” with a “j,” for example, doesn’t alter the meaning. And many changes to a DNA sequence have no effect on the encoded amino acid sequence at all.

So that’s what a VUS is, a DNA sequence of a particular gene of interest that’s rather rare in a population, and that may or may not mean something. And their numbers will decline and then vanish as the databases build and their entries are annotated and validated. But until they do, I think that sharing all that we know about variants of possibly disease-causing genes, to prevent unnecessary treatments, is the only ethical path to take.

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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