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  4:42:00 PM

Questions over wireless-controlled contraceptives

New ethical dilemmas may be coming if a Massachusetts company succeeds in developing a contraceptive chip which could be activated and deactivated with wireless technology.

MicroCHIPS will begin preclinical testing of its device next year. If it passes safety and efficacy tests, it could be on the market by 2018. According to Technology Review, “the device would be more convenient for many women because, unlike existing contraceptive implants, it can be deactivated without a trip to the clinic and an outpatient procedure, and it would last nearly half their reproductive life.”

The chip measures 20 x 20 x 7 millimetres and would be implanted under the skin of the buttocks, upper arm, or abdomen where it would dispense daily doses of the hormone levonorgestrel. To conceive, women would turn the dosage off with a remote control. To resume contraception, they would log in to the system and turn it back on. It is designed to dispense contraception for 16 years. The device could dispense other drugs, but the company is initially using contraceptives.

The idea originated with philanthropist and billionaire Bill Gates, who is keen to develop new methods of birth control as part of his foundation’s programs for the developing world.

Even if the chip is safe and effective, wireless control raises a host of issues which need to be addressed. Any device which is controlled wirelessly can be hacked. Absolutely watertight solutions would be needed to prevent angry ex-boyfriends, the NSA, snooping journalists or controlling governments from manipulating women’s fertility.

Dr Robert Farra, of MIT, believes that these scenarios are unrealistic. He told the BBC: "Communication with the implant has to occur at skin contact level distance. Someone across the room cannot re-programme your implant. Then we have secure encryption. That prevents someone from trying to interpret or intervene between the communications." 

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  3:38:00 PM

Oldest Down syndrome skeleton found in France

Earlier cultures may not have stigmatized people with Down syndrome as much as we do, archaeologists have suggested after examining a site in France. In an article in the International Journal of Paleopathology, says Maïté Rivollat at the University of Bordeaux in France and colleagues comment on a skeleton of a 5–7 year old child from Saint-Jean-des-Vignes in north-eastern France from the 5th or 6th century. It appears to be the earliest and youngest skeleton of its type ever discovered.

The child almost certainly suffered from Down syndrome, but he or she was not treated any differently from other members of her community when buried. He was placed on her back and oriented east-west with the head at the western end, just like most of the others found in the necropolis.

"[we] infer that this Down syndrome child was not treated differently at death than others in the community. We interpret this as meaning that the child was maybe not stigmatized during life, the first time a Down syndrome individual has been so viewed in the context of the ancient community."

Although some archaeologists believe that there are depictions of Down syndrome in painting and sculpture as old as 1500BC, only two “sub-adult” skeletons have been discovered.  

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  2:47:00 PM

Government responds to Canadian bioethicists’ complaint

Last week BioEdge reported that Canadian bioethicists were angry at the Harper Government’s refusal to appoint a strong and formally credentialed leader to oversee ethics in the Canadian Institutes of Health Research (CIHR). This week a spokesman for the CIHR, David Coulombe, responds.

BioEdge: Just for background: What has provoked the call for more and closer ethics oversight?  Have there been incidents in the recent past which were deemed unethical behaviour?

David Coulombe: In 2012, CIHR Governing Council directed CIHR to undertake a review of the approaches the organization currently uses to meet its mandate in the area of ethics.  What provoked the review was Governing Council’s wish to ensure effective alignment of internal efforts, as well as to achieve optimal impact vis-à-vis CIHR’s direction and processes and those of the newly created Tri-Council (CIHR, NSERC, SSHRC) Secretariat for the Responsible Conduct of Research.  The result was the establishment of the Task Force on Ethics Reform at CIHR, which conducted the review.

As far as I can see, what Canadian bioethicists want is one of their fraternity in the organisational structure with some clout.  Why is it impossible to have a VP for ethics?

CIHR Governing Council based its final decision on an international scan of health research funders.  These organizations were the Medical Research Council (UK), National Health and Medical Research Council (Australia), National Institutes of Health (USA), and the European Commission.  The international scan revealed that several models are used for incorporating ethics at the core of research funding organizations.  For example:

  • NIH in the USA has a mechanism for cross-organization coordination of ethics activities involving clinical research;
  • NHMRC in Australia has a statute-based Health Ethics “Principal Committee” of its Governing Council, and can establish ad hoc working group(s) with ethics expertise as needed.

The scan also revealed that leaders of the ethics functions within health research funding organizations are not typically ethics experts.  Rather, they have experts throughout the organization and their committees to support them.  CIHR Governing Council was convinced that the proposed new leadership model, championed by CIHR’s Chief Scientific Officer/VP-Research and Knowledge Translation – and with an enhanced Governing Council Standing Committee on Ethics – will lead to a cohesive and integrated approach to ethics at CIHR.

Why doesn't the "ethics champion" have a degree in bioethics or ethics?  Could not someone else have been found who had the credentials?

CIHR’s Chief Scientific Officer/VP-Research and Knowledge Translation, Dr Jane Aubin, believes in the importance of ethics and has made a formal commitment to championing ethics at CIHR.  This commitment has been fully endorsed by the President, Governing Council and Scientific Directors.

Dr Aubin has had many opportunities to learn about ethics in her past professional experience as an end user:

  • as a basic scientist having to deal with the ethical use of animals in research;
  • as a researcher submitting research protocols to the Research Ethics Board;
  • as a researcher and administrator within the University of Toronto, including  integrity committees; and
  • as a Scientific Director of one of CIHR’s Institutes, fully integrating the Ethics Designate of the Institute’s Advisory Board into discussions and decisions, and championing ethics initiatives in the Institute.

More recently, in her role as Chief Scientific Officer and VP-Research and Knowledge Translation here at CIHR, she has had the opportunity to build on this knowledge through her participation in meetings of the Standing Committee on Ethics, discussions with Institute Advisory Board Ethics Designates, and discussions with the committee advising on CIHR’s Strategy for Patient-Oriented Research streamlining of ethics review.

Finally, Dr. Aubin can count on extensive ethics expertise at CIHR, beginning with the new Standing Committee on Ethics, as well as from the Ethics Office and the Tri-Council Secretariat on Responsible Conduct of Research.

Is this controversy an example of credentialism gone mad?

The ethics community is engaged and passionate.  While we disagree on how the CIHR ethics mandate can best be achieved, we agree that CIHR must continue to play a leadership role.

We are committed to playing a strong leadership role by integrating ethics at the core of CIHR and encouraging interdisciplinary, innovative, and integrative research on ethical issues pertaining to health.  We believe that our new structure with a strong shared leadership will create an environment where ethics is at the forefront of what we do and that it will gain the reassurance and recognition that it deserves.

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  2:14:00 PM

Remembering Nikola Tesla, eugenicist

Billionaire entrepreneur Elon Musk celebrated Nikola Tesla’s birthday this week with a US$1 million donation to set up a Tesla museum in Long Island. The Serbian-American inventor, who died in 1943, was a prodigious inventor and is regarded by some of his admirers as the greatest geek who ever lived. With time, he has become a cult figure, which explains his appearance in the Oscar-nominated film The Prestige

Apart from inventing alternating electric current, Tesla was a futurist. In 1935 he gave an interview to the American magazine Liberty (now defunct) in which he peered 100 years into the future. Of interest to readers of BioEdge is his enthusiastic endorsement of eugenics, a common feeling before World War II.

“The year 2100 will see eugenics universally established. In past ages, the law governing the survival of the fittest roughly weeded out the less desirable strains. Then man’s new sense of pity began to interfere with the ruthless workings of nature.
“As a result, we continue to keep alive and to breed the unfit. The only method compatible with our notions of civilization and the race is to prevent the breeding of the unfit by sterilization and the deliberate guidance of the mating instinct.

“Several European countries and a number of states of the American Union sterilize the criminal and the insane. This is not sufficient. The trend of opinion among eugenists (sic) is that we must make marriage more difficult. Certainly no one who is not a desirable parent should be permitted to produce progeny. A century from now it will no more occur to a normal person to mate with a person eugenically unfit than to marry a habitual criminal.”

Tesla is a hard man to pigeonhole. But perhaps his views were driven by his mechanistic view of human nature. In the same interview he asserted that “Man, like the universe, is a machine”. And rather than technology adapting to human needs, humans need to adapt to technology:

“At present we suffer from the derangement of our civilization because we have not yet completely adjusted ourselves to the machine age. The solution of our problems does not lie in destroying but in mastering the machine.”

Tesla's admirers lament the fact that many of his ideas died with him. Perhaps this is one which is better off forgotten.

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  3:57:00 PM

Canadian bioethicists sunk in dejection over government inaction

The bioethics community in Canada is enraged at the Harper Government’s refusal to appoint a strong and formally credentialed leader to oversee ethics in the Canadian Institutes of Health Research (CIHR).

In a report last year a government-appointed task force reminded the government that “CIHR is obligated legally to ensure that ethics has a central place within the organization. This is not optional; it is legally required.” Subsequently, an open letter to parliamentarians signed by 50 bioethicists and health law experts has demanded “strong leadership” from a person “recognized nationally and internationally as a leading scholar and researcher in ethics”.

It was not to be. Instead the CIHR’s Governing Council snubbed the bioethicists by appointing a so-called “Ethics Champion” in the CIHR. Taking the fall for the Governing Council is Dr Jane Aubin, who is a highly respected expert in medical biophysics. But she had to confess to a hostile audience at the Canadian Bioethics Society Conference in Vancouver that she had no formal qualification in ethics. In the blog Impact Ethics Juliet Guichon, of the University of Calgary, wrote:

“We were all exceedingly polite; yet we were sad. In our respective workplaces, we teach the ethics equivalents of the Empress of Ireland and the Titanic. Obviously, trouble can arise in health research because of lack of understanding or inattention to ethics.
“We didn’t (and still don’t) get it. Why would Ottawa not want a person with ethics expertise at the helm to avoid trouble, and to foster research in best practice? It is false economy to do otherwise, as the cruise industry knows. Should we wait for another Costa Concordia before valuing prevention experts?”  

* The text incorporates a correction to the original version.

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  3:00:00 PM

What are the issues in post-mortem sperm retrieval?

In 2010 21-year-old Niklas Evans was assaulted outside a bar in Texas. He ended up in a coma and died after 10 days. His heartbroken mother, Missy Evans, requested the hospital to retrieve her son’s sperm so that she could create a grandchild with a surrogate mother. The case was too controversial for American fertility clinics so she ended up travelling to South Africa.

Did Missy and her doctors act ethically in removing sperm from Niklas’s dead body without his consent? This is the question that Anna Smajdor, of the University of East Anglia, tackles in the Journal of Medical Ethics, based on a discussion of some cases which have occurred in England. Like many other bioethicists, she opposes it.

The dead still have interests. The logic of post-mortem sperm retrieval without explicit consent could be extended to many other issues,  like organ extraction, exhibition of the body, probate law and so on. Legally speaking, much more than a child is at stake.

The validity of inferred consent is a dangerous principle. “In medicine generally, consent for procedure X cannot be inferred from someone's previous beliefs about situation Y,” she writes. If men knew what was involved in electro-ejaculation, they might well refuse their consent, even if they did express a wish to have children.

Proxy consent for one’s own benefit is a dangerous principle. She writes: 

Relatives can agree to donate a loved one's tissue, but they cannot demand access to that tissue for themselves. The reasons for this are straightforward. Human tissues and organs are valuable commodities. This means that the bodies of dead and dying patients are vulnerable to exploitation. If the person testifying as to the patient's wishes and providing proxy consent is alsothe one who stands to gain from the tissue that is made available, there is a clear conflict of interest.

The desire for offspring is not sufficient reason. From a woman’s ardent desire for a child one cannot infer consent. “Couples’ reproductive decisions are not necessarily based on symmetrical and equally held desires … It is risky and unjust to assume that one partner's reproductive desires can be inferred from those of the other. And if this is the case in the living, it is still more so in the case of the dead or dying, who cannot articulate their dissent.”

Smajdor makes two specific recommendations. First, that the rules for posthumous gamete donation be tightened. Second, that the discretionary authority of the UK’s fertility watchdog, the Human Fertilisation and Embryology Authority, be rescinded so that it cannot permit the export of gametes obtained without consent. 

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  2:49:00 PM

Court orders France to recognise surrogacy children

Surrogacy may be banned in France, but it must recognise children born to surrogate parents abroad, the European Court of Human Rights has ruled.

This may have brought to an end a long-running case brought by two French families who had both used an American surrogate mother to gestate a child conceived with the father’s sperm. The ECHR said that refusal to recognise the children’s parentage “undermined the children’s identity within French society”.

Courts in California and Minnesota had recognised the couples as the legal parents more than 10 years ago. However, French authorities, suspecting that the cases involved surrogacy arrangements, refused to enter the birth certificates in the French register of births, marriages and deaths. the register. The children were living in a legal limbo – residents of France, but not citizens or legally-recognised offspring.

An appeal to the French Court of Cassation in 2011 failed. That court ruled that recording the births in the register would give effect to a surrogacy agreement that was null and void on public-policy grounds under the French Civil Code.

“This is a great relief,” declared one of the fathers, Dominique Menesson, after the judgement and called on French authorities not to appeal against it. The lawyer for the two couples has claimed that 2,000 children are in the same situation as his clients’ children.

The case may have broader implications. If children of overseas surrogate mothers will automatically become French citizens, it will be easier for gay couples to create families. Dean Hutchinson, a lawyer for Circle Surrogacy, an international agency which specialises in gay clients, observed:

“Countries that are members of the European Court of Human Rights must recognize the parentage of parents who have a genetic connection to their children born through surrogacy abroad, as this is in the best interests of the child. Our analysis of the case shows that, as long as at least one parent has a genetic connection to the child, the authorities must recognize parentage and grant citizenship— even if the country does not allow surrogacy. This is a blessing to intended parents from countries like France, Italy, Spain, and Germany that do not recognize surrogacy and have placed impediments to parents returning home with children born through surrogacy.”
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  12:23:00 PM

Last act in stem cell research tragedy

The sorry saga of yet another flawed stem cell paper riddled with fraudulent data has come to an end. Nature has retracted a paper and a letter, both published in January, which claimed that physical perturbation of cells could create genetic effects. At the time the results were trumpeted on the front pages of newspapers around the world.

However, scepticism soon set in after other scientists failed to replicate the results. Japan’s RIKEN Institute, where the principal author, Haruko Obokata, worked, launched an investigation. One after another the authors retracted the paper. It appears that several careers have been destroyed by the incident and that RIKEN itself may be radically reformed.

In a contrite editorial Nature insists that fundamentally it was not to blame for the debacle, which has placed the whole field of stem cell research under a cloud. “We have concluded that we and the referees could not have detected the problems that fatally undermined the papers. The referees’ rigorous reports quite rightly took on trust what was presented in the papers.”

As for the future: Nature is drafting new protocols for assessing submissions:

“… although editors and referees could not have detected the fatal faults in this work, the episode has further highlighted flaws in Nature’s procedures and in the procedures of institutions that publish with us. We — research funders, research practitioners, institutions and journals — need to put quality assurance and laboratory professionalism ever higher on our agendas, to ensure that the money entrusted by governments is not squandered, and that citizens’ trust in science is not betrayed.”
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  11:07:00 AM

Is a day of doom looming for bioethics?

Ragnarök is the day in Norse mythology when gods and men meet their doom. After three years of continuous winter, bloody battles and many natural disasters, the world will be flooded, and all but a few will die.

Predictions of a Ragnarök for bioethics surface regularly in academic journals. The latest comes from a sociologist at the University of California, San Diego, John H. Evans, the author of The History and Future of Bioethics: A Sociological View. Writing in the Journal of Clinical Ethics, he forecasts a bleak future for practicioners of bioethics when they seek to offer advice for large organisations.

Before bioethicists start claiming that "ethics" demands an action that is contrary to the interests of people with actual power, they should become clearer on the basis of their authority … Note that there are very few possible claims to authority for the bioethics profession.
Many professional jurisdictions are made through claims to truth, justified by science. Engineers have jurisdiction over designing hospital buildings that will not fall over in an earthquake, because they use methods that have been almost universally accepted as producing truth (for example, physics]. Doctors claim jurisdiction over heart surgery because it is "true" that cutting this way instead of that leads to higher survival. Lawyers claim jurisdiction over certain tasks in the hospital because the government has essentially granted them jurisdiction through public law.
But, by whose authority does the bioethicist assert their truth? The problem, in the U.S. in particular, is that “ethics” are not thought to be “true,” but rather relative to its citizens. No one is entitled to his or her own view of scientific facts, but everyone is entitled to their own view of ethics. Bioethics has thus always had a very weak claim of authority.
To recap: it has never been clear how the bioethics profession justifies using “accepted ethical principles” in [healthcare ethics consultation] when it is supposed to be clarifying the ethics of others. This is a weakness and may lead to challenge. More critically, before bioethicists move too strongly into organizational ethics, where they will encounter people with true power, they should derive an answer to the questions: “Whose ethics do you represent?" and “How do you know what their ethics are?” Two answers that will not work in a pluralistic liberal representative democracy are: “I represent my own ethics," and “I represent the ethics of the collective wisdom of a particular academic tradition."

Dr Evans recommends that whatever the public thinks should become the constitutional dogma of bioethics, as determined by sociologists. This obviously has its own problems. The distinguished bioethicist Daniel Callahan, in a response to the Evans paper, points out that “if surveys had been relied upon to fashion policy, there would be few rights for women and minorities”.

The good news is that the world is born anew in Norse mythology. Perhaps bioethics will spring alive after the apocalypse.

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  9:50:00 AM

BMJ backs assisted suicide

One of the world’s leading medical journals has endorsed the legalisation of assisted suicide. An editorial of the BMJ (formerly the British Medical Journal), says, “Lord Falconer’s Assisted Dying Bill is expected to receive its second reading in the House of Lords this month. The BMJ hopes that this bill will eventually become law… Let us hope that our timid lawmakers will rise to the challenge.”

The authors, Fiona Godlee, the editor-in-chief, Tony Delamothe, the UK editor; and Rosamund Snow, the patient editor, have given fresh comfort to the supporters of an assisted suicide bill which has failed several times before in the British Parliament.

Apart from reassuring readers that there are few dangers in legalisation, they base their argument four-square on the widely-accepted principle of autonomy.

“People should be able to exercise choice over their lives, which should include how and when they die, when death is imminent. In recent decades, respect for autonomy has emerged as the cardinal principle in medical ethics and underpins developments in informed consent, patient confidentiality, and advance directives. Recognition of an individual’s right to determine his or her best interests lies at the heart of efforts to advance patient partnership. It would be perverse to suspend our advocacy at the moment a person’s days were numbered.”

A strong influence in framing their argument is the experience of Oregon, where assisted suicide is legal – and unproblematic, in their view. Extrapolating Oregon’s figures to England and Wales, the BMJ editors contend that legalisation would hardly affect the working lives of British doctors:

“… each year about one patient per general practice of 9300 patients would discuss the issue of assisted dying; each general practice would issue one prescription for life ending medication every five or six years, and every eight to nine years one patient per general practice would take life ending medication.”

The editorial was immediately disavowed by the publisher of the BMJ, the British Medical Association. Dr Mark Porter, chairman of the BMA council, said: “There are strongly held views within the medical profession on both sides of this complex and emotive issue. ‘The BMA remains firmly opposed to legalising assisted dying. This issue has been regularly debated at the BMA’s policy forming annual conference and recent calls for a change in the law have persistently been rejected.”

As one would expect, there were a number of responses to the editorial. A palliative care physician questioned whether it would be right to frustrate the autonomy of patients who were not terminally ill who wanted to commit suicide. A psychiatrist wrote that legalisation would corrupt the profession and hurt public trust. “Instead of killing patients, why not try talking to them?”

Kevin Yuill, a history professor and the author of Assisted Suicide: The Liberal, Humanist Case Against Legalization, argued that assisted suicide is a moral issue which does not depend on opinion polls. “The UK abolished the death penalty in 1998 (rightly, in my mind) because we recognised that it is wrong, even for the best possible reasons, for the state to take a life. Make no mistake: the Falconer Bill will reinstate the death penalty for those who do not think their lives are worth living.”

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