Tag: genetic engineering

Bioethics News

The FDA Approves a Landmark Cancer Drug

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The Food and Drug Administration on Wednesday approved a new therapy to treat leukemia in kids and young adults—a decision whose importance is as much symbolic as it is practical.

Kymriah, from the Swiss pharmaceutical company Novartis, is a cancer therapy that represents several things at once: a game-changing way to treat cancer through genetic engineering, a novel paradigm for the biotech business, and the latest turn in the debate over just how astronomically expensive a life-saving therapy can be.

Kymriah is strikingly effective for young patients with acute lymphoblastic leukemia, or ALL, but it is far more involved than taking a pill or getting an infusion. It requires inserting a human-designed gene into a patient’s own T cells so they recognize and ferociously attack cancer cells. Researchers began modifying T cells for patients in the 1990s—and now the technology called CAR T-cell therapy is finally ready for prime time in treating cancer.

Of several dozen ALL patients in a clinical trial for Kymriah, 83 percent were cancer-free after three months. It is a lifeline for patients in which traditional treatments like chemotherapy and bone-marrow transplants had failed. When the FDA’s advisory committee initially voted in favor of approving Kymriah, one member called it “the most exciting thing I’ve seen in my lifetime” for childhood leukemia. Novartis is hardly the only company interested in CAR T. Kymriah is the first approved therapy, but several clinical trials—mostly notably Kite Pharma’s for lymphoma—are right behind it.

(To clear up any possible confusion about terminology: The FDA and others have chosen to call CAR T-cell therapy a form of gene therapy—and thus deemed it the first gene therapy to be approved in the United States.

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 Rush to Develop ‘Utterly Transformative’ Gene Therapies

July 24, 2017

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Companies and universities are racing to develop these new therapies, which re-engineer and turbocharge millions of a patient’s own immune cells, turning them into cancer killers that researchers call a “living drug.” One of the big goals now is to get them to work for many other cancers, including those of the breast, prostate, ovary, lung and pancreas.

“This has been utterly transformative in blood cancers,” said Dr. Stephan Grupp, director of the cancer immunotherapy program at the Children’s Hospital of Philadelphia, a professor of pediatrics at the University of Pennsylvania and a leader of major studies. “If it can start to work in solid tumors, it will be utterly transformative for the whole field.”

But it will take time to find that out, he said, at least five years.

… Read More

Image: By NIAID/NIH – NIAID Flickr’s photostream, Public Domain, https://commons.wikimedia.org/w/index.php?curid=18233598

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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

Cross Post: Speaking with: Julian Savulescu on the ethics of genetic modification in humans

Could genetic engineering one day allow parents to have designer babies?
Tatiana Vdb/flickr, CC BY

William Isdale, University of Melbourne

What if humans are genetically unfit to overcome challenges like climate change and the growing inequality that looks set to define our future?

Julian Savulescu, visiting professor at Monash University and Uehiro professor of Practical Ethics at Oxford University, argues that modifying the biological traits of humans should be part of the solution to secure a safe and desirable future.

The University of Melbourne’s William Isdale spoke to Julian Savulescu about what aspects of humanity could be altered by genetic modifications and why it might one day actually be considered unethical to withhold genetic enhancements that could have an overwhelmingly positive effect on a child’s life.

Listen to the conversation

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

Speaking with: Julian Savulescu on the ethics of genetic modification in humans

Could genetic engineering one day allow parents to have designer babies? Tatiana Vdb/flickr, CC BY

What if humans are genetically unfit to overcome challenges like climate change and the growing inequality that looks set to define our future?

Julian Savulescu, visiting professor at Monash University and Uehiro professor of Practical Ethics at Oxford University, argues that modifying the biological traits of humans should be part of the solution to secure a safe and desirable future.

The University of Melbourne’s William Isdale spoke to Julian Savulescu about what aspects of humanity could be altered by genetic modifications and why it might one day actually be considered unethical to withhold genetic enhancements that could have an overwhelmingly positive effect on a child’s life.


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William Isdale does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond the academic appointment above.

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

Should We Cure Genetic Diseases?

June 07, 2017

by Professor Bonnie Steinbock

Should We Cure Genetic Diseases?

In “Trying to Embrace a ‘Cure’,” (New York Times, June 4, 2017), Sheila Black notes that in the near future there may be a treatment that could amount to a cure for the genetic illness she and two of her children have — X-linked hypophosphatemia or XLH. Although XLH is not life threatening, it has significant disadvantages, including very short stature (short enough to qualify as a type of dwarfism), crooked legs, poor teeth, difficulty in walking, and pain. A cure would seem to be cause for celebration.

But Ms. Black is ambivalent about the prospect. Although she acknowledges the potential benefits both to individuals and to society, the issue is, for her, complex.

Having a serious disability may enable the development of certain virtues. She writes, “… to be human often entails finding ways to make what appears a disadvantage a point of strength or pride.” Or, as Nietzsche put it,  “That which does not kill us, makes us stronger.”

It’s very likely that having polio made Franklin Roosevelt emotionally more mature and strengthened his character, but would that be a reason to oppose the development of the Salk vaccine? Comedians often credit their talent from having been bullied as children; novelists and playwrights find inspiration in their awful childhoods. Admiring their ability to overcome adversity does not mean being ambivalent about ending bullying and child abuse.

Another reason is that disabilities have created communities that are a source of support and identity.

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

Interview with Arthur Caplan

by Kaitlynd Hiller and Rachel F. Bloom

It is a difficult task to succinctly describe the professional accomplishments of Arthur Caplan, PhD. For the uninitiated, Dr. Caplan is perhaps the most prominent voice in the conversation between bioethicists and the general public, as well as being a prolific writer and academic. He is currently the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics at NYU Langone Medical Center and NYU School of Medicine, having founded the Division of Bioethics there in 2012. Additionally, he co-founded the NYU Sports and Society Program, where he currently serves as Dean, and heads the ethics program for NYU’s Global Institute for Public Health. Prior to joining NYU, he created the Center for Bioethics and Department of Medical Ethics at the University of Pennsylvania Perelman School of Medicine, serving as the Sidney D. Caplan Professor of Bioethics. Dr. Caplan is a Hastings Center fellow, also holding fellowships at The New York Academy of Medicine, the College of Physicians of Philadelphia, the American Association for the Advancement of Science, and the American College of Legal Medicine. He received the lifetime achievement award of the American Society of Bioethics and Humanities in 2016.

Dr. Caplan’s experience is not at all limited to the academic realm: he has served on numerous advisory counsels at the national and international level, and is an ethics advisor for organizations tackling issues from synthetic biology to world health to compassionate care. Dr. Caplan has been awarded the McGovern Medal of the American Medical Writers Association, the Franklin Award from the City of Philadelphia, the Patricia Price Browne Prize in Biomedical Ethics, the Public Service Award from the National Science Foundation, and the Rare Impact Award from the National Organization for Rare Disorders; he also holds seven honorary degrees.

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

Dear Mr. President: It’s Time for Your Bioethics Commission

by Craig Klugman, Ph.D.

Last week, seven Democratic members of the U.S. House Representatives sent a letter to the White House asking President Trump to appoint a director to the Office of Science and Technology Policy (OSTP), position that normally serves as the presidential science advisor. The impetus for writing the letter was a communication from the Deputy National Science Advisor that two hoax reports, that tried to undermine climate change, were circulating through the West Wing as “science.” The Congresspersons state “Where scientific policy is concerned, the White House should make use of the latest, most broadly-supported science…Relying on factual technical and scientific data has helped make America the greatest nation in the world.” Among the signers are a PhD in math and a PhD in physics. They hold that the U.S. faces strong questions that revolve around science, both opportunities and threats, and the need for a scientist who can understand and explain the importance of objective fact to the chief executive is essential.

This article led me to think that the U.S. also faces a lot of issues regarding health and medicine and their impact on society. Consider the task of creating a new health plan, CRISPR/CAS-9, in vitro gametogenesis, the threat of Zika, extra uterine gestational systems, legalized marijuana, digital medicine—pharmaceutical computing for treating disease, head transplants, and DYI science are among the bioethical issues that will effect policy in the coming few years. Thus, it is time for President Trump to call for his Presidential Bioethics Commission.

The last bioethics advisory body ended in January 2017, although many of the staff are still winding down the office and archiving the many reports and papers produced.

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

Role of genetic engineering in European agriculture

Criticises the attitude of politicians, on not recognising the value of new farming technologies

The scientific advisor HFFA Research GmbH has published a study entitled “ The economic, social and environmental value of plant breeding in the European Union” on the role of genetic improvement in the European farming sector. The Report, which criticises the attitude of politicians, on not recognising the value of new farming technologies (agriculture genetic engineering), concludes that genetic advances have allowed production of European crops to be increased up to 74% in the last 15 years. According to its authors, the increased production derived from genetic advances has helped to stabilise the markets, reduce price volatility and increase the world food supply. They are also responsible for increasing the European GNP by 14 billion Euros. It has also managed to slow the expansion of land destined for agriculture, preserving 19 million hectares that had been destined for farming without these technological advances. It has also prevented the emission of 3.4 million tonnes of CO2 by limiting land use change.

Photo: Cenex

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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

Synthetic life and biodiversity

Written by Dr Chris Gyngell

Last year, the first truly novel synthetic life form was created. The Minimal Cell created by the Venter Lab, contains the smallest genome of any known independent organism.[1] While the first synthetic microbe was created in 2010, that was simply a like for like synthetic copy of the genome of an existing bacterium.  Nothing like the Minimal Cell exists in nature.

This great advance in synthetic biology comes at a time where natural life forms are being manipulated in ways never seen before.  The CRISPR gene editing system has been used to create hulk-like dogs, malaria proof mosquitoes, drought resistant wheat and hornless cows. The list of CRISPR-altered animals grows by the month.

Such developments hasten the need for a systematic analysis of the ethics of creating new forms of life. In a recent paper[2], Julian Savulescu and I draw attention to how thoughts regarding the value of biodiversity may bear on this question.

The idea that biodiversity is valuable is ubiquitous. The United Nations “Convention on Biodiversity”, signed by over 160 countries, recognises the “intrinsic value of biological diversity”.[3]  The idea that biodiversity is valuable has also greatly influenced the commercial sector and is a cornerstone of the modern corporate social responsibility movement. The value of biodiversity has even been recognised by the Catholic Church. Pope Francis devotes an entire section of his Encyclical Letter, “On Care For Our Common Home” to the Loss of Biodiversity, describing a new Sin, the destruction of biological diversity.

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

The Future of Bioethics: Organ Transplantation, Genetic Testing, and Euthanasia

By Ana Lita

When you think of bioethics, some of the first hot-button topics you may consider are organ transplantation, fertility and genetic engineering, and end-of-life-care. The Global Bioethics Initiative serves as a platform to address many bioethical questions and engages in public debates to develop resolutions to present and emerging issues.

Dr. Ana Lita, founder of the Global Bioethics Initiative, discusses the various areas GBI addresses and highlights the organization’s contributors in their prospective fields. She acknowledges the valuable contribution of the current president of GBI, Dr. Bruce Gelb, in the field of organ transplantation. She also addresses the original co-founder of GBI, Dr. Charles Debrovner, and his lifelong passion in the field of fertility and genetic engineering. Lastly, Dr. Lita offers a brief insight into the future of Bioethics in these uncertain times.

ORGAN MARKETS AND THE ETHICS OF TRANSPLANTATION 

Recent developments in immunosuppressive drugs and improved surgical techniques have now made it much easier to successfully transplant organs from one human body to another. Unfortunately, these developments have led to the rise of black-markets in human organs. This underground market is where people who need kidneys to survive or to improve the quality of their lives, for example, purchasing such organs from impoverished persons in the developing world. In January 2017, scientists announced that they successfully created the first human-pig hybrid and a pig embryo with some human characteristics. Given the increasing need for transplant organs, should such markets be regulated and legalized?  Could the success of therapeutic cloning eliminate the need to consider this option?

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.