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Topic: Stem Cell Research
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.

December 20, 2012 | Posted By Zubin Master, PhD

Last month, I discussed a research integrity case making international headlines of an iPS cell study conducted by a researcher Hisashi Moriguchi who had allegedly falsified or fabricated data, provided false institutional affiliation, plagiarized work, and had questionable publication practices. In this post, I want to outline a few of the lessons we can learn from this case.

I think Péter Kakuk said it best when he wrote that the Hwang cloning scandal “might shed light on the often neglected benefits of the 'social control of science'".  As a trained scientist, I can say that I used to believe that many of the safeguards felt more like impediments to research progress. As a bioethics researcher, I still feel there are kinks in the system of ethical oversight and there is evidence to support this view. However, I also believe that the ethical safeguards are in place to promote the responsible conduct of research and ensure that research is performed by upholding the utmost standards of integrity. In every issue of Nature or Science there is some report of research misconduct or misbehavior. There have been studies done in the US and many other nations about the frequency of misconduct. Yet despite such reports, I feel many scientists still believe there are too many research hurdles only to catch a few bad apples. This view needs to shift.

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 16, 2012 | Posted By Zubin Master, PhD

This blog will have two parts. In this first entry, I present will discuss a recent case of stem cell fraud and the subsequent blog entry will discuss possible lessons to learn appearing next month.

The tale begins when Woo-Suk Hwang, a once celebrated hero of South Korea, claimed to have made the first, patient-specific human embryonic stem cell (hES) line through a technique called somatic cell nuclear transfer (commonly referred to as research or therapeutic cloning). This study was soon after proven to be fraudulent. Not to get into too many details, but this technique requires obtaining ova from women providers, enucleating its genetic material, and placing the nucleus from a somatic cell and parthenogenically activating the egg. This initiates embryonic development and at about day 3-4 of development (where the embryo is at the blastocyst stage), hES cells can be isolated from the inner cell mass of blastocysts. This incredible feat in stem cell research was published in Science in 2004 and another study in 2005. In 2006, Hwang was discredited for fabricating results and after an investigation, he was convicted for embezzlement and bioethical allegations. He embezzled approximately 830 million won (US $700,000) of government funds and apparently used 2,200 eggs obtained from his female postgraduate students and junior researchers. All wasted!

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 17, 2012 | Posted By Zubin Master, PhD

Stem cell tourism is a pejorative term used to describe clinics that offer under or untested stem cell interventions to patients with debilitating 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 under or untested stem cell interventions, some of which are being challenged by the FDA. The stem cell tourism market is an internet-based, direct-to-consumer market. There is a lack of scientific evidence and clinical research supporting the claims made by clinics in regards to the efficacy of these so-called “treatments”. The evidence sold to patients are testimonials by other patients saying how great they feel and how it has helped them and given hope. This is further fueled as some public perception studies indicate that several patients are frustrated and seem to distrust their domestic healthcare, research and regulatory system. So why offer these therapies? Well for starters, stem cell providers could make a ton of money (ranging from $5,000 to $30,000), especially because sometimes patients require repeated treatments. The market has more recently attracted celebrity types including several high profile athletes, Hollywood stars, and even a US State Governor.

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 1, 2012 | Posted By Ricki Lewis, PhD

On July 11, Wills Eye Institute ophthalmologist Carl Regillo delicately placed 100,000 cells beneath the retina of 52-year-old Maurie Hill’s left eye. She was rapidly losing her vision due to Stargardt disease, an inherited macular dystrophy similar to the much more common dry age-related macular degeneration (AMD).

Maurie’s disease was far along, the normally lush forests of photoreceptor cells in the central macula area severely depleted, especially the cones that provide color vision. Would the introduced cells nestle among the ragged remnants of her retinal pigment epithelium (RPE) and take over, restoring the strangled energy supply to her remaining photoreceptors? They should, for the cells placed in Maurie’s eye weren’t ordinary cells. They were derived from human embryonic stem cells (hESCs).

I’ve waited 15 years to see human embryonic stem cells, or their “daughter” cells, make their way through clinical trials. And thanks to Maurie’s sharing her story, I’m witnessing translational 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.

August 3, 2012 | Posted By Ricki Lewis, PhD

On Sunday morning, July 21, I faced a room of people from families with Leber congenital amaurosis (LCA), an inherited blindness caused by mutations in any of at least 18 genes. It was the final session of the Foundation for Retinal Research’s bi-annual LCA family conference, and I was there to discuss the history of gene therapy. But I zapped through that quickly, because the future is much more intriguing.

The excitement pervading the room that day was palpable, following a day of scientific updates, and not only because those with young children were soon to visit Sesame World and the sights of Philadelphia.


E
xome sequencing identified the rare mutation that causes Gavin Stevens’ hereditary blindness (Leber congenital amaurosis, or LCA). (Photo: Jennifer Stevens)

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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