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|This week in BioEdge|
Switzerland will hold a constitutional referendum on June 14 to decide whether to legalize preimplanation genetic testing. Swiss law currently only permits three embryos to be created in IVF treatment because this is the number which can be immediately implanted. If the constitution is altered, it will be possible to create 12 embryos, some of which could be tested for genetic diseases and the others can be frozen.
While nearly all the political parties support the amendment, it faces a substantial opposition. Marco Romano, a parliamentarian for the centre Christian Democrats, was in favour of it until he spoke to doctors in a clinic:
“I spoke at length with a professor and I had the impression that the specialists want to use anything that technology makes possible, to the point of playing with life, reducing it to a point that is almost banal …
“In the United States, 10% of testing is used to determine the sex of the child. In Switzerland, the parliamentary debate very clearly showed the willingness of some people to go even further. In accepting PGD, we open a door and we don’t know exactly where it will take us.”
The news agency SwissInfo says that Switzerland is actually a “hardliner”, compared to other countries. Of 15 countries in Western Europe, 12 legalised PGD long ago. Even under the proposed legislation, “saviour siblings” would still be banned.
Political scientist Georg Lutz, of the University of Lausanne, told SwissInfo that voters are split on the issue:
“ it’s really hard to find any clear trends: voters of the parties on the left and right were divided and the only clear smaller trend was that people who attend religious services were more likely to be in favour of protection from manipulation and against stem cell research. The other small trend was that the French-speaking part of Switzerland leans slightly more towards science than the German-speaking part. But there’s no age difference, no enormous gender difference.”
In happier days
Italian celebrity surgeon Paolo Macchiarini, who created artificial windpipes with cadaver-derived scaffolding and stem cells, has been found guilty of scientific misconduct by an investigator from Sweden’s Karolinska Institute.
Dr Macchiarini’s operations were widely reported and seemed to bring almost miraculous relief to three patients. But the post-operative reality was different. Two of the patients have died, and the third has been hospitalized in intensive care for nearly three years.
The investigation was prompted by doctors caring for the patients who found that their condition was not nearly as good as Dr Macchiarini described in his publications. According to the investigator, the surgeon “omitted some data and also fabricated or falsified some data regarding the postoperative state of patients”.
The report is not yet available in English but should be released soon. Consult Retraction Watch for further developments.
A woman at the centre of a debate over euthanasia in India has died after 42 years in a minimally conscious state. In 1973 Aruna Shanbaug, a 25-year-old nurse in Mumbai, was brutally assaulted and strangled by a contract cleaner. She did not die, but was left severely brain-damaged.
In 2010 journalist Pinki Virani applied on her behalf for euthanasia. The case went all the way to the Indian Supreme Court which decided that while “passive euthanasia” by withdrawing nutrition and hydration might be permitted, the decision was up to her surrogate decision-maker. In Aruna’s case it was King Edward Memorial Hospital and it adamantly supported on-going palliative care.
It was a complex case and in their judgement, Justices Markandey Katju and Gyan Sudha Misra acknowledged that “we feel like a ship in an uncharted sea, seeking some guidance by the light thrown by the legislations and judicial pronouncements of foreign countries”. In the end they set down that “life support” can be withdrawn provided that a close relative or “next friend” or even the doctors request it. However, approval must be sought from one of India’s 21 High Courts to ensure that the decision is in the best interest of the patient. This, the justices insisted, was essential.
“We cannot rule out the possibility that unscrupulous persons with the help of some unscrupulous doctors may fabricate material to show that it is a terminal case with no chance of recovery. There are doctors and doctors. While many doctors are upright, there are others who can do anything for money.”
For 42 years the staff of King Edward cared for the disabled woman. The judges paid tribute to their devotion in 2011. “The whole country must learn the meaning of dedication and sacrifice from the KEM hospital staff. In 38 years Aruna has not developed one bed sore,” the judges wrote. They praised “their noble spirit and outstanding, exemplary and unprecedented dedication in taking care of Aruna for so many long years. Every Indian is proud of them.”
“We are happy she died a natural death. Mercy killing was not right for her, she was as alive as anyone else and used to respond to us,” said Anuradha Padhare, one the nurses who looked after Shanbaug, told the Indian Express. “We were her guardians as her family refused to take her home. We were her only family.”
Do we really need ever-more accurate tests to detect Down syndrome in unborn children? This is the question posed by Canadian bioethicist Chris Kaposy in the Impact Ethics blog. He questions “a ‘corporate arms race’ to develop prenatal tests for Down syndrome that are accurate and less invasive, cheaper, easier to administer, and that can be administered earlier in pregnancy than previous methods of testing.” Most of the time – some estimates are as high as 90% -- women who test positive undergo an abortion.
“The larger ethical question,” he writes, “is whether this pursuit of profit is good for people who have Down syndrome or even good for the rest of us.”
Recent research by Dr Brian Skotko at Massachusetts General Hospital suggests that most Down syndrome people and their families are happy with their lives. “The arms race to develop these tests is not being driven by the needs of people with Down syndrome or the needs of their families,” he says. In fact, says Dr Kaposy,
“… the social utility of these tests is incommensurate with the effort needed to create them. In contrast to the scientist who devotes her life to the treatment of cancer, … devotion to create a test that helps parents to avoid the birth of people who tend to enjoy their lives seems somehow less ambitious, or off the mark.”
The fear of a miserable death in a hospital bed rather than at home is driving public support for mercy-killing law in the UK, a Birmingham City University academic has warned.
Responding to a report published on Wednesday by The UK Parliamentary and Health Service Ombudsman, listing some of the worst cases in recent years of terminally ill patients dying without dignity, Timothy James, senior lecturer in Medical Law and Ethics at Birmingham City University, said: "For most people, dying at home isn't about autonomy, it's about dealing with the fear of dying in a hospital with poor end of life care. The fear of dying in misery in a hospital is what is driving the assisted dying debate."
"We've known for a long time now that the option should be available for terminally ill patients to die at home. We are seeing too many cases where proper pain control is not being given."
Referring to care in the English NHS, the ombudsman’s report details some of the cases investigated over the last four years, including that of a 29-year-old male dying of cancer who was admitted to hospital and left without pain relief for 11 hours.
A Filipino nurse working in Britain has been found guilty of two counts of murder after deliberately contaminating the intravenous fluids of patients.
Victorino Chua, 49, described by detectives as a narcissistic psychopath, injected insulin into saline bags and ampoules while working on two acute wards at Stepping Hill hospital, Stockport, in June and July 2011.
In addition to two patients who died from the insulin overdose, another patient suffered severe brain damage and dozens of others grievous bodily harm.
Chua took the insulin from unlocked fridges in Stepping Hill’s treatment rooms.
When a forensic scientist examined some of the saline bags, it was noticed that there was a small v-shaped cut to the rubber septum of the resealable bung and two puncture holes to the inner membrane of the bung consistent with a hypodermic needle.
The judge presiding over the case, Mr. Peter Openshaw, said that Chua showed no remorse, and described his crimes as “strikingly sinister and truly wicked.” Chua chose not to personally administer the insulin to most of the patients, so it was left to chance which of them were poisoned.
Chua was arrested six months after the first poisoning incident. Police conducted an extensive investigation and, after constructing a Venn diagram of staff rostered on at the time of the poisonings, managed to narrow down a list of potential suspects to Chua alone.
Investigations by police found inconsistencies in Chua's medical qualifications, which they raised with the Department of Health and the Home Office, as well as contacting the Nursing and Midwifery Council (NMC).
Since the Chua case, the NMC has audited all 11,500 nurses from the Philippines who arrived between 2002 and 2006 and found none that required any regulatory action. “There were no irregularities, although obviously we don’t have the capacity to detect any highly sophisticated frauds,” a NMC spokeswoman said.
Regulators in the United States and Australia are examining the burgeoning field of stem cell therapies. Using patients’ own stem cells extracted from fatty deposits in their bodies, doctors are treating dozens of conditions ranging from sports injuries to multiple sclerosis to dementia to hair loss.
However, the doctors don’t know how the stem cells work and there often is no evidence that they do work, other than optimistic anecdotes. According to a report by AP, more than 190 clinics in the United States are offering stem cell therapies. "It's sort of this 21st century cutting-edge technology. But the way it's being implemented at these clinics and how it's regulated is more like the 19th century. It's a Wild West," says Dr. Paul Knoepfler, a stem cell researcher at the University of California at Davis.
Many of the clinics are franchises organized by large for-profit companies which provide equipment and some training seminars. The largest, says AP, is the Cell Surgical Network, co-founded in 2012 by, who a former Beverly Hills plastic surgeon, Dr Mark Berman. The company’s website lists at least 28 conditions which can be treated with injections of a “fat-based soup”. "I don't even know what's in the soup," Berman told AP. "Most of the time, if stem cells are in the soup, then the patient's got a good chance of getting better."
The US Food and Drug Administration has been unable to regulate the stem cell market because the stem cells come from the patient and are not new drugs and only a minor surgical procedure is needed.
Stem cell scientists are highly critical of the industry. On his blog, Dr Knopfler interviewed Dr Berman and his partner and then drew his own conclusions: “
“One of the deepest differences that I have with Drs. Lander and Berman is related to my core belief in evidence-based medicine. I believe in having compelling pre-clinical evidence before you start to do a specific kind of new or experimental medicine on human patients. To my way of thinking, for example, prior to getting even one patient involved with an experimental medical approach you should do pre-clinical studies on animals for a given medical condition with the specific medical intervention in question. Then you collect data on safety and efficacy …
I do not personally believe in collecting millions of dollars from patients for interventions that are still arguably, in my opinion, experimental.”
In Australia, the Therapeutic Goods Administration, is studying whether autologous stem cell therapies ought to be regulated. Dr Martin Pera, of Stem Cells Australia, a consortium of stem cell researchers said in his submission to the TGA that “Immediate action is required to curb the growth of exploitative unproven and unfounded practices”.
"Under the current system there is no requirement for monitoring or reporting adverse events. We're completely in the dark whether these treatments have the potential to do harm or any good," he told the Sydney Morning Herald.
About 70% American women who resort to IVF to have a child go into debt. According to a small survey reported in the Wall Street Journal, 44% borrow more than US$10,000.
“Why all this debt? IVF is expensive. Each treatment can cost $15,000 to $20,000, and for most women, health insurance doesn’t cover it. More than 80% of the women in Prosper’s survey underwent at least two IVF treatments, or ‘cycles.’”
The imperative to have a child is so great that women are deferring other important expenditure, including buying a home, to pay for fertility treatment.
“If treatment costs don’t fall, they could become a big source of financial stress for the growing ranks of Americans putting off families to achieve some modicum of security. Before saving for Junior’s college education, couples may need to save up to have Junior himself.”
Daniel P. Sulmasy is the Kilbride-Clinton Professor of Medicine and Ethics in the Department of Medicine and Divinity School at the University of Chicago, where he serves as Associate Director of the MacLean Center for Clinical Medical Ethics and as Director of the Program on Medicine and Religion. He is also a member of the Presidential Commission for the Study of Bioethical Issues (PCSBI). Professor Sulmasy has written numerous books on topics related to bioethics, and published many articles in bioethics and medical ethics journals.
In this exclusive interview with BioEdge, Professor Sulmasy shared his thoughts on the complex notion of informed consent.
Xavier Symons: Some academics deride the ‘fetishization’ of informed consent or the ‘cult of consent’. What's going on? Most of us see it as our greatest safeguard.
I understand the sentiment, but informed consent is still critically important. Informed consent has become bureaucratized and, unfortunately, therefore equated by many health care professionals with merely obtaining a signature on a form. Too few practitioners take consent to be a process and a serious moral obligation.
While this can also be true in the research setting, I also think too many ethicists and researchers view informed consent as a sufficient justification for enrolling in human experimentation, and that is also misguided. Some experiments are just too risky or too scientifically flawed to justify doing them even if subjects do consent. These days, patients need more than ever to be involved in their care. The informed consent process is the entrée to their involvement.
XS: You have argued that “free choice is the context of morality, not the content of morality”. Don't most doctors disagree with you?
I think, sadly, most would not understand what I mean by that statement, and were I to explain, I think they so would have internalized “respect for autonomy” as a principle that they would need to listen to me for a long time to be persuaded that I am correct. As Aristotle puts it, ethics is about what to do, when what to do is up to us.
The goal of ethics is not to increase people’s choices. Rather, ethics concerns the quality of the choices that people freely make. While we ought not to unduly limit people’s freedom, ethics ought to help people to use their freedom to make good choices. So, we ought not merely to be giving patients lists of medical options like a menu in a restaurant.
We ought to help them to make good choices, and that includes permitting physicians to make recommendations based on their experience and practical wisdom. Patients can freely decline the physician’s recommendation, but they deserve guidance to help them to make the best choices that they can make.
XS: Can't limits on informed consent be seen as a subtle paternalism?
This depends on what those limits are. Some limits on patient choice are justified and the ethical question ought to be whether patients are free to demand from the health care system whatever they choose. For example, I defend a narrow standard of biomedical futility, based on the judgment that a treatment will not work or that the patient will die soon even if the treatment is given.
Under such conditions, one does not, in my view, need informed consent from the patient or family not to provide requested interventions. This is based on the principle that there can be no moral obligation to do what cannot work, and can only result in harm to the patient. This is just common sense ethics, not paternalism. Judgments based on broader understandings of futility, by contrast, can be paternalistic. For example, if the doctor determines that a treatment might work but the quality of life expected for the patient would be too low to justify it even if the family is requesting it, that judgment would be paternalistic and, in my view, unjustified.
XS: Recently BioEdge reported the case of a pregnant Australian woman who refused a blood transfusion on religious grounds and died along with her baby. How would you have navigated this tragic situation?
This is truly tragic. The sort of case you describe might, for instance, involve a Jehovah’s Witness who holds a religious belief that blood transfusion is gravely sinful. As a general rule, under US law, patients can refuse any treatment for themselves. Nonetheless, also as a general rule, parents are precluded from “martyring” their children. That is, they cannot refuse life-saving medical care for their children on the basis of their own religious beliefs.
Such legal protections, however, only kick in at birth. Until that time, the mother’s right to refuse treatment trumps the effect of that refusal on her developing fetus. For instance, the US Supreme Court banned one city’s policy of incarcerating pregnant cocaine addicts to protect the fetus from the adverse effects of cocaine. So, in the case you describe, one could plead on moral grounds with such a patient on behalf of the not yet born child, but could not transfuse her, legally, against her wishes.
XS: The Grey Matters report from the President's bioethics commission suggested that patients with impaired consent capacity be included in neuroscience research. How is this consistent with protecting the disadvantaged?
Some medical conditions that are poorly understood and urgently need more research impair the capacity of those who suffer from them to consent to research, making research difficult or impossible to carry out. These conditions are typically neurological afflictions such as Alzheimer disease. People suffering from dementia, for instance, constitute a very vulnerable population, and they deserve protection from exploitation.
Yet a total ban on enrolling such persons in research studies would be short-sighted. The Commission recommends cautious use of surrogate decision makers (such as family members) to give consent for enrolling such patients in a limited set of studies that either hold promise as potential therapies or advance our understanding of the disease from which they suffer. There would need to be safeguards—limits on such surrogate consent—but not an outright ban.
For example, patients with impaired cognition could not be enrolled as subjects in studies about other diseases from which they did not suffer, as this would treat them as mere means of benefiting others. There would also need to be stricter limits on the level of risk that surrogates could consent to permit their loved ones to undertake in such research compared with the risk that a patient with intact decisional capacity might be allowed to take on. Patient assent would be required even if they cannot actively consent (i.e., refusals by patients who are cognitively impaired ought to be respected).
And there needs to be a harmonization of the patchwork of regulations across jurisdictions in the US (and internationally) that set different and often conflicting standards for surrogate consent. We believe reasonable persons would agree to permit such a system, and to have such rules applied to them, were they anticipating the possibility that they might one day become cognitively impaired.