Tag: diagnosis

Bioethics Blogs

A Modest Proposal

FDA should regulate digital games, and potentially other apps, as medical devices.

Why, pray tell?

One doesn’t have to look very hard to find a growing belief (recognition?) that video games are addicting.  CBS has been on the story since at least 2007.  In 2014, “60 minutes” suggested that a violent video game could prompt murder.  Well, they posed it as a question, but to raise it as they did sounds kind of like asking someone, “have you stopped beating your wife?”  And this past April, they did a piece with a former Google employee who suggested that tech companies are designing games, if not apps in general, to draw people into compulsive use.  They revisited the topic, with the same interviewee, in June, using the term “brain hacking.”  Frontline on PBS did a series on the topic in 2010, looking at concerns about internet addiction as well as arguments that some games may hone desirable skills.

Concern about the effect our entertainment media have on us, especially on our kids, is certainly not new.  Remember Tipper Gore, who, among other things, wrote a book about the subject 30 years ago?

The difference comes if our apps and games are not just addictive and self-reinforcing, but if their creators and marketers not only know it but make them that way on purpose.

According to the FDA, a medical device, subject to premarketing and postmarketing regulatory controls by the FDA, is defined in Section 201(h) of the Food, Drug, and Cosmetic Act as (emphasis mine in what follows):

  • “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

In the Journals – August 2017 by Livia Garofalo

Here is the article round-up for August, put together in collaboration with Ann Marie Thornburg.  There is a special issue section of Social Science and Medicine out this month on Austerity, Health, and Wellbeing (abstracts below). Also of note is a recent ‘Takes a Stand’ statement on the End of AIDS published in Global Public Health by Nora Kenworthy, Richard Parker, and Matthew Thomann. You can take advantage of the article being temporarily free access and on early view here. Enjoy!

 

Cultural Anthropology (Open Access)

Tangles of Care: Killing Goats to Save Tortoises on the Galápagos Islands

Paolo Bocci

If calls to care for other species multiply in a time of global and local environmental crisis, this article demonstrates that caring practices are not always as benevolent or irenic as imagined. To save endemic tortoises from the menace of extinction, Proyecto Isabela killed more than two hundred thousand goats on the Galápagos Islands in the largest mammal eradication campaign in the world. While anthropologists have looked at human engagements with unwanted species as habitual and even pleasurable, I discuss an exceptional intervention that was ethically inflected toward saving an endemic species, yet also controversial and distressing. Exploring eradication’s biological, ecological, and political implications and discussing opposing practices of care for goats among residents, I move past the recognition that humans live in a multispecies world and point to the contentious nature of living with nonhuman others. I go on to argue that realizing competing forms of care may help conservation measures—and, indeed, life in the Anthropocene—to move beyond the logic of success and failure toward an open-ended commitment to the more-than-human.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics News

Brain Injury and the Civil Right We Don’t Think About

August 25, 2017

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And there was something else: She at times was able to use her left eye to answer simple yes or no questions. That morning, she seemed to relish her new found fluency. She responded with verve, as if the determined downward swoop of her eye could signal an exclamation point.

Communicating with one eye may not seem like much, but it was something to behold. Maggie, as she was known, had suffered a complex stroke six years earlier, during her senior year at Smith College, that involved areas deep in her brain. She had been thought to be in the “vegetative state” — the term commonly used to define the unconscious brain state most of us associate with the right to die movement and the legacies of Karen Ann Quinlan, Nancy Cruzan and Terri Schiavo.

Later, Maggie was found to be in the “minimally conscious state” — a term medically formalized in 2002. Unlike vegetative patients, those in MCS are conscious. They demonstrate intention, attention and memory. They may reach for a cup, say their name and notice you when you walk into their room. The problem is that these actions may be rare and intermittent, so when family members who witnessed them share their observations with staff members, they are often attributed to a family’s wishful thinking.

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The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Fetal tissue and commerce

You may have seen in the general press that Indiana University is asking a federal judge to declare unconstitutional that state’s law banning research on the remains of aborted fetuses.  I noticed an article in the Wall Street Journal (subscription required).  An open-access account can be found here.

I oppose abortion, but I can imagine for the sake of argument that, if one allows for abortion, that it might be claimed that the tissue of an aborted unborn human could ethically be donated for research.  It seems to me that such an argument would construe this donation to be similar to donation of organs for transplantation.  In this case, the mother would be speaking for her (newly-deceased) unborn to make the decision, since the aborted one would not have decision-making capacity.

For such an action to be remotely ethical, donation of tissue could not in any way influence the decision to have an abortion–as, indeed, federal restrictions on fetal tissue research currently require.  There should be no profit to the donor or the abortion provider in the process.  In light of the Planned Parenthood brouhaha over this subject, I might suggest that the researchers seeking the tissue for research be required to bear any costs for the preparation of the tissue.  And something like the dead donor rule for organ transplantation would have to apply.  But that’s probably a trivial point in this case.  Never mind that the dead donor rule itself is under attack these days.

I imagine it’s clear that I don’t find this argument very persuasive. 

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

A Reflection on Blood Donation Policy in Canada

Landon J. Getz reflects on the current sexual abstention period within Canada for blood donations by men who have sex with men.

__________________________________________

Driving through Halifax during pride week, I noticed a Pride advertisement on the back of a city bus. It noted a headline from a Global News article titled: Canada’s limitations on gay blood donations ‘ridiculous’: HIV researchers. Currently, in Canada, men who have sex with men are prohibited from donating blood if they have had sex with a man in the year prior to their donation. Even though many LGBTQ advocates and HIV researchers are saying this deferral period on blood donation by men who have had sex with men is ‘ridiculous,’ Canadian Blood Services and Health Canada do not seem to agree. Approximately one year ago, the current 1-year deferral period policy replaced a 5-year deferral period. The anniversary of this policy change marks an opportunity to reflect on Canada’s blood donation policy and what it means for the LGBTQ community.

Historically, bans, deferral periods, and restrictions on blood donation by gay/bisexual men have been rooted in fear of harming patients by exposing them to contaminated blood. HIV was discovered in 1983, and from there new methods of diagnosis were discovered. Unfortunately, this did not stop HIV-infected blood from entering the blood supply, leading to what is known today as the “Tainted Blood Scandal.” Consequently, roughly 2000 Canadians were exposed to HIV via blood products in the early 1980s. However, a lack of policy and proper diagnostic testing procedures played important roles in this problem.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Talking back to science?

By Stephen Rainey

In June 2017, the European Court of Justice ruled that it was legal for a French citizen to sue a drug company for damages following a vaccination, and an illness. The ruling caused some consternation as it seemed a legal vindication of anecdote over scientific rigour.

This is a dramatic case, not least owing to the position in which vaccines find themselves, post Andrew Wakefield and the rise of the anti-vaxxer movement. Nevertheless, it forms a part of a wider narrative in which scientific activity is not always very open to questions from outside science. This broader theme is worth some scrutiny.

Vaccine injury

Shortly following a vaccination against Hepatitis B a French citizen, JW, found himself in declining health. Soon after the decline began, a diagnosis of Multiple Sclerosis (MS) was made. Having had no prior personal or family history of such an illness, and having been in good health prior to the inoculation, JW concluded that the injections must have been to blame for his developing MS. His assertion of this was not supported by scientific investigation. Rather, he could think of the vaccination as the only unusual event that preceded closely his sudden, unexpected development of the condition.

The French courts found themselves unable to agree on whether such a basis as this is sufficient to sue a pharmaceutical company. Eventually, the case was sent to the European Court of Justice (ECJ) which ruled,

“…that the temporal proximity between the administering of a vaccine and the occurrence of a disease, the lack of personal and familial history of that disease, together with the existence of a significant number of reported cases of the disease occurring following such vaccines being administered, appears on the face of it to constitute evidence which, taken together, may lead a national court to consider that a victim has discharged his burden of proof.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Teaching Disability Studies in the Era of Trump by Pamela Block

In spring semester of 2017 we (Pam Block and Michele Friedner) co-taught the graduate course “Conceptual Foundations of Disability Studies.” Though the readings were the same as in previous iterations of the course, the emphasis and tone of the class shifted, not just because of the co-teaching but because we were now teaching in a context in which the rights and lives of disabled people are at increased risk. This essay will focus on one class session devoted to a discussion of how disability studies and eugenics are strikingly intertwined in some ways, and why it is salient and important to think about eugenics in the present moment, especially in relation to the current United States presidency.

Eugenics opens up a way to talk about immigration; traits and qualities of and in people; desirability; deservedness; “good” and “bad” science; and the making of facts. Eugenics comes to mind when we think of silencing and containing nasty women and ejecting bad hombres. While we are not arguing that Trump himself advocates eugenics, we argue that a study of the history of eugenics offers an entry point to considering the emergence of past and present norms and normals, especially in relation to perspectives on bodily variation. We also think that a discussion of eugenics affords different ways of conceptualizing what disability studies scholars Snyder and Mitchell (2010) call “able-nationalism,” (riffing off of Puar’s (2007) work on homonationalism). That is, a discussion of eugenics allows for consideration of how disability—and the values attached to it– is mobilized in different time periods, in the service to the nation.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Orkideh Behrouzan’s Prozak Diaries: Psychiatry and Generational Memory in Iran by Dina Omar

Prozak Diaries: Psychiatry and Generational Memory in Iran

Orkideh Behrouzan

Stanford University Press, 2016, 328 pages

 

Orkideh Behrouzan’s first ethnographic endeavor, Prozak Diaries (2016), explores a question that has provoked much interest in the Middle East in recent years: what’s with all the talk about depression nowadays? The influence of Western clinical psychiatry seems to traverse language: the Farsi word afsordegi, for example, is often substituted by ‘depreshen.’ Prozak Dairies is a multifaceted exploration of the pervasiveness of depreshen talk, or the use of psychiatric language more generally, in Iranian society. The main thrust of Prozak Diaries considers the extent to which modern clinical psychiatric language has become vernacular—gradually normalized within Iranian popular culture and public discourse and co-constitutive with trends in psychiatric treatments and scholarly debates. Behrouzan identifies depreshen, as well as other psychopathologies such as attention deficit hyperactivity disorder (ADHD) and post traumatic stress disorder (PTSD), as diagnoses that have grown in popularity over the past three decades. She then follows the many elusive manifestations of psychiatric discourses and therapeutic practices amongst Iranians. Behrouzan asks questions that are not only relevant to Iranians but which also reflect global trends pertaining to increased rates of prescribing and consuming psycho-pharmaceuticals, an adoption of American clinical language, and an acceptance of an agenda standardized by American pharmaceutical companies. How, she asks, has the normalization of the psychiatric vernacular engendered new ways “of knowing, interpreting, and perceiving oneself in the world?” How might the contemporary psychiatric vernacular open up new ways of expressing mental or emotional conditions in Iran?

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Double Dutch euthanasia evokes sympathy through age and romance

by Craig Klugman, Ph.D.

O true apothecary!
Thy drugs are quick. Thus with a kiss I die.
– Romeo & Juliet, Act 5, Scene 3

In a scene reminiscent of Romeo and Juliet, a Dutch couple were voluntarily euthanized together after sharing their final kiss. Nic Elderhorst, 91, had a stroke 5 years ago that left him with limited mobility and chronic pain. Trees, 91, his wife and primary caregiver, had declining physical health and was diagnosed with vascular dementia. She feared that she could no longer care for him. Both feared living without the other and had stated for a long time that they had hoped to die together.

Headlines around the world focused on the romance of their euthanasia. “Dying Together was their deepest wish” declared one British paper. Another said “Loving couple, 91, pass away in rare double euthanasia” not only showing the romance, but changing the active process of killing to the metaphor of “passing away.” “Elderly couple got ‘deepest wish’ declared the Washington Post. “Elderly couple kiss, hold hands before double-euthanasia” was published in New Zealand.

The Netherlands is one of the few countries in the world that permits voluntary euthanasia, where a physician administers a drug to fulfill a person’s request to end his/her life. To qualify, a patient must make a considered request, have unbearable and hopeless suffering, be informed about the situation and future possibilities, and have no reasonable alternatives. Thus, a person does need to have a “terminal illness” or “irreversible condition” in order to request and receive life-ending procedures.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Will CRISPR fears fade with familiarity?

With all these ‘test tube’ babies grown up, how have our reactions to the technology evolved? AP Photo/Alastair Grant

The first “test-tube baby” made headlines around the world in 1978, setting off intense debate on the ethics of researching human embryos and reproductive technologies. Every breakthrough since then has raised the same questions about “designer babies” and “playing God” – but public response has grown more subdued rather than more engaged as assisted reproductive technologies have become increasingly sophisticated and powerful.

As the science has advanced, doctors are able to perform more complex procedures with better-than-ever success rates. This progress has made in vitro fertilization and associated assisted reproductive technologies relatively commonplace. Over one million babies have been born in the U.S. using IVF since 1985.

And Americans’ acceptance of these technologies has evolved alongside their increased usage, as we’ve gotten used to the idea of physicians manipulating embryos.

But the ethical challenges posed by these procedures remain – and in fact are increasing along with our capabilities. While still a long way from clinical use, the recent news that scientists in Oregon had successfully edited genes in a human embryo brings us one step closer to changing the DNA that we pass along to our descendants. As the state of the science continues to advance, ethical issues need to be addressed before the next big breakthrough.

Birth of the test-tube baby era

Louise Brown was born in the U.K. on July 25, 1978. Known as the first “test-tube baby,” she was a product of IVF, a process where an egg is fertilized by sperm outside of the body before being implanted into the womb.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.