Welcome to the Nexus of Ethics, Psychology, Morality, Philosophy and Health Care

Welcome to the nexus of ethics, psychology, morality, technology, health care, and philosophy
Showing posts with label Genetic Engineering. Show all posts
Showing posts with label Genetic Engineering. Show all posts

Sunday, August 29, 2021

A New Era of Designer Babies May Be Based on Overhyped Science

Laura Hercher
Scientific American
Originally published 12 July 21

Here is an excerpt:

Current polygenic risk scores have limited predictive strength and reflect the shortcomings of genetic databases, which are overwhelmingly Eurocentric. Alicia Martin, an instructor at Massachusetts General Hospital and the Broad Institute of the Massachusetts Institute of Technology and Harvard University, says her research examining polygenic risk scores suggests “they don’t transfer well to other populations that have been understudied.” In fact, the National Institutes of Health announced in mid-June that it will be giving out $38 million in grants over five years to find ways to enhance disease prediction in diverse populations using polygenic risk scores. Speaking of Orchid, Martin says, “I think it is premature to try to roll this out.”

In an interview about embryo screening and ethics featured on the company’s Web site, Jonathan Anomaly, a University of Pennsylvania bioethicist, suggested the current biases are a problem to be solved by getting customers and doing the testing. “As I understand it,” he said, “Orchid is actively building statistical models to improve ancestry adaptation and adjustments for genetic risk scores, which will increase accessibility of the product to all individuals.”

Still, better data sets will not allay all concerns about embryo selection. The combined expense of testing and IVF means that unequal access to these technologies will continue to be an issue. In her Mendelspod interview, Siddiqui insisted, “We think that everyone who wants to have a baby should be able to, and we want our technology to be as accessible to everyone who wants it,” adding that the lack of insurance coverage for IVF is a major problem that needs to be addressed in the U.S.

But should insurance companies pay for fertile couples to embryo-shop? This issue is complicated, especially in light of the fact that polygenic risk scores can generate predictions for more than just heart disease and cancer. They can be devised for any trait with a heritable component, and existing models offer predictions for educational attainment, neuroticism and same-sex sexual behavior, all with the same caveats and limitations as Orchid’s current tests for major diseases. To be clear, tests for these behavioral traits are not part of Orchid’s current genetic panel. But when talking about tests the company does offer, Siddiqui suggested that the ultimate decision makers should be the parents-to-be. “I think at the end of the day, you have to respect patient autonomy,” she said.

Saturday, June 19, 2021

Preparing for the Next Generation of Ethical Challenges Concerning Heritable Human Genome Editing

Robert Klitzman
The American Journal of Bioethics
(2021) Volume 21 (6), 1-4.

Here is the conclusion

Moving Forward

Policymakers will thus need to make complex and nuanced risk/benefit calculations regarding costs and extents of treatments, ages of onset, severity of symptoms, degrees of genetic penetrance, disease prevalence, future scientific benefits, research costs, appropriate allocations of limited resources, and questions of who should pay.

Future efforts should thus consider examining scientific and ethical challenges in closer conjunction, not separated off, and bring together the respective strengths of the Commission’s and of the WHO Committee’s approaches. The WHO Committee includes broader stakeholders, but does not yet appear to have drawn conclusions regarding such specific medical and scientific scenarios (WHO 2020). These two groups’ respective memberships also differ in instructive ways that can mutually inform future deliberations. Among the Commission’s 18 chairs and members, only two appear to work primarily in ethics or policy; the majority are scientists (National Academy of Medicine, the National Academies of Sciences and the Royal Society 2020). In contrast, the WHO Committee includes two chairs and 16 members, with both chairs and the majority of members working primarily in ethics, policy or law (WHO 2020). ASRM and other countries’ relevant professional organizations should also stipulate that physicians and healthcare professionals should not be involved in any way in the care of patients using germline editing abroad.

The Commission’s Report thus provides valuable insights and guidelines, but multiple stakeholders will likely soon confront additional, complex dilemmas involving interplays of both science and ethics that also need urgent attention.

Friday, January 10, 2020

The Complicated Ethics of Genetic Engineering

Brit McCandless Farmer
cbsnews.com
Originally posted 8 Dec 19

Here is an excerpt:

A 2017 survey at the University of Wisconsin-Madison asked 1,600 members of the general public about their attitudes toward gene editing. The results showed 65 percent of respondents think gene editing is acceptable for therapeutic purposes. But when it comes to whether scientists should use technology for genetic enhancement, only 26 percent agreed.

Going forward, Church thinks genetic engineering needs government oversight. He is also concerned about reversibility—he does not want to create anything in his lab that cannot be reversed if it creates unintended consequences.

"A lot of the technology we develop, we try to make them reversible, containable," Church said. "So the risks are that some people get excited, so excited that they ignore well-articulated risks."

Back in his Harvard lab, Church's colleagues showed Pelley their work on "mini brains," tiny dots with millions of cells each. The cells, which come from a patient, can be grown into many types of organ tissue in a matter of days, making it possible for drugs to be tested on that patient's unique genome. Church aims to use genetic engineering to reverse aging and grow human organs for transplant.

Pelley said he was struck by the speed with which medical advancements are coming.

The info is here.

Sunday, November 24, 2019

Is biohacking ethical? It’s complicated. A new Netflix series explains why.

A baby’s hand sporting a UPC barcode on its wrist holds onto an adult’s finger.Sigal Samuel
www.vox.com
Originally posted October 22, 2019

Here is an excerpt:

Biohacking raises a lot of questions with huge ethical implications. Should biohacking yourself be a human right or should your control over your own body be curtailed — possibly even criminalized — if it’s risky to you or others? (Many biohacking pursuits exist in a legal gray zone but are not yet outright illegal, or not enforced as such. Some new gene therapies profiled in Unnatural Selection, like Jackson Kennedy’s, are approved by the Food and Drug Administration.) Will biohacking enhance life for all of us equally or will it widen the gap between haves and have-nots?

Perhaps we’d do best to strictly limit the use of new technologies like CRISPR. But then again, given that people are dying and these technologies might help, can we morally afford to not use them?

Ethical objections to biohacking

While some people who engage with biohacking view themselves as part of the scientific establishment and often voice ethical concerns about technologies like CRISPR, others have a strong anti-establishment streak.

Unnatural Selection assigns uneven weight to different camps — proponents of the new technologies get more airtime than their critics, perhaps because it’s more visually interesting to watch people inject themselves with new DNA than it is to watch finger-wagging bioethicists warn about risks.

The info is here.

Wednesday, November 20, 2019

Super-precise new CRISPR tool could tackle a plethora of genetic diseases

CRISPR-Cas9 gene editing complex, illustration.Heidi Ledford
nature.com
Originally posted October 21, 2019

For all the ease with which the wildly popular CRISPR–Cas9 gene-editing tool alters genomes, it’s still somewhat clunky and prone to errors and unintended effects. Now, a recently developed alternative offers greater control over genome edits — an advance that could be particularly important for developing gene therapies.

The alternative method, called prime editing, improves the chances that researchers will end up with only the edits they want, instead of a mix of changes that they can’t predict. The tool, described in a study published on 21 October in Nature1, also reduces the ‘off-target’ effects that are a key challenge for some applications of the standard CRISPR–Cas9 system. That could make prime-editing-based gene therapies safer for use in people.

The tool also seems capable of making a wider variety of edits, which might one day allow it to be used to treat the many genetic diseases that have so far stymied gene-editors. David Liu, a chemical biologist at the Broad Institute of MIT and Harvard in Cambridge, Massachusetts and lead study author, estimates that prime editing might help researchers tackle nearly 90% of the more than 75,000 disease-associated DNA variants listed in ClinVar, a public database developed by the US National Institutes of Health.

The specificity of the changes that this latest tool is capable of could also make it easier for researchers to develop models of disease in the laboratory, or to study the function of specific genes, says Liu.

The info is here.

Wednesday, October 23, 2019

The Moral Choices on CRISPR Babies

Sheldon Krimsky
The American Journal of Bioethics
Published online September 26, 2019

In late November 2018, Chinese scientist Dr. He Jiankui announced at the Second International Summit on Human Genome Editing in Hong Kong that he had used CRISPR/Cas 9 gene editing on two female embryos that were brought to term through an in vitro fertilization (IVF) pregnancy. The world scientific community was ill-prepared for the announcement since the moral issues surrounding the editing of human embryos were under discussion but hardly resolved. The recommendation of the 12-member organizing committee of the 2015 International Summit on Human Gene Editing in Washington, DC, stated that it would be irresponsible to undertake any clinical use of germline editing unless and until the safety and efficacy issues were resolved and there was a broad consensus on the specific application, and that such use could proceed only under appropriate regulatory oversight (International Summit on Human Genome Editing 2015). Similar recommendations were made by the National Academies of Sciences, Engineering, and Medicine. This editorial gives two reasons for genetically modifying embryos and three reasons against it.

The summary of arguments for and against genetically modifying embryos is here.

Thursday, August 15, 2019

World’s first ever human-monkey hybrid grown in lab in China

Henry Holloway
www.dailystar.co.uk
Originally posted August 1, 2019

Here is an excerpt:

Scientists have successfully formed a hybrid human-monkey embryo  – with the experiment taking place in China to avoid “legal issues”.

Researchers led by scientist Juan Carlos Izpisúa spliced together the genes to grow a monkey with human cells.

It is said the creature could have grown and been born, but scientists aborted the process.

The team, made up of members of the Salk Institute in the United States and the Murcia Catholic University, genetically modified the monkey embryos.

Researchers deactivates the genes which form organs, and replaced them with human stem cells.

And it is hoped that one day these hybrid-grown organs will be able to be translated into humans.

Scientists have successfully formed a hybrid human-monkey embryo  – with the experiment taking place in China to avoid “legal issues”.

Researchers led by scientist Juan Carlos Izpisúa spliced together the genes to grow a monkey with human cells.

It is said the creature could have grown and been born, but scientists aborted the process.

The info is here.

Wednesday, July 31, 2019

US Senators Call for International Guidelines for Germline Editing

Jef Akst
www.the-scientist.com
Originally published July 16, 2019

Here is an excerpt:

“Gene editing is a powerful technology that has the potential to lead to new therapies for devastating and previously untreatable diseases,” Feinstein says in a statement. “However, like any new technology, there is potential for misuse. The international community must establish standards for gene-editing research to develop global ethical principles and prevent unethical researchers from moving to whichever country has the loosest regulations.” (Editing embryos for reproductive purposes is already illegal in the US.)

In addition, the resolution makes clear that the trio of senators “opposes the experiments that resulted in pregnancies using genome-edited human embryos”—referring to the revelation last fall that researcher He Jiankui had CRISPRed the genomes of two babies born in China.

The info is here.

Saturday, July 6, 2019

Congress weighs dropping ban on altering the DNA of human embryos used for pregnancies

Embryonic cell divisionSharon Begley and Andrew Joseph
www.statnews.xom
Originally posted June 4, 2019

A congressional committee is expected to vote on Tuesday to drop a ban on altering the genomes of human embryos intended for pregnancies, which could open the door to creating babies with genetic material from three people or with genomes that have been modified in a way that would be inherited by their descendants, as China’s “CRISPR babies” were.

The prohibition on modifying the DNA of embryos for reproduction (as opposed to doing so in basic research that stops short of pregnancies) has been attached to bills that fund the Food and Drug Administration since December 2015. But last month, a House appropriations subcommittee approved a version of an FDA spending bill without the amendment, or rider — amid worldwide condemnation of the CRISPR babies experiment last year and calls by leading scientists for a global moratorium on creating gene-edited babies.

“People don’t appreciate that this is the only piece of legislation in the United States that stands between us and genetically engineered children,” said science historian J. Benjamin Hurlbut of Arizona State University, who supports a “global observatory” to track uses of CRISPR, the powerful genome-editing technology.

The info is here.

Friday, June 28, 2019

‘We as a species need to come to terms’ with CRISPR technology

Ashley Turner
www.CNBC.com
Originally posted May 21, 2019

Here is an excerpt:

Former FDA Commissioner Scott Gottlieb said Tuesday that He’s research was a “horrible experiment and it established a horrible precedent.” Gottlieb said He’s experiment risked causing people to “rightfully” turn away from the science.

Gottlieb said he has yet to see any compelling arguments in favor of human germline editing.

Paul Dabrowski, CEO of Synthego, a genome engineering company, agreed the scientific community is not yet ready for germline editing. He wondered whether allowing parents to choose to genetically alter their future children can be ethical if they’re not the one who is having their DNA changed.

“How do you make sure you can align the person who is consenting and the person who is taking the risk?” Dabrowski asked.

Stanford’s Hurlbut said there are risks to editing DNA, as those traits can then be passed down to future generations. Editing certain genes can also cause changes in other genes, according to Hurlbut.

“We want to be very careful, nature is a profound balance and if we intervene in a way that is not profound we can upset things,” Hurlbut said.

The info is here.

Sunday, June 9, 2019

German ethics council expresses openness to eventual embryo editing

Sharon Begley
www.statnews.com
Originally posted May 13, 2019

Here is an excerpt:

The council’s openness to human germline editing was notable, however. Because of the Nazis’ eugenics programs and horrific human medical experiments, Germany has historically been even warier than other Western countries of medical technologies that might violate human dignity or could be exploited for eugenic purposes. The country’s 1990 Embryo Protection Act prohibits germline modifications for the purpose of reproduction.

“Germany has been very reluctant to get involved with anything that could lead to a re-introduction of eugenic practices in their society,” Annas said.

Despite that history, a large majority of the council called further development and possible use of germline editing “a legitimate ethical goal when aimed at avoiding or reducing genetically determined disease risks,” it said in a statement. If the procedure can be shown not to harm embryos or the children they become, it added, then altering a gene that otherwise causes a devastating illness such as cystic fibrosis or sickle cell is acceptable.

While some ethicists and others argue against embryo editing on the ground that it violates the embryos’ dignity, the German council wrote, “the question also arises as to whether the renunciation of germline intervention, which could spare the people concerned severe suffering, would not violate their human dignity, too.” Similarly, failing to intervene in order to spare a future child pain and suffering “would at least have to be justified,” the council said, echoing arguments that some families with a history of inherited diseases have.

The info is here.

Thursday, March 21, 2019

China’s CRISPR twins might have had their brains inadvertently enhanced

Antonio Regalado 
MIT Technology Review
Originally posted February 21, 2019

The brains of two genetically edited girls born in China last year may have been changed in ways that enhance cognition and memory, scientists say.

The twins, called Lulu and Nana, reportedly had their genes modified before birth by a Chinese scientific team using the new editing tool CRISPR. The goal was to make the girls immune to infection by HIV, the virus that causes AIDS.

Now, new research shows that the same alteration introduced into the girls’ DNA, deletion of a gene called CCR5, not only makes mice smarter but also improves human brain recovery after stroke, and could be linked to greater success in school.

“The answer is likely yes, it did affect their brains,” says Alcino J. Silva, a neurobiologist at the University of California, Los Angeles, whose lab uncovered a major new role for the CCR5 gene in memory and the brain’s ability to form new connections.

“The simplest interpretation is that those mutations will probably have an impact on cognitive function in the twins,” says Silva. He says the exact effect on the girls’ cognition is impossible to predict, and “that is why it should not be done.”

The info is here.

Thursday, March 14, 2019

An ethical pathway for gene editing

Julian Savulescu & Peter Singer
Bioethics
First published January 29, 2019

Ethics is the study of what we ought to do; science is the study of how the world works. Ethics is essential to scientific research in defining the concepts we use (such as the concept of ‘medical need’), deciding which questions are worth addressing, and what we may do to sentient beings in research.

The central importance of ethics to science is exquisitely illustrated by the recent gene editing of two healthy embryos by the Chinese biophysicist He Jiankui, resulting in the birth of baby girls born this month, Lulu and Nana. A second pregnancy is underway with a different couple. To make the babies resistant to human immunodeficiency virus (HIV), He edited out a gene (CCR5) that produces a protein which allows HIV to enter cells. One girl has both copies of the gene modified (and may be resistant to HIV), while the other has only one (making her still susceptible to HIV).

He Jiankui invited couples to take part in this experiment where the father was HIV positive and the mother HIV negative. He offered free in vitro fertilization (IVF) with sperm washing to avoid transmission of HIV. He also offered medical insurance, expenses and treatment capped at 280,000 RMB/CNY, equivalent to around $40,000. The package includes health insurance for the baby for an unspecified period. Medical expenses and compensation arising from any harm caused by the research were capped at 50,000 RMB/CNY ($7000 USD). He says this was from his own pocket. Although the parents were offered the choice of having either gene‐edited or ‐unedited embryos transferred, it is not clear whether they understood that editing was not necessary to protect their child from HIV, nor what pressure they felt under. There has been valid criticism of the process of obtaining informed consent.4 The information was complex and probably unintelligible to lay people.

The info is here.

Wednesday, March 6, 2019

Stanford investigates links to scientist in baby gene-editing scandal

Guardian staff and agencies
The Guardian
Originally posted February 7, 2019

Stanford University has begun an investigation following claims some of its staff knew long ago of Chinese scientist He Jiankui’s plans to create the world’s first gene-edited babies.

A university official said a review was under way of interactions some faculty members had with He, who was educated at Stanford. Several professors including He’s former research adviser have said they knew or strongly suspected He wanted to try gene editing on embryos intended for pregnancy.

The genetic scientist sparked global outcry after he claimed in a video posted on YouTube in November 2018 that he had used the gene-editing tool Crispr-Cas9 to modify a particular gene in two embryos before they were placed in their mother’s womb. He – who works from a lab in the southern Chinese city of Shenzhen – said the twin girls, known as Lulu and Nana, were born through regular IVF but using an egg that was modified before being inserted into the womb. He focused on HIV infection prevention because the girls’ father is HIV positive.

The info is here.

Monday, February 11, 2019

Recent events highlight an unpleasant scientific practice: ethics dumping

Science and Technology
The Economist
Originally published January 2019

Here is an excerpt:

Ethics dumping is the carrying out by researchers from one country (usually rich, and with strict regulations) in another (usually less well off, and with laxer laws) of an experiment that would not be permitted at home, or of one that might be permitted, but in a way that would be frowned on. The most worrisome cases involve medical research, in which health, and possibly lives, are at stake. But other investigations—anthropological ones, for example—may also be carried out in a more cavalier fashion abroad. As science becomes more international the risk of ethics dumping, both intentional and unintentional, has risen. The suggestion in this case is that Dr He was encouraged and assisted in his project by a researcher at an American university.

Wednesday, February 6, 2019

Are scientists’ reactions to ‘CRISPR babies’ about ethics or self-governance?

Nina Frahm and Tess Doezema
STAT News
Originally published January 28, 2019

Here is an excerpt:

The research community widely agreed that He and his colleagues crossed an ethical line with the first inheritable genetic modification of human beings. Gene-editing experts as well as bioethicists described the transgression as being conducted by a “rogue” individual. But when leading voices such as NIH Director Francis Collins assert that He’s work “represents a deeply disturbing willingness by Dr. He and his team to flout international ethical norms,” what are they actually expressing concern about? Who determines what are the ethics of altering human life?

We believe that the alarm being sounded by the scientific community isn’t really about ethics. It’s about protecting a particular form of scientific self-governance, which the “ethics” discourse supports. What are currently treated as matters of research ethics are in fact political and social questions of fundamental human importance.

Key decisions about when and how it will be appropriate to make inheritable changes to human beings currently lie in the hands of scientists. Although ethics are repeatedly invoked, the most prominent condemnations of He’s actions don’t actually address whether it’s ethical to tinker with human life through gene editing. A largely ignored part of the story are the five “draft ethical principles” of He’s lab at the Southern University of Science and Technology of China. If the outcry from scientists was truly about ethics, we would be seeing a discussion of the relative merits of He’s ethical principles, engagement with their content, and perhaps an exploration of how to jointly achieve a better set of operating principles. Instead, the ethics of using CRISPR for germline gene editing have apparently been determined and settled among scientists, closing down a meaningful debate about the limits and opportunities of genetic engineering.

The info is here.

Tuesday, February 5, 2019

China's Latest Cloned-Monkey Experiment Is an Ethical Mess

Ryan F. Mandelbaum
www.gizmodo.com
Originally published January 19, 2019

Chinese researchers have cloned five gene-edited monkeys with a host of genetic disease symptoms, according to two scientific papers published today.

The researchers say they want to use the gene-edited macaques for biomedical research; basically, they hope that engineering sick primates will reduce the total number of macaques used in research around the world. But their experiment is a minefield of ethical quandaries—and makes you wonder whether the potential benefits to science are enough to warrant all of the harm to these monkeys.

The researchers began by using CRISPR/Cas9 to alter the DNA of a donor macaque. CRISPR/Cas9 is the often-discussed gene editing tool derived from bacteria that combines repeating sequences of DNA and a DNA-cutting enzyme in order to customize DNA sequences. Experts and the press have heralded it as an important advance due to how quickly and cheaply it can alter DNA, but recent research has demonstrated it may cause more unintended effects than previously thought.

(cut)

This research combines a ton of ethical issues into one package, from those surrounding animal rights to cloning to gene editing. As bioethicist Carolyn Neuhaus from The Hastings Center summarized her reaction to the announcement: “Whoa, this is a doozy.”

The info is here.

Monday, January 28, 2019

Second woman carrying gene-edited baby, Chinese authorities confirm

Zhou Xiaoqin, left, loads Cas9 protein and PCSK9 sgRNA molecules into a fine glass pipette as Qin Jinzhou watches at a laboratory in Shenzhen in southern ChinaAgence France-Presse
Originally posted January 21, 2019


A second woman became pregnant during the experiment to create the world’s first genetically edited babies, Chinese authorities have confirmed, as the researcher behind the claim faces a police investigation.

He Jiankui shocked the scientific community last year after announcing he had successfully altered the genes of twin girls born in November to prevent them contracting HIV.

He had told a human genome forum in Hong Kong there had been “another potential pregnancy” involving a second couple.

A provincial government investigation has since confirmed the existence of the second mother and that the woman was still pregnant, the official Xinhua news agency reported.

The expectant mother and the twin girls from the first pregnancy will be put under medical observation, an investigator told Xinhua.

The info is here.

Thursday, January 3, 2019

As China Seeks Scientific Greatness, Some Say Ethics Are an Afterthought

Sui-Lee Wee and Elsie Chen
The New York Times
Originally published November 30, 2018

First it was a proposal to transplant a head to a new body. Then it was the world’s first cloned primates. Now it is genetically edited babies.

Those recent scientific announcements, generating reactions that went from unease to shock, had one thing in common: All involved scientists from China.

China has set its sights on becoming a leader in science, pouring millions of dollars into research projects and luring back top Western-educated Chinese talent. The country’s scientists are accustomed to attention-grabbing headlines by their colleagues as they race to dominate their fields.

But when He Jiankui announced on Monday that he had created the world’s first genetically edited babies, Chinese scientists — like those elsewhere — denounced it as a step too far. Now many are asking whether their country’s intense focus on scientific achievement has come at the expense of ethical standards.

The info is here.

Thursday, June 7, 2018

Protecting confidentiality in genomic studies


MIT Press Release
Originally released May 7, 2018

Genome-wide association studies, which look for links between particular genetic variants and incidence of disease, are the basis of much modern biomedical research.

But databases of genomic information pose privacy risks. From people’s raw genomic data, it may be possible to infer their surnames and perhaps even the shapes of their faces. Many people are reluctant to contribute their genomic data to biomedical research projects, and an organization hosting a large repository of genomic data might conduct a months-long review before deciding whether to grant a researcher’s request for access.

In a paper published in Nature Biotechnology (https://doi.org/10.1038/nbt.4108), researchers from MIT and Stanford University present a new system for protecting the privacy of people who contribute their genomic data to large-scale biomedical studies. Where earlier cryptographic methods were so computationally intensive that they became prohibitively time consuming for more than a few thousand genomes, the new system promises efficient privacy protection for studies conducted over as many as a million genomes.

The release is here.