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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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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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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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