At a Crossroads: Medicaid and Health Policy in the U.S.

Bioethics in the News logoThis post is a part of our Bioethics in the News series

By Hannah Giunta, DO, PhD, MPH

Recently, U.S. states were granted federal permission to pilot a variety of initiatives that will require able-bodied, adult Medicaid recipients to attend school, work, volunteer, or participate in rehabilitation to receive benefits. Earlier this month, Kentucky became the first state to successfully apply for a waiver allowing them to trial work requirements. While the majority of Medicaid recipients—including children, enrollees with disabilities, and full-time caregivers—are exempt from these changes, the initiation of a work requirement represents a dramatic shift in health policy unprecedented in our nation’s history. While I am not opposed to work requirements for cash assistance, access to health care is a fundamentally different matter. Even if the work requirement could be implemented without negative downstream effects, it still values people’s lives according to what they contribute.

When Medicaid was first signed into law as part of the 1965 Social Security Act by President Johnson, it represented the culmination of a larger social debate about poverty and health. A general consensus emerged that no American should be left without access to needed medical care whether due to age, disability, or disadvantage. Against the backdrop of Johnson’s “War on Poverty” and “Great Society” initiatives, access to health care was rightly seen as a crucial factor in economic empowerment and development. Johnson stated unequivocally in his January 1964 State of the Union address to Congress:

This budget, and this year’s legislative program, are designed to help each and every American citizen fulfill his basic hopes—his hopes for a fair chance to make good; his hopes for fair play from the law; his hopes for a full-time job on full-time pay; his hopes for a decent home for his family in a decent community; his hopes for a good school for his children with good teachers; and his hopes for security when faced with sickness or unemployment or old age. (Peters and Woolley, The American Presidency Project)

But, there was also a sense that America could do right by the poor and disadvantaged. Later in the same State of the Union address, Johnson stated:

This administration today, here and now, declares unconditional war on poverty in America. I urge this Congress and all Americans to join with me in that effort. It will not be a short or easy struggle, no single weapon or strategy will suffice, but we shall not rest until that war is won. The richest Nation on earth can afford to win it. We cannot afford to lose it. (Peters and Woolley, The American Presidency Project)

Image description:  President Lyndon B. Johnson signing the Medicare amendment at the Harry S. Truman Library in Independence, Missouri on July 30, 1965. Former president Harry S. Truman is seated at the table with President Johnson. Image source: Wikimedia Commons.

Thus, from the very beginning, the Medicaid program was justified based on the importance of economic empowerment and also on the basis of the compassion and decency a rich nation ought to show its citizens. In its present forms, the work requirement will go a long way toward undermining both of these justifications.

From the perspective of economic empowerment, one of the major arguments made in favor of the work requirement emphasizes personal empowerment through work. As Seema Verma, head of the Centers for Medicare and Medicaid Services, reiterated in her public comments, community involvement through work can be a source of empowerment and possibly help recipients transition to jobs with health benefits. Yet, while Americans certainly want good jobs with benefits, current work requirement proposals do little to help Medicaid recipients climb the economic ladder. There is no additional funding for education, workforce placement services, or incentives for companies to hire these workers at a living wage. It is unclear how simply requiring people to find jobs improves the situation. Of course, some might argue that people should take any 20-hour per week job they can find if they want benefits. While you can make an argument in favor of this proposition, you cannot simultaneously herald work requirements as a force for economic empowerment. Workers are likely to end up in the same dead-end jobs available before the work requirement. Additionally, with no upgrade of their skills or qualifications, I imagine the likelihood of them obtaining a job with decent health insurance coverage is the same as it is right now. The only difference is that now workers who lose a job and cannot find new employment lose their health insurance too. If they volunteer, we as a society might benefit from these workers’ efforts. But, though volunteering is laudable, it is unlikely to result in a major step up on the economic ladder and places further burdens on individuals who are already on the margins.

pill bottle and money
Image description: a prescription pill bottle is on its side with capsules still inside and spilling out onto a surface of U.S. $20 bills. Image source: Images Money/Flickr Creative Commons.

Not to mention, the work requirement may paradoxically exacerbate the health inequities Medicaid was designed to address in the first place. For instance, children, pregnant women, and full-time caregivers make up a large number of Medicaid recipients. They are currently exempt from the work requirements, but their family members are not. Imagine how much more hardship a family will face if a partner or parent loses coverage. Adult caregivers and children may be forced into a losing battle between their own needs and the needs of the newly uninsured family member.

Most crucially, the issue at stake in this debate is truly whether health care is a human right or a commodity provided or traded to those who contribute something in return. Of course, supporters of the work requirement will point out that they merely want those enrollees who can work to contribute something in exchange for free benefits. It is human nature to count the cost of our generosity. However, in a society as rich as our own, should anyone go without needed care? Is the life and health of an individual who has not held a job in years worth less than the life of someone who works 20 hours each week? According to the work requirements, it seems like the answer is a resounding “yes.” Of course, the person could seek care at the emergency room—a place of last resort for many people without resources. But, can’t we do better than that? The question really becomes: can the United States care for its own, or has the most powerful nation in history lost its way? We can decide to declare defeat or we can develop new battle strategies to win the war on poverty once and for all. How we answer this challenge will undoubtedly determine how future historians look back on this time.

hannah-giunta-2017-cropHannah Giunta, DO, PhD, MPH, is a first year pediatric resident at Mayo Clinic and proud alumnus of Michigan State University. She completed her PhD in spring 2016 under the direction of Dr. Tom Tomlinson and her medical degree in May 2017.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Tuesday, February 13, 2018. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Pseudoscience and Measles in Minnesota

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series

By Hannah C. Giunta, DO, PhD, MPH

A recent measles outbreak in the Minneapolis-St. Paul, MN metro area is all over the news. More than thirty children have been treated at local hospitals, and at least 50 measles cases have been confirmed. The local Somali immigrant community has been hardest hit in large part due to their low vaccination rates. Commentators have demanded a variety of measures to control the vaccine-preventable disease, including enhanced border security. However, there has been less coverage of the outbreak as evidence of systemic social injustice.

Indeed, no matter what ones views are on compulsory vaccination, Somali parents’ vaccine refusal is not a case of informed, empowered parental choice but one of disadvantage and exploitation. The Somali immigrant community has been targeted by anti-vaccine activists spreading scientifically suspect information. Activists have taken advantage of an as yet unexplained increased rate of severe autism (but not autism in general) in the Somali community, encouraging parents not to vaccinate while spreading long debunked claims about the link between vaccination and autism. Realizing that internet rumors were not effective, activists have taken to personally visiting families and warning them about the dangers of vaccination. Yet, there is a real temptation to place some of the blame for the epidemic on Somali parents. Even commentators who rightly place blame on the anti-vaccine activists and declare the situation quite literally “a natural experiment” do not take the extra step of calling activists what they really are: gamblers and fraudulent pseudo-scientists willing to bet on the lives of disadvantaged children. This is not a case about free speech or poor parental decision-making; rather, it is a case of advocates conducting a so-called “natural” experiment where they stand to possibly gain the benefits (i.e. possible support for their cause) without taking on or acknowledging any of the risks faced by their subject-victims. The activists are guilty not just of being ill-informed and having dubious goals but also of perpetrating a larger social injustice.

While people certainly have the right to free speech and we all have a responsibility to evaluate the information presented to us, anti-vaccine advocates in this case chose to target a vulnerable population and to take advantage of individuals’ lack of empowerment. Of course, they did not set out to conduct a classic scientific experiment, but they are certainly still guilty of participating in a type of experiment. Some might say that the activists were just trying to help Somali families because they sincerely believe in a link between autism and vaccination. Others would argue that these individuals are not qualified scientists and were not performing research. But, the activists’ project was more devious than misinformation. The activists sought to target a minority community, take advantage of a medical puzzle, keep community members in the dark about their true objectives, and to recruit participants into a risky gamble where “benefits” primarily accrue to the activists themselves. After all, if the activists could point to any decline in the autism rate (regardless of causation) or show the public that vaccine-preventable infections are simple childhood illnesses from which children recover without incident, they would have more “data” to support their cause. The very fact that parents believed the activists likely lent more credibility to the anti-vaccine crusade in populist minds. If enough people believe the message, surely there must be something to it?

Image description: a baby is in the hospital with measles in the Philippines. Image source: CDC Global/Flickr Creative Commons

The social injustice implications of a pseudo-research paradigm come into focus when we consider three major aspects of the case in question. First, the activists exploited their own relative privilege by providing biased information. There is no way that individuals engaged with the anti-vaccine campaign are unaware of vaccine-preventable diseases and the risks they present. They simply choose not to focus on those risks. They so strongly support their own hypothesis that they believe it to be true despite evidence to the contrary, much like a researcher might believe that nothing could possibly go wrong in an experiment. Anti-vaccine activists usually have access to many sources of information and thereby a certain degree of epistemic privilege. They have socioeconomic resources to travel to ethnic enclaves and meet with Somali families. On the other hand, the Somali community in Minnesota continues to struggle with poverty, unemployment, and related social ills. Somali children are already at-risk for poorer health outcomes, but the activists did not consider this relative health disadvantage.

Secondly, the activists maximized their own benefits while placing all of the burdens on the Somali children. The segregation of poor Somali immigrants into certain ethnic enclaves virtually insures that children, including the activists’ children, outside these neighborhoods face much less risk of illness. Should there be a serious outbreak, Somali children would bear the burden, not the activists’ children. The Somali community would also be blamed for not vaccinating their children, absolving the activists’ of responsibility through a leveraging of their privileged social position.

Lastly, even with obvious evidence that the Somali community is suffering a measles outbreak, activists have failed to reach out and attempt to retract their message. Their pseudoscientific project continues unabated. They cloak themselves in the language of science while allowing a natural experiment to run wild and harm innocent children. Clearly, they believe their agenda and hypothesis about autism causation are more important than the lives of innocent children. Measles does kill, and over 30% of children will experience one or more complications, including diarrhea and dehydration, pneumonia, and encephalitis. Perhaps, if anti-vaccine crusaders wish to engage in pseudoscience, we should hold them to the standards and responsibilities of real medical scientists, including the wrongful death of any children who succumb and the continuing expense of measles-related complications. You can’t yell “fire” in a crowded room if there really isn’t a fire, and activists have crossed a line and are doing just that. We, in the name of equitable health outcomes, need to remind activists that words do matter and their experiment has failed.

hannah-giunta-2017-cropHannah C. Giunta is a May 2017 graduate of the Michigan State University DO-PhD program. She received her MPH in May 2015 and her philosophy PhD in May 2016. Dr. Giunta is an incoming Mayo Clinic Pediatrics Resident.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, June 1, 2017. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Thorny Questions After a French Clinical Trial Goes Wrong

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series

By Hannah Giunta, MPH, PhD

The problem of balancing access to new drugs with the conduct of rigorous clinical trials is not new. Indeed, readers might be interested in checking out a previous Bioethics in the News column that dealt with the right to try novel therapies. But, despite all the coverage, answers are hard to find. The public want access to new therapies that are safe and effective; but, both patients and professionals remain relatively uninformed of how and why the current process operates as it does. While we may rebalance the benefits and burdens of drug development, we can never provide early and widespread access without risk.

During his campaign, President Trump repeatedly promised to eliminate red tape at the Federal Food and Drug Administration (FDA) and speed the approval process for potentially life-saving medications; although, just how he will attempt to accomplish these objectives remains unclear. But, many ethicists are alarmed that current regulations and requirements do not go far enough. Early phase trials are by their design risky propositions. A recent CNN article by Jen Christensen brings these concerns to the forefront. In the article, Christensen highlights the trepidations of several leading ethicists about the current clinical trial process, emphasizing the fact that clinical trial sponsors do not need to provide proof of efficacy in order to begin early phase trials even though the trials can have significant risks for participants. Christensen focuses on a 2016 French clinical trial where six healthy volunteers were gravely injured, and in one case even killed, during a phase 1 trial of a novel painkiller. Previous trials of similar compounds had shown the agents to be clinically ineffective, but the company was not required to show proof of possible clinical efficacy before launching the trial. Ethicists in Christensen’s article suggest that the solution is creating an independent advisory body within the FDA charged with evaluating preclinical evidence of efficacy. Is this a good idea? Possibly, if indeed there is sufficient scientific literature to review and that literature correlates to some degree with efficacy in humans. But, it will not change the necessary step of administering a drug to humans for the first time. No amount of animal testing can establish precisely what will happen in vivo. The very nature of experimentation necessitates a certain level of risk, and early access without risk is impossible.

Image description: a person’s hands are shown holding a stethoscope. They are wearing a white doctor’s coat. Image source: Alex Proimos/Flickr Creative Commons

In the current system, the FDA focuses on the safety and toxicity of compounds in phase 1 trials before moving on to efficacy assessments in phase 2 and 3 trials. The thought seems to be that toxicity is the first bar to overcome, since efficacy matters little if subjects are harmed by the drug itself. The classic model for phase 1 trials is the dose escalation study where participants are randomly assigned to receive an ever increasing dose of an experimental agent until unacceptable toxicities develop. In the current case, 90 healthy volunteers were recruited for just such a trial. News of a problem was first publicized in January 2016 after one participant was declared brain dead and five others were hospitalized (Bichell, 2016). Medical findings at the time indicated that the previously healthy man who died suffered a massive stroke in his brainstem. Five other men who received an equally high dose of the experimental agent after the first man became symptomatic were also hospitalized. Four suffered headaches, altered consciousness, and short-term memory difficulties (Bichell, 2016).

The question of how the trial went wrong is an indictment and profound misunderstanding of the current system. The investigators gave extremely high levels of the drug in order to determine what dose would be toxic and at what dose the pain receptor in question would be 100% blocked by the agent (Bichell, 2016). In other words, they did it for rigorous scientific reasons in accordance with their approved protocol. The scientific purpose of a phase 1 trial is to establish the dosage level that is toxic. Agents in a phase 1 trial are not dosed as they would be in clinical practice. A second complaint leveled at investigators concerns the fact that similar agents tested in previous trials had failed to markedly reduce pain (Bichell, 2016). Again, these complaints belie a poor understanding of the drug development process. Small differences in chemical structure can make a large difference in pharmaceutical outcomes, and scientists never know when a compound will radically change medical practice. The nature of research means that many drugs will not be successful, but a few will be. A final complaint lodged against the trial investigators suggested that some neurotoxicity in animal studies should have forced scientists to re-evaluate their plan for a phase 1 trial. But, even the scientist lodging this complaint admits that these injuries have happened with other experimental agents (not this particular class of drugs), and those agents caused no problems in human subjects (Bichell, 2016). Of note, the sponsor has made changes regarding how they are notified of subject hospitalization due to concern that additional volunteers received a high dose after the first man was hospitalized.

So, how does what happened last year in France factor into current promises to speed access to new drugs? By scientific standards, the phase 1 trial in question did not fail. It established the outer limits of toxicity. The outcry over what happened in France highlights the differences between how scientists think and how most patients and health care professionals think. Most drugs in the development pipeline will never gain FDA approval. Scientists are concerned with insuring safety and efficacy through a rigorous scientific process that takes time. What is a promising drug today may be a complete flop tomorrow. Expanding access requires that we accept a different standard of evidence (i.e. retrospective clinical data, clinical dosing guidelines without scientifically established maximum doses, etc.). Accepting different standards may make a lot of sense, but it will not mean access without risk. Perhaps the most important step we should take is to test drugs in people who suffer from the disease in question and not healthy volunteers. At least then, the burdens will be borne by those who stand to benefit. Yet, any of these solutions will not change the fact that medical progress is not a straight line, and we are putting people at risk today for the sake of tomorrow.

Hannah Giunta photoHannah Giunta is an eighth year DO-PhD student at Michigan State University. She received her MPH in May 2015 and her philosophy PhD in May 2016. She is currently completing her medical school clerkships and plans to graduate in May 2017.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, March 9, 2017. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Rights and Responsibilities at the End of Life

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series.

By Hannah Giunta, MPH, PhD 

Questions about end-of-life care are always vexing, but a recent article in U.S. News and World Report suggests that cancer patients continue to receive useless but harmful treatments at the end of life (Thompson, 2016). A new research study presented at the American Society of Clinical Oncology’s (ASCO’s) annual meeting revealed that a big part of the problem comes from a lack of meaningful dialogue among physicians, patients, and family members. Indeed, in many cases, serious discussions never take place. Dr. Ronald Chen, a radiation oncologist at the University of North Carolina’s Lineberger Comprehensive Cancer Center, and his colleagues examined de-identified claims data from patients younger than 65 with advanced cancer who died between 2007 and 2014 and were enrolled in Blue Cross Blue Shield insurance plans. They found that nearly three-quarters of patients with a variety of advanced cancers received aggressive care within the last 30 days of life—a proportion that remains virtually unchanged even after the ASCO issued warnings to physicians about the harm of such treatments in 2012 (Begley, 2016). Unfortunately, these treatments are not only unlikely to help but can be quite harmful. Andrew Epstein, an ASCO palliative care expert, explains, “Much more often than not, these types of care at the end of life are not helpful, and they are emotionally and physically harmful for patients, and emotionally harmful to the patients’ loved ones” (Thompson, 2016).

Image description: an image of Rosie the Riveter is combined with a pink ribbon representing breast cancer awareness, and text that reads “we can do it.” Image source: Flickr user Beverly & Pack.

The ASCO’s “Choosing Wisely” guidelines encourage physicians not to perform invasive procedures or try last-ditch chemotherapy and radiation regimens when patients are already significantly debilitated and unlikely to benefit. But, although the ASCO has encouraged end-of-life discussions, experts on end-of-life care worry about evidence that most terminally ill patients don’t even know they are in their final days. A separate study recently published in the Journal of Clinical Oncology found that only 7% of patients who had scans, knew their cancer was quickly progressing, and discussed their prognosis with a physician acknowledged that they likely had mere months to live. Physicians frequently used overly optimistic language, and patients did not press their physicians for more information or explanation. As Holly Prigerson, an expert on end-of-life care at Weill Cornell Medicine, suggested, oncologists are generally “very reluctant to put a number on how long patients to have live” (Epstein et al., 2016). This reluctance likely stems from a fear of being characterized as overly pessimistic or as giving up on patients too quickly. Thus, we are left with the question of what to do with the results of these two studies. Why are physicians and patients so reluctant to discuss end-of-life choices and care options?

I believe there are two primary issues at play here. First, there appears to be unwillingness on the part of physicians to broach difficult subjects. It is especially problematic that despite general professional agreement about the need for less aggressive end-of-life care physicians routinely fail to have frank discussions with patients and steer them toward appropriate palliative options. I surmise that part of what is going on here has to do with the difficulty of changing perspectives. Few physicians would voice disapproval for palliative care in theory, but it is difficult to give up the fight and focus only on palliation. The medical community wants to “beat” cancer, not admit defeat. The culture of cancer has been shaped by a warrior myth whereby giving up on a cure is unacceptable. The only acceptable response is to fight the cancer to the very end, even if that fight requires significant sacrifices. No doubt, cancer culture is fueled by the general public’s expectations as well (Page, 2015); but, since physicians ultimately control access to aggressive care, they must take a large share of responsibility for the warrior ethos. Physicians would have great social power if they presented a united front in favor of palliative care.

Cancer Warrior results screen shot
Image description: a screen shot of search engine results for “cancer warrior” shows a glimpse of the socially acceptable “warrior” culture.

But, it is not enough for physicians to endorse and openly encourage palliative care. Secondly, we must consider what rights and responsibilities patients have when faced with critical illness. Too much of the discussion about end-of-life care to date has focused exclusively on the rights of patients to seek last-ditch treatment options. There is less discussion about patients’ right to receive comprehensive hospice and palliative care, and there is absolutely no discussion about the responsibilities patients have when they exercise their rights. It seems obvious that patients have a right to understand their prognosis and make informed decisions, but what of their responsibilities? Patients have a concomitant responsibility to be informed consumers when they seek care in accordance with their individual capacities. Part of becoming an informed consumer is recognizing that there will come a time in life when modern medicine no longer has an answer. That time may be sooner or later than a patient anticipates, but it will assuredly come. Preparation for these decisions is a patient’s responsibility. I would argue that current social pressures on patients to be so-called warriors who give up everything for a cure—no matter how unlikely or far-fetched said cure is—both limit individual choice (Page, 2015) and simultaneously allow patients not to discharge their responsibilities as informed consumers.

Remedying current end-of-life care challenges requires changes in attitude and behavior on the part of physicians and patients. Physicians have a professional responsibility to educate themselves and to offer patients reasonable treatment options—options that will most likely be palliative rather than curative. But, patients also have a role. They have a responsibility to think about end-of-life decisions. As human beings, we know our time is inevitably finite. We have a responsibility to prepare for end-of-life choices in the same way that we make plans for dependents, write wills, and purchase life insurance. Now, we just have to find ways to change behavior. So, to start the discussion, I am asking, “How can we collectively speak out against the current cancer warrior culture and help physicians and patients appreciate their rights and responsibilities?”

hannah-giunta-100Hannah Giunta
 is an eighth year DO-PhD student at Michigan State University. She received her MPH in May 2015 and her philosophy PhD in May 2016. She is currently completing her medical school clerkships.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, July 7, 2016. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Individual vs. Public Benefit in Liver Donation

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Hannah Giunta

Earlier this month, the United Network for Organ Sharing (UNOS) announced it would hold a public hearing regarding concerns about disparities in donated liver access across U.S. geographic regions. (Q13 Fox News 2014) While donated livers are supposed to go to the sickest patients first, geography is still taken into consideration. So, the person closest to death is not always the first to get a donated liver. Rates of liver donation are highest in the Midwest and South where centers often serve predominantly rural areas and see less overall demand. Patients on the coasts commonly have to wait longer before qualifying for a transplant. This disparity has resulted in patients with means flying across the country to get an organ while lower income patients have to simply wait at home. UNOS considers the number of waiting list deaths resulting from this disparity serious and is entertaining various solutions. One proposal under consideration would involve redrawing regional boundaries to decrease the total number of regions. Those larger regions would then each serve a more equitable number of patients. To date, this proposal has drawn intense criticism, with lawmakers in the U.S. House of Representatives signing an opposition letter in an attempt to stop any map redrawing. (WIBW 2014)

UNOS Region Map
UNOS Region Map

Yet, both critics and proponents of the changes seem to be arguing from self-interest instead of from a well-grounded public health-focused perspective. On the one hand, critics worry that organ-rich areas will become organ “farms” for those areas of the country where grassroots efforts to increase donations have been less successful. Dr. Sean Kumer, a transplant surgeon at the University of Kansas, expressed this sentiment, noting, “What they are attempting to do is say, ‘Hey, those guys have all the organs. Let’s go over and poach those’ instead of having their own grass-roots campaign to identify new donors.” (Q13 Fox News 2014) The University of Kansas publicly announced its opposition to the proposed changes (Bruce 2014), and at first glance, it does seem intuitive that regions where more effort is expended for organ donor recruitment and procurement have a right to increased access. Yet, this view is actually problematic. First, this claim might stand up if transplant centers did not receive support and benefits from belonging to a national network, but I believe they likely benefit from information sharing, training, and system-wide resources. Secondly, it is difficult to tease out just what a needy individual’s responsibility is for circumstances in the larger population. If an individual lives on one of the coasts and personally advocates organ donation but others choose not to donate, then is that individual less deserving of an organ? What about areas where certain religious or cultural groups oppose organ donation? Should needy patients who might support donation themselves bear the burden of others’ different choices? Conversely, what if a patient lives in a region where organ donation is high but they personally are not donors? Should they enjoy the benefit of increased access?

Proponents of map changes also argue from a predominantly self-interested position. Surgeons at the University of Pittsburgh signed on in favor of the proposal—but not really because they see it as a more equitable way to allocate scarce medical resources. (Smydgo 2014) Rather, Pittsburgh surgeons work in an area that stands to gain the most from redrawing the map. It’s unclear whether they would support a proposal that might not be advantageous to their own region. Neither side seems concerned about the broader public implications of liver transplant inequities.

Obviously, any question about the allocation of scarce medical resources is certain to reignite age-old controversies pitting the welfare of individual patients against equitable access for all those in need. I believe this line of thought creates a false dichotomy—one where physicians operate independently of the larger health care system and patients are completely autonomous agents who are not impacted by complex social issues and practices. While seeing one’s duties as specific to an individual patient is helpful in the everyday practice of medicine, it is too narrow a conception when navigating one’s role in a complex public system. Indeed, I would argue that because pervasive inequality has been shown to negatively impact all involved, including one’s current and future patients, physicians have a duty to promote larger public health goals (see Wilkinson 2011 for more on how social inequality impacts us all). By taking a narrow stance on what constitutes one’s ethical obligations, physicians like Dr. Kumer assume their actions impact only their patients, and equally, they then assume they are selflessly fighting to insure access for the needy. However, transplanting an organ into one patient inevitably means it is not available for some other person. In a case where a less seriously ill patient receives an organ ahead of a more critical patient, the sicker individual could be left to die when both lives might have been saved if the healthier patient had waited a bit longer for a transplant. I am dubious that physicians are as willing to acknowledge their indirect role in a disadvantaged patient’s death as they are to take credit for a life saved.

In the narrowest sense, a physician has an obligation to an individual patient. Dr. Kumer articulates this sense of obligation. Especially when making time-sensitive medical decisions, physicians commonly do not have the luxury of considering broader social implications. But, when a physician is operating within the context of a specific allocation system and that entire system is under review, he can and ought to fairly analyze policy implications. Such analysis does not ethically conflict with his duties to individual patients. Yet, it would be unfair not to acknowledge that Dr. Kumer’s position is held by a large and increasing number of physicians. Despite the Institute of Medicine’s recommendation that more physicians earn public health degrees, the proportion of physicians in public health programs continues to decline (cited in Donohoe and Martin 2014). Biomedicine has become increasingly separated from the social and cultural dimensions of patients’ lives and from a broader ethical commitment to the public’s overall health. It therefore is understandable that individual physicians are reticent to engage in these types of discussions, but their complacency cannot be ethically justified. Part of a physician’s professional duties should involve taking an interest in system-wide inequalities, including those perpetuated by the medical system itself. In this case, neither the critics nor the proponents are discharging their ethical obligations.

Those who disagree with my position will undoubtedly contend that asking physicians to serve two masters is unfair; am I advocating that physicians should focus on their role as public health advocate instead of their daily responsibilities to patients? My answer is a resounding “No.” When a patient is on the operating table, the responsible surgeon is and should be focused solely on what actions can be taken to insure that individual’s survival. But, in broader discussions of public policy, there is no reason that carrying out one’s professional obligations as a physician obviates one from considering societal implications and the public’s health. It is just as much of an ethical lapse not to fulfill this obligation as it would be not to promote a patient’s interests in the operating room. Until we can conceive of a world where patients and physicians can operate without being impacted by broader social structures, individual patient welfare and system wide justice are not antithetical to one another. At the very least, individual welfare and social justice are not separate considerations. In my opinion, they are intimately intertwined.


hannah-giunta-100Hannah Giunta is a sixth year DO-PhD student pursuing a PhD in Philosophy and Bioethics.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, October 9, 2014. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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The Joshua Hardy Case: Lessons Yet to Learn

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Hannah Giunta

Earlier this month, major news outlets reported the story of 7-year-old Josh Hardy, a current end-stage cancer patient at St. Jude Children’s Research Hospital. Hardy has faced and overcome cancer four times after first being diagnosed with rhabdoid tumors of his kidneys when he was only nine months old. After treatment for his kidney cancer, he relapsed, and cancer was again found first in his thalamus and then in his lung. In November 2013, Josh was diagnosed with myelodysplastic syndrome and required a bone marrow transplant. The weakening of his immune system caused him to come down with a particularly vicious case of adenovirus, and current antivirals have failed to control that infection. After approved drugs failed, Hardy’s doctors suggested that the experimental agent brincidofovir might offer the only viable chance at a cure. St. Jude previously hosted a clinical trial where patients who received the drug demonstrated a decrease in adenovirus-specific viral load. Hardy’s parents petitioned manufacturer Chimerix to provide the drug through a compassionate use protocol, but the company refused, saying that giving the drug to Josh and other critically ill patients would likely slow down the drug’s approval process. Chimerix officials also explained that the drug had not been proven effective in advanced adenovirus cases like Josh’s and that they did not have a current clinical trial in which they could enroll Josh. Public outcry over Chimerix’s refusal of the request, which included death threats directed at company executives, eventually pushed Chimerix to reconsider its decision and work with the FDA to start a new clinical trial in which Josh could enroll.

Although Josh Hardy’s case has been uneasily resolved, at least for the time being, public reaction reveals that larger questions are still unanswered. First and foremost, we continue to struggle with distinguishing our research system from our clinical care system in the U.S., and the resulting therapeutic misconception causes dashed dreams and animosity between drug developers and well-meaning, though misinformed, patient advocates. The truth is that the medication Josh is receiving out of compassion may make his life worse in the end, and failure to recognize this reality means false hope for families and insufficient attention paid to Josh’s quality of life. Secondly, there is a conflict between the needs of current patients like Josh and the needs of future patients who will benefit most from a fully approved medication. That conflict can only be meaningfully resolved when we have an honest discussion about what compromises we are willing to make. We cannot have both a drug development system that releases cutting edge medications meeting our stringent safety standards efficiently and one that makes unproven medications available on demand. The clinical trial system is not designed to release experimental agents for public consumption, even when that consumption occurs according to compassionate use protocols. Failing to get to the bottom of these conflicts leads to unnecessary heartache and public outrage.

Philosophers, researchers, and clinicians have struggled for years with how to prevent and ameliorate the impact of the therapeutic misconception. Defined as the failure to appropriately distinguish between the goals of research and the goals of clinical care, the therapeutic misconception leads to patients and family members believing that clinical trials are actually cutting edge treatment options, rather than legitimate experiments designed primarily to yield generalizable knowledge. In an effort to maintain hope for current patients, clinicians recruit participants with end-stage disease in order to push a research agenda forward while anecdotally hoping that somehow the experimental agent might benefit the enrollees. Unfortunately, previous reviews of pediatric cancer protocols suggest that substantial survival time is relatively rare. In fact, significant survival time was actually less common than drug-related toxicity (Kim et al. 2008). In Josh Hardy’s case, brincidofovir has only been shown to be effective in patients who did not have advanced adenovirus infection. Even then, the drug only demonstrated the ability to decrease viral load, and with Josh’s weakened immune system, his body may still not be able to clear the infection. Tissue damage is likely already significant after two months of illness. Most importantly, Josh has other significant co-morbidities and has had multiple cancer relapses. After Josh received his first dose of the drug, his own father admitted that his son faces a long road and is in bad shape overall (Cohen 2014). Seeing Josh weak, frail, and seemingly miserable in his hospital bed should leave us wondering whether this little boy has suffered enough. Perhaps, he might be better off if we focused solely on palliation and allowed the time he has left to be more comfortable and meaningful for him and his family.

The unique goals of medical research stem largely from a need to standardize clinical trials as much as possible to meet FDA standards. In order to show efficacy and safety, researchers use the gold standard double-blind, placebo-controlled clinical trial design. While this design helps researchers show aggregate differences in outcomes, it makes it less likely that individual patients will benefit from trial enrollment. In the trial earliest stages, participants are often randomly assigned to dosage groups, meaning that some participants may not even be receiving a therapeutic dose. In subsequent phases, participants are still randomly assigned to treatment arms of the trial, and if clinician-researchers don’t know what treatment a participant is receiving, it’s unlikely that they can provide individualized medical care for their patients. Living up to the FDA approval system’s high scientific requirements is a reality for Chimerix and other pharmaceutical companies, so distributing a drug in a less controlled situation presents a conflict. Maybe it is time to consider whether or not more novel trial designs or blended designs where patients receive an experimental intervention in a less controlled setting might help address this problem. Pediatric oncologists have recently expressed this opinion in a major research journal (Kearns and Morland 2014). Until we decide how rigorous our drug review standards need to be, we are forcing companies to confront a constant conflict between the human need for compassion and the larger social goal of developing new treatments.

Josh Hardy may or may not survive his current illness, although I hope and pray that he prevails. But, no matter the outcome, the Josh Hardy case should not be the end of our discussion. Josh’s story should push us toward a national conversation that asks the big questions. Most importantly, it requires us to reconsider the popular notion that research can serve two masters (i.e. the public and current patients) as well as the idea that length of life ought always to be our barometer for ultimate success in the face of terminal illness.


Cohen, Elizabeth. “Josh Hardy’s father says son faces ‘long road to recovery.’” 15 Mar 2014. Last accessed on 3/17/2014 at

Kearns P, Morland B. New drug development in childhood cancer. Curr Opin Pediatr. 2014 Feb;26(1):37-42. doi: 10.1097/MOP.0000000000000054. PubMed PMID: 24362409.

Kim A, Fox E, Warren K, Blaney SM, Berg SL, Adamson PC, Libucha M, Byrley E, Balis FM, Widemann BC. Characteristics and outcome of pediatric patients enrolled in phase I oncology trials. Oncologist. 2008 Jun;13(6):679-89. doi: 10.1634/theoncologist.2008-0046. PubMed PMID: 18586923.

Lupkin, Sydney. “Dying Boy to Get Unapproved Drug After Family’s Plea.” 12 Mar 2014. Last accessed on 16 Mar 2014 at

Lupkin, Sydney.  “Family Petitions For Unapproved Drug To Save Son.” 11 Mar 2014. Last accessed on 16 Mar 2014 at

hannah-giunta-100Hannah Giunta
 is a fifth year DO-PhD student pursuing a PhD in Philosophy and Bioethics.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, April 3, 2014. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Considerations for Minors and Euthanasia Laws

Bioethics-in-the-News-logoThis post is a part of our Bioethics in the News series. For more information, click here.

By Hannah Giunta

While euthanasia has been legal in Belgium since 2002, the government recently began considering changes to existing laws that would guarantee a legal right to die for minors as young as 12 (Blake 2012). This policy change has generated a great deal of controversy, particularly in light of several troubling cases that have recently been made public. No matter what their personal beliefs about euthanasia, bioethicists, health care professionals, those involved in public policy, activists, and all citizens with any vested interest need to carefully examine the ethical implications of various policy changes by asking themselves reflective, critical questions. So, in this blog post, I hope to get readers thinking about the issue by posing four such critical questions that I believe we should consider when analyzing the right to euthanasia for minors.

Question 1: Are minors developmentally capable of making decisions about euthanasia?

There is a general consensus that medical decisions should only be made by competent patients who have the ability to understand the implications of their actions. While scientists once believed that the teenage brain was nearly fully developed, recent evidence suggests that the frontal lobes, the areas of the brain responsible for critical thinking and predicting consequences, are still not connected in the adolescent brain (Knox 2010). The fact that teenagers’ brains are not fully developed may make it difficult for them to accurately understand what life with a significant medical condition entails. They may also have difficulty realizing the gravity and finality of choosing to die. Although no one wants to deny a teenager’s lived experience with her disease, it would be just as unfair to ask her to make decisions she cannot reasonably be expected to make. Thus, we need more information about how teenagers actually make these types of decisions when thinking about the ethics of euthanasia in this population.

Question 2: What effect will this have on families?

Though they are preparing for independent life, teenagers are still integral members of the family unit. Any policy that affects one member of the family unit affects the entire unit. Allowing minors to choose euthanasia fundamentally changes the relationship they have with their parents and the relationship parents have with medical providers. If minors can choose to die when confronted with a serious illness, questions arise about what other decisions they should be allowed to make independently, and these questions force everyone to consider what role the family should play in these minors’ lives. Will families be pressured to choose euthanasia if their child requests it in order to avoid a legal battle? Will parents and other family members still have opportunities to say goodbye to their child in meaningful ways? The medical establishment is inordinately powerful, and it is important to consider how shifting end-of-life decision-making away from families will impact their ability to participate in their children’s care.

Question 3: How will the law be implemented?

Belgium’s euthanasia laws are designed with safeguards to insure only patients who are intractably ill can choose death. Patients requesting euthanasia are supposed to be suffering from extreme, incurable pain and make repeated, informed requests to end their lives in writing. Doctors must provide patients with information about their prognosis and any benefits they might derive from alternative treatments, including palliative care. Physicians are required to keep detailed records and report all instances of euthanasia to a national commission that can cooperate with law enforcement if it appears to have been inappropriate (Cohen-Almagor 2009). But, the law’s implementation has allowed physicians to be primarily independent decision-makers about euthanasia without significant regulatory oversight. Some health care providers believe that Belgium’s euthanasia laws are an important way of addressing such a taboo subject. Others report significant abuse of the law. For instance, in approximately 3% of cases, drugs are administered without the patient’s explicit consent. The lack of consensus about how best to implement euthanasia laws contributes to many ethical concerns about the practice. Any moves to expand the law should only be undertaken after a critical examination of how the current system functions.

Question 4: Given increasing concerns about the way initial euthanasia laws have developed over the past 10 years, what additional safeguards will be in place to protect minors?

Belgium’s euthanasia laws were originally designed only for patients with no hope of recovery. However, several more controversial cases have come to light. Deaf twin brothers were euthanized last year after they found out that they were going blind. The brothers had no terminal medical conditions but reported that they could not imagine life without being able to see each other. The brothers had not yet actually lost their vision and made the decision to die pre-emptively (Ortiz 2013). In another case, a young woman fighting an ongoing battle with anorexia nervosa exercised her right to euthanasia because she no longer wanted to live with intense mental suffering. The woman was sexually abused by her psychiatrist; her next psychiatrist, who verified she was competent to choose euthanasia, was a good friend of the initial doctor who perpetrated the abuse (Cook 2013). Other contentious practices have also become commonplace, including organ harvesting after euthanasia and the extension of euthanasia rights to prisoners serving long-term sentences. With all of these questionable practices, there is considerable concern about vulnerable individuals. Current safeguards appear to be few and far between, and minors could be even more vulnerable than mentally distraught adults. If minors are allowed to make such grave decisions for themselves, bioethicists must ensure that additional safeguards beyond the usual regulatory requirements are in place to prevent unscrupulous, coercive practices.

The preceding questions are only four of the ones we should be asking when evaluating euthanasia policies as applied to minors. Please feel free to contribute more to the discussion. I hope that we can have a rich conversation with one another over the next few weeks!


hannah-giunta-100Hannah Giunta is a fourth year DO-PhD student pursuing a PhD in Philosophy and Bioethics.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Friday, April 12. With your participation, we hope to create discussions rich with insights from diverse perspectives.

You must provide your name and email address to leave a comment. Your email address will not be made public.