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Topic: Bioethics and Public Policy
April 11, 2014 | Posted By Wayne Shelton, PhD

In my last blog I alluded to the effect of an assumed point of view, particularly a set of ideological set of assumptions around which a community is organized, has on the way we interpret data about how we perceive risks and benefits and make decisions about a range of issues.  I was applying this perspective to public health perspectives such as the risks of gun ownership and forgoing vaccinations. In this blog, I will sketch out a theoretical approach for how humans process and understand information a bit more and conclude with some questions for my next blog about how to understand the obligations of those who are in the best positions to understand public health data, such as the better educated and healthcare workers.

We often assume that most people are capable of coming to objective and fair beliefs and reasonable decisions about various empirical topics, e.g. the effects of climate change, if only we have access to valid, scientific information.  Thus, we often further assume that the goal of having more enlightened people to make more enlightened decisions about public health issues, or for that matter political issues and most other issues of public interest, is simply a matter of bringing to bear more complete and clear knowledge for people to understand. This is the assumption that Dan Kahan (a law and psychology professor from Yale Law School) and his research team calls the “More Information Hypothesis”. However recent research shows that this hypothesis is simply not true—in fact the more information people on opposite sides of an issue get, the more divided and intractable the conflict becomes. The simple fact of making more information accessible clearly does not resolve most public issues that are connected to well-established ideological and philosophical perspectives.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

April 3, 2014 | Posted By Bruce D. White, DO, JD

A March 24, 2014, article in the New York Times about the dangers of liquid nicotine used in e-cigarettes and the lack of Food and Drug Administration (FDA) involvement in its regulation emphasized a decades old problem.

Before 2009, Congress prohibited the FDA from regulating tobacco products as customarily marketed. When the Food, Drug, and Cosmetic Act (FDCA) was enacted in 1938, Congress specifically defined drugso as to exclude tobacco products. In effect, Congress reserved the regulation of tobacco products to itself. More than likely, Congress – understanding the economic impact of tobacco at the time – preferred to retain a direct hand. This singular control by Congress was reiterated by the US Supreme Court in FDA v. Brown & Williamson Tobacco Corp. (1990) when the FDA asserted itself and attempted to prohibit the sale of tobacco products to minors by regulation. In Brown & Williamson, the Court struck the regulation down.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

March 31, 2014 | Posted By Zubin Master, PhD

I have written on this blog about the topic of stem cell tourism and the different strategies that have been proposed to stop the phenomenon. Just to provide a background on the topic from a previous blog: stem cell tourism is used to describe an internet-based direct-to-consumer advertised industry where clinics offer untested and unproven stem cell interventions as bonafide therapies to patients with a range of diseases and injuries including Parkinson’s disease, multiple sclerosis, ALS, blindness, cancer, cerebral palsy, spinal cord injury and many others. Basically there is no scientific evidence of safety of efficacy of these modalities to offer them on a for-profit basis to patients. The term was originally coined as a form of tourism because patients traveled from countries like the U.S., U.K., Canada and Australia to clinics in countries with lax regulations, but this simply is not the case anymore. There are several clinics within highly regulated countries like U.S. that offer stem cell interventions.

Of the several strategies people have discussed, one of the first has been on the topic of providing education to patients and the public. Here, people argue that providing education on the dangers of stem cell tourism might actually sway patients to not undertake unproven stem cell interventions. As some scholars have mentioned, education might not be as effective because it depends on a “rationale actor model” where we assume that patients will behave rationally and make choices based on weighing the harms and benefits of seeking unproven treatments. More so, such an argument does not sufficiently consider the hope patients have to ameliorate their disease, reduce pain or other symptoms, and increase their quality of life. While these counterarguments are certain rational and likely to be true, there is yet no solid evidence showing whether education on stem cell tourism is effective at swaying people from traveling for unproven interventions. But even if before we go into whether education might influence a patient’s decision to travel for unproven stem cell treatments, I think we need to assess the role of patient education in medicine.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

December 31, 2013 | Posted By Zubin Master, PhD

Bioethics research is closely tied with policy. While discrepancies exist, I classify bioethics as an interdisciplinary field of study. As most interdisciplinary fields, one aim of bioethics is to develop practical solutions for real world problems in the biomedical and clinical sciences among other fields it impacts. Thus much of bioethics scholarship is closely intertwined and aims to inform health, social and science policy. Bioethics scholarship is also meaningful in attempting to raise awareness and educate researchers, practitioners, patients and the public on many areas of ethics in the health sciences. As a bioethics academic who has worked in both Canadian and U.S. institutions, I have enjoyed the benefit of examining policy and educational landscapes in both countries. Today, I want to specifically talk about research integrity policies, practices and education in Canada and compare it to the U.S.

What is research integrity?

Academics in every discipline including the fundamental and applied sciences (i.e., biomedical science, engineering), the social sciences, and humanities are self-governed professionals who conduct research upholding principles of research integrity. Research integrity (a.k.a. scientific integrity or the responsible conduct of research) captures a range of principles and practices governing ethical research. It includes practices such as research misconduct (commonly known as fabrication, falsification, and plagiarism), authorship and publication ethics, peer review, mentoring, conflicts of interest, research involving animals and humans and social responsibility. Yet beyond outlining principles and practices, there is a growing field of research on research integrity where scholars try and improve our understanding of the normative and practical aspects of research integrity. I’ve written about different topics within research integrity including what is conceptual bioethics research? and peer review in previous AMBI blogs.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

November 14, 2013 | Posted By John Kaplan, PhD

I have written a few times in this blog about the stupidity of certain politicians in relation to their positions about science and the role of science in public policy. It is time for me to admit that, thankfully, many politicians are actually quite enlightened about the value of science. Today I will identify two such individuals, albeit not current politicians, who had a sophisticated appreciation of the relationship between scientific inquiry and the understanding of the world such inquiry produces to public policy, national security, and the underpinnings of democracy.

This year marks the one hundred fiftieth anniversary of the founding of the National Academy of Sciences. This national academy was founded in 1863 by Abraham Lincoln. He had a good deal going on that year, the Civil War and the Emancipation Proclamation among other things. But he still possessed and demonstrated the vision to create a body of distinguished scientists who would be available to provide scientific advice for the United States government.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

October 2, 2013 | Posted By Zubin Master, PhD

I have previously discussed the topic of stem cell tourism in previous AMBI blogs. To provide a brief introduction from another blog, stem cell tourism is used to an internet-based direct-to-consumer advertised industry where clinics offer untested and unproven stem cell interventions as bonafide therapies to patients with a range of diseases and injuries including Parkinson’s disease, multiple sclerosis, ALS, blindness, cancer, cerebral palsy, spinal cord injury and many others. Basically there is no scientific evidence of safety of efficacy of these modalities to offer them on a for-profit basis to patients. The term was originally coined as a form of tourism because patients traveled from countries like the U.S., U.K., Canada and Australia to clinics in countries with lax regulations, but this simply is not the case anymore. There are several clinics within highly regulated countries like U.S. that offer stem cell interventions.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

August 30, 2013 | Posted By Zubin Master, PhD

Stem cell tourism is a pejorative term used to describe clinics that offer untested stem cell interventions as bonafide therapies to patients with injuries and diseases. This includes Parkinson’s disease, multiple sclerosis, ALS, blindness, cancer, cerebral palsy, spinal cord injury and many others. We used to think about stem cell tourism as potential patients traveling to clinics from countries like the US, UK, Canada and Australia to countries with lax regulations, but this simply is not the case anymore. There are several clinics within the US that offer stem cell interventions to treat back aches or sports injuries. This direct-to-consumer market has more recently attracted celebrity types including several high profile athletes, Hollywood stars, and even a US State Governor.

Clinics generally tend to overemphasize benefits, and use rhetoric terms like “alternative medicine” or “experimental treatment” to explain that it is another form of treatment not offered by conventional medicine. But at the end of the day, there is an almost complete lack of scientific evidence supporting the claims made by clinics in regards to the efficacy of these stem cell interventions. The evidence provided to patients is based only on testimonials by other patients; no other measures are used to determine treatment efficacy. The overemphasis of benefits when patients tell others of how great they feel and how it has helped them and given hope only fuels their frustration and distrust in their domestic healthcare, research and regulatory system. The stem cell clinics play on the hype and power of stem cells and they stand to make money as therapies range from $5,000 to $30,000 and in many cases clinics require patients to have repeated treatments.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

July 5, 2013 | Posted By John Kaplan, PhD

Usually when I write about stupidity in Congress I wait a couple of months before doing it again. However, I cannot help myself. This is low hanging fruit and I have to pick it. This is “truth is stranger than fiction” type of stuff. You cannot make this up. In this blog post I would like to introduce the readers to Representative Michael Clifton Burgess M.D., republican representative from Texas’ 26th Congressional District. Dr. Burgess was born in December 1950. I mention this only because it was the same month I was born. He graduated with a Bachelors of Science from North Texas State University. He graduated from medical school at The University of Texas Health Science Center at Houston. He completed his residency in Obstetrics and Gynecology from Parkland Memorial Hospital in Dallas. He also completed a Masters degree in Medical Management from the University of Texas at Dallas. Dr. Burgess is the founder and chair of the Congressional Health Care Caucus, albeit it’s only member. This all suggests the likelihood that Dr. Burgess is smart. His recent statements seem to refute that likelihood.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

June 27, 2013 | Posted By Marleen Eijkholt, PhD

Sarah is a 10-y old girl with cystic fibrosis who, until recently, was in desperate need of a lung transplant. The doctors had estimated that Sarah would only have a couple more weeks to live without a transplant. Recent news headlines reported about her quest for this transplant, the success of the operation and, over the weekend, they issued the happy news about her regaining consciousness. Most of this news paralleled comments about the battle to revise the legislation, and underscored antagonism towards policy or policy makers (lawyers and ethicists), as if hindering good medicine. 

In this post I would like to comment on this antagonism, and propose that the policy makers did quite a good job in Sarah’s case. I propose that we need a symbiotic relation between medicine and policy makers. As a clinical ethicist with a background in law, I feel a lot of fear for ‘lawyers’, and prejudice against the idea that law, ethics and medicine can go together. In this post, I seek to outline how they can go together, and how Sarah’s case provides an opportunity for partnership. I must note here, however, that this issue is a minor one given the terrible ordeal of all the involved individuals.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

June 7, 2013 | Posted By John Kaplan, PhD

I have commented previously on the stupidity with which some members of congress approach science. I never seem to have any trouble finding new material on this subject. The House Committee on Science, Space and Technology seems to be an especially rich source of such material.  You would think that the members of congress from Oklahoma and Texas would be pretty busy these days. With a huge fertilizer explosion in Texas and the direct hit of a massive EF5 tornado in More, Oklahoma the need for humanitarian aid and rebuilding would be enough to keep Senator Tom Coburn (R-Oklahoma) and Representative Lamar Smith (R-Texas) quite busy, as well they should be. But these guys are nonetheless able to find plenty of time to mess with the operations of the National Science Foundation (NSF).

Senator Coburn initiated this latest episode earlier this year by successfully attaching language to the 2013 appropriation for the National Science Foundation that prohibits funding for any political science research unless the director of the NSF certifies that it relates to national security or economic development. Representative Smith, the chair of the House Committee on Science, Space and Technology has now initiated an attempt to apply these principles to the entire portfolio of NSF funding in all disciplines. The current guidelines to reviewers of grant applications for funding by NSF to address the “intellectual merit” of the research proposal as well as its broader impact on society and the scientific community.

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our website.

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BIOETHICS TODAY is the blog of the Alden March Bioethics Institute, presenting topical and timely commentary on issues, trends, and breaking news in the broad arena of bioethics. BIOETHICS TODAY presents interviews, opinion pieces, and ongoing articles on health care policy, end-of-life decision making, emerging issues in genetics and genomics, procreative liberty and reproductive health, ethics in clinical trials, medicine and the media, distributive justice and health care delivery in developing nations, and the intersection of environmental conservation and bioethics.
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