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Topic: Stem Cell Research
April 3, 2014 | Posted By John Kaplan, PhD

The scientific and medical potential of stem cells hold so much promise that progress in this area is widely followed with intense interest. Since pluripotent stem cells are able to differentiate into any cell type they hold the promise of leading to therapies for a wide variety of diseases and disabilities which cause human suffering and end lives prematurely. This field of research and development has attracted the efforts of large numbers of the most brilliant and talented biomedical researchers in the entire world. This raises the vexing question of why some of these brilliant and talented researchers are doing some very stupid things.

It seems like only yesterday (it was actually in 2004 and 2005) that Hwang Woo-Suk a renowned Korean veterinarian and researcher published the first reports in Science Magazine of the derivation of pluripotent stem cells from human embryos and subsequently the successful cloning of human embryonic stem cells. Hwang was a national hero. However these studies were recognized in 2006 as being the result of fraud.  I remember wondering then, just as I am wondering now, how someone could risk all that they had earned by committing such blatant fraud. How could they not realize that misconduct in such important work would be discovered and punished. I do not get it.

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.

January 27, 2014 | Posted By Michael McNichol and Zubin Master, PhD

Since the discovery of human embryonic stem cells in 1998, many promises have been made by individuals and groups about the potential of stem cell research to revolutionize the practice of regenerative medicine. Yet to date, very little has been seen in terms of novel therapies in the clinic. Because of the substantive economic investments made in stem cell research in order to realize the promise they can offer, greater efforts to translate stem cell research into medicines has ensued. However, many factors might impede the clinical translation of stem cell research. In this blog, we briefly highlight the ethical and scientific issues surrounding the successful translation and commercialization of stem cell research.

The process of clinical translation begins with preclinical research using in vitro systems and animal models to show proof-of-principle and demonstrate safety and efficacy of a potential therapeutic. For example, if a stem cell is to be transplanted into a patient to treat a degenerative disease, then the type of stem cell that is being used must show that it can successfully treat a similar disease in animals prior to testing the product in humans. There are many reasons for using appropriate animal models that mimic human diseases: low cost, reproductive cycle, number of offspring, genetic similarity, similarity in the manifestation of the disease in humans, and ease of handling. However, there are many limitations to animal models that do not result in direct translation in humans, meaning what may work in animals may not at the end of the day be effective in people. While we choose animals as models to mimic human disease, the biology of animals is still significantly different than humans and thus may simply not translate 100%. This issue is difficult to get around. 

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.

September 24, 2013 | Posted By Jane Jankowski, LMSW, MS

At a Labor Day party earlier this month, I was among the lucky guests filling a plate with an array of tasty picnic food ranging from the traditional cook out items to exotic salads and fruits, all washed down with a blueberry martini. (NO, I do not have the recipe.) Food represents many things in our culture and expresses values in subtle ways – and not so subtle ways. Bidding farewell to summer and enjoying the blessings of some great local produce, I noted that the centerpiece of my meal was a thick grilled hamburger.  Unless otherwise stated, it is presumed to be made of beef. And I had to wonder: will burgers like this one become scarce in my lifetime? With the recent production of meat grown from bovine stem cells, there is speculation that lab-grown meat product will someday replace animal meat as a primary food source. It seems important to consider what is, um, at stake for consumers, for science, and the evolving culture of lab grown food.

As for this new use of stem cell technology, I think we need to question whether or not this was the best use of resources. At  an estimated cost of over $300k, it was terribly expensive to create, but many new technologies come at a price. This Petri dish patty was reported to not taste very good, a shortcoming blamed on the absence of fat in this manufactured patty. However, it was deemed safe to eat and as far as I know, none of the taste testers became ill from ingesting the “schmeat.” Engineered beef might find a welcome in areas where there is mistrust about food safety and where food supply for meat products is limited. Yet, refrigeration needs may still prove a formidable barrier even if cost of manufacture and shipping could be assured. 

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.

June 20, 2013 | Posted By Zubin Master, PhD

Last month, I covered in Part I of this blog the ethical debates surrounding the moral status of human embryos and the potential harms to women as egg providers for cloning research. I also described how the technique of research cloning (a.k.a. somatic cell nuclear transfer) works. For today’s blog post, I want to argue that bioethicists should not leave moral debates behind because the science of stem cell research has moved on in a different direction as it is likely to leave people uneasy and frustrated because no clear way to move forward has been resolved and the debate has almost ceased to continue.

Bioethical discourse surrounding the moral status of human embryos and payment of women for eggs became stagnant upon the discovery of induced pluripotent stem cells (iPSCs). iPSCs were heralded as free of ethical concern because this technique creates hESC-like cells without the creation and destruction of human embryos and it doesn’t require eggs from women. The technique aims to dedifferentiate specialized cells (e.g., skin cells) into a more pluripotent state prior to directing their differentiation into specific cell types needed for repair or regeneration. Even George W. Bush in his Eight State of the Union address stated that the iPSC breakthrough can expand the frontiers of medicine without destroying life. Although iPSCs may obviate ethical concerns surrounding moral status and harms to women, they haven’t served to replace hESC research. In fact, one study shows that hESCs and iPSCs are being used together which makes sense because hESC research serves as a control for iPSC research. In addition, there are also many other ethical challenges to iPSC research including moral complicity as well as research ethics issues including informed consent, privacy and withdrawal. I have argued along with Gillian Crozier that perhaps an ethical and political compromise in stem cell research is needed in order to permit stem cell research to be performed using eggs and embryos for a certain period until such time that non-egg and non-embryo sources for the derivation of stem cells can be used. But because iPSCs have received such hype, ethics discourse around research cloning and deriving hESCs has received far less attention in the past 4-5 years.

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.

May 28, 2013 | Posted By Zubin Master, PhD

For Part I of this blog, I will highlight a new discovery where scientists have now been able to create cloned stem cells and I will review two ethical debates that were central to earlier discourse surrounding stem cell research: (1) the moral status of human embryos and (2) the potential physical and social harms to women as egg providers.

So finally research cloning (a.k.a. therapeutic cloning) has been achieved! The technique is called somatic cell nuclear transfer (SCNT) and now has been used to derive human embryonic stem cells (hESCs) (Tachibana et al.Cell 2013). Performing SCNT using human oocytes is an astonishing accomplishment and has significant ethical and clinical implications.

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 25, 2013 | Posted By Zubin Master, PhD

Several scholars claim that hyping different biotechnologies will lead to a loss of public trust which in turn will result in a loss of support for science. This has been discussed in the context of genomics research, gene therapy, stem cell research, biobanking, neuroimaging research, and nanotechnology. The problem most articulate is that hype in terms of promising medical benefits to the public will generate an expectation by the public and when such expectations are unmet, the public’s support for science will wane. Certainly there is social science evidence to support that (a) hype over many biotechnologies is present in the popular media and (b) several actors are involved in hyping science including scientists, media, politicians, and others. And while the idea that hype and unmet expectations could result in a loss of public trust and support for science seems logical and to some degree intuitive, I think the reality is that the relationship between hype, public trust, and the loss of support for science is quite complex. It is also complicated to measure empirically and to date, there is no study I have come across that demonstrates this relationship. In fact, the one study evaluating the public and donor’s perceptions on hype and stem cell research actually shows that people “aren’t taken in by media hype.”

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.

February 19, 2013 | Posted By Lisa Campo-Engelstein, PhD

The Dickey-Wicker Amendment (DWA) was passed in 1996 and prevents federal funding of research that destroys embryos. This congressional prohibition defines a human embryo as “any organism not protected as a human subject” that was “derived by fertilization, parthenogenesis, or any other means from one or more human gametes.” While there has been much debate in the bioethics and popular press media about the ethics of embryo research, what has been almost entirely overlooked is the ethics of parthenote research.

The DWA conflates embryos and parthenotes even though there are important scientific and ethical differences between them. Parthenotes are cells derived by parthenogenesis, the process in which eggs become activated to begin dividing without fertilization. Because there is no sperm involvement, parthenotes contain genetic material from only one source (i.e. the egg). In contrast, embryos are created through fertilization and contain genetic material from two genetically dissimilar cells (i.e. egg and sperm). Another important difference is that while embryos can result in a live birth baby, human parthenotes cannot. Human parthenotes, whether they come into existence naturally or in a lab, die in the early stages of development. Scientists can create human parthenotes in the lab by activating eggs through chemical stimuli that mimic fertilization, but studies in other mammals indicate that, without the required genetic imprinting, further development is ruled out.

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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ABOUT BIOETHICS TODAY
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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