Tag: translational research

Bioethics Blogs

Human genome editing report strikes the right balance between risks and benefits

Gene therapy is growing in its capabilities, but there should be limits to its use. Shutterstock

If you recognise the words “CRISPR-mediated gene editing”, then you’ll know that our ability to alter DNA has recently become much more efficient, faster and cheaper.

This has inevitably led to serious discussions about gene therapy, which is the direct modification of someone’s DNA to rectify a genetic disorder, such as sickle cell anaemia or haemophilia. And you may also have heard of deliberate genetic enhancement, to realise a healthy person’s dreams of improving their genome.

Both of these issues have now been tackled in a comprehensive report on gene editing released today by the US National Academy of Science and National Academy of Medicine.

The message is fairly simple: relax, we’ve seen this all before, little if any harm has eventuated, and society is well placed to move forward together on this.

A definite maybe

Of all human technologies, recombinant DNA has arguably been one of the safest. There have been multiple benefits in both medicine and agriculture. And the legitimate concerns that arose when viruses were first mixed with bacterial genes, when cloning was first introduced, and when stem cells were developed, have not come to pass.

I cannot list all the benefits here, but if you have received the Hepatitis B vaccine or Australian Ian Fraser’s Gardasil vaccine, which protects against cervical cancer viruses, you have been protected from disease thanks to recombinant DNA technology.

However, you probably haven’t received somatic gene therapy, which is gene alteration directed at fixing one cell type, such as defective blood or liver cells.

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 Medicalization of Mental Illness in Gun Violence

By Carolyn C. Meltzer, MD
Dr. Meltzer serves as the William P. Timmie Professor and Chair of the Department of Radiology and Imaging Sciences and as the Associate Dean for Research at the Emory University School of Medicine. Her work focuses on applying novel advanced imaging strategies to better understand brain structure-function relationships in normal aging, late-life depression, and Alzheimer’s disease. She is also involved in oncologic imaging research and, while at the University of Pittsburgh, oversaw the clinical evaluation of the world’s first combined PET/CT scanner. She established the Emory Center for Systems Imaging to broadly support the advance of imaging technologies in basic and translational research, including beta testing of the first human combined MRI/PET scanner. Dr. Meltzer has also served as the Chair of the Neuroradiology Commission and Chair of the Research Commission on the American College of Radiology’s Board of Chancellors, President of the Academy of Radiology Research, Trustee of the Radiological Society of North America Foundation, and President of the American Society of Neuroradiology.
On January 6, 2017, a young man pulled a semiautomatic handgun from his checked baggage and shot and killed several passengers in the Fort Lauderdale airport. In the days following the incident, information about erratic behavior and his prior involvement in incidents of domestic abuse emerged.
Image courtesy of Wikimedia Commons

The US has the highest rates of both gun-related deaths and mass-shooting incidents. In the latest available statistics from the Center for Disease Control and Prevention (CDC), 33,304 people were killed by firearms in 2014. Over the past decade (2007-2016), there have been 16 mass shootings in the US (Mother Jones’ Investigation: US Mass Shootings 1982-2016), including several — at Virginia Tech, an Aurora theatre, the Sandy Hook Elementary School, Charleston’s Emanuel African Methodist Episcopal Church, and the Pulse nightclub in Orlando – that drew substantial national attention.

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

October 2016 Newsletter

Applications for Ongoing Internship Program are Now Open!
International students and volunteers are welcome to apply
Global Bioethics Initiative accepts applications for unpaid internships for students interested in bioethics. These internships provide students with the opportunity to learn about pertinent issues in global health and bioethics and gain skills in research, project management, and organizing events. Candidates interested in interning with us should contact the Executive Director, Dr. Ana Lita at alita@globalbioethics.org. Read more here.
Stay tuned for GBI Summer Programs 2017 in Manhattan, New York and Dubrovnik, Croatia!
Manhattan Summer School Program on Global Bioethics, July 11 – 22, 2016
Participant Testimonials – Read More Here!
“One of the main reasons I decided to attend Global Bioethics Initiative’s Summer Program is to learn more specifically about the nature of global bioethics. We are all global citizens of the world and I learned so much more about our global populations and their ethical issues. The presenters were experts in their field and challenged us all to think. It is difficult to choose one particular lecture since they were all so thought provoking, from stem cell research, gene editing, ethical issues in international research, global epidemics, religious traditions and impact on bioethics, organ harvesting, ethics of transplantation, and the list goes on. I have been in the clinical and academic nursing field for over 25 years but I learned so much from every single presentation.” Esma Paljevic EdD, RN, CPNP, Assistant Professor, Lienhard School of Nursing, Pace University
“In just the first week of the course, I’ve been exposed to world-class thought leaders speaking on critically emerging ethical issues of global impact in ways that transform hypothetical case studies to real-world dilemmas.

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

Student Testimonials Manhattan Summer School Program, July 11 – 22, 2016

In just the first week of the course, I’ve been exposed to world-class thought leaders speaking on critically emerging ethical issues of global impact in ways that transform hypothetical case studies to real-world dilemmas. Nowhere else could I have had the opportunity to engage in provocative dialogue with the Board President of Doctors Without Borders about the horrific ethical challenges and dilemmas the organization faces in war zones. A truly profound experience for a long-time nursing professor and biomedical researcher who has taught bioethics for many years. Nancy King Reame, MSN, PhD, FAAN, Director, Pilot Studies Resource of the Irving Institute for Clinical & Translational Research, Mary Dickey Lindsay Professor of Nursing (Emerita), Columbia University Medical Center

GBI summer school definitely exceeded my expectations. The guided tour to the United Nations Headquarters offered us an exciting opportunity to get a behind-the-scenes view of the UN at work. We visited the newly renovated General Assembly Hall, the Security Council Chamber, the Trusteeship Council Chamber, and the Economic and Social Council (ECOSOC) Chamber in the renovated Conference Building. We also learned about how the United Nations addresses issues such as human rights, disarmament, peace and security, and the Sustainable Development Goals, closely related to GBI’s mission. I found the field trip to be fantastic, and the summer program overall was extremely interesting and informative. All lecturers were extremely respected within their fields. My favorite lectures were those of Dr. Jonathan Garlick and Dr. Bruce Gelb. Dr. Garlick spoke about stem cells, CRISPR, and the possibility of same-sex couples being able to have biological children as a result of stem cell research, while Dr.

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

Stem cells and the production of organoids at the forefront of biomedical science

There are topics in which biomedical interest merges with ethical interest. One of these is undoubtedly the subject of stem cells wich appears to be the biomedical science forefront. Few issues in the biomedical sciences arouse as much interest as these, and for this reason, the prestigious journal Nature Cell Biology will analyse a series of articles, two of which have now been published.

The first (Nature Cell Biology 18; 238-245, 2016) discusses evidence for and against the role that stem cells might play in cell maintenance and repair in the liver and pancreas, concluding that repair of these organs depends more on cells that are already mature than on the stem cells themselves.

The second (Nature Cell Biology, 18; 246-254, 2016) reviews the in vitro creation of human organoids (small human organ structures), since these are an essential weapon to improve our understanding of biological processes, and even for the development of new clinical applications. This article discusses the advances, problems and possible applications of these organoids, reviewing the historical aspects of their development, and types of organoids already obtained, which include tissues as varied as the lung, salivary glands, oesophagus, stomach, bowel, colon, liver, pancreas, prostate, lung, retina, ear, brain and kidney.

Many of these organoids have been developed from adult cells from the corresponding organs, both animal (mainly murine) and human, as well as from embryonic stem cells and iPS cells. Using embryonic stem cells in these experiments entails objective ethical problems that cannot be put aside.

The organoids obtained are being used for a wide range of purposes, ranging from basic research to their clinical application, i.e.

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

Stem Cell Trial Suggests Damaged Heart Tissue Could Be Regenerated

July 25, 2016

(The Guardian) – People suffering from heart disease have been offered hope by a new study that suggests damaged tissue could be regenerated through a stem cell treatment injected into the heart during surgery. The small-scale study, published in the Journal of Cardiovascular Translational Research, followed 11 patients who during bypass surgery had stem cells injected into their hearts near the site of tissue scars caused by heart attacks.

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

New Frontiers in Animal Research Neuroethics at the Center for Neuroscience and Society

By Tyler M. John

Tyler John is a postbaccalaureate fellow at the National Institutes of Health Department of Bioethics interested in resource allocation, animal ethics, and moral theory. This fall, he will begin a PhD in Philosophy at Rutgers University. 


The opinions expressed are the authors’ own. They do not reflect any position or policy of any U.S. governmental entity, including the National Institutes of Health or the Department of Health and Human Services. 
On June 9-10, I joined a gathering of philosophers, psychologists, veterinarians, and biomedical researchers for the Animal Research Neuroethics Workshop at the Penn Center for Neuroscience and Society. The workshop, organized by neuroethicists Adam Shriver, James Serpell, and Martha Farah, focused on the ethical issues raised by new advances in neuroscience research with non-human animals. Here, researchers from many disciplines came together to share notes from the field and discuss new neuroethics problems. 
Over two days, we discussed problems like, What is the moral status of so-called “brains in dishes”? Is it morally permissible for scientists to cognitively enhance mice, rats, and chimps, giving them advanced cognitive capacities? Is it even conceptually possible to have a mouse model of human depression given the substantial psychological differences between humans and mice? What, more broadly, should we say about the scientific validity and moral permissibility of current neurological research on non-human animals? 

Despite our vast disciplinary diversity and some disagreement about issues in moral theory, participants were very quickly able to bridge disciplinary divides and create broad areas of consensus.

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

Debate over New FDA Commissioner

The Duke Chronicle

In a previous post, I argued in favor of Rob Califf as FDA Commissioner. Here is an article from the Duke Chronicle, exploring more of this important debate.

Dr. Robert Califf, former vice chancellor of clinical and translational research, may soon be taking helm of the U.S. Food and Drug Administration, but not without resistance from organizations and politicians who argue that his experience at Duke has made him too close to the industry.

President Barack Obama announced his nomination of Califf—who is currently the deputy commissioner for Medical Products and Tobacco—for FDA commissioner in September. Since then, certain health and patient advocacy organizations and politicians have voiced concerns about Califf’s ability to lead the regulatory agency of the pharmaceutical industry, given his extensive history working with drug companies and leading clinical trials. Many in the medical community have endorsed him, however, arguing that his well-known expertise and scientific integrity make him the best candidate for the job, which involves decisions on whether certain drugs or medical products are safe and effective enough to bring to market.

“Rob has gotten almost uniform support from his academic colleagues, even some of which are very strongly anti-industry,” said Dr. Eric Peterson, executive director of the Duke Clinical Research Institute, who added that he considers Califf a mentor and a role model. “Dr. Califf is an incredible scientist and a wonderful doctor. Rob is considered incredibly knowledgeable and fair and a change agent in all of the things seen as needed by the FDA.”

Califf’s nomination awaits approval from the Senate Committee on Health, Education, Labor and Pensions.

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

An F.D.A. Commissioner With Ties to the Pharmaceutical Industry? Heaven Forbid?

On September 16, 2015, President Obama nominated the internationally known Duke University cardiologist-researcher Robert M. Califf, MD, to be Commissioner of Food and Drugs. He will replace Margaret Hamburg, MD, who left the agency last March. Dr. Califf – a registered Democrat but well regarded by Senate Republicans – has served as Deputy Commissioner at the F.D.A. since February. The Senate must confirm the commissioner.

Immediately prior to joining the F.D.A., Dr. Califf was professor of medicine and vice chancellor for clinical and translational research at Duke. While at Duke, he founded the Duke Clinical Research Institute and served as director of the Duke Translational Medicine Institute. A highly esteemed expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf has led many landmark clinical trials and authored or co-authored over 1,200 publications in the peer-reviewed literature. He is one of the American Medicine’s most frequently cited authors in the biomedical sciences. His credentials are unimpeachable. Two of Dr. Califf’s area of interests are improving the design of drug research projects and streamlining the regulatory process to bring innovative drugs to market more quickly.

However, he also has many strong ties to the pharmaceutical and medical device industries. One article called him the ultimate drug industry insider.

It may seem logical to be suspicious of having a F.D.A. Commissioner who understands clinical drug research inside and out. After all, Dr. Califf learned much by working with drug and device manufacturers over the years, directing a clinical research trials center with an annual $200 million budget and with 65% of that amount coming from big pharma.

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

No trial stands alone

“The result of this trial speaks for itself!”

This often heard phrase contains a troubling assumption: That an experiment can stand entirely on in its own. That it can be interpreted without reference to other trials and other results. In a couple of articles published over the last two weeks, my co-authors and I deliver a one-two punch to this idea.

The first punch is thrown at the US FDA’s use of “assay sensitivity,” a concept defined as a clinical trial’s “ability to distinguish between an effective and an ineffective treatment.” This concept is intuitively appealing, since all it seems to say is that a trial should be well-designed. A well-designed clinical trial should be able to answer its question and distinguish an effective from an ineffective treatment. However, assay sensitivity has been interpreted to mean that placebo controls are “more scientific” than active controls. This is because superiority to placebo seems to guarantee that the experimental agent is effective, whereas superiority or equivalence to an active control does not rule out the possibility that both agents are actually ineffective.  This makes placebo-controlled trials more “self-contained,” easier to interpret, and therefore, methodologically superior.

In a piece in Perspectives in Biology and Medicine, Charles Weijer and I dismantle the above argument by showing, first, that all experiments rely on some kinds of “external information”–be it information about an active control’s effects, pre-clinical data, the methodological validity of various procedures, etc. Second, that a placebo can suffer from all of the same woes that might afflict an active control (e.g.,

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.