Contemplating Fentanyl’s Double Duty

Comments open through December 13

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

By Sabrina Ford, PhD

In August 2018, Nebraska used fentanyl as part of a lethal cocktail to execute Carey Dean Moore, a prisoner sentenced to the death penalty for committing murder. This action by the state presents an ethical paradox. Tens of thousands of lives are lost to opioid overdose each year and fentanyl now was being used as part of a powerful execution cocktail. How do we comprehend this curious juxtaposition of the use of synthetic opioid drugs, complicated by our understanding of the human condition? To further muddy this absurdity, President Donald Trump suggested that illegal dealers of synthetic opioids, like fentanyl, should be sentenced to death if convicted.

To be clear, this neither is a commentary on the death penalty nor is it intended to be read as a political stance, but instead is an exploration of the phenomenon of dousing physical pain and avenging emotional pain. That is, how do we understand powerful pain-killing prescription medications as a solution to relieve suffering… physical, emotional, societal?

To give further context to this conundrum, the news media seemed equally confused. On August 14, 2018, The Washington Post reported on the fentanyl execution in Nebraska, with minimal mention about the epidemic of deaths by synthetic opioid. In fact, the word “overdose” did not appear in the news article. On August 18, 2018 the Post ran a separate opinion piece on synthetic opioid overdose deaths in the United States, but failed to mention the execution that took place just four days earlier. On August 23, 2018, Bloomberg reported on Trump’s comment about enacting the death penalty for those convicted of illegally dealing fentanyl. Does it stand to reason that a fentanyl dealer would be executed by a fentanyl cocktail? This gives new meaning to “all who draw the sword will die by the sword”.5

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Image description: a medical syringe is shown on a flat white surface, with the needle in focus with a drop of liquid hanging from the tip of the needle. The background is not in focus. Image source: Dr. Partha Sarathi Sahana/Flickr Creative Commons

Connecting the Dots

BBC News did attempt to connect the dots between overdose and execution, but only as factual statements placed side by side. The BBC News and other news outlets outlined the combination of drugs used to execute Moore including diazepam, fentanyl, cisatracurium besylate, and potassium chloride. One reason why Nebraska State Penitentiary chose fentanyl was because that drug is obtainable – available in the prison for the medical treatment of pain for inmates. Interestingly, controversy about the use of this drug combination was not because it included fentanyl, with a reputation for ending life, but instead was because it was an untested chemical combination administered by lethal injection to enforce the death penalty.

Pleasure and Pain

Human suffering typically is experienced existentially – mentally and physically. In our daily lives, we often think of suffering as psychological and emotional, and in sickness and death, suffering is associated with a physical state. The philosophical understanding of suffering is grounded in Hedonism. Hedonism is an ethical framework that posits pleasure is good and pain is bad. There is not enough space to explore ethical and epistemological digressions, but let us take a short cut for now.* Pleasure and pain present a long-standing dilemma to the human experience. As hedonistic creatures, we are wired to seek pleasure and longevity, but sometimes our search for pleasure ends in pain, suffering, and even death—the very state we seek to avoid. Akin to searching for the fountain of youth, some opioid users are searching for good in the form of pleasure, an ethereal altered state of consciousness. Too much of a good thing can lead to bad, in the form of death by opioid overdose. How to untangle the conundrum of addiction is something physicians, psychologists, and philosophers have attempted to solve for thousands of years.

Double Duty

Alas, we know that opioid addiction has as one of its greatest risks, titration of just enough of the drug to achieve the ultimate high—just close enough to death to touch heaven. Fentanyl as a prolific painkiller has become America’s death knell. On August 14, 2018, fentanyl also became an elixir to carry out justice and avenge murder. Interestingly, as mentioned above, the pharmaceutical combination was administered by a series of four drugs delivered by intravenous drip: diazepam, to induce sleep; fentanyl, a potent pain medication; cisatracurium besylate, to paralyze and stop breathing; and potassium chloride, to stop the heart; not too different from the process of dying by opioid overdose.

How do we as Americans make sense of this strange state of affairs? We want our suffering to stop, whether it be physical, mental, or even societal. It would seem that fentanyl has become a drug of choice.

*Suggested reading: Epicurus. Epicurus – Stanford Encyclopedia of Philosophy. Metaphysics Research Lab, Stanford University. 2018.

Many thanks to Jamie Alan, RPh, PharmD, PhD and Cara Poland, MD, Med, FACP, DFASAM for technical assistance.

ford-cropSabrina Ford, PhD, is an Assistant 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 Thursday, December 13, 2018. 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.

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Dr. Stahl presents on physician-assisted suicide, opioid epidemic in November

Devan Stahl photoCenter Assistant Professor Dr. Devan Stahl gave three presentations this month at local and national events.

Dr. Stahl was invited to give a talk at Georgetown University on November 9 as part of their conference on “Physician-Assisted Suicide and Euthanasia: Theological and Ethical Responses.” In her talk, “Understanding the Voices of Disability Advocates in Physician-Assisted Suicide Debates,” she discussed the disability rights perspective on physician-assisted suicide (PAS) and how it relates to Christian ethics. The presentation argued for the importance of faithfully attending to concerns regarding PAS raised by disability advocates, and considered the ways that the Church has historically failed to offer full honor and respect to the lives of people with disabilities. By attentively listening to disability groups who oppose PAS, Christians may come to realize that they too participate in unjust structures and systems that threaten the lives and dignity of disability advocates.

On November 14, Dr. Stahl was the keynote speaker at the annual Ernest F. Krug III Symposium on Biomedical Ethics, presented by Oakland University William Beaumont School of Medicine. Her talk was titled “The Disability Rights Critique of Physician Aid in Dying Legislation.” Dr Stahl spoke to an audience of medical students and faculty about the disability rights perspective on physician aid in dying, and how it differs from the debates happening in mainstream bioethics. Over the past three decades, disability rights advocates have provided clear and consistent opposition to the legalization of physician aid in dying (PAD), which many believe threatens the lives and well-being of persons with disabilities. The presentation reviewed the common objections to PAD from disability advocates and considered what such objections reveal about the systemic failings of our current health care system.

At the American Academy of Religion Annual Meetings in Denver, CO, Dr. Stahl joined a panel of speakers discussing religious responses to the opioid epidemic. She discussed the ethical tensions that physicians experience when managing the opioid crisis, including whether and how to trust patients who request opioids, the validity of opioid contracts and drug screens, as well as the current legislative restricts on opioid prescribing.

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Would you ever consent to have your medical procedure broadcast on social media?

No Easy Answers in Bioethics logoEpisode 10 of No Easy Answers in Bioethics is now available! This episode features Dr. Devan Stahl, Assistant Professor in the Center for Ethics and the Department of Pediatrics and Human Development, and Dr. Christian Vercler, Clinical Associate Professor of Plastic Surgery in the Department of Surgery at the University of Michigan and Co-Chief of the Clinical Ethics Service in the Center for Bioethics and Social Sciences in Medicine. Drs. Stahl and Vercler address a trend known as Snapchat surgeons – plastic surgeons who amass sometimes millions of followers on the social media platform Snapchat by posting uncensored videos of operations they are performing. Together they offer their insight and expertise on the issue, and discuss whether these Snapchat performances are ethical. They also delve into the societal norms and power dynamics at play, and address how to move forward within the profession of plastic surgery in a world where social media seems to be here to stay.

Ways to Listen

This episode was produced and edited by Liz McDaniel in the Center for Ethics. Music: “While We Walk (2004)” by Antony Raijekov via Free Music Archive, licensed under a Attribution-NonCommercial-ShareAlike License. Full episode transcript available.

About: No Easy Answers in Bioethics is a podcast series from the Center for Ethics and Humanities in the Life Sciences in the Michigan State University College of Human Medicine. Each month Center for Ethics faculty and their collaborators discuss their ongoing work and research across many areas of bioethics—clinical ethics, evidence-based medicine, health policy, medical education, neuroethics, shared decision-making, and more. Episodes are hosted by H-Net: Humanities and Social Sciences Online.

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Dr. Cabrera will help guide ethical development and use of electrical-based psychiatric treatments

Laura Cabrera photoA team led by Center Assistant Professor Dr. Laura Y. Cabrera will examine the ethical concerns, beliefs, and attitudes of psychiatrists, patients, and healthy members of the public, including caregivers, regarding the development and use of psychiatric electroceutical interventions (PEIs).

The U.S. National Institutes of Health BRAIN Initiative has awarded a four-year, $1,414,478 grant to the Michigan State University team, which also includes Professor Aaron M. McCright (Sociology), Associate Professor Robyn Bluhm (Philosophy and Lyman Briggs College) and Associate Professor Eric Achtyes (Director of the College of Human Medicine Division of Psychiatry and Behavioral Medicine).

Using electrical stimuli to treat psychiatric conditions, PEIs offer great promise in addressing the profound suffering related to such disorders. While PEIs have been available in various forms for years, divergent perceptions among medical professionals, patients, and the broader public have impeded their wider adoption in practice. Key stakeholders’ concerns, beliefs, and attitudes also might affect the future adoption of novel, more invasive PEIs. As new PEIs emerge in the neurotechnology landscape, it is urgent to understand such concerns and related social policy choices.

“This grant could not come at a better time, and we are grateful to the National Institutes of Health for recognizing the importance of this issue and supporting our proposal,” said Dr. Achtyes, who has seen firsthand the benefits of such treatments.

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Pictured left to right: Laura Cabrera, Aaron McCright, Eric Achtyes, Robyn Bluhm.

Dr. Cabrera, whose research focuses on neuroethics and is leading the effort as the Principal Investigator, said, “I am delighted for this exciting opportunity to lead our team of experts and work together towards the sustained ethical development and translation of this type of psychiatric treatment.”

The significance of this work lies in anticipating potential future policy challenges in ways that will both effectively safeguard sustained ethical PEI development and translation, and benefit individuals affected by mental health disorders.

“One strength of our project is that we have experts from philosophy, neuroethics, psychiatry, and sociology working closely together. So, the insights we generate will likely transcend typical disciplinary boundaries and hopefully will be more meaningful to key stakeholders,” said Dr. McCright.

Please visit the Center’s website for updates on this project.

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Recognizing Menstrual Supplies as Basic Health Necessities: The Bioethics of #FreePeriods

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

By Sean Valles, PhD

Activism against “period poverty” has gone mainstream

Within the last month, Scotland became the first country to provide free menstrual products in schools, and London student Amika George earned a Campaign Award from the influential Bill and Melinda Gates Foundation for starting the #FreePeriods social activism campaign. Why is the accessibility of menstrual products getting attention from human rights activists and governments? Because for many people* they are basic necessities that remain out of reach.

A survey commissioned by Proctor and Gamble’s Always® brand of menstrual products reports “nearly one in five American girls have either left school early or missed school entirely because they did not have access to period products.” Take that survey with a grain of salt, given who sponsored it, but it provides a sense of the scope of a previously-known problem. Like most problems that disproportionately hurt people who are already most marginalized by society, “period poverty” has only received sporadic attention in media outlets and public conversation. Previous reporting on the subject includes discussions of the problem among people who are homeless in San Francisco, and among adolescents from low-income families, living in the Pine Ridge Indian Reservation and in the Nashville area.

“Period poverty” is gradually getting recognized as one piece of the complex cycle of poverty. Imagine finally getting a job interview after struggling with unemployment, only to have to choose between skipping the interview or trying to make a makeshift pad out of wadded toilet paper or an old sock, then hoping it doesn’t fall out or leak in front of the would-be boss. When one can’t afford the health/hygiene supplies to avoid bleeding on one’s clothes (nor afford to replace any clothes stained by a period), a lack of timely access to menstrual products can have the drastic effect of making it hard to participate in public life.

Bioethics of access to menstrual products

Access to menstrual products is clearly a problem, but is it a bioethics problem? Absolutely. As the FDA will tell you, menstrual pads, reusable menstrual cups, tampons, etc. are medical devices. Menstrual products are medical technologies used to manage one’s hygiene according to cultural norms. It is a bioethical harm to limit a person’s access to the tools a society has decided are necessary for meeting its basic standards of hygiene.

After decades firmly in the U.S.’ collective ethical blind spot, public opinion on how society ought to respond to “period poverty” is divided, and has a conspicuous gender gap. In the U.S., almost three-quarters of women support providing free menstrual supplies in schools, while just over half of men do. Half of women agree public bathrooms should provide free menstrual supplies while just over a third of men do. I’m a little surprised to see that latter set of numbers so low, but I suppose we’re still accustomed to the idea that toilet paper and hand soap are necessary health/hygiene products that must be available in every public bathroom, while menstrual supplies are typically kept in paid dispensers or not available at all.

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Image description: a close up photograph of a menstrual product dispenser, showing coin slots for pads and tampons available for 25 cents each, quarters only. Image source: Beth Van Dam/Flickr Creative Commons.

Adding insult to injury, Michigan continues to impose a sales tax on menstrual products, whereas food and medicines are exempt. Most states have similar taxes on menstrual products, even though legal scholars, such as Crawford and Waldman, have argued that the taxes are doubly unconstitutional; they violate both the Equal Protection Clause and the core constitutional principal that laws must have a rational basis. Legislation to end Michigan’s “Tampon Tax” received unanimous supporting votes in the Senate Finance Committee in March of 2017, but has been effectively ignored by the Senate since then. I suspect that the lack of progress, despite unanimous committee support, is related to the fact that in Michigan’s legislature there are three male legislators for every female legislator (on a related note, take a look at the names of the authors in the bibliography at the end of this post).

That tax loophole is part of a category of problems: bioethical harms resulting from sexist economic inequities. It is not the only example, either. For instance, among personal care products that are marketed to men and women (e.g. razors and shaving cream), there is an average markup of 13% on the items marketed to women. Meanwhile, the gender wage gap leaves women only making around 80% of what men make.

Some of the problems hiding in our bioethical blind spot will be complex and difficult to solve, such as the problem that dental care has long been treated as separate from medical care (Medicare and Medicaid largely exclude coverage). By contrast, the inaccessibility of menstrual products would be far easier to fix. Very minor changes to tax policies and social norms could make menstrual products as widely available as toilet paper. Most households still buy the toilet paper of their choosing, but we expect even the shabbiest public bathrooms to have toilet paper in it for free.

We can fix this

When will we start treating menstrual products like the health/hygiene/medical necessities they are? Scotland has recognized that at the very least no student should miss class because they don’t have access to sanitary pads. What is the argument against this? Perhaps a generic political concern about former social privileges getting recast as legally-mandated rights or socially-demanded expectations? Whatever the merits of that general concern, nobody wins when low-income students miss school and low-income women miss job interviews because they don’t have pads. If nothing else, where is our human empathy for those suffering the preventable indignities of being stuck without a pad?

#FreePeriods.

*A note on biology
Sex, gender, and human bodies are complex and diverse. Not all post-adolescent/pre-menopausal women menstruate. Not all people who menstruate are women. Not all menstrual bleeding happens in the uterus: endometriosis is a common (but too rarely discussed in public) condition in which endometrial (uterine) tissue implants in other parts of the body and responds to menstrual cycles by bleeding much like the uterine tissue does. Complex and diverse.

Sean Valles photo

Sean A. Valles, PhD, is an Associate Professor in Lyman Briggs College and the Department of Philosophy at Michigan State University. His book Philosophy of Population Health: Philosophy For A New Public Health Era was published by Routledge in May 2018.

Join the discussion! Your comments and responses to this commentary are welcomed. The author will respond to all comments made by Thursday, November 15, 2018. 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: Trump’s Attempt to Reignite the Coal Industry Is Another Health Policy BlunderPolitics and the Other Lead Poisoning: The Public Health Ethics of Gun Violence; Climate Change and Medical Risk

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Center faculty present at 20th annual American Society for Bioethics and Humanities conference

ASBH logo blueCenter faculty members Dr. Len Fleck and Dr. Devan Stahl recently presented at the 20th annual American Society for Bioethics and Humanities (ASBH) conference, held October 18-21 in Anaheim, CA.

Leonard Fleck photoDr. Fleck presented on “Parsimonious Precision Medicine: Wicked Problems.” The phrase “precision medicine” refers to targeted cancer therapies and immunotherapies that are aimed at defeating metastatic cancers with specific genetic signatures. There are more than ninety such FDA approved therapies, all of which have costs of more than $100,000 per year with some costing as much as $475,000 (CAR-T cell therapies). To date, none are curative. On the contrary, for the vast majority of patients gains in life expectancy are measurable in weeks or months, not years. These results suggest that for a just and caring society with limited resources to meet virtually unlimited health care needs, we ought to be more parsimonious in how we use these drugs and who we choose to treat.

The key point of the presentation was that whether we choose to be parsimonious in our use of targeted therapies or not, we will generate what the literature has come to describe as “wicked problems” (ethically, economically, and politically speaking). A “wicked” problem is essentially a problem for which every proposed solution (including doing nothing) generates even more problems that are equally, or more, challenging.

Devan Stahl photo

Dr. Stahl gave two panel presentations at ASBH this year. The first, “Theories of Identity and the Problem of Precedent Autonomy,” explored the ethical tensions that arise when patients in disordered states of consciousness appear to have current preferences that contradict their prior wishes. The panelists, including Dr. John Banja (Emory University) and Dr. Nancy Jecker (University of Washington), discussed the limits of philosophical analysis and theory regarding the status of precedent autonomy.

In her second presentation, Dr. Stahl was joined by Darian Goldin Stahl (Concordia University) and Dr. Jeffrey Bishop (Saint Louis University) to discuss their latest book Imaging and Imagining Illness, which explores the effect of medical imagining on patients and ways medical images can be transformed through art and philosophy.

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Web of Interests Surrounding Medicines Makes Patient Access Increasingly Difficult

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

By Jennifer Carter-Johnson, PhD, JD

A recent New York Times article described the problems that patients are having gaining access to a new class of cholesterol reducers, called PCSK9 inhibitors. This difficulty extends not just to the uninsured but also to patients with insurance. The drug costs are exorbitant, listing as more than $14,000 per year for a drug that may need to be taken indefinitely. Insurance companies are balking at paying so much for the new drug when cheaper cholesterol reducers are available. Patients for whom the old cholesterol reducers do not work are forced to jump through many time-consuming hoops – mountains of paperwork, proof that other drugs have failed, and appeals after initial denials of coverage – before drug coverage approval for the PCSK9 inhibitors.

It is easy to blame the drug companies in this situation. Why must they charge so much?!?! This question has become more common considering recent news stories about drug company price increases designed only to increase profits. But high drug costs are only one obstacle for patients to access drugs. Insurance coverage dictates cost of drugs to patients from nominal co-pays to out-of-pocket self-funding. Attempts to address one issue without addressing the entire web of interests is doomed to failure.

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Image description: A close-up photograph of a spider web that is covered in water droplets. The web takes up the entire frame and is in focus, the background is blurred and includes green and purple tones. Image source: nils.rohwer/Flickr Creative Commons

Drug Companies and Federal Regulations

Drugs cost money and time to develop and produce. All drugs must undergo scrutiny from the U.S. Food and Drug Administration, where drug developers must prove both the safety and efficacy of the potential drug before it is sold. The process takes on average 12 years between lead compound identification and final approval, and often costs close to a billion dollars absent streamlined approval processes for certain rare diseases. The billion-dollar cost estimate includes the cost of research for the failure of the many compounds that enter clinical trials but are deemed either unsafe or ineffective for the disease to be treated.

Thus, drug companies charge prices to recoup this huge research investment. Prices also pay for manufacturing and advertising as well as profit margins of close to 20% to fuel further investment. While there are mechanisms in place to incentivize generic drug manufacturers to enter the market and decrease prices through competition, branded drug companies have strategies to delay generic entry that have come under recent legal scrutiny.

Private Insurance and Federal/State Medical Programs

While drug costs are high due to the myriad factors described briefly above, patients are often insulated from some of those costs by insurance companies that cover the cost of drugs. Insurance comes in a variety of forms. Private insurance may be procured on the open market or through employer coverage. In the latter, the employer may cover some or all the costs of the insurance. Senior citizens rely on the Federally-sponsored Medicare program for medical coverage, though private supplements insurance policies are also the norm. Those too young for Medicare and too poor for private insurance (with or without an employer subsidy) are forced to rely on state Medicaid programs.

Unfortunately, not every insurance plan covers every drug. Insurance companies produce a formulary of covered drugs for each plan. The insurance plan negotiates a price, often significantly cheaper than the drug’s list price, that it will pay the drug manufacturer. More expensive drugs may require insurance pre-approval and multiple rounds of paperwork from the prescribing doctor.

Insurance companies have an incentive to reduce the usage of expensive drug alternatives. For private insurance companies, that incentive is profit. In fact, for-profit insurance companies know how to play this game quite well; many have profits in excess of 6 billion dollars. Medicaid and Medicare programs have limited budgets for all medical costs including drugs. While increased Medicaid funding for states offered through the Affordable Care Act was effective in decreasing uninsured rates, government funding is always in flux due to political pressures.

Doctors and Pharmacists

Doctors have great discretion in prescribing drugs. While doctors hold their patients’ health as the highest goal, knowledge of insurance (or its lack) may influence the doctor’s choice of drugs. Denial of a drug may well mean many, many more forms for a doctor who wants to make sure her patient has the best, most expensive drug. Doctors who do this for multiple patients could soon find themselves spending as much time on drug paperwork as medical care. Many doctors have taken to giving samples of drugs – left by drug companies as part of their advertising budgets – to patients who cannot afford the drug but need it.

Pharmacists exist at the epicenter of the patient’s dilemma. Patients often find out that insurance is not covering the drug when the pharmacist explains the situation. More troubling is the fact that drug prices are sometimes cheaper for a patient without insurance. For instance, a patient may have a twenty-dollar co-pay, but the drug may only cost ten dollars. For years, pharmacists have been subject to “gag clauses” in contracts between pharmacies and pharmacy benefit managers that prevent them from disclosing to the patient the cheaper alternative. Recent legislation signed this month has banned this practice.

Patients

Caught in this web of diverse and conflicting interests are the very people for whom drugs are created and vetted and prescribed – patients. Drug manufacturers must be able to recoup costs, but if no one can afford the drug how will they make sales? Additionally, drug pricing is a convoluted process that varies between insurance policies, pharmacies, and branded or generic formulations. Insurance coverage is often dictated by employer, age, or resources. Lack of coverage for a specific drug might mean the patient is faced with choosing a different drug or a different job. But asking about insurance formularies during a job interview would be quite difficult even if switching jobs in the midst of a medical crisis were possible. On the other hand, determining drug needs in advance is almost impossible. Finding a doctor with the time to work with a patient on an involved approval process is becoming more difficult given the increasing shortage of doctors in the United States.

Sitting in the center of this web of interests, patients have the most to gain and the most to lose from any overhaul of our drug system. It is impossible to fix all the problems by focusing only on the problems in one area. Unfortunately, patients are also a very small voice in the web that includes pharmaceutical companies, insurance companies, and medical professionals.

Jennifer Carter-Johnson photo

Jennifer Carter-Johnson, PhD, JD, is an Associate Professor of Law in the College of Law at Michigan State University. Dr. Carter-Johnson is a member of the Michigan State Bar and the Washington 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 Thursday, November 1, 2018. 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: Humanity in the Age of Genetic ModificationDefining The Spectrum of “Normal”: What is a Disease?Dawn of False Hope: Spread of “Right To Try” Laws across the U.S.Designing Children: Patents and the Market are not Sufficient Regulation

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