Tag: industry

Bioethics Blogs

When Women are Surrogate Mothers: Is that work?

Alana Cattapan, Angela Cameron, and Vanessa Gruben warn that speaking about “compensation” is a way of avoiding difficult conversations about payment to surrogates.

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A recent Canadian Medical Association Journal (CMAJ) news article reported that the Canadian Fertility and Andrology Society (CFAS) has called for the federal government to reconsider the ban on payment for surrogacy in Canada. The article suggests that industry professionals and academics alike are coming around on compensation for surrogacy, with support growing all the time.

In Canada, payment for surrogacy, egg donation, and sperm donation is banned under the 2004 Assisted Human Reproduction Act. Under the Act, surrogates (like egg donors and sperm donors) can be reimbursed for receipted expenses. With a note from their doctor, surrogates can also receive some money for lost work-related income during pregnancy.

The Act states that this reimbursement of expenses must follow the relevant regulations. Until now, however, these regulations have never been drafted. After more than a decade, Health Canada is now in the throes of making them. This is occurring as surrogacy in Canada is expanding to accommodate more and more people from countries where surrogacy is more expensive, harder to access or banned completely.

Women Working in a Field by Winslow Homer 1867.

It is in this context that the CFAS (which is a part-medical association, part-industry organization representing the fertility industry and its doctors, lawyers, scientists and ethicists) has called for the government to reconsider the ban on payment.

 It is important to know that the market in surrogacy in Canada is a profitable one.

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

Heads Up: Time to Say Goodbye to Football

by Craig Klugman, Ph.D.

Suppose a prescribed drug caused brain damage in 99.1% of people who took it. Would you take the drug? How long before that drug was pulled from the marketplace and the lawsuits against the manufacturer began? What if that drug made the company $7.2 billion per year? What if those who took the drug became celebrities for a brief period of time? Would you consider taking it then? Most rational people would refrain from the medication and the FDA would remove it from the market.

If you substitute the word “football” for “drug,” then you know the results of a new study in

JAMA, which definitively proves that football is bad for one’s health. In the study of 111 brains of former NFL players donated to the researchers, 110 (that’s 99.1% of the sample) showed evidence of chronic traumatic encephalopathy (CTE). Researchers examined a total of 202 donated brains. Ninety-one brains came from non-NFL players including those who played in pre-high school; high school; college, semi-pro, and Canadian Football League. Of those brains 66 showed evidence of CTE (72.5%). The percent of players with CFL increases with the level of football play (which is a substitute for number of years in the sport and number of likely concussions).

Level of PlayPercent of Brains Showing CTE
Pre-High School0%
High School21%
College91%
Semi-Pro64%
CFL88%
NFL99%
*Maez, Daneshvar, Kiernan 2017

The severity of the brain’s CTE was correlated with the level of play as well. One hundred percent of high school player’s brains had mild CTE and 86% of professional players had severe CTE.

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

What an Artificial Intelligence Researcher Fears about AI

As an artificial intelligence researcher, I often come across the idea that many people are afraid of what AI might bring. It’s perhaps unsurprising, given both history and the entertainment industry, that we might be afraid of a cybernetic takeover that forces us to live locked away, “Matrix”-like, as some sort of human battery

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

Diagnostic dilemmas: When potentially transient preexisting diagnoses confer chronic harm

By Elaine Walker
Elaine Walker is the Charles Howard Candler Professor of Psychology and Neuroscience at Emory University.   She leads a research laboratory that is funded by the National Institute of Mental Health (NIMH) to study risk factors for psychosis and other serious mental illnesses.  Her research is focused on the behavioral and neuromaturational changes that precede psychotic disorders.   She has published over 300 scientific articles and 6 books. 
The diagnostic process can be complicated by many factors. Most of these factors reflect limitations in our scientific understanding of the nature and course of disorders. But in the current US healthcare climate, legislative proposals concerning insurance coverage for preexisting conditions add another layer of complexity to the diagnostic process. It is a layer of complexity that is riddled with ethical dilemmas which are especially salient in the field of mental health care. The following discussion addresses the interplay between medical practice and health-care system policy in the diagnostic process. The diagnosis of psychiatric disorders is emphasized because they present unique challenges [1]. 

Of course, some of the complications associated with diagnosis are a function of ambiguous and/or changing diagnostic criteria. For example, the criteria for designating the level of symptom severity that crosses the boundary into clinical disorder change over time as a function of scientific advances. This has occurred for numerous illnesses, including metabolic, cardiovascular, and psychiatric disorders [2]. Further, especially in psychiatry, diagnostic categories undergo revision over time, even to the extent that some behavioral “syndromes” previously considered an illness have been eliminated from diagnostic taxonomies.

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

How the FDA Produces Knowledge (and Is Not So Weird)

The Federal government has wrested billions of dollars from the drug and device industry in settlements of claims that the companies broke the law by promoting their products “off-label” for uses not approved by the FDA.  In response, companies have asserted that … Continue reading

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

Personalized Medicine: Our Future or Big Data Voodoo?

Kumar Ethirajan, MD

NOTE: Kumar Ethirajan, MD, an oncologist specializing in cancer genetics in the Kansas City area since 1993 and member of the Center for Practical Bioethics’ board of directors, will present this topic as part of the Center’s BIOETHICS MATTERS lecture series on Wednesday, July 19, 7:00 pm, at the Kansas City Public Library Plaza Branch, 4801 Main Street, Kansas City, MO. Bring your perspectives, questions and personal stories. Admission is free. All are welcome. 

Personalized medicine has the potential to revolutionize medicine. Actually, that’s not true. Personalized medicine IS REVOLUTIONIZING medicine. 

Personalized medicine IS our future! Yet, based on a 2013 survey by GfK, a global consumer research firm, just 27% of people have heard of the term personalized medicine and, of those, only 4% understand what the term means.

You may have heard personalized medicine referred to as genomic medicine, precision medicine or individualized medicine. Whatever you call it, it’s medicine that uses information about your genes to prevent, diagnose and treat disease. In cancer, it’s about using information about a tumor to discover certain biomarkers or genes and, hopefully, having a drug to treat it. So far, researchers have discovered more than 1800 disease genes, created more than 2,000 genetic tests for human conditions, and have 350 drugs currently in clinical trials.

So, this is great, right? Yes. But consider that some 30% of the world’s stored data is generated by the healthcare industry – and that a single patient on average generates 80 megabytes per year! With healthcare data exploding like this, shouldn’t we be thinking about the questions it raises?

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

Rethinking the Belmont Report? Yes!

Some bioethicists link the beginnings of our field to the Nazi Medical experiments and the Nuremberg Trial (Annas). Whether this is the beginning of bioethics is debatable, but without a doubt, research ethics has been a central topic in the field. In fact, the very first federal bioethics commission laid out the principles of research ethics in the Belmont Report. Later, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended to the President and Congress that a uniform framework and set of regulations should govern human subjects research.  This effort reached fruition under The Federal Policy for the Protection of Human Subjects or the “Common Rule” that was issued in 1991.  Since then, there have been no major changes to the regulations – until now.  After a five-year process and thousands of comments, the new “final rule” was released on January 19th, 2017.  The July 2017 issue of the American Journal of Bioethics addresses these changes.  In addition to our usual open peer commentaries, we are posting a number of blog posts written in response to the AJOB target article.


by Emily Caldes, MA, CIP and Jennifer B McCormick, Ph.D., MPP

As noted by Friesen, Kearns, Redman and Caplan in their review of the Belmont Report, the Belmont Commission tackled the difficult task of distinguishing research from practice. The report defines research activities as those intended to develop or contribute to generalizable knowledge, and it defines practice as activities intended to enhance the well-being of particular individuals or groups of individuals.

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

Companies Announce Support for SDG 14 Implementation

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June 2017: Private companies continue to announce support for Sustainable Development Goal 14 (life below water) implementation. Albertsons Companies and Calysta are the latest to relay how they will help the international community meet targets on oceans. Their initiatives focus on sustainable fisheries and aquaculture, in particular, and join announcements from other industry players like Dell, Adidas and the New Plastics Economy, which address marine plastic pollution.

Albertsons Companies, one of the largest US supermarket companies, announced its support for SDG 14. It joined the Seafood Task Force and signed on to the pledge on Committing to Social Responsibility in Global Fisheries and Aquaculture, a voluntary commitment made by the private sectors, NGOs and the UN, during the UN Ocean Conference. The Seafood Task Force, a multi-stakeholder alliance that is combating human rights and environmental issues in seafood supply chains, was initially formed to address issues of forced labor, illegal fishing and human trafficking in Thailand’s seafood supply chains, and aims to serve as a model for global supply chains. Albertsons Companies has already established a Responsible Seafood Policy, which lays out standards that the top wild and farmed seafood products sold by the company are expected to meet.

Calysta, a company that produces sustainable products to improve global food security, pledged to support SDG 14 by advancing technology to promote sustainable aquaculture, which is the world’s fastest growing food production system and is increasing demand for new protein sources. Calysta produces FeedKind protein, a sustainable, traceable and natural feed ingredient that does not rely on wild fish catch.

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

The Impossibility of the Inert: Placebo and the Essence of Healing by Thomas J. Csordas

The concept of placebo is predicated on the opposition between active and inert, deploying this opposition to assert that an action or substance with no inherent active principle can have a paradoxical effect “as if” it were active.1 My thesis is that there is no such thing as the inert in human affairs, relationships, or experience. Think of the apparently simple retort of the bullied child that “sticks and stone may break my bones but names can never hurt me.” Contrary to this retort, names can indeed hurt. They are not inert, but carry an actual force identifiable as hate or disdain. And what of the retort itself? Is it a vain, desperate, and ultimately inert act of self-protection, effective only insofar as it taps into the “as if” logic of the placebo? I think not, though like any remedy it must be applied under the right conditions and with the understanding that it may not be uniformly effective in the degree to which it buffers the noxious influence of name-calling with an equivalent, self-confident force of self-esteem. There is also, however, an easily overlooked element of materiality in the retort. That is its rhythm: the fact that it is phrased in trochaic meter. It is not only that meter adds the force of incantation or song, but that it directly engages the embodied existential immediacy of the situation, contributing an element of jauntiness encompassing not only tone of voice but posture and gesture.

The notion of materiality as I have just used it is of value in reflecting on the impossibility of the inert.

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 Advisory Committees and Industry-Funded Patient Advocacy

Cross-posted on Objective Intent and Notice & Comment.

Industry funding of patient advocacy organizations recently has received attention from media and researchers.  For example, one 2017 study in the New England Journal of Medicine found that over 80% of patient advocacy organizations with annual revenues of at least $7.5 million reported receiving industry funding; another study in JAMA Internal Medicine found that approximately 65% of patient advocacy organizations with a median annual revenue of about $300,000 reported receiving industry funding; and a post on the Hastings Center’s website (and an earlier JAMA Internal Medicine editorial) reported that one pharmaceutical company funded an advocacy organization that, in turn, recruited other patient advocacy groups to speak in favor of the company’s drug when the FDA was considering approving it.  This last story highlights one area where the rubber meets the road with respect to FDA and patient advocates’ conflicts of interest: advisory committee meetings.

Advisory committees play an important role at FDA, including for new drug approvals.  Often when FDA is considering whether to approve a new drug, it will ask an advisory committee—a group of outside experts—to provide the agency with advice on various scientific questions about the drug.  At a typical drug-related advisory committee meeting, the drug company and FDA will each take a turn presenting the scientific evidence about the unapproved drug, then there will be an open public hearing at which any interested member of the public may speak, followed by the advisory committee’s discussion of, and vote on, the questions that FDA has posed 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.