Tag: food

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

We Can and Must Rebuild the Bridges of Interdisciplinary Bioethics

by Darryl R. J. Macer

This editorial is made available on bioethics.net. The editorial along with the target article and open peer commentary is available via tandfonline.com

Although we can argue that bioethics is holistic and found in every culture, and still alive among people of many indigenous communities as well as the postmodern ones, the academic discipline of bioethics as interpreted by many scholars has attempted to burn bridges to both different views and to persons with different life trajectories and training. The bridges between different cultural and epistemological foundations of bioethics have also been strained by the dominance of Western paradigms of principlism and the emergence of an academic profession of medical bioethics.

This editorial reacts to the points made in the article by Lee, “A Bridge Back to the Future: Public Health Ethics, Bioethics, and Environmental Ethics.” This issue of the American Journal of Bioethics (AJOB) includes a number of commentaries on this theme, and challenges readers to reconsider the manner in which they conceive of bioethics, as well as the range of literature and scholars that they consider to as legitimate sources of wisdom. Such a new approach will not only breathe fresh light into the important work of all scholars, students, and teachers, but also offer some fresh references for contemporary policy changes that face us. Let us approach these issues like an ostrich who is taking her head out of the sand after some years of monodisciplinary focus. To be clear, Lee and some others writing here have apparently not had their head in the sand, as the interrelatedness of health and the environment is clear through the examples shared.

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

‘Breakthrough’ Leukemia Drug Also Portends ‘Quantum Leap’ In Cost

August 23, 2017

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“From what we’re hearing, this will be a quantum leap more expensive than other cancer drugs,” said Leonard Saltz, chief of gastrointestinal oncology at Memorial Sloan Kettering Cancer Center in New York.

Switzerland-based Novartis hasn’t announced a price for the medicine, but British health authorities have said a price of $649,000 for a one-time treatment would be justified given the significant benefits.

The cancer therapy was unanimously approved by a Food and Drug Administration advisory committee in July, and its approval seems all but certain.

… Read More

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KHN

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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 News

Drugs that Go Through FDA’s Expedited Review Might Be Better Drugs

August 14, 2017

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A new paper in the latest issue of Health Affairs is worth a look. “Drugs Cleared Through The FDA’s Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process“:

We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999–2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes.

The FDA has a strict process for drug approval, requiring a number of phases of testing to establish safety and efficacy. It can, however, expedite this process when it thinks a drug may address an unmet clinical need. Of course, you want such a process to be fair and work. You want it to be focused on “better” and “more important” drugs. The 21st Century Cures Act moved even further. Some worry that loosening standards will lead to increased exposure to harm, especially if there isn’t proof that these drugs provide more benefits.

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The Incidental Economist

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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 News

Call for Papers: Health and Food Ethics

August 14, 2017

October 2018

Health and Food Ethics

Hippocrates once said, “Let food be thy medicine and medicine be thy food.” Physicians in some U.S. cities have followed this advice by writing prescriptions for patients to obtain fresh produce through healthy food outreach programs. Clinical encounters, however, cannot fully reverse the negative health effects of low quality diets. Further, millions remain hungry as the quantity of the global food supply is at risk. Providing safe, nutritious, and environmentally- sustainable food to all is a great challenge, and if the global community cannot find solutions to feed the world, economic and social costs will be high. “Ending hunger, achieving food security, improving nutrition, and promoting sustainable agriculture” is one of the Sustainable Development Goals set forth by the United Nations. As such, a central question worth exploring in the October 2018 issue of the AMA Journal of Ethics is: What should be the roles of health professionals in promoting accountability by governments, non-governmental and civil society organizations, and the food and beverage industry in promoting strategies that can meet the nutrition and health needs of our global population? Other issues include: reducing and redistributing food loss and waste; incentivizing responsible food production and labeling practices; communicating about food practices and food access during clinical encounters; and strategies to promote food security as a goal of health professions.

Manuscripts submitted for peer review consideration and inclusion in this issue must follow all Instructions for Authors and be submitted by 12 February 2018.

Link for more information


Image: By Original: lyzadangerDerivative work: Diliff – http://www.flickr.com/photos/lyza/49545547, CC BY-SA 2.0, https://commons.wikimedia.org/w/index.php?curid=1405631

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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 News

CRISPR, Pigs, Organs, Ethics: Some Key Considerations

Michael S. Dauber, M.A., GBI Visiting Scholar

Luhan Yang and members of her research team at eGenesis have taken a crucial step in growing organs in animals that may be used to provide organs for therapeutic transplants in humans, according to a study published in Science Magazine on Thursday, August 10th. Researchers involved in the study used CRISPR, a genetic editing technique, to “knock out” 25 genes that cause porcine endogenous retroviruses (sometimes referred to as “PERV genes”) that make ordinary pig organs unsuitable for transplants because PERVs can infect human transplant recipients. The result was the birth of 37 baby pigs without PERV genes.

The move comes at a time when CRISPR experiments are becoming increasingly popular. Last week, a team led by Shoukhrat Mitalipov published the results of the first successful attempt to modify human embryos using CRISPR by American scientists in Nature. The researchers successfully deleted a gene responsible for several fatal heart conditions.

While the results are a significant step in developing techniques for growing organs suitable for human transplantation, scientists must still travel a long road before any human patients will receive such organs. Researchers will need to determine whether or not organs from pigs developed using CRISPR can be safely and effectively transplanted into other animals first. Another hurdle is the cost and complexity of the technique: Yang’s experiments with her team involved embryos produced through cloning, an expensive technique that is not always completely effective: indeed, in Yang’s study, only a few of the cloned embryos were viable.

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

Right to Try: Why Logic and Facts Won’t Win This One

by Craig Klugman, Ph.D.

Last week the U.S. Senate passed bill S. 204, the Trickett Wendler Right to Try Act of 2017. Trickett Wendler was a woman with ALS. The ALS association and her family lobbied Congress to support this bill to give all patients living with a terminal illness the “right” to purchase experimental drugs from pharmaceutical companies. Essentially, this bypasses the FDA’s compassionate use program. Instead of filing an application for FDA compassionate use (which the FDA approves 99% of the time), the patient asks the drug manufacturer directly. As I have written in this space before, such laws threaten public health efforts through the FDA to ensure safe and efficacious pharmaceuticals.

Currently, 37 states have such right-to-try laws and more have considered them. The push for these laws begins with the Barry Goldwater Institute, a libertarian think-tank, funded in part by the Koch brothers. Last month I had the surreal experience of debating two right-to-try supporters (one from a business school and one from the Goldwater Institute) about these laws which they base in a “right to self-medicate.” There were two of us against self-medication and two in favor of it.  You can read the commentaries and responses of the debaters here.

In this essay, I do not plan to restate my arguments against right-to-try. You can read my thoughts on this policy here and here. Instead, this post will examine the tools of argumentation that my opponents employed in the debate. It is important to show their debate techniques so that we all have a better understanding of how to analyze claims to support right-to-try and to realize why better facts and better arguments are falling on deaf ears.

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

Why vegetarians should be prepared to bend their own rules

Alberto Giubilini
Republished from Aeon Magazine

It’s a common enough scenario. A vegetarian has been invited to a friend’s place for dinner. The host forgets that the guest is a vegetarian, and places a pork chop in front of her. What is she to do? Probably her initial feelings will be disgust and repulsion. Vegetarians often develop these sorts of attitudes towards meat-based food, making it easier for them to be absolutists about shunning meat.

Suppose, though, that the vegetarian overcomes her feelings of distaste, and decides to eat the chop, perhaps out of politeness to her host. Has she done something morally reprehensible? Chances are that what she has been served won’t be the kind of humanely raised meat that some (but not all) ethical vegetarians find permissible to consume. More likely, it would be the product of cruel, intensive factory farming. Eating the meat under these circumstances couldn’t then be an act of what the philosopher Jeff McMahan calls ‘benign carnivorism’. Would the vegetarian guest have done something wrong by breaking her own moral code?

Most vegetarians are concerned about animal suffering caused by meat consumption, or about the impact of factory farming on the environment. For simplicity’s sake, I will consider only the case of animal suffering, but the same argument could be applied to the other bad consequences of today’s practices of factory farming, including, for example, greenhouse gas emissions, inefficient use of land, and use of pesticides, fertiliser, fuel, feed and water, as well as the use of antibiotics causing antibiotic resistance in livestock’s bacteria which is then passed on to humans.

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 – July 2017 by Danya Glabau

American Quarterly

Regina Kunzel

Among the central themes of the eclectic field of mad studies is a critique of psychiatric authority. Activists and academics, from a range of positions and perspectives, have questioned psychiatry’s normalizing impulses and have privileged mad-identified knowledges over expert ones. One of the most successful assaults on psychiatric authority was launched by gay activists in the 1960s and early 1970s, resulting in the removal of homosexuality from the American Psychiatric Association’s (APA) Diagnostic and Statistical Manual of Mental Disorders (DSM) in 1973. But if that event marked an inspirational victory against psychiatric power, it was also, as Robert McRuer notes, “a distancing from disability.”1Revisiting this history through analytic lenses offered by disability and mad studies defamiliarizes familiar historical narratives and unsettles the critique of psychiatric authority, especially when countered by claims to health.

 

Conflicts over the value, meaning, and efficacy of vaccination as a preventive practice suggest that vaccination resistance stages disagreement within modern biological citizenship. This paper explores how immunity circulates in both vaccination controversy and biopolitical philosophies. Two positions—one characterized by somatic individualism, flexible bodies, reflexive approaches to knowledge, and the idea of the immune system as “the essential relation the body has with its vulnerability,” and another characterized by the immunitary paradigm, biosecurity, trust in expert systems, and vaccination—emerge. Understanding that oppositional relation can reframe public understanding of vaccine skepticism and public health responses to it.

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.