Informed consent and conscientious objection are easy to fulminate about, but tricky to discuss with consistency. Take, for instance, the delicate topic of requests for hymen restorations and virginity certificates. Worldwide, an estimated 5,000 women were victims of honour killings in 2000. If a young woman from a culture which sanctions honour killing approaches a doctor, what should he or she do?
Refusal is not a popular or even, in some jurisdictions, a legal option for doctors who are asked to refer for an abortion or to prescribe contraception. But a request which reinforces “patriarchal norms” is different.
Swedish ethicists surveyed about 1000 general practitioners and 1000 gynaecologists. They report in the Journal of Medical Ethics that a small majority would agree to the woman’s request. However, a large minority, supported by the Swedish community, insist that they would never do so. In other words, conscientious objection to patriarchal norms is socially acceptable, even if it involves refusing a woman’s fully informed request for a medical procedure:
“the political message in Sweden is that hymen operations should be considered a non-option and that the appropriate response to such requests should be information about the medical aspects of sexuality and human rights and, if necessary, referral to police or social authorities for protection. The main argument for this practice is that Swedish society should take a stand against practices expressing control of female sexuality. The official Swedish viewpoint hence expresses a zero tolerance policy against patriarchal norms and values.”
Opposition to these practices in Sweden is so vehement that doctors try to dissuade women. If this fails, it is not illegal to perform them, but they do so reluctantly and secretly.
The authors favour the pragmatic policy followed by doctors in the Netherlands. There doctors inform women of the issues involved, but do the procedure if they insist. This allows them to give women better health care.
While the US Food and Drug Administration examines the possibility of allowing “three-parent embryos” to fight some lethal mitochondrial diseases, the UK has decided to press ahead. This week the government launched a consultation on how to regulate the technique.
It is estimated that 1 in 200 children born every year in the UK have some form of mitochondrial DNA disorder. These disorders, including heart disease, liver disease, loss of muscle co-ordination and other serious conditions that can have a devastating, even fatal, impact on the people who inherit them. At present, mitochondrial donation techniques to prevent the transmission of serious mitochondrial disease are prohibited.
The UK’s Chief Medical Officer, Professor Sally Davies said: “Allowing mitochondrial donation would give women who carry severe mitochondrial disease the opportunity to have children without passing on devastating genetic disorders. It would also keep the UK at the forefront of scientific development in this area.”
This is more accurate than describing the technique as “life-saving”. Rather than helping existing children, the technique creates a “designed” embryo with genetic material taken from two eggs. Embryos which do not make the grade are presumably discarded.
David King, of Human Genetics Alert, a lobby group, was critical of the latest step. "If passed, this will be the first time any government has legalized inheritable human genome modification, something that is banned in all other European countries," he said in a statement. "Such a decision of major historical significance requires a much more extensive public debate."
An Italian woman in her 80s decided to die in an assisted suicide clinic in Switzerland because she was ‘losing her good looks’. Oriella Cazzanello – who was seldom visited by her children– caught a train to a clinic in Basel where her life was ended for a fee of €10,000. Her family, who reported her missing to the police, only learned of her death when her attorney received the ashes and the death certificate in the mail.
Mrs Cazzanello chose to end her life because she was ‘weighed down by ageing and the inevitable loss of the looks of which she was proud’ the Italian news agency ANSA reported. Assisted suicide is illegal in Italy, but legal in Switzerland, even if the person requesting it is not terminally ill.
Coincidentally, researchers at the University of Bern released a paper this week which indicates that 16% of those who die in Swiss suicide clinics do not have an underlying health problem. They just want to end it all because they are weary of life. They concluded:
"Assisted suicide in Switzerland was associated with female gender and situations that may indicate greater vulnerability such as living alone or being divorced, but also with higher education and higher socio-economic position."
New studies are suggesting that doctors need to be more cautious when they release genetic information to patients.
A recent article in the American Journal of Psychiatry has examined the effects of informing patients of genetic predispositions to disease on their subsequent cognitive performance. The authors of the article, from the University of Indiana and UC San Diego, found that respondents who were informed of a disposition to Alzheimer’s performed worse on memory tests and had reduced confidence in the current power of their memory.
In the study, which involved almost 150 participants, some of the patients were given the results of genetic test for Alzheimer’s predisposition, whilst others were tested but not told of their results.
The researchers found that those participants who were informed of their predisposition to Alzheimer’s performed far worse on the tests for objective and subjective memory. The ”informed” participants showed poorer comprehension when asked to recount narratives and recall images. In subjective memory tests they were far more pessimistic about the strength of their current memory.
In addition avoiding the negative psychological effects of the test, the authors of the study suggested doctors bear in mind this phenomenon when assessing whether a patient has Alzheimer’s: ‘Clinicians and researchers should consider patients’ knowledge of their genotype or knowledge of possession of other Alzheimer’s biomarkers when evaluating older adults who may or may not be at risk for developing dementia’.
The meeting focused on how to get more British parents to declare they have adopted a surrogate child (which is done through applying for a parental order). Many parents believe any such application will be rejected, for they have paid a woman more than out of pocket expenses to carry the child. This payment is technically illegal in Britain. Parents are also concerned that the regulations in foreign surrogacy clinics do not meet the standards required for the granting of a British PO. The upshot is that about 1,000 children of surrogate mothers enter Britain each year and many of them lack a clear parental status.
The conference has backed the establishment of a International Convention on Surrogacy, along the lines under consideration by the Hague Conference on Private International Law. Bilateral agreements between governments may be quicker way to address the issue. It was also suggested that the UK Government should make it easier to apply for Parenting Orders, by lowering the cost and quickening the process.
What is it about stem cells that attracts scientific misconduct? Even a decade after the exposure of one of the most egregious charlatans of the 20th century, Korean scientist Hwang Woo-suk, there is a long train of discoveries which turn out to be based on shoddy or even fraudulent work.
The latest scandal has come to light in Germany. Cardiologist Bodo-Eckehard Strauer, who retired in 2009, has claimed that stem cells derived from bone-marrow cells will repair damage in diseased hearts. Now a investigators at the University of Düsseldorf says that there is evidence of misconduct in his clinical trials. It has handed a report to police prosecutors.
Strauer’s work has been under attack in Germany for years, with his critics complaining that he had transformed the results of a single case into an amazing “global innovation”.
Last year, a commentary on an analysis of Strauer’s work in the International Journal of Cardiology was scathing in its assessment of his work:
“The analysis by Francis et al. suggests that there have been numerous publications of the same sets of data from Strauer’s group. Moreover what initially appear to be duplicate publications provide contradictory descriptions of experimental designs and of results. At the same time there are implausible agreements between data in populations of different sizes as well as statistical and arithmetic impossibilities in other datasets. I can see no logical option but to suspend belief in any of the data reported in these publications until an appropriate investigation has been performed.”
According to 2012 figures, IVF babies now make up 1.5% of all children born in the United States. According to a report from the Society for Assisted Reproductive Technology (SART), its 379 member clinics performed 165,172 cycles, or procedures involving IVF, in 2012. These resulted in the birth of 61,740 babies, an increase of more than 2000 infants from 2011. With an estimated 3.9 million births in the US in 2012, IVF babies now constitute about 1 in every 67 births.
This is a new high for the US, although rates in other countries are far higher. According to the European Society for Human Reproduction (ESHRE), in Belgium, Denmark, Finland, Iceland, Norway, Slovenia and Sweden at least 3.0% of all babies born were conceived by ART. An estimated 5 million children have been born through IVF around the world.
An independent comment by investigative journalist Miriam Zoll.
The most comprehensive study to date evaluating the effectiveness of egg freezing revealed that, despite a new flash freezing technique, high failure rates continue to be associated with egg freezing procedures across all age groups.
The May 2013 data meta-analysis study published in Fertility and Sterility found that using a technique known as ‘vitrification’ did reveal some improvements for women younger than 30 but that there were certainly no guarantees. Tracking outcomes of 2265 thaws in 1805 patients the study found:
For women aged 30, the failure rate of an embryo deriving from slow freeze method of egg freezing to transfer was 91% (8.9% success); with vitrification (flash freezing) the failure rate was 77% (13.2% success).
Women aged 40: 96% failure rate with the slow freeze method (4.3% chance of success) and a 91% failure rate with V (8.6% success)
There were some live births recorded with the slow freeze method at age 42 and some with vitrification at age 44, but these were very small percentages.
Miscarriage rates in women between the ages of 30 and 40 who used the slow freeze technique were 35-41 percent. The use of vitrification in this age group reduced miscarriage to 19 – 22 percent.
Researchers concluded: “Our analysis revealed age 36 years as the cut point to provide the best discrimination between successes vs. failures, hence optimal results may be expected in patients who are younger than this age threshold (younger than age 36 is best).”
In October 2012, the American Society for Reproductive Medicine (ASRM)––the lobby and voluntary regulatory arm of roughly 500 infertility clinics in the U.S.––lifted the “experimental” label from this still young science.
Its Practice Committee said it was not yet ready to endorse widespread use of egg freezing for elective treatments and, while randomized controlled studies were rare, the committee said it did find ‘sufficient’ evidence to “demonstrate acceptable success rates in young, highly selected populations.”
Citing a lack of data on safety, efficacy, cost-effectiveness, and potential emotional risks, their report states, “Marketing this technology for the purpose of deferring childbearing may give women false hope and encourage women to delay childbearing. Patients who wish to pursue this technology should be carefully counseled.”
As would be expected, once their decision became public, their warnings about women’s age and infant health was obscured and eventually obliterated by the dust kicked up by a stampede of panicked but hopeful 30 and 40-something women running to the nearest fertility clinic to have their eggs harvested for future use––for anywhere between US$10,000 and $15,000 or more.
One must wonder why the ASRM felt so compelled to provide a stamp of approval for a procedure still lacking in reliable safety and efficacy data. As legal scholars Debora Spar and Naomi Cahn have written in their books, The Baby Business and Test Tube Babies, respectively, in the context of an unregulated industry in the United States, it is virtually impossible to separate the medical and market forces at play when new techniques and procedures are advertised to potential clients.
The blurred boundaries between fertility clinics wanting to provide patients with safe, evidence-based procedures while also needing to generate business to meet their bottom lines puts that much more pressure on consumers to know what they are signing up for.
All of contemporary bioethics springs from the Nuremberg Doctors Trial in 1947. Seven Nazi doctors and officials were hanged and nine received severe prison sentences for performing experiments on an estimated 25,000 prisoners in concentration camps without their consent. Only about 1,200 died but many were maimed and psychologically scarred.
So did the US do to the hundreds of Japanese medical personnel who experimented on Chinese civilians and prisoners of war of many nationalities, including Chinese, Koreans, Russians, Australians, and Americans? They killed an estimated 3,000 people in the infamous Unit 731 in Harbin, in northeastern China before and during World War II – plus tens of thousands of civilians when they field-tested germ warfare. Many of the doctors were academics from Japan's leading medical schools.
Well, almost nothing. Twelve doctors were tried and found guilty by the Soviets in the Khabarovsk War Crime Trials in 1949, but they were all repatriated in 1956. American authorities dismissed the trials as Soviet propaganda. Many of the doctors in Unit 731 went on to successful careers in Japan after the War. The commander of the unit, Shirō Ishii, lived in relative obscurity but his successor late in the war, Kitano Masaji, became head of one of Japan’s leading pharmaceutical companies.
How did the Japanese doctors escape justice?
A fascinating answer appears in the Cambridge Quarterly of Healthcare Ethics. The broad outline of the story has been well documented, even if it is not widely known. To cut a long story short, the Americans struck a deal with the doctors. They traded immunity from prosecution for access to scientific information from the ghastly Japanese experiments – many of which are too grim to detail here. (If you have the stomach for it, a remorseful doctor describes, at the age of 90, some of his vivisection experiments in an article in the Japan Times.)
A report from US scientists who interviewed the staff of Unit 731 and the surviving records concluded that “Such information could not be obtained in our own laboratories because of scruples [sic] attached to human experimentation. . . . It is hoped that the individuals who voluntarily contributed this information will be spared embarrassment [ie, not tried for crimes against humanity] because of it and that every effort will be taken to prevent this information from falling into other hands [ie, the Soviets].”
The authors of the article observe that: “Although it is only conjecture, it is tempting to read into these statements a further conclusion that the Americans, contrasting their slow progress at Camp Detrick [a US biological warfare research facility] with the apparently vast accomplishments of Unit 731, were appreciative of what the Japanese lack of ‘scruples’ had achieved.”
The remarkable feature of the investigation of the crimes of Japanese military doctors was that it was American scientists who foiled attempts to prosecute them. They won over the US Army lawyers to their point of view. An Army task force concluded that “ “The value to the U.S. of Japanese [biological warfare] data is of such importance to national security as to far outweigh the value accruing from ‘war crimes’ prosecution.””
From a distance of 70 years, what explains this moral blindness? The article suggests two reasons. First, the Japanese were so ruthless that they left no evidence, no maimed and scarred survivors, no one to touch the hearts of newspaper readers, no heart-wrenching stories of torment. They were all slaughtered. Second, “wartime exigency”.
“Wartime exigency does more than simply prioritize national security over human rights. It urges toughness and decisiveness in decision-making, such that a moral blindness that would be seen as a deficiency in other times is instead seen as a virtue and a necessity.”
The authors conclude that the American authorities were clearly “accomplices after the fact” to these appalling crimes.
After 11 years of participation in euthanasia, an official complaint has finally been lodged with the Belgian Medical Association against the leading practitioner in Belgium, Dr Wim Distelmans. In a three-page letter Tom Mortier and Dr Georges Casteur allege that Distelmans did not have the expertise to evaluate whether Mortier’s mother, Godelieve De Troyer, was ready for voluntary euthanasia.
They point out that Distelmans is not a psychiatrist or even the woman’s family doctor, but a cancer specialist. However, De Troyer was physically healthy and not suffering from physical pain. Before contacting Dr Distelmans she spoke with psychiatrists who thought that she could recover from her evident emotional distress. She was also taking medication which can cause suicidal ideation, but Dr Distelmans did not seem to take that into account.
Feature stories in the media describe tender deathbed euthanasia scenes of patients surrounded by grieving but serene relatives. But Mortier says that De Troyer did not want her family to be notified because she was suffering from clinical depression. He feels devastated because he was unable to bid her farewell when she died in 2012.
However, Distelmans’s supporters point out that the law is crystal clear about informing relatives of a euthanasia request. The doctors are supposed to inquire, but if the patient refuses, it would be a violation of doctor-patient confidentiality to contact the relatives.
Mortier and Casteur have also questioned how euthanasia is currently regulated in Belgium. De Troyer made a donation of 2,500 Euros to Distelmans’s right-to-die association, LEIF, two months before she died. Distelmans administers euthanasia to many patients, but he is also the head of the commission which investigates failure to observe the euthanasia law. They suggest that this is a clear conflict of interest and that the composition of the commission should change.
Distelmans was reluctant to comment on the complaint to the media, but he did point out that it was the first complaint which had ever been made against him in 11 years of doing euthanasia.