Three-parent babies green-lighted in the UK

h/t Bioedge

A genetically engineered baby could be born in the UK before Christmas. The UK government has given a licence to Newcastle University to create three-parent embryos to combat mitochondrial diseases.

The UK’s fertility authority, the Human Fertilisation and Embryology Authority(HFEA), had already announced in December that licences for the controversial procedure were to be granted on a case-by-case basis. It appears that a number of couples have applied for the procedure, so the University will have no trouble in enrolling patients.

Sally Cheshire, chair of the UK’s fertility authority, said: “I can confirm today that the HFEA has approved the first application by Newcastle Fertility at Life for the use of mitochondrial donation to treat patients. This significant decision represents the culmination of many years hard work by researchers, clinical experts, and regulators, who collectively paved the way for Parliament to change the law in  2015 to permit the use of such techniques.

“Patients will now be able to apply individually to the HFEA to undergo mitochondrial donation treatment at Newcastle, which will be life-changing for them, as they seek to avoid passing on serious genetic diseases to future generations.”

Critics described the move as “ethically reckless”. Mark Bhagwandin, of the pro-life charity Life, told the Daily Telegraph:

“We had hoped that the HFEA would have listened to the thousands of people who have expressed concern about three parent embryos. Instead it has ignored the alarm bells and approved a procedure which will alter the human genome. It is at the very least reckless and irresponsible given that we have absolutely no idea what the long term consequences are to us interfering with the human genome.
"Whilst we are deeply sympathetic to the plight of people with mitochondrial related diseases, the end does not always justify the means. Our understandable search for therapies to help overcome illness and disabilities must be done in an ethical way and balanced against the unconditional acceptance of all human beings, whatever differences they may have."

When stem cell treatments go wrong, they really go wrong

h/t Bioedge

Three elderly women in Florida have been blinded by an unproven treatment, as a reminder of how dangerous stem cell therapies can be. The New England Journal of Medicine reports that the women signed up for a purported clinical trial in 2015 – for which they had to pay US$5,000. Within a week, they experienced a variety of complications, including vision loss, detached retinas and haemorrhage. Before the surgery, the vision in their eyes ranged from 20/30 to 20/200. They are now blind.

The article is a "call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research," said Jeffrey Goldberg, of Stanford University School of Medicine and a co-author.

"There's a lot of hope for stem cells, and these types of clinics appeal to patients desperate for care who hope that stem cells are going to be the answer, but in this case these women participated in a clinical enterprise that was off-the-charts dangerous," said Thomas Albini, another co-author.

At the clinic, U.S. Stem Cell Inc, fat cells from the patients’ abdomens were processed to obtain stem cells which were injected into their eyes. Patients reported that the entire process took less than an hour. The patients had both eyes treated at once -- even though most doctors would opt for a conservative approach to observe how the first eye responds.

"There is a lot of very well-founded evidence for the positive potential of stem therapy for many human diseases, but there's no excuse for not designing a trial properly and basing it on preclinical research," Goldberg said.

The "trial" lacked nearly all of the components of a properly designed clinical trial, including a hypothesis based on laboratory experiments, assignment of a control group and treatment group, collection of data, masking of clinical and patient groups, and plans for follow-up, Goldberg and Albini said. "There was a whole list of egregious things," Albini said.

New Zealand river declared a legal person

h/t Bioedge

In the latest wrinkle in debates over personhood, a Māori iwi (tribe) in New Zealand has succeeded in getting Parliament to recognise the Whanganui River as a legal person.

"It's not that we've changed our worldview, but people are catching up to seeing things the way that we see them," Adrian Rurawhe, a Māori member of Parliament. The North Island river, New Zealand’s third longest, also known by its Māori name of Te Awa Tupua, will be represented by two legal guardians, one appointed by the iwi and the other by the government.

The settlement, which has been in dispute for at least 140 years, also includes NZ$80 million in financial redress and $30 million toward improving the environmental, social, cultural and economic health and well-being of Te Awa Tupua. 

Riverine personhood is an untested concept in a Western legal system. According to the government, Te Awa Tupua will now have its own legal personality with all the corresponding rights, duties and liabilities of a legal person. Lawyers say that the river cannot vote and cannot be charged with homicide if people drown in it. But it will have to pay taxes, if liable. The gender of the river is unspecified at the moment.

"I know the initial inclination of some people will say it's pretty strange to give a natural resource a legal personality," said New Zealand's Treaty Negotiations Minister Chris Finlayson. "But it's no stranger than family trusts, or companies or incorporated societies."

As soon as the third reading of the bill passed, members of the gallery broke into a waiata (a song of celebration) which is well worth watching. 

Peter Singer interviewed about, well, everything

h/t Bioedge

The Journal of Practical Ethics recently posed 20 hardball questions to Peter Singer about his philosophy. It is a terrific insight into his thinking as his long career draws to a close.

About utilitarianism: Why do many intelligent and sophisticated people reject utilitarianism? Some people give more weight to their intuitions than I do—and less weight to arguments for debunking intuitions. Does that reduce my confidence in utilitarianism? Yes, to some extent, but I still remain reasonably confident that it is the most defensible view of ethics. I don’t know if everyone will accept utilitarianism in 100 years, but I don’t find the prospect frightening. It would only be frightening if people misapplied it, and I do not assume that they will.

On critics: There have been many critics of my views about euthanasia for severely disabled infants. I had some good discussions with the late Harriet McBryde Johnson, who was not a philosopher but a lawyer who had a rich and full life despite being born with a very disabling condition. As long as she was alive, when I wrote anything on that topic, I wrote with her potentially critical response in mind.

The objective truth of morality: You could just say “these are my normative views, and I’m going to treat them as if they were true, without thinking about whether moral judgements really can be objectively true.” If you do that, then in practice your decisions will be the same whether or not moral judgements can be objectively true. But given that I think morality is highly demanding, it becomes easier to say that, since morality is so highly demanding, and there is nothing irrational about not doing what morality demands, I’m not going to bother doing what I know to be right. If there are objective reasons for doing what morality demands, it’s more troubling to go against them.

On absolute moral standards: There are still absolutists. Some are proponents of the “new natural law” tradition, which has its roots in Catholic moral theology, even though it is presented as a secular position. Others are Kantians, many of them outside English-speaking philosophy. In Germany, for example, you would find wide support for the idea that we should not torture a child, even if (as in Dostoevsky’s example in The Brothers Karamazov) that would produce peace on earth forever. To me it seems obvious that if by torturing one child you could prevent a vast number of children (and adults) suffering as much or more than the child you have to torture, it would be wrong not to torture that child. 

On inconsistency: The view that I take in Practical Ethics and some other writings is not that not aiding is the same as harming in all respects... [So why not donate a spare kidney?]  don’t think I’m weak-willed, but I do give greater weight to my own interests, and to those of my family and others close to me, than I should. Most people do that, in fact they do it to a greater extent than I do (because they do not give as much money to good causes as I do). That fact makes me feel less bad about my failure to give a kidney than I otherwise would. But I know that I am not doing what I ought to do.

On adopting out a [hypothetical] Down syndrome child: For me, the knowledge that my [hypothetical] child would not be likely to develop into a person whom I could treat as an equal, in every sense of the word, who would never be able to have children of his or her own, who I could not expect to grow up to be a fully independent adult, and with whom I could expect to have conversations about only a limited range of topics would greatly reduce my joy in raising my child and watching him or her develop.

On dogs, pigs, and disabled babies: Most people think that the life of a dog or a pig is of less value than the life of a normal human being. On what basis, then, could they hold that the life of a profoundly intellectually disabled human being with intellectual capacities inferior to those of a dog or a pig is of equal value to the life of a normal human being? This sounds like speciesism to me, and as I said earlier, I have yet to see a plausible defence of speciesism. After looking for more than forty years, I doubt that there is one.

On bestiality and infanticide: I don’t put forward provocative views for the sake of doing so. I put them forward where I think they have a basis in sound argument, and where it serves a purpose to have them discussed. I hope that other philosophers will do the same.

On the future:  I worry that if people who think a lot about others and act altruistically decide not to have children, while those who do not care about others continue to have children, the future isn’t going to be good.

On moral bioenhancement: I have some practical concerns: will it work? Will there be unexpected negative side-effects? But suppose that we can put aside those worries and can be highly confident that the proposed bioenhancement will reduce suffering and increase happiness for all affected—then I have no problem with human bioenhancement. Indeed, it would be a very positive thing. As for moral bioenhancement specifically, I doubt that it will happen quickly enough, or spread widely enough, to solve the global moral problems like climate change that we face right now. But once again, if we could do it, that would be very good.

Catholics shouldn't totally reject human gene editing – but it still has ethical problems

h/t CNA

By Adelaide Mena

Washington D.C., Feb 23, 2017 / 02:50 am (CNA/EWTN News).- Recent American guidelines for human gene modification have raised important ethical questions, especially with regard to modifying the genes of unborn children and of reproductive cells.

The National Academy of Sciences last week released a 261-page report on guidelines for editing the human genome to treat diseases and other applications. The report covers a wide array of topics, from the editing of adult cells for therapies such as cancer treatment, to the editing of embryos and germ cells (reproductive cells, i.e. ova and sperm), to the question of human enhancement.

John DiCamillo, an ethicist at the National Catholic Bioethics Center, spoke to CNA about the perils and the promises of gene editing, as well as the oversights contained in the National Academy of Sciences' report.

“Gene editing generally can be morally legitimate if it has a directly therapeutic purpose for a particular patient in question, and if we’re sure we’re going to limit whatever changes to this person,” DiCamillo explained. In this regard, the report’s guidelines for laboratory treatment of somatic – or non-reproductive – cells and human trials of somatic cell treatments were reasonable, he noted.

DiCamillo pointed to upcoming clinical gene therapy trials for cancer and proposed gene therapy treatments for disorders such as sickle cell disease. However, it’s important to limit these trials to non-embryonic persons, to ensure that the modifications – intended as well as unintended – are not carried in the patient’s reproductive cells.

While this would mean that patients treated for inheritable diseases “could still transmit it to their children,” any children who then developed the disease could themselves be treated through the same process.

The question of transmission to descendants opens two more points discussed in the National Academy of Sciences report: the modification of ova and sperm, as well as edits to the genomes of embryos. Both changes would mean that people would maintain these edits in all of their cells for all of their lives – and could pass on these edited genes to new generations.  

“There could be limited situations that could exist where the germ line could be legitimately edited. In other words, making changes to sperm, to eggs, or to early embryos as a way of potentially addressing diseases – inheritable diseases and so forth,” DiCamillo stated.  

However, permitting edits to germ line cells could also be “very dangerous on multiple levels,” he warned.

There are considerable, and not yet fully controllable, risks to genetic manipulation. A person conceived with edited genes could experience a range of “unintended, perhaps harmful, side effects that can now be transmitted, inherited by other individuals down the line.” An embryo who experiences gene modification could also carry and pass on edited genes, particularly if edits were performed before his or her reproductive cells began to differentiate themselves.

The National Academy of Sciences' regulations surrounding germ cells and embryos are also problematic for what they overlook, DiCamillo commented.

Manipulating sperm and ova requires removing them from a person’s body; if conception is achieved with these cells, it is nearly always through in vitro methods. This practice of in vitro fertilization is held by the Church to be ethically unacceptable because it dissociates procreation from the integrally personal context of the conjugal act.

In addition, scientific researchers rarely differentiate between experimentation on sperm or ova – which are cells that come from a human subject – and embryos, which are distinct persons with their own distinct genomes, DiCamillo noted.

The National Academy of Sciences’ guidelines reflect this lack of distinction between cells and embryos. “That’s very misleading because embryos are not germ line cells; they are new human beings,” DiCamillo said.

For research on embryos to be ethical, he continued, therapies should be ordered to treating and benefitting that “that particular embryo, not just for garnering scientific knowledge or seeing what’s going to happen.” DiCamillo condemned policies that see destruction of embryonic persons as a back-up if research does not go as planned, as well as current policies that require destruction of embryos as standard procedure.

“We’d be in that area of very dangerous exploitation of human life and destruction of human life,” he warned.

While the guidelines stumble across ethical roadblocks in regards to gamete and embryo research, the new report’s rules regarding human enhancement are strong, DiCamillo said.

The ability to edit genomes could also be used for purposes other than medical treatment. A whole host of human traits could be enhanced or changed, such as vision, intelligence, or abilities. “There’s any number of things that we could do to change the qualities of human beings themselves and make them, in a sense, super-humans … this is something that would also be an ethical problem on the horizon,” he warned.

The existence of these gene altering therapies raises a question of how much modification and enhancement is permissible. DiCamillo praised the report for its recommendation “entirely against enhancement efforts and that these should not be allowed.”

Currently, gene editing of both germ cells and somatic cells is legal in the United States, including on embryos. However, various US government institutions have policies in place prohibiting federal funding of such research efforts on germ cells and on embryos.

Furthermore, Food and Drug Administration regulations prohibit gene modification on viable human embryos – meaning that human embryos who receive gene modification are always destroyed.

The new guidelines from the National Academy of Sciences are significant because they lay a groundwork for future policy on human gene modification. They cautiously welcome the use of gene therapy on human embryos who are not later targeted for destruction after experimentation concludes.

DiCamillo recalled, however, that “they are merely guidelines – they are advice from the National Academy of the Sciences to the government in regards to future policy. This is not itself a new regulation or policy that the government has established.”

The ethics of gene editing has been questioned for several years – the Congregation for the Doctrine of the Faith addressed the issue in Dignitas personae, its 2008 instruction on certain bioethical questions. It has become more pressing recently, however, because a new technique known as CRISPR is easier to use and less expensive than previous means of gene editing.

Although the ethical questions surrounding gene modification are many and there are a number of problematic applications of these technologies, DiCamillo cautioned Catholics not to renounce completely human gene modification: “We don’t want to be hyper-reactive to the dangers. We have to realize there’s a great deal of good that can be done here.”

He pointed again to the kinds of modifications that can treat deadly genetic diseases and treatments that can be done in an ethical manner, with full respect to the dignity of human persons.

“We do need to be attentive to where the dangers are,” he warned, “but we don’t want to … automatically consider any kind of gene editing to be automatically a problem.”

Is denying transgender rights a kind of torture?

h/t Bioedge

Street mural in Brussels    

A completely different way of viewing transgender issues comes from the Oxford Human Rights Hub. Geoffrey Yeung, a Hong Kong activist studying at Oxford, argued last year that restrictions on transgender people are banned by the United Nations Convention Against Torture (CAT). He pointed out that

Many countries ... impose heavy burdens (such as sterilisation, surgery, hormonal treatment and psychiatric diagnosis) on transgender people before they can legally be recognised in their preferred gender ... [The Committee Against Torture has] explicitly recommended the repeal of “abusive” preconditions to legal gender recognition and called for respect for transgender people’s “autonomy and physical and psychological integrity”. 

The UN’s Special Rapporteur on torture, Juan E. Méndez, has given this interpretation of the Convention his blessing. “We have a tendency to regard violations against these groups as ill-treatment even where they would more appropriately be defined as torture,” Mr. Méndez said in a report to the Human Rights Council about gender-based violence.

Even if transgenders are not getting the bastinado, Yeung points out that what they experience in many countries is a kind of psychological torture:

It is important to make clear that what constitutes systematic ill-treatment (and thus torture under the CAT) is the legal requirement that all transgender people must undergo certain forms of medical or surgical treatment — regardless of their personal desires or medical necessity — to be recognised in their preferred gender.

If sex reassignment surgery is the answer, what is the question?

Sex reassignment surgery requires the intervention of doctors. But what kind of treatment is it? Is it a therapy for a disease which should be offered only after psychiatric authorization? Or is it a biomedical enhancement which anyone can freely choose?

The answer to this theoretical question has practical consequences. If it is a therapy, then transgenderism is a disease. If it is an enhancement, then it hardly deserves to be funded by the government.

In a very interesting article in the Journal of Medicine and Philosophy, Tomislav Bracanović, of the University of Zagreb, in Croatia, analyses the competing conceptions.

Transgender scholars contend that sex reassignment surgery is not a therapy for gender identity disorder, because the feeling of being a man in a woman’s body or a woman in a man’s body is not a disorder. It is a “normal, albeit rare, human condition that is medicalized as a consequence of general discrimination of transsexual population. It should be removed, therefore, from all classifications of mental disorders, and sex reassignment surgery should be made available without medical “gatekeepers” deciding who qualifies for it and who does not.”

Their conclusion is that a sex change is no more a therapy than a “nose job”. They would prefer to describe sex reassignment surgery as an enhancement, like cosmetic surgery.

But is it plausible to describe it as non-therapeutic enhancement? Bracanović believes that it is not. “It does not improve, augment, or increase—above average—any trait or function typically mentioned in philosophical debates about enhancement. Intelligence, vision, hearing, physical strength, and immunity, for example, after sex reassignment surgery remain more or less the same as they were before.”

There is another way of framing enhancement, though: the welfarist model – does it enhance quality of life? At first blush this seems plausible because people who have had the operation report more satisfaction and a decrease in dissatisfaction. However, Bracanović  points out that the evidence for this is weak. There have been very few long-term studies of postoperative transsexuals’s quality of life.

... imagine the “sex change drug” that has the same risk–benefit ratio as sex reassignment surgery. Even if it improved the condition of many clinical trial subjects, it would probably not be approved by any regulatory agency (as either “therapy” or “enhancement”), if a large number of subjects mysteriously disappeared from the trial after taking the drug.

So Bracanović concludes that it would be wise to keep the gatekeepers for this type of surgery and to restrict access to it. Given the current state of knowledge, there is too great a risk of harm to the patients. Furthermore, if it is an enhancement which increases a person’s well-being, as transgender scholars contend, it is obviously more like enhancement for artistic ability rather than curing paraplegia. With limited resources, society would normally focus on paraplegia rather than gender dysphoria. The only way to prioritise it above paraplegia would be to medicalise it and describe it as a serious disorder – which theorists vehemently reject.

h/t Bioedge