Tag: Bioethics in the News

FDA Approval of New Alzheimer’s Drug May Harm More Than It Helps

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

By Jennifer Carter-Johnson, PhD, JD

On June 7, 2021, the United States Food and Drug Administration (FDA) approved a controversial new Alzheimer’s Disease drug—aducanumab—to be sold by Biogen under the name Aduhelm. Alzheimer’s disease is estimated to currently be affecting over 6 million Americans plus their families, who must watch the mental decline of their loved ones and provide increasing levels of care as the disease progresses.

Controversy

Unfortunately, the approval of Aduhelm has generated a large amount of controversy because the FDA approval came despite the rejection of the studies of the drug’s efficacy by the FDA advisory committee. The opposition to the FDA’s approval has been so heated that three of the eleven-person advisory committee have resigned.

Detailed discussions of the science behind Alzheimer’s disease and the Aduhelm clinical studies can be found elsewhere. In summary, as Alzheimer’s disease progresses, protein plaques—amyloid and tau—build up in the patients’ brain. The progression of these plaques correlated with decreased mental acuity in patients. Therefore, drug candidates that target these plaques have been of interest to scientists for many years.

While the clinical data associated with Aduhelm supported a decrease in brain plaques in early-stage Alzheimer’s patients, the data did not show that decreasing plaques by the drug resulted in slowed progression of Alzheimer’s disease. In addition, the data showed that some patients have brain swelling as a result of the drug. Using this data, the FDA approved Aduhelm for broad use for all Alzheimer’s patients.

FDA Approval Process

Generally, to gain approval to sell a new drug, a company will complete a series of clinical trials to determine if a drug candidate is safe and effective for a given disease. Safety and efficacy are balanced against each other and consideration is given to the severity of the disease to determine if approval will be granted. As an example, a highly effective drug that is also highly toxic would not be approved as a simple headache remedy but may be approved as a treatment against a fast-growing, inoperable form of brain tumor. Conversely, an ineffective drug should never be approved no matter how safe it is—such are the wares of snake-oil salesmen of the past.

The FDA also has an Accelerated Approval pathway to allow drugs for diseases that have few treatments to proceed to market more quickly. It is under this accelerated path that the FDA approved Aduhelm. The accelerated pathway allows companies to use biomarker changes rather than disease improvement to show efficacy in the drug approval process. The FDA used the decrease in amyloid plaques as the biomarker for approval of the new Alzheimer’s drug—despite the fact that the clinical trial studies were submitted to show efficacy against disease progression. Moreover, the advisory committee was not informed of potential accelerated approval. Only after the clinical trial data was found unacceptable by the advisory committee did the FDA switch to the accelerated approval pathway. Perhaps most importantly, other drug candidates have been abandoned after amyloid plaque removal did not halt progression of the disease, so biomarkers may not be effective ways to judge the halt of Alzheimer’s progression.

The accelerated approval is, in effect, a contingent approval. Biogen will be allowed to sell Aduhelm, but it must gather data as to whether the drug is actually effective. If clinical data does not eventually support reduced disease progression, then the FDA can rescind the approval, and Biogen will no longer be able to sell the drug. The FDA’s approval of the Aduhelm may be harmful in the long run for several reasons.

Medicine IV infusion
Image description: A close-up photo of an IV drip containing clear liquid. Image source: stux/Pixabay.

Trust in FDA

The move by the FDA to approve Aduhelm could lead to a decrease in trust in the agency. First, the controversial nature of its approval over the recommendations of the scientists who reviewed the data created a controversy that is playing out across the news media as people wonder why an ineffective drug has been approved.

In fairness, the accelerated approval process is contingent, but due to the way the accelerated approval was used scientists did not have the opportunity to weigh-in on the use of biomarkers in that approval. That way in which the accelerated approval process was tapped, only after the regular approval process seemed doomed to fail, may well erode trust that the FDA evenly applies its own rules. Additionally, it is very difficult to rescind these accelerated approvals, and if the drug approval is rescinded public perception will likely be highly negative. Finally, according to Biogen it may take up to nine years to gather the data to complete the required studies.

New Drug Development

Aduhelm is not the only drug candidate in its class in clinical trials for Alzheimer’s disease treatment. Other drug candidates that include patients who receive a placebo rather than the drug candidate are undergoing clinical trials. Since these studies tend to be double-blinded—neither the doctor nor the patient knows if the drug or the placebo has been administered—patients will likely drop out of these other studies in order to be assured of receiving some drug. Thus, Alzheimer’s drug development will be slowed, in favor of a drug that has no demonstrable efficacy. Additionally, these new drug manufacturers may also ask for similar approval, based on biomarkers that may not be indicative of clinical effectiveness.

False Hope

Patients and Alzheimer’s advocates pushed for approval of this drug. But a drug with contingent approval may give these patients and their families false hopes. We have seen in Right to Try legislation–legislation allowing patients to use un-approved drugs in the FDA approval pipeline–both a fundamental lack of understanding of the FDA approval process as well as the desperation of patients for whom there are no clear treatment options. I have argued before that Right to Try laws prey on the emotionally fragile. Here the FDA’s controversial accelerated approval may have the same result—patients clamoring for a drug that does not work.

In addition, the cost of the drug will be borne by insurance companies that may well decide not to cover the drug. While the drug is approved for all stages of Alzheimer’s, clinical studies were only aimed at early-stage disease. In effect, the FDA has shifted its responsibility as gatekeeper for effective drugs to insurance companies for whom profit is a driving force.

Drug Cost

The cost of Aduhelm in light of the lack of efficacy data presents its own problems. Biogen has indicated that the average yearly cost of Aduhelm will be $56,000, not including the cost of doctors, hospital or clinic visits, and supplies to receive the infusions, or the cost of brain scans to monitor for swelling and brain bleeds as side effects. This cost, like most drugs, will be passed on to consumers through direct payments, increased insurance premiums, and higher budget expenditures for Medicare and Medicaid. One study reported that if 500,000 people on Medicare are prescribed the drug, it would cost $29 billion per year with copays of over $11,000 per year.

Biogen defends its pricing of the drug. According to its own press release, Biogen “established the price of Aduhelm based on the overall value this treatment is expected to bring to patients, caregivers, and society.” This expected value seems high for a drug that may not work but admittedly reflects normal drug company calculations in a system where insurance covers most prescriptions and the uninsured either do without or rely on the generosity of the drug company.

Because FDA approval is contingent, the FDA can remove the drug from the market if the required data do not show efficacy. However, the money paid for the failed treatment regime will not be refunded. Patients are paying to take this risk.

In the end, the FDA’s approval of Aduhelm will impact the way the agency is perceived, and the way other companies approach the drug approval process. Neither of these changes will be for the better.

Jennifer Carter-Johnson photo

Jennifer Carter-Johnson, PhD, JD, is Associate Dean for Academic Affairs and Associate Professor of Law at the Michigan State University College of Law.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Monday, July 5, 2021. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Pandemic and Endemic COVID-19 Ethics: Lessons from the history of tuberculosis

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

By Karen M. Meagher, PhD

Recent U.S. headlines are starting to reflect a dawning public awareness that health experts have long suspected: COVID-19 might be with us for a long time. In January 2021, almost 90% of coronavirus expert respondents to a poll by Nature considered it “likely” or “very likely” that the virus will continue to circulate somewhere on the globe for years to come. As vaccine rollout continues, the crisis in India has yet again revealed the devastating consequences of pandemic mismanagement. Only two infectious diseases have been successfully eradicated globally: smallpox, and the lesser-known rinderpest. A world in which COVID-19 is endemic might be one that requires long-term public health planning and requires bioethics to recalibrate. The global health and social impact of the pandemic makes COVID-19 challenging to compare to other infectious diseases. However, ongoing multidisciplinary analysis of tuberculosis (TB) provides one demonstration of the possible contributions of bioethics looking forward.

Pandemics as social levelers

A bacterial as opposed to viral infection, TB outbreaks peaked in different places across the world throughout the 1700s and 1800s (Barnes, 2020). During such periods, TB affected people across social strata. Affluent instances of TB contributed to the emergence of social narratives romanticizing TB as a condition striking those with a more sensitive and artistic temperament (Bynum, 2012). Prior to the emergence of germ theory, TB was considered a hereditary condition, running in families with such temperamental proclivities. The notoriety of some TB patients bears resemblance to early celebrity cases of COVID-19 that circulated on social media, normalizing infection while illustrating both recovery and vulnerability. The social and cultural variability of such notoriety is also significant, with India’s highly publicized celebrity suicides during lockdown requiring more analysis to tease apart the mental health impact of COVID-19. Meanwhile, the death of well-known human rights advocates, such as actor Vira Sathidar, from COVID-19 has prompted reflection on the pandemic’s cost to India’s creativity in addition to the devastating loss of life.

Outdoor Play and Tuberculosis print from 1922
Image description: Print from 1922 shows a girl sitting by a window watching children playing outdoors. The title reads “Outdoor Play and Tuberculosis,” with the text: “Outdoor play is as necessary to health as food or sleep. At home, let the children play in the yard or on a well-guarded roof. At school, ample open air playgrounds must be provided. The city that fails to provide public playgrounds may be forced to provide tuberculosis sanatoria.” Image source: public domain/GetArchive.

Hopes for eradication

In the early 1900s, incidence of TB declined as living and nutrition conditions improved, and as populations acquired natural immunity. Some of these improvements were prompted by critiques of industrialization, which contributed to crowded and inhumane living and working conditions (Barnes, 2020).And yet, the same romantic narratives that normalized TB in the affluent also reflected and fostered social indifference to—and scapegoating of—the poor living with TB (Bynum, 2012). The development of effective antibiotic treatment and a childhood vaccine accelerated population health gains in the 1940s and 1970s respectively. The relative influence of economic, political, and biomedical casual factors in driving the decline of TB continues to generate debate across epidemiology and social sciences. Public health gains during this century shaped hopes for global TB eradication.

Rising inequality

However, the 1990s marked a time of increased recognition of resurgent TB across all nations. As with the recent COVID-19 surge in India, a social model of health is needed to account for resurgence of TB. 20th century rates were simultaneously influenced by global policy failure to address health needs of those in poverty, cultural and political events, and new pathogen variants. The rise of HIV and AIDS produced a distinct yet overlapping pandemic, as the immunocompromised are especially vulnerable to TB co-infection. Multidrug resistant tuberculosis (MDR-TB) had been developing alongside use of antibiotics. Medical anthropologist and physician Paul Farmer has been widely critical of global economic policy, which influenced bifurcated standards of care in affluent Western nations and the global south and to the rise of MDR-TB. The moral valence of communities worth investing in is also intertwined with histories of colonialism and ongoing racial and class dynamics that we have seen recapitulated during COVID-19 within the U.S. and globally.

Resistance and its social meaning

Antimicrobial resistance raises a distinct set of ethical issues, from obligations of antimicrobial stewardship to imperatives for drug and diagnostic tool development. The potential for development of COVID-19 vaccine resistance is an ongoing concern. Some fear that SARS-CoV-2 variants have mutations that render them uninhibited by (resistant to) neutralizing antibodies, thereby creating the possibility of “escaping” the immune system response seen in the already infected and/or vaccinated. The development of immune escape is a crucial factor in determining whether COVID-19 becomes endemic. The social implications of pathogen genomics are multifaceted:

  1. First, identification of new variants is now viewed by media organizations as newsworthy, influencing public perception of how outbreaks occur. The history of TB demonstrates that public interest could wane if media organizations in affluent nations lose interest in their novelty.
  2. Second, genomic surveillance illustrates one of the most promising areas of precision public health, requiring ethical guidance for establishing trust, transparency, and community welfare. However, the history of TB demonstrates the continuing global disparities in global health surveillance laboratory capacity.
  3. Third, Emily Martin’s ethnographic work on American understandings of immunity demonstrates the interplay between depictions of the body and pathogens, expert and lay experiences of disease, and social ideals (Martin, 1994). COVID-19 has undoubtedly altered human views of their relationship to microbes and will continue to do so in unanticipated ways.

Economics & TB

Currently, almost one quarter of the world’s population lives infected with tuberculosis. Many have a latent TB infection, which is not contagious. However, if untreated, latent TB can develop into active TB. The World Health Organization estimates that 10 million people fell ill and 1.4 million people died from TB in 2019. India leads the world in TB cases, an often-noted harbinger of its potential role in COVID-19 global health outcomes. The social determinants of health continue to need greater policy attention: 49% of people with TB continue to face catastrophic costs, defined as greater than 20% of annual household income. Drug resistance exacerbates these economic barriers: around 80% of people with MDR-TB face catastrophic costs. The economics of COVID-19 echo these relationships. As I write, members of the World Trade Organization are negotiating details of waiving COVID-19 vaccine intellectual property rights.

  • Black and white photo of a tuberculosis ward of the Hasköy Hospital for Women
    Image description: Black and white photo of a tuberculosis ward of the Hasköy Hospital for Women in the late 19th century. Image source: public domain/GetArchive.
  • A row of empty beds in a hospital ward in Assam, India in response to the 2020 COVID-19 pandemic
    Image description: A row of empty beds in a hospital ward in Assam, India in response to the 2020 COVID-19 pandemic. Image source: AnjanBorah/Wikimedia Commons.

Endemics and social justice

The newly renamed MSU Center for Bioethics and Social Justice is an apt reflection of the shifting role of bioethics, including its attention to matters of population health. Emeritus faculty member Judith Andre notably argued bioethics is best understood as a multidisciplinary practice (Andre 2002). Bioethics practices must change in response to persistent and rising health inequities, including in infectious disease. TB outbreaks have affected community health for millennia, impacting residents of ancient Egypt and Greece. It is Ancient Greek, too, that provides the etymological differentiation between pandemic and endemic infections: pan, meaning “all,” en meaning “in,” and demos meaning “people.” We can sustain hope that COVID-19 will fade into the background, becoming another one of many common childhood coronavirus illnesses that does not confer serious symptoms. However, as this brief glimpse of the ethics and history of TB illustrates, COVID-19 merits distinct ethical analysis to avoid complacency.

Join the conversation

Global eradication of COVID-19 through universal vaccination requires a collective effort on a scale rarely achieved in human history. How do you think bioethics can generate new collaborations to sustain the global response to COVID-19? What values are relevant to you if COVID-19 becomes in the people as well as affecting all of us in this global emergency?

Photo of Karen M. Meagher

Karen M. Meagher, PhD, is an Assistant Professor of Biomedical Ethics Research at Mayo Clinic. Her main research interest is in ethics and social implications of human and pathogen genomics. She also holds the position of associate director of public engagement in which she leads a community engagement network for the Mayo Clinic Biobank in the Center for Individualized Medicine.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, May 27, 2021. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Continue reading “Pandemic and Endemic COVID-19 Ethics: Lessons from the history of tuberculosis” →

If Whole Genome Sequencing is So Cheap and Quick, Why Shouldn’t Everyone Have It Done?

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

By Leonard M. Fleck, PhD

The headline in New York Times Magazine reads: “Scientists can now sequence an entire genome overnight.” This is amazing. It took ten years and $3 billion to do the first mapping of the human genome, all three billion base pairs. Today the entire genome of any individual can be mapped for less than $1000. Why is that important? There are preventative, diagnostic, therapeutic, reproductive, and public health reasons. The public health reasons are most evident with the speed with which all the variants of COVID-19 have been mapped.

Having one’s genome mapped can provide an individual with some foreknowledge of health risks to which they might be vulnerable (always keeping in mind environmental factors linked to inherent genetic risks, also keeping in mind the uncertainty and probabilities associated with the vast majority of health risks identified in this way). The risks of medical harm related to genetic ignorance can be reduced. A family of genes referred to as P450 determine whether we are normal, fast, or slow metabolizers of drugs. If we are fast metabolizers, a normal dose will be metabolized too quickly with diminished effectiveness. If we are slow metabolizers, a normal dose will accumulate to potentially life-threatening levels in some cases. Roughly 7% of 1200 FDA approved medications are affected by actionable germline inherited pharmacogenes. Even more importantly, 18% of outpatient U.S. prescriptions (more than four billion per year) are affected by actionable germline pharmacogenomics.

Whole Genome Sequencing (WGS) can assist future possible parents to determine the best reproductive option if they know they represent specific genetic risks to future possible children, e.g., if each were a carrier for a mutated cystic fibrosis gene. In addition, WGS can be used to make accurate diagnoses of very rare disorders that would otherwise require harmful, invasive, diagnostic odysseys. This will be very important in the context of infants in the NICU or children in the PICU.

A technician who has long dark hair and is wearing safety glasses, a white coat, and purple gloves, loads DNA samples into a desktop genomic sequencing machine
Image description:  A technician loads DNA samples into a desktop genomic sequencing machine at the Cancer Genomics Research Laboratory, part of the National Cancer Institute’s Division of Cancer Epidemiology and Genetics (DCEG). Image source: Daniel Sone/National Cancer Institute/Unsplash.

I remind students that unlike normal medical tests that only yield information about the person who has the test, genetic tests tell us about genetic features of a range of close relatives. Hence, if a genetic test identifies a serious health vulnerability in me, that information can be used to alert other family members of that same vulnerability of which they might otherwise have been ignorant (and which might well be medically manageable before clinical symptoms emerge that might then suggest an irreversible disease process). The therapeutic potential of WGS is most evident today in the case of metastatic cancer. WGS can provide base-pair resolution of an entire tumor genome in a single run, thereby revealing the unique mutations and genomic alterations in the cancer tissue. This will often allow the identification of a targeted cancer therapy, such as imatinib, that targets the distinctive genetic features of a cancer, such as chronic myelogenous leukemia.

In the reproductive context WGS can be used as a non-invasive prenatal screening tool to offer a comprehensive assessment of the fetus. Likewise, WGS could be used at birth as a screening tool to offer a more comprehensive assessment of the infant than the current gene panel, which is only looking for fifty-six rare genetic disorders. This increases the opportunities for timely therapeutic interventions, when available.

Given all these potential therapeutic benefits, what would be the potential ethical challenges? Cost is an issue that raises health care justice problems. Though the sequencing itself costs less than $1000, the analysis, interpretation and counseling bring the cost to $3000 (though in the case of cancer treatment the cost will be $10,000). Few health insurers cover these costs. Should access to WGS then be publicly funded, as a matter of health care justice, perhaps as part of a basic benefit package guaranteed to all? If all 330 million Americans wanted WGS, the cost would be $990 billion. Would that be either a wise or just use of limited health care resources, given all sorts of other unmet health care needs in our society?

One of the main rationales for doing WGS is preventive, i.e., to identify significant health vulnerabilities whose risk of actualization can be reduced by behavioral change. However, the critical question is whether we can be very confident that most patients would commit to the required behavioral changes. Available medical evidence suggests pessimism in this regard, which would imply that WGS with this expectation represented a poor use of social resources. No one believes McDonald’s business plans are threatened by WGS.

If WGS is used to replace current neonatal screening practices, are the privacy rights of newborns put at risk, given later in life genetic vulnerabilities that would be revealed? Would these concerns be mitigated if only medically actionable information were revealed to parents, all other information being set aside until that child reached adulthood? However, what exactly is the scope of “medical actionability?” That child might be vulnerable to some serious genetic disorders much later in life. This would not be a concern for the child as a child. But that child might have older relatives for whom this information would have considerable potential relevance. What are the ethical issues associated with either revealing or failing to reveal that information to potentially “at-risk” relatives?

A very important feature of genetic information gleaned from neonatal WGS (and all WGS for that matter) is that the vast majority of that information will be either of unknown or highly uncertain significance. This will be especially true because of the thousands of mutations that would be part of anyone’s DNA. For parents of a newborn, such uncertainty could be distressing for years and years. However, there is also the uncertainty associated with the responsibilities of primary care physicians in this regard. Who is supposed to have responsibility for tracking changes in genetic knowledge regarding those genetic variations in an individual as medical research advances? And who would be responsible for conveying this new information to parents or adult children, and judging what should be told and when? This is a very complex medical information management problem, relative to which current physician complaints regarding the electronic medical record would fade into insignificance.

Let us assume that WGS is going to be done more thoughtfully and more parsimoniously, such as a diagnostic or therapeutic context where such information would be most useful. What will still happen is the discovery of all sorts of incidental genetic information, sometimes with frightening potential consequences. Imagine this bit of medical dialogue: “Mr. Smith, we were looking for the genetic roots of your heart disease (which we found), but we also discovered your genetic vulnerability to an early-onset form of dementia.” Many patients would not want to know this. How is a physician supposed to know what a patient does or does not want to know in this regard?

Finally, WGS could generate new problems of health care justice. Imagine that the incidental finding in the prior paragraph was a 10% lifetime risk of some serious but treatable cancer. I personally would not be especially distressed by such a finding. However, other individuals might be especially anxious and demand all manner of expensive diagnostic tests on a semi-annual basis to rule out any indications of disease initiation. Would that individual have a just claim to such resources at social expense?

To return to the title of this essay, perhaps the fact that WGS is quick, easy to do, and relatively inexpensive is insufficient reason to justify the promiscuous promulgation at social expense of this technology. Perhaps more thoughtful social and professional deliberation regarding the issues identified in this essay would yield less ethically fraught uses of WGS. Then again there could be the 2030 version of the electronic medical record with room for terabytes of genetic information and thousands of new tabs and subtabs!

Leonard Fleck photo

Leonard M. Fleck, PhD, is Professor in the Center for Bioethics and Social Justice and the Department of Philosophy at Michigan State University.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, May 6, 2021. 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.

More Bioethics in the News from Dr. Fleck: Religious Coercion of Physicians: Whose Conscience Is It Anyway? Health Care and Social Justice: Just Take Two Aspirin for Your Tumor If You Cannot Afford Your Cancer Care; Medicare For All: This Is Going to Hurt; Greed Is God: The Divine Right to Avaricious Drug Pricing; Gene Editing: God’s Will or God’s Won’t

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Human Microchip Implantation: A Bridge Too Far?

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

By Sabrina Ford, PhD

Technology. It invades every corner of our lives and for the most part improves the quality of life. From typing on a flat panel with a little TV screen attached, to a smartphone enabling users to share with others collected data that lives in the cloud. A CT/X-ray image of a C2 spinal fracture (aka Hangman’s Fracture) taken in the middle of the night at a small Midwestern rural hospital is sent to a West Coast spine surgeon, and within minutes, an expert opinion is returned to that rural hospital. Technology is convenient, pervasive, and unavoidable.

In the past 15 years, discussion and related controversy has taken place about a Radio Frequency Identification Device (RFID) or microchip that can be implanted in human bodies. That chip would contain, store, and update data about us. Might such an implant be a benefit or a risk? Some investors are betting on its appeal. The compound annual growth rate (CAGR) from 2020-2027 of the healthcare microchip is expected to grow by 22% and be valued over $6.4 million by 2027. RFID microchips (herein referred to as microchips) are already used for many things from your credit/debit card, to those efficient logistics used to move your Amazon package.

Illustrated cyborg eye with electronic circuits
Image description: An illustrated cyborg eye with electronic circuits. Image source: jemastock/Vecteezy.

Getting to the bridge

Implanted microchips are a terrifying idea to some of us—sufficiently frightening to harken images of robots and androids—the stuff of science fiction. For some of us, implanting something foreign in our bodies for the management of big data and convenience is disturbing. Another concern might be the potential breach of privacy and the surveillance of our daily life. If the chip contains medical, personal, social information, and GPS data, could we lose all autonomy? Do we maintain our autonomy if, with sufficient information, we consent to the decision? What will all the information be used or misused for? What if our employer, insurer, or a government entity decides to check on us?

These questions raise other concerns about autonomy. Enough employers considered compulsory microchips for their employees that in 2020, Michigan and several other states introduced and passed bills designed to prevent employers from forcing employees to accept microchip implants. This pre-emptive strike was against a growing technology, utilized perhaps to track safety, productivity and movement. As with many things in the United States, some vulnerable employees with microchips might be targeted, either unintentionally or intentionally, thereby putting them at further economic and social disadvantage.

Some have already crossed the bridge

It is estimated that currently approximately 10,000 people in the world have implanted microchips. Perhaps that doesn’t sound like many, but if investors are hedging their bets correctly, the technology is on its way to widespread adoption. A large number of those “cyborgs” reside in Sweden and employ the technology not for health care reasons, but instead use microchip implants to unlock their car doors, buy a coffee, or swipe into the gym. That rate of chip adoption makes sense in a society like Sweden, which is the second most cashless society (after Canada) in the world.

Photo of microchip being held between two fingers
Image description: A photo of an RFID implant held between two fingers. Image source: Dan Lane/Flickr Creative Commons.

Many argue that an RFID tag and implanted microchips can increase cybersecurity. Not being able to log into your computer without first swiping into the building and into your office door might offer a level of comforting protection against physical hacking in the workplace. In addition, many in healthcare delivery believe medical mistakes would be greatly reduced and quality of care increased if our medical charts were loaded on microchips, monitoring disease states like heart disease and diabetes, improving management of medications, and reducing surgical mistakes. If, with microchips, first responders or doctors had real-time access to accurate medical information there is potential to save lives in medical emergencies. The HITECH Act—or Health Information Technology for Economic and Clinical Health Act—calls for the interoperability of electronic health information for privacy and safety of the patient. As it is now, it doesn’t make sense for an individual to have different electronic health records in a number of physician offices. If our world were to be efficiently hyperconnected, one can argue that everyday life could be improved and streamlined.

A bridge too far

But would it be? We are covered, watched, followed, and violated through our digital footprint on a daily basis. Perhaps not necessarily with microchips, but pause to consider your actions today. You took your morning walk as public cameras captured your movement down the block, into the convenience store for a cup of coffee, where you used your debit card or smartphone to pay for the transaction, and that transaction was caught on the store camera. You then check your fitness wearable for heart rate, steps, route, and all that other good stuff. Later, you swipe in and out of the building as you stop into your office for a few hours, in and out of several doors, and log on to your computer—accessing various applications in the cloud—all the while answering your email and checking your calendar. Later in the day, you visit your doctor, either in person or via telemedicine, and she enters your ailments, diagnostic tests ordered, and electronic prescriptions into the electronic health record. As you wind down for the evening you make your market list in your favorite grocery store app, use your smart television to access your favorite shows, and access your books on a reading app. All of this is accomplished in the cloud, and on the “grid” in huge databases. Is this trek through the digital world so much different than a microchip that holds your digital footprint? You’ve left a day’s breadcrumb trail on almost every aspect of your life, and not even as consciously as Hansel and Gretel. As for implants in general, clearly Americans accept them, as witnessed by artificial joints, IUDs, cochlear implants – and don’t forget about those implants for hair and breasts.

Over the bridge

The described dilemma is that implanting a chip has the potential to be a violation of rights, yet the chip might equally offer safety and convenience. The implantable microchip is not fully developed and has a long way to go, but the technology is on its way. Microchips today are not sufficiently powerful to collect and communicate big data or to follow us all over the world the way our smartphones do. As with most technologies, the tipping point for implantable chips will come when they become so very useful that they’re simply hard to refuse.

ford-sabrina-2020

Sabrina Ford, PhD, is an Associate Professor in the Department of Obstetrics, Gynecology and Reproductive Biology and the Institute for Health Policy in the Michigan State University College of Human Medicine. Dr. Ford is also adjunct faculty with the Center for Ethics and Humanities in the Life Sciences.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Tuesday, March 16, 2021. 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.

More Bioethics in the News from Dr. Ford: COVID-19 Vaccine: “Not throwing away my shot”; Contemplating Fentanyl’s Double Duty

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Lessons on eating in a pandemic

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

By Megan A. Dean, PhD

Though COVID-19 is not a food-borne illness, the coronavirus outbreak has drastically changed the way many of us eat. According to one survey from mid-2020, 85% of people in the U.S. “have altered their food habits as a result of the pandemic.”

Image description: Restaurant operating during the COVID 19 pandemic has a sign posted: “Please wait outside until your name is called, or if you received a text message. Thank you!” Image source: thom masat/Unsplash.

While the bare supermarket shelves of early March have been replenished (except for the bucatini shelf, apparently), many are still struggling to get adequate food. An estimated 54 million people in the U.S. now face food insecurity, “the disruption of food intake or eating patterns because of lack of money and other resources.” This is an increase of over 17 million since the start of the pandemic.

Another change is where people eat and with whom. Restrictions on indoor dining and shifts to online work and school mean that many are cooking and eating at home more often than before. Stay-at-home orders, gathering restrictions, and the closure of dining rooms in workplaces and institutions also mean that many are limiting their dining companions to those within their own households. For some, this means eating alone. For example, in summer 2020, 87% of nursing home residents ate most of their meals in their rooms alone, up from 32% prior to the pandemic.

Emotional or stress eating is also on the rise. It may come as no surprise to those of us who have endured 2020 and the first few weeks of 2021 that many are using food as “a way to suppress or soothe negative emotions, such as stress, anger, fear, boredom, sadness and loneliness.” These are just a few of the ways the pandemic has impacted eating in the U.S., but each offers lessons about some of the ethical challenges we face regarding food and eating.

Who stays hungry?

In the U.S., many of those who face food insecurity are children: 30 million children regularly rely on schools for free or reduced-price meals. But due to pandemic-related school closures, only 15% of eligible kids are now receiving these meals. As Cory Turner notes, many school districts have shifted to a meal pickup plan, but lack of transportation and time off from work mean that some caregivers cannot retrieve meals during scheduled pickup times. While some school districts have made creative efforts to distribute meals in other ways, many children go without.

These logistical challenges echo ongoing issues with the distribution of other goods and services essential to good health. Mitchell Katz argues that the U.S. health care system assumes that patients are middle-class; accessing medical care often requires reliable transportation, time off during working hours, or paid sick leave, which many working-class people simply do not have.

Image description: People wearing gloves and face coverings work to package food into plastic bags for distribution. Image source: Joel Muniz/Unsplash.

Like health care, food assistance is only helpful if it is accessible to those who need it. Emergency food benefits programs like the Pandemic EBT give eligible children’s caregivers much more flexibility, enabling them to purchase groceries on their own schedule. However, only six states and Puerto Rico have renewed this program for the 2020-2021 school year.

The value of eating

Asked to look ahead to 2021, many people said that when it comes to food, they were most excited to once again share meals with family and friends.

This desire for shared dining highlights the fact that eating is a rich source of value that extends far beyond nutrition, pleasure, or ostensible effects on body weight, whatever those New Year’s diet ads try to tell us.

There is social value in sharing a meal with coworkers, friends, or neighbors; cultural value in holiday meals, wedding feasts, funeral receptions, graduation toasts; aesthetic value in enjoying food and drink in the ambiance of a restaurant, café, or bar. Eating with others can also have moral value; it provides opportunities to show respect for others, build moral character, and establish moral community.

Some of this value can be found in eating at home. But for many, foregoing meals with friends, dates, colleagues, and loved ones has impoverished day-to-day life. This is not an argument against public health restrictions on dining; there are good, evidence-based reasons for many of these regulations (though more should be done to support restaurants and food service workers while indoor dining remains high risk). But acknowledging these losses enables us to mitigate them where possible, and where not, at least recognize they are worth mourning.

Eating and self-control

A final lesson can be learned from emotional eating, which is often framed as a lapse in self-control, “giving in” to cravings for unhealthy but comforting foods. I have argued elsewhere against the idea that such “mindless” eating is necessarily bad. Here I’ll highlight one way that pandemic-related increases in emotional eating point to the limited role of self-control in determining how we eat.

Image description: A person is sitting down eating a bowl of popcorn with a remote in their other hand. Their face from their mouth up is out of frame. Image source: JESHOOTS.COM/Unsplash.

For many, the pandemic has meant the collapse of eating routines and schedules alongside significant changes in physical proximity to food. Instead of having access to food only in the work lunchroom or on scheduled breaks, some people now work all day next to their refrigerators. Parents who would normally spend the school day working, running errands, socializing, or exercising, may spend much of their day in the kitchen preparing food for their kids.

As Quill R. Kukla puts it, our routines, schedules, and social and material surroundings constitute scaffolding for our actions. They constrain and enable what we do. When we are able to exercise self-control or agency, it is often because we have supportive scaffolds in place. So it’s entirely unsurprising that we eat differently when our daily structures of living have changed so radically. Recognizing this can help us avoid unjustly shaming ourselves and others for our eating, and also help us strategize more effectively about how to change that eating, if we so desire. It is important to acknowledge that now—as always—our ability to construct and inhabit supportive scaffolding is limited by work and family obligations, resources, living situations, and the like. And as many of us have learned over the past year, sometimes much of that is out of our direct control.

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Megan A. Dean, PhD, is an Assistant Professor in the Department of Philosophy at Michigan State University. She works in feminist bioethics, with a focus on the ethics of eating.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Tuesday, February 4, 2021. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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Continue reading “Lessons on eating in a pandemic” →

CRISPR Dangers Highlight the Need for Continued Research on Human Gene Editing

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

By Jennifer Carter-Johnson, PhD, JD

The excitement and potential of CRISPR to treat severe genetic conditions by editing disease-causing DNA has taken an unexpected hit. A recent Wall Street Journal article highlighted the unexpected results from a CRISPR study in which attempts to edit a human gene responsible for blindness resulted in the loss of the entire chromosome from the cells in the embryos. These results echo another study conducted in human cell lines published earlier in 2019.

CRISPR is a targeted gene editing process that allows scientists to direct genetic modifications with far more precision than prior procedures. CRISPR has been touted as a gigantic leap in the ability to modify DNA by creating or repairing pinpoint DNA mutations without affecting other areas of the chromosome on which the gene resides. The recent study indicates that the technique might not be as straightforward in humans – and thus neither will be its use to fight disease.

Blue DNA double helix puzzle with missing pieces
Image description: A partially assembled puzzle that is an image of blue double helix DNA molecule structures. Image source: Arek Socha/Pixabay

CRISPR Technology – Promise and Problems

The value in CRISPR mediated genetic modification can be seen in a wide variety of biotechnology products, such as genetically modified crops and new biologics. But perhaps the most exciting and most controversial potential for CRISPR can be found in the desire to modify embryonic genomes to remove genetic abnormalities for which we currently have no cure.

This promise of embryonic gene editing is appealing not only because it would remove the condition from the child born from the gene-edited embryo, but also because the offspring of that child would also be free of the condition. CRISPR gene editing – because it is done at the embryonic stage – creates germline mutations that are passed to future generations. In a therapeutic use of CRISPR, those mutations would be cures for often untreatable diseases.

However, it is this very promise that raises many of the problems with CRISPR embryonic gene editing. Much debate has surrounded embryonic gene editing. Until this recent news, there were fears that CRISPR may make gene editing too easy. The technological development of CRISPR in embryonic gene editing is moving at a breakneck pace as scientists around the world are working on procedures. Biohackers work in their garages and livestream the use of CRISPR to edit their own genomes.

Many are debating which genes should be targeted and how fast the research into actual trials should proceed. Most agree that severe diseases would be the best place to start, but should the technology be deployed for cosmetic benefits such as eye color, or diseases for which a treatment exists? The dangers of CRISPR editing are unclear, and there has been an informal moratorium on the use of the technology to create children. Despite that, there has been at least one rogue scientist who has created genetically modified embryos and brought them to full term birth.

International Policy on Human Gene Editing

The scientific research is not occurring in a vacuum. Each country decides how CRISPR can be used in its medical system – both when the technique is safe enough and on which diseases it should be used.

An international commission recently pronounced that the technology is not ready for clinic implementation because scientists don’t understand the full safety issues surrounding its use in human embryos. The commission described some of the potential clinical uses in the future and outlined a basic safety protocol for approval.

One of the creators of CRISPR, Jennifer Doudna, has also spoken out against applying CRISPR too hastily to embryonic gene editing. 

Based on the recent studies showing loss of chromosomes, the international commission and other scientists are correct to call for a moratorium on clinical embryonic gene editing.

Blue and green DNA double helixes and binary code
Image description: An abstract image of blue and green double helix structures and binary code (zeros and ones) against a black background. Image source: Gerd Altmann/Pixabay

CRISPR – The Path Forward

The setback in CRISPR gene editing does not mean that the technology and research should be discarded. The potential to change lives is too great; however, the dangers of use with our current understanding are even greater. So how do we move forward with CRISPR in embryonic gene editing? The answer must include balance – in research strategies and in voices.

While the technology is not ready for clinical use, and we have not yet determined which uses would be appropriate if it were available, the science should not stand still. The research surrounding CRISPR gene editing will yield insights into human biology that we cannot predict. For example, the loss of chromosome length in human embryonic cells undergoing CRISPR treatment seems to be different than the response of other species of embryonic cells. And debates about the appropriate use of the technology will allow us to discover more about ourselves as humans. 

As we debate the best way to develop and deploy CRISPR technology, we should look to a variety of stakeholders. Scientists have a solid track record in understanding when recombinant DNA technology has potentially hazardous implications. In the 1970s, the Asilomar Conference allowed scientists to put together research guidelines that allowed the technology to be developed without harming public health. In fact, the international scientific consensus not to use the technology such as described above indicates that scientists are beginning that work. Such a moratorium on clinical uses gives us time to understand how to deploy the technology in the safest manner.

Additionally, there is a role for the voices of the patients whose lives could be changed by the technology. Patients may not be in the best place to judge when the technology should be deemed safe enough to deploy, but they certainly will have input about which mutations cause hardships that merit the risk of germline editing. Many of these patients already work with scientists on potential treatments for their diseases. CRISPR discussions may open another avenue for many.

Finally, there is a role for legal regulation of the use of CRISPR. Governments should listen to the voices of scientists and potential patients in drafting these regulations. But as shown by the example of at least one rogue scientist, there needs to be teeth to the moratorium on CRISPR clinical use at this time. CRISPR and its use in human gene editing raise complicated issues and hold great promise as a powerful tool to defeat genetic diseases. The development of those technologies will not be straightforward or without risk and will require more basic science research to achieve clinical efficacy. But with proper planning, we may learn more about ourselves as humans on the path to a cure.

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Jennifer Carter-Johnson, PhD, JD, is Associate Dean for Academic Affairs and Associate Professor of Law in the Michigan State University College of Law. Dr. Carter-Johnson is a member of the Michigan State Bar. She is registered to practice before the U.S. Patent and Trademark Office.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Tuesday, December 15, 2020. 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.

More Bioethics in the News from Dr. Carter-Johnson: Biohacking: How a DIY Approach to Biology Can Shape Our Future; Web of Interests Surrounding Medicines Makes Patient Access Increasingly Difficult; Humanity in the Age of Genetic Modification; Defining The Spectrum of “Normal”: What is a Disease?; Dawn of False Hope: Spread of “Right To Try” Laws across the U.S.

Continue reading “CRISPR Dangers Highlight the Need for Continued Research on Human Gene Editing” →

The White House outbreak: How to criticize irresponsible leaders without getting stuck in the illness blame game

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By Sean A. Valles, PhD

In a twist of fate, there was an outbreak of COVID-19 at a White House celebration of the nomination of Amy Coney Barrett for the Supreme Court of the United States. This elicited a wide range of reactions to seeing a gathering of opponents of strict COVID-19 control measures being hurt by the very pandemic they have downplayed. While others have worried about the moral philosophy of taking pleasure in others’ suffering, or the hypocrisy of evading rules one publicly espouses, I have a different worry. A poll shortly after the White House outbreak found that a majority of respondents believed that Trump had acted “irresponsibly” in how he had handled his personal risk of infection from people he interacted with. While I do not worry about the president being blamed for his illness, I do worry about the wider cultural practices of 1) victim-blaming by attributing a person’s illness to their personal moral failure, and 2) insisting that health is a matter of individual choice. While the distinction might not seem important at first, I will argue there is an important difference between victim-blaming the ill and holding leaders accountable for setting bad examples with their conduct and other leadership failures. The first kind of blame is toxic in a society, and the second kind of blame is an important part of a well-functioning democracy.

President Donald Trump in the Oval Office nominating Amy Coney Barrett to the Supreme Court
Image description: President Donald J. Trump and First Lady Melania Trump pose for a photo with Judge Amy Coney Barrett, the President’s nominee for Associate Justice of the Supreme Court of the United States, her husband Jesse and their children on Saturday, Sept. 26, 2020, in the Oval Office of the White House. Image source: Official White House Photo by Andrea Hanks.

Blaming people for their ill health is a strategy with an awful track record. It doesn’t do any good for the people subjected to “you’re too fat” messages. It doesn’t do any good for survivors of sexual assault or domestic violence. When directed inward, we self-blame for failing to do enough de-stressing self-care, rather than directing our blame to more appropriate targets like the needlessly bad working conditions or economic insecurities that make us stressed in the first place. Repeated messages that “sickness is the result of individual moral failure” also reinforce stigma. Stigma is a nasty phenomenon, with a “corrosive impact on the health of populations” and is particularly bad in cases of infectious diseases like COVID-19 because it actively encourages people to hide their infection, which is obviously bad for them and for others who interact with them.

A second problem with blaming people for their ill health is that ethics of blaming individual behavior reflects a misunderstanding of how health behavior works in the first place. Seemingly individualistic choices like diet, condom use, smoking, alcohol consumption, etc. are not made independently. We choose such things in roughly the same way we “choose” our religions or the languages we speak at home. Yes, each of us can choose to practice an entirely different religion (or lack thereof), and each of us can learn and use a different language in the home. Some of us do. In all of these cases, though, the vast majority of us don’t venture too far from a combination of what we learned while growing up and the cues we get from the people we interact with. We eat the foods familiar, convenient, and affordable to us. We adopt the values and beliefs (including trust in aspects of the scientific endeavor) of our communities, etc. Individual choices exist, but they exist within larger social contexts that have powerful but subtle effects on our choices.

Each of our everyday behaviors related to COVID-19 exist in a complex ecosystem of influences. Mask wearing and other social distancing measures have become intensely politicized and tied to masculinity. Masks and other health behavior measures also create new inconveniences and financial expenses. Social pressures also vary vastly from one setting to the next—in one store there are prodding questions and judgmental stares for wearing a mask, at an adjacent store there are similar pressures on those who don’t wear a mask. How we move our bodies and (un)cover our faces within these intense social pressures is not simply an individual choice.

Take the case of one of the attendees of the party at the White House, University of Notre Dame President, the Rev. John I. Jenkins. He did not wear a mask at the indoor/outdoor party, shook hands with attendees, and otherwise did not follow the standards he had imposed on members of his own university. He knew better and did not do better. Many of us have likely also gone against our better judgment to fit the incautious social distancing norms of a setting. Whether it is the university president or the university student, this is indeed hypocritical, and irresponsible in a sense. But, such blame is aside from the point, and more importantly it contributes to the sort of harmful cultural practices mentioned earlier—especially victim-blaming and stigmatizing the ill. Pointing out hypocrisy and the assigning of blame for individual health behavior distracts from the far more damaging thing Jenkins and the other leaders at the White House party did. As cultural leaders, they undercut efforts to build new norms, like public mask-wearing, the habit of greeting people without needlessly touching hands, etc.

We ought to blame Trump, Jenkins, and many other leaders who attended that party. We ought to blame them for failing in their relationships to the people they lead. That is a devastating form of irresponsibility. And it is very important to separate that kind of blame and irresponsibility accusation from the destructive form of blame discussed above: blaming people for having irresponsible relationships with their bodies/health.

The “personal responsibility” blame game has been the go-to talking point of conservative governors as they use their power to obstruct or dismantle public health measures. “You shouldn’t have to order somebody to do what is just in your own best interest and that of your family, friends and neighbors,” according to Alabama Governor Kay Ivey. Scolding people about “personal responsibility” during a public health crisis is a strategy based on how one wishes the world worked and not how it is actually working. Along similar lines, abstinence-only sex education doesn’t work (“teenagers: be sexually responsible by just not having sex before marriage!”), and neither does “just say no to drugs” education. Jenkins was at least right to point out that his behavior was a failure of leadership. As many of my colleagues in population health science say, we need to build a “culture of health.” That will require leaders suited to the task, and we ought to blame them when they fail in that leadership. Just skip the personal health blaming.

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Sean A. Valles, PhD, is an Associate Professor with an appointment in the Michigan State University Lyman Briggs College and the Department of Philosophy (where he is also Associate Chair). His research spans a range of topics in the philosophy of population health, from the use of evidence in medical genetics to the roles played by race concepts in epidemiology. He is author of the 2018 book Philosophy of Population Health: Philosophy for a New Public Health Era. He is also co-editor (with Quill R. Kukla) of the Oxford University Press book series “Bioethics for Social Justice.”

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, November 5, 2020. 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.

More Bioethics in the News from Dr. Valles: We Need Healthier Schools, and Student Activists Are Stepping Up; Recognizing Menstrual Supplies as Basic Health Necessities: The Bioethics of #FreePeriods; Trump’s Attempt to Reignite the Coal Industry Is Another Health Policy Blunder; Politics and the Other Lead Poisoning: The Public Health Ethics of Gun Violence; Climate Change and Medical Risk

Continue reading “The White House outbreak: How to criticize irresponsible leaders without getting stuck in the illness blame game” →

A COVID-19 Vaccine Won’t Stop the Pandemic

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By Parker Crutchfield, PhD

As the COVID-19 pandemic continues to maim and kill thousands and devastate countless others, many are pinning their hopes of returning to a life resembling normal upon the development of a vaccine. The Centers for Disease Control and Prevention has even advised states and cities to be prepared to allocate up to 800 million doses of a vaccine in late October or early November. But it is highly unlikely that a vaccine will do much to stop the pandemic and related significant harm. For a vaccine to get us out of the pandemic, it needs to be developed, distributed, and received. Regardless of its development and distribution, if people don’t take it, then it won’t do any good. And there isn’t much reason to think that many people will take it, at least initially.

Image description: an illustration of a bottle with a white label that says “COVID-19 Vaccine” in black text. The bottle is different shades of blue with a dark blue background. Image source: Shafin Al Asad Protic/Pixabay.

Allocation Models

Recently, a team of scholars advocated for a scheme to allocate the eventual vaccine, the Fair Priority Model. This model, like most models of allocation, assumes that the vaccine will initially be scarce. On this assumption, the allocation then proceeds in phases, the first preventing the most significant harms such as death, the second preventing other serious harms and concomitant economic devastation, and the third addressing community transmission. Other models may set different priorities by, for example, putting health care workers or racial and ethnic minorities first in line.

Developing allocation models is important. But they all rest on a questionable assumption: that the people to whom the vaccine is allocated actually want it, or are at least willing to take it. Scarcity is just as much a matter of demand as it is a matter of supply.

Demand for a Vaccine

Recent evidence suggests that, generally, people won’t take the vaccine initially, even if offered. Almost 80% of people said they wouldn’t get it, if available, at least until others have done so, according to a recent CBS News poll. A return to something resembling normal life requires around 70-80% of the population to be immune.

Mistrust of the politicization of vaccine development or of the scientific practices involved may be responsible for much of the population’s apparent hesitation. But reasonable people may also simply not want to be first in line for a new immunity enhancer. Thus, whatever criteria are used, the allocation scheme must incorporate consideration of demand, not simply supply.

For example, the first allocation according to the Fair Priority Model should go to those people whose being vaccinated would most likely prevent death and who want the vaccine. If the vaccine is allocated to health care workers, the allocation must be to people who are health care workers and who want the vaccine. That is, demand for a vaccine should be just as much a component of allocation models as any other consideration.

Voluntary or Compulsory?

Allocation models must consider the population’s demand for a vaccine in order for such models to provide useful guidance on distribution. Given the apparent lack of demand, giving people the choice of whether to take the vaccine is unlikely to stop the pandemic any time soon. But demand only matters if people have an option. One way to avoid having to consider the population’s willingness to take the vaccine, and to dramatically decrease the time it takes to boost 70-80% of the population’s immunity, is to take that willingness out of the equation and make it compulsory.

Already some vaccinations are compulsory, depending on a person’s circumstances. Some have argued that the COVID-19 vaccine should be mandatory. One common principle in philosophy is that ought implies can. This means that what one’s moral obligations are hinges on what one can do. Even if one can justify compulsory COVID-19 vaccination, it’s unlikely that this is something that can be achieved. Compulsory vaccination is not something we can do, which means it’s not something we should do.

Consider, for example, the widespread reluctance to wear a mask and the flouting of social distancing guidelines. Wearing masks and social distancing are very minor burdens to bear for others’ well-being. While it is true that mask and social distancing mandates push against unrestrained permission to do what you want when you want to do it, others be damned, these intrusions are arguably minor (though are admittedly disruptive). Requiring 70-80% of the population to go someplace and get poked by a needle on multiple occasions or sprayed in the nose are much greater liberty intrusions. It is a pipe dream to think that a vaccine mandate would be accepted by the very same population who refuses to bear the more minor burdens of mask wearing and social distancing, which amounts to at least 29% of the population, enough to undermine our ability to stop the pandemic.

Different Baskets for Our Eggs

If administration of the COVID-19 vaccine is voluntary, not enough people will volunteer to get it. If administration is mandatory, still not enough people will get it. The vaccine’s allocation can only be either voluntary or mandatory. Either way, not enough people will get it, at least at first. The only conclusion to draw is that a vaccine is not going to stop the pandemic, at least any time soon. If ought implies can, we ought not pin our hopes upon a vaccine, because we cannot hope for it to work to stop the pandemic. There is no light at the end of the tunnel.

Image description: a narrow tunnel between two brick walls that leads to darkness. Image source: Peter H/Pixabay.

However, incentives and disincentives can change a person’s mind. Other than the incentive intrinsic to getting the vaccine—the preservation of human life and well-being—are there others that might make people more willing to get it, such as money or tax breaks? Or are there disincentives to vaccine refusal that might convince someone it is better to get it than it is to refuse? Carrots or sticks?

If neither, then we’re in for the long haul.

Parker Crutchfield photo

Parker Crutchfield, PhD, is Associate Professor in the Program in Medical Ethics, Humanities, and Law at the Western Michigan University Homer Stryker M.D. School of Medicine, where he teaches medical ethics and provides ethics consultation. His research interests in bioethics include the epistemology of bioethics and the ethics of enhancement, gene editing, and research.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, October 8, 2020. 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.

More Bioethics in the News from Dr. Crutchfield: Trust and Transparency in Quarantine; Public Health Crisis Warrants Liberty Restrictions; We Should Tolerate and Regulate Clinical Use of Human Germline Editing

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“There’s no proof that anything works!” The ethics of COVID-19 research

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By Robyn Bluhm, PhD

The New York Times Magazine recently published a long-form story about the tension between treating patients with COVID-19 by any means that might improve their chances of survival and recovery, and enrolling them in clinical trials to establish the safety and efficacy of these treatments, thus improving care both for future patients and for those who survived the trial. As with many stories about health care in the current pandemic, this article both raises perennial issues in bioethics and shows them in their starkest form: the seriousness of the condition of these patients and the lack of knowledge about how best to help them mean that the ethical dilemma described in the story is particularly clear. But a closer look at work in bioethics and the epistemology of clinical research suggests that, while the dilemma is clear, there are more ways forward than the two incompatible ways portrayed in the story.

The story begins by describing the clash between a critical-care physician faced with a COVID-19 patient whose condition was worsening, and a researcher who had enrolled that patient in a clinical trial. The former wanted to give the patient a higher-than-standard dose of the anticoagulant she was being treated with, even though this might mean that she would need to be withdrawn from the trial. The latter advocated for the importance of maintaining the integrity of the study, saying that acting on instinct instead of on evidence “was essentially ‘witchcraft’.”

Unsurprisingly, this characterization did not go over well with the other doctors in the meeting. A less contentious way of describing the situation might have been to say that, while doctors use their clinical judgment to make decisions about how best to use available evidence in caring for a particular patient, this only works when there is evidence available. And everyone agrees that, in the case of COVID-19, there is horrifyingly little evidence. This means that enrolling COVID-19 patients in clinical trials is not depriving them of standard care (care that such patients would ordinarily receive if not in the trial)–standard care for this condition does not yet exist.

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Image description: An illustration of a health care worker wearing blue scrubs, head covering, and face covering. Surrounding them are a stethoscope, face mask, syringe and surgical tools, thermometer, and microscope. The background is light pink. Image source: sunshine-91/Vecteezy.

There is a lot to think about here. Importantly, it’s not the case that the doctors treating seriously ill patients had no idea what to do. They had a wealth of experience treating patients with severe viral infections, with acute respiratory distress syndrome, with cardiac arrest, or with pathological immune reactions (the “cytokine storm” sometimes seen in chemotherapy patients). Some of this knowledge informed the care of early COVID-19 patients, raising the question of which treatments could be successfully generalized to this new patient group.

The notion of generalizable knowledge is in fact central to research ethics. The Belmont Report, which guides research ethics oversight in the United States, draws a bright line between research and clinical practice on the basis of their ostensibly distinct goals. Research aims to provide generalizable knowledge, while clinical practice aims to benefit an individual patient. This way of drawing the distinction meant that when physicians depart from standardly-accepted care in the treatment of an individual patient, it does not count as research (and therefore does not require ethics review). It also leads to the problem described above: enrolling a patient in a research study requires that they forgo their right to individualized care and are treated according to study protocol. Deviations from the protocol, such as the one described in the opening of the New York Times story, are prohibited. Patients whose care does not follow the protocol will usually be withdrawn from the study.

But this sharp distinction between research and practice also makes assumptions about the kind of clinical research being conducted. Schwartz and Lellouch (1967) distinguish between “explanatory” and “pragmatic” approaches to clinical trials. Explanatory trials are designed to minimize the influence of any factors, other than the experimental therapy, that could affect the outcome being measured. These other factors include additional medications and the presence of comorbid disease. Pragmatic trials, by context, are designed to resemble actual clinical practice, where patients often take more than one medication and often have more than one health problem. Pragmatic trials may also enroll a wider variety of participants (especially older participants), permit alterations in the study protocol, be more flexible in the timing of outcome measurement; in general, they are more flexible in their design and analysis. A given trial will fall somewhere on the spectrum between “highly explanatory” and “highly pragmatic” in its design.

In the case of COVID-19, there are good reasons to favor trials that are more pragmatic. First, there are so many factors that might affect prognosis (or were previously thought to do so) – age, gender, weight, blood type, various pre-existing conditions – that the study population cannot be narrowly defined. If it is, then the results of the study will apply only to people in that narrow population. Second, care for critically ill patients is rapidly developing. Even in the absence of an established drug regimen, survival rates have been improving. This means that by the time a trial is completed, the experimental therapy will be implemented in a very different context of care. Perhaps more importantly, because of these first two reasons, a strict, explanatory trial is less likely to give generalizable knowledge than a more pragmatic one (Bluhm and Borgerson, 2018). Research that reflects clinical practice is more likely to be useful in improving clinical practice.

Robyn Bluhm photoRobyn Bluhm, PhD, is an Associate Professor with a joint appointment in the Department of Philosophy and Lyman Briggs College at Michigan State University. She is a co-editor of The Bloomsbury Companion to Philosophy of Psychiatry.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, September 3, 2020. 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.

More Bioethics in the News from Dr. Bluhm: Philosophy, Mental Illness, and Mass Shootings; “Ask your doctor” – or just check Instagram?; Antibiotics: No Clear Course; To Floss or Not to Floss? That’s not the question

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Women cannot afford “nice”: The unpaid labor of gendered caregiving

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By Karen Kelly-Blake, PhD

“Caring for myself is not self-indulgence, it is self-preservation, and that is an act of political warfare.” -Audre Lorde

Much has been written about finding meaning in illness. Others have written about finding meaning in caregiving. But taking care of someone else’s s!#t has its own intrinsic meaning, and for much of the time, it’s not all good.

For some, doing this work may allow them redemption—to repent for past wrongs, or it might allow them to display their humanity in ways they have not done before. Some may experience joy with self-sacrifice. I wish you well. Amid the crucible, women are performing all sorts of gendered work, and especially gendered care work. What do I mean by that? Women perform the majority of caregiving work to family and friends, i.e. women are the ones taking care of someone else’s s!#t. This work is unpaid, labor intensive, and career limiting if not career destroying.

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Image description: An illustration of a faceless woman with six arms, each arm holding objects that represent a particular set of tasks: correspondence, computer work, food, entertainment, cleaning, and childcare. Image source: Multitasking Vectors by Vecteezy.

Care work offers few rewards, but it is necessary, and it is often silently expected of women. Unpaid labor that diminishes or denies opportunity for growth and sustenance is unfair, unjust, unsustainable, and wrong. Caregiver resilience may be a thing but is most likely a statement of privilege. Women do the work to the detriment of self-care, careers, outside friendships and interests, and other family relationships. Un- and under-paid gendered care work is a real and present danger to the overall wellbeing of women. As a society, we cannot keep telling women that this kind of gender discrimination in care work, especially for their family, is okay. It is not okay. Women must acknowledge all the ugliness that comes with taking care of someone else’s s!#t—the resentment, anger, frustration, disappointment, loss, fear, disgust, exhaustion, defeat.

So, who will do this work?

Dare I say, salaried home health assistants with all the benefits afforded fully employed persons—health insurance, retirement, educational assistance, PTO, etc. BUT then, who will do that work? Women, and more specifically women of color and immigrants. Whether women do it as unpaid family labor or as salaried health aides, women do care work. It may be reasonable to assume that the salaried worker may be better able to handle the emotional demands of the work. The unpaid family care worker is burdened with history, regrets, slights, insults, lies, disappointments, unforgiven and unforgivable acts, whereas the salaried care worker is not burdened with that baggage, and thus, may be a better and perhaps even a more caring caregiver. Absent the burden and weight of historical relationship bonds, women—as daughters, sisters, spouses, and mothers—may be able to find meaning in just being themselves.

Although the inequity of gendered work has always been there, the COVID-19 pandemic has shed revealing light on this inequity, just as it has on racism. Women are performing job duties remotely from home, becoming teachers, chefs, activity directors, housekeeping staff, laundry workers, and of course the calm in the storm, etc. Working the second shift does not go far enough in describing that reality—women hold on average about 100 jobs that are unpaid! These jobs historically have been the purview of women, but gendered work in the home is the cause of much friction in marriages. Moreover, women are balancing care of children with the care of parents, at times both their own and those of their spouse. Those women fortunate enough to retain their jobs and work remotely were immediately immersed in work that was unfamiliar and, in many cases, unwanted—24/7 care and attention to children, spouses, and others. For those caring for the ill, the disabled (mentally, physically, or cognitively), or the aged, or any individual with any range of functional and psychological limitation, the pandemic significantly increased the workload. Many people do this care work because they want to, out of whatever love and obligation they have for the care receiver. For others, there is no one else to do the work and it may feel, and indeed be, life limiting. Engaging in this work during a pandemic is especially challenging.

Oftentimes, a crash course in highly technical aspects of care (flushing ports, inserting feeding tubes, cleaning wounds, managing LVADs, etc.) leaves one completely bewildered. This disjuncture between necessary specialized care exposes the schism in care work that overwhelms and burdens.

Photo of woman on the floor with hands over her face
Image description: Image description: A woman sits on the floor leaning against the back of a couch. Her elbows are resting on her knees with her hands clasped together over her face, eyes closed. Image source: Pixabay.

Because of shelter-in-place orders, the pandemic has also heightened concerns about domestic violence, child abuse, elder abuse, and alcohol and substance use disorders. We consequently will need to ramp up behavioral health and trauma-informed care services. Sadly, history predicts how unlikely we are to effectively meet this challenge. Essential caregivers unable to work remotely have had to expose themselves and their children to increased risk of disease, because their children had to remain in daycare or in multigenerational spaces with no means to isolate.

Gendered care work can no longer hide under the auspices of family love and selflessness. Caregivers oftentimes die before the care receiver. There is nothing heroic or laudable about a preventable early death. Too much togetherness can breed resentment. There is always something needed, an ask or a want. There is little give in return. Even a sincerely offered “thank you” neither diminishes nor alleviates profound fatigue.

How do we mitigate the harmful effects of such inequitable gendered expectations?

  • Recognize the gender inequity of care work and the harm such blindness inflicts.
  • Pave the way for long-term care access, regulation, and insurance.
  • Pay care workers (both in institutional and home health settings) a salary with PTO, retirement, and benefits (educational and promotion opportunities).
  • Provide paid family leave for family and friend care workers, so that they can focus on the care work they want to do without worrying about economic self-harm.
  • Ensure enhanced respite care and family mental health support.

Taking care of someone else’s s!#t is hard, labor-intensive work, both physically and mentally, and it must be recognized as such. We can no longer silently accept the gender discrimination inherent in care work. We all must bear the burden and the weight, and take care of each other’s s!#t.

Disclaimers: The title is gendered caregiving, which, for the purposes of this blog, focuses on the traditional gender binary of women and men doing caregiving. While clearly in the minority, men do provide unpaid care work. I afford no special credit for doing this work because one is a man. It is akin to saying, “my husband is babysitting the kids”—um, no they are doing the hard work of parenting. My goal is to highlight the burden of care work that is performed primarily by women. Women do not get gold stars for work that they have historically been expected to do.

The author acknowledges her own lifelong role as a caregiver. I do not aim to speak to every person’s experience with doing this work. Instead, I seek to highlight that the continued gender inequity and unpaid labor of care work harms women. If we are to be a just society, it is imperative for us to take care of the caregivers.

Karen Kelly-Blake photoKaren Kelly-Blake, PhD, is an Associate Professor in the Center for Ethics and Humanities in the Life Sciences and the Department of Medicine in the Michigan State University College of Human Medicine.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, July 30, 2020. With your participation, we hope to create discussions rich with insights from diverse perspectives.

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More Bioethics in the News from Dr. Kelly-Blake: The Burden of Serving: Who Benefits?; Patient dumping: why are patients disposable?; Incarcerated AND Sick: At Risk for Pain, Injury, and Death; White Horse, White Faces: The Decriminalization of Heroin Addiction; Racism and the Public’s Health: Whose Lives Matter?; Concussion in the NFL: A Case for Shared Decision-Making?

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