Tag: food

Bioethics Blogs

More than Local Arrangements: How Conference Logistics Can Speak to Values by Sarah Pickman

In the fall of 2016, my colleagues Tess Lanzarotta, Marco Ramos, and I met as the core organizers for the “Critical Histories, Activist Futures” conference to hammer out our individual roles. We decided that I would take on the role of head of local arrangements, managing all of the practical logistics for the conference: food, room reservations, registration, etc. “Local arrangements” is, at first glance, a series of crucial but unsexy grunt work tasks. Perhaps, at this very moment, images from your own past of stacking folding chairs and wrestling with projector cords are beginning to swirl in your head at the mention of this phrase. Before you roll your eyes and click away, let me try to convince you that local arrangements can be a productive space to think about what an academic conference looks like and who it is for, as well as to grapple with the limits of the conference as a model for academic discourse.

I embraced the role initially because I do feel strongly that in order for an event to achieve its objectives, the mundane aspects must be taken care of and must run as seamlessly as possible. Prior experience organizing events has taught me that no matter how interesting and well-presented a symposium or lecture’s content is, if there is not enough food served afterwards or the room is very cold that’s all anyone will talk about. This is to say nothing of my own personal experience as a graduate student, scooping up free sandwiches at events and watching my professors race each other to the coffee dispenser during break times.

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 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.”

That strikes me as a pretty broad remit.

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

An Animal Bioethicist in Seattle

Andrew Fenton voices concerns about invisible unnecessary harm to non-human animals and a cost of ethical inconsistency.

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I recently had the pleasure of attending the 10th World Congress on Alternatives and Animal Use in the Life Sciences in Seattle, Washington. It was an interdisciplinary affair, with lots of scientists as well as philosophers, bioethicists, and representatives from various animal advocacy groups. The sessions I attended were interesting and it was great to see so many, involved in the use, care, or defense of animals used in science under one roof (and engaging each other!). It’s a hazard of our vocation as bioethicists to keep an eye out for incongruities. One jumped out at me. Let me set it up so that it jumps out at you too.

The World Congress, which began to meet way back in 1993 in Baltimore, Maryland, is geared toward the “3Rs” of animal research and facilitates discussions of breakthroughs, advances, failures of this research, as well as of research ethics. What are the 3Rs? In order of appearance in popular animal ethics framework (found in Russell and Burch’s 1959 book, The Principles of Humane Experimental Technique), they are: Replacement, Reduction, and Refinement. Replacement concerns replacing sentient animals currently used in particular areas of testing or research with either animals who are less vulnerable to harm or non-sentient animals (such as insects) or models (such as tissue cultures or computer simulations). Reduction concerns reducing the number of sentient animals used in particular studies or protocols. Refinement concerns minimizing or eliminating scientifically unnecessary or unavoidable distress in the sentient animals used in testing or research.

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

Don’t Blame Food Stamps for Obesity in America

Tasia Smith: “Politicians and scholars sometimes cast obesity as a problem that largely afflicts the poor. But as most obese adults aren’t poor and most low-income adults aren’t obese, this is a misconception”

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

An ‘Army Of People’ Helps Houston Cancer Patients Get Treatment

September 1, 2017

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As rains pounded Houston on Sunday, Dr. Karen Lu took to Twitter and conveyed both alarm and reassurance: “Roads around @MDAndersonNews impassable. Our on-site ride out team is caring for patients and we are all safe.

Lu is a professor of gynecologic oncology and interim chief medical officer at the University of Texas MD Anderson Cancer Center, a top cancer hospital and research center. Earlier that morning, the hospital had sent a high-water vehicle — a box truck — to Lu’s neighborhood, and she walked eight blocks through flooded streets to meet it.

The storm forced the hospital to close to outpatients. Surgeries, chemotherapy and radiation treatment and other appointments were put on hold for the 13,000 people MD Anderson sees each week.

Inside the hospital, doctors, nurses, technicians and facilities and food service staff were keeping things running for more than 500 inpatients and their families.

Lu spoke to Morning Edition host Mary Louise Kelly as the hospital was shifting into recovery mode Thursday.

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NPR: Shots

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

Offshore Herpes Vaccine Trial Under Investigation

September 1, 2017

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The government of St. Kitts and Nevis has launched an investigation into the clinical trial for a herpes vaccine by an American company because it said its officials were not notified about the experiments.

The vaccine research has sparked controversy because the lead investigator, a professor with Southern Illinois University, and the U.S. company he co-founded did not rely on traditional U.S. safety oversight while testing the vaccine last year on mostly American participants on the Caribbean island of St. Kitts.

The trial received financial backing from a former Hollywood filmmaker who has asserted the vaccine was highly successful in stopping herpes outbreaks. Since then, a group of investors, including Donald Trump supporter Peter Thiel, have backed the ongoing vaccine research with a $7 million investment that could include additional clinical trials in Mexico and Australia.

Neither the Food and Drug Administration nor a safety panel known as an institutional review board, or an “IRB,” monitored the testing on the 20 human subjects. Now, the government of St. Kitts and Nevis says that the researchers also did not officially seek permission to test the vaccine, which took place from April to August 2016.

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Scientific American

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

Cross Post: FDA Approves First CAR-T Cell Therapy for Pediatric Acute Lymphoblastic Leukemia

Tremendous progress continues to be made against the Emperor of All Maladies, cancer. One of the most exciting areas of progress involves immunotherapy, a treatment strategy that harnesses the natural ability of the body’s own immune cells to attack and kill tumor cells. A lot of extremely hard work has gone into this research, so I was thrilled to learn that the Food and Drug Administration (FDA) just announced on August 30 its first approval of a promising type of immunotherapy called CAR-T cell therapy for kids and young adults with B-cell acute lymphoblastic leukemia (ALL)—the most common childhood cancer in the U.S.

The post Cross Post: FDA Approves First CAR-T Cell Therapy for Pediatric Acute Lymphoblastic Leukemia appeared first on Ampersand.

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

The FDA Approves a Landmark Cancer Drug

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The Food and Drug Administration on Wednesday approved a new therapy to treat leukemia in kids and young adults—a decision whose importance is as much symbolic as it is practical.

Kymriah, from the Swiss pharmaceutical company Novartis, is a cancer therapy that represents several things at once: a game-changing way to treat cancer through genetic engineering, a novel paradigm for the biotech business, and the latest turn in the debate over just how astronomically expensive a life-saving therapy can be.

Kymriah is strikingly effective for young patients with acute lymphoblastic leukemia, or ALL, but it is far more involved than taking a pill or getting an infusion. It requires inserting a human-designed gene into a patient’s own T cells so they recognize and ferociously attack cancer cells. Researchers began modifying T cells for patients in the 1990s—and now the technology called CAR T-cell therapy is finally ready for prime time in treating cancer.

Of several dozen ALL patients in a clinical trial for Kymriah, 83 percent were cancer-free after three months. It is a lifeline for patients in which traditional treatments like chemotherapy and bone-marrow transplants had failed. When the FDA’s advisory committee initially voted in favor of approving Kymriah, one member called it “the most exciting thing I’ve seen in my lifetime” for childhood leukemia. Novartis is hardly the only company interested in CAR T. Kymriah is the first approved therapy, but several clinical trials—mostly notably Kite Pharma’s for lymphoma—are right behind it.

(To clear up any possible confusion about terminology: The FDA and others have chosen to call CAR T-cell therapy a form of gene therapy—and thus deemed it the first gene therapy to be approved in the United States.

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

FDA Approves First CAR-T Cell Therapy for Pediatric Acute Lymphoblastic Leukemia

Caption: Cancer survivor Emily Whitehead with her dog Lucy.
Credit: Emily Whitehead Foundation

Tremendous progress continues to be made against the Emperor of All Maladies, cancer. One of the most exciting areas of progress involves immunotherapy, a treatment strategy that harnesses the natural ability of the body’s own immune cells to attack and kill tumor cells. A lot of extremely hard work has gone into this research, so I was thrilled to learn that the Food and Drug Administration (FDA) just announced today its first approval of a promising type of immunotherapy called CAR-T cell therapy for kids and young adults with B-cell acute lymphoblastic leukemia (ALL)—the most common childhood cancer in the U.S.

ALL is a cancer of white blood cells called lymphocytes. Its treatment with chemotherapy drugs, developed with NIH support, has transformed ALL’s prognosis in kids from often fatal to largely treatable: about 90 percent of young patients now recover. But for those for whom the treatment fails, the prognosis is grim.

In the spring of 2012, Emily Whitehead of Philipsburg, PA was one such patient. The little girl was deathly ill, and her parents were worried they’d run out of options. That’s when doctors at Children’s Hospital of Pennsylvania, Philadelphia, gave Emily and her parents new hope. Carl June and his team had successfully treated three adults with their version of CAR-T cell therapy, which is grounded in initial basic research supported by NIH [1,2]. Moving forward with additional clinical tests, they treated Emily—their first pediatric patient—that April. For a while, it was touch and go, and Emily almost died.

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

Book Review: Cells Are The New Cure (BenBella Books, Inc., 2017). ISBN 9781944648800.

$26.95. Reviewed by Michael S. Dauber, MA

 

Cells Are The New Cure, written by Robin Smith, MD, and Max Gomez, PhD, is a book about the history of medical research on cells, both human and non-human, and recent developments in these techniques that have made cellular medicine one of the most promising fields for therapeutic exploration. While the book’s title suggests an exclusive focus on the healing aspects of genetic modification and human stem cell therapy, the text is much more than that: it is a roadmap for understanding the origins of such techniques, the current state of affairs in cellular and genetic therapies, the administrative landscape investigators must traverse in conducting research, and the areas in which we still need to make progress.

Smith and Gomez make an argument that is structurally simple yet gripping: they suggest that targeted therapies involving stem cells and genetic modifications are the future of medicine by pointing to the immense amount of studies in those fields that have yielded beneficial results. While many readers might acknowledge this fact even before reading the book, many may not be aware of the full extent of the knowledge we have gained from research on cells and genetics, or the myriad ways this knowledge has been applied. Of course, Smith and Gomez cover the big diseases that most people think of when imagining medical research: cancer, heart disease, neurodegenerative conditions, etc. However, the book also contains detailed information about how we age, what may cause certain allergies, how the body repairs itself, and the ways stem cell therapies, genetic editing techniques, and other complex medicines that build on these methods can be used to treat these conditions.

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.