The number of cases of Alzheimer’s disease is set to treble by 2050, according to the peak dementia research group, Alzheimer’s Disease International (ADI). ADI, which will brief G8 nations at a special conference in London on Wednesday, estimates that there will be 135 million people living with dementia in 2050, up from the current number of 76 million. It is calling on governments to develop comprehensive policies to prepare for the dramatic increase:
“The absence of dementia public policy renders governments woefully unprepared for the dementia epidemic and there is an urgent need for a collaborative, global action plan for governments, industry and non-profit organisations like Alzheimer associations.”
There are also concerns about ability of poorer countries to deal with the epidemic. According to the briefing, over two-thirds (71%) of people with dementia will be living in low- and middle-income countries. The researchers stress that while funding for dementia research is crucial, there is an equally important need for good quality care and support for caregivers. Priority must also be given to policymaking, development of health and social care services, and health systems.
Next year marks the 50th anniversary of the Declaration of Helsinki, the benchmark for ethical medical research on subjects. To mark the occasion, the World Medical Association, which is responsible for updating the document, has issued a seventh revision. The WMA president, Margaret Mungherera, President of the WMA, explains the scope of the changes:
"We have spent two years consulting our national medical association members, outside experts and the public and we are satisfied that today we have a Declaration that requires greater transparency about medical research, greater accountability and increased patient safety. The changes also place more obligations on the sponsors of research, on the researchers themselves and on host governments to protect research subjects."
The origins of the Helsinki Declaration lie in the atrocities by Nazi doctors during World War II. In the wake of the war crimes trials, the 1947 Nuremberg Code set down ten conditions for research to be ethical. This was the first standard of human research ethics. However, this needed to be refined to cover the ever-expanding need to test medical advances on human subjects.
The result was the 1964 Declaration of Helsinki. The first edition contained 11 articles and 713 words. With constant revision, it has grown to 37 articles and 2,240 words which are read and glossed like a Biblical text.
One of the leading US experts on research ethics, Dr Ezechiel Emanuel, of the University of Pennsylvania, has been highly critical of the new draft in articles in JAMA and The Lancet. He claims that:
"there are nine distinct problems with the current version of the Declaration of Helsinki: it has an incoherent structure; it confuses medical care and research; it addresses the wrong audience; it makes extraneous ethical provisions; it includes contradictions; it contains unnecessary repetitions; it uses multiple and poor phrasings; it includes excessive details; and it makes unjustified, unethical recommendations."
In addition, he says, constant revision "undermine the legitimacy of the Declaration". A statement of ethical principles should be unchanging; otherwise it makes researchers think that they are not truly authoritative.
Saudi couples who are unable to have children are employing surrogate mothers in Asia and Europe even though surrogacy has been condemned by the country's Islamic Jurisprudence Council. An article in the Arab News did not estimate how many couples have done this. However, a number of doctors favour a more liberal interpretation of the law.
Dr Samir Abbas, a member of the Saudi Society of Gynaecology and Obstetrics, says “Such a phenomenon should not be treated as taboo, since the mechanism of food being fed to the fetus through the umbilical cord is akin to the act of a woman breastfeeding another person’s child, which is permissible in Islam.” Some commentators on the story also suggested that the husband take a second wife if the first is unable to bear a child.
In China surrogacy is also illegal, so some couples are going to US surrogacy agencies. The take-away cost of a child for them is between US$120,000 and $140,000. But if the child is born on American soil, it is constitutionally guaranteed US citizenship. This may come in handy for the commissioning parents as a way of getting a US education for the child or as a path to US residency for them. Surrogacy also allows parents to choose the gender of their baby and gives them a chance at having a second child in country which still enforces the one-child policy.
The search for UK volunteers willing to ditch privacy and donate their genome and health data to science has begun with the launch of the Personal Genome Project UK. The organisers hope to find 100,000 donors.
PGP-UK aims to offer every participant analysis of their genome, as part of a novel open consent protocol, enabling genomic data to be linked to medical and health records to create an information-rich resource that is made available under open access, allowing free and unrestricted access.
"Donating your genome and health data to science is a great way to enable advances in the understanding of human genetics, biology, and health," said Professor Stephan Beck, the director of the project.
Surrendering the right to genetic privacy is a novel development, especially at a time when countries all around the world are worried about keeping their data private from Google and security agencies. Entry to the project requires a thorough understanding of the risk of someone linking an on-line genome with a real person. "This is not for everyone," Jane Kaye, director of the Centre for Law, Health and Emerging Technologies at Oxford University, told The Guardian. "We are talking about information altruists here."
The US was the first country to roll out an open-source genome project. The genetic records of about 700 people have been published so far, but thousands have applied.
The program has its critics. "To put 100,000 genomes on the web so anyone can download them and use them is more than creepy," says Ross Anderson, a computer security expert at Cambridge University. "I wouldn't dream of doing it. You don't know where that's going to get to, we don't know enough about this yet.
Helen Wallace, of GeneWatch UK, also expressed reservations. "GeneWatch UK's view is that people should think twice before agreeing to share their genome openly. Remember your DNA contains a unique genetic code which can be used to track you and identify your relatives. Stored online it will be accessible to police, security and border agencies based in any country," she said.
"This project is sponsored by companies who are lobbying to expand the market for whole genome sequencing and open this data up to commercial exploitation. Genes are poor predictors of most diseases in most people but companies from Google to the private healthcare industry want to data-mine this information for personalised marketing, massively expanding the market for drugs sold to healthy people."
Shocking details surfaced this week of an Italian woman who had her baby forcibly delivered whilst visiting the UK last year. Alessandra Pacchieri, a Ryan air employee in Britain to complete a short airhostess training course, was taken to a psychiatric hospital in Essex by authorities after suffering an emotional breakdown. There doctors sedated her and her baby was forcibly delivered.
The woman was only allowed to see her baby ten times before she was barred from contact. The baby is currently up for adoption.
High Court judge Justice Mostyn sanctioned the forced Caesarean section and adoption, believing it to be in the best interests of the child. A legal team organized by the Italian government is currently appealing Mostyn’s custody decision.
Dr Philip Nitschke at his assisted suicide clinic.
A euthanasia clinic has been set up by Australia's leading euthanasia activist, Dr Philip Nitschke, in Adelaide. Police are keeping a close watch on activities there, but Dr Nitschke, who is used to working at the very edge of the law, is said to be doing nothing clearly illegal.
The clinic, a small renovated cottage in the suburb of Gilberton, has information about options for assisted suicide and facilities for video-conferencing with people in Australia and overseas who want to know how to kill themselves without legal risk to loved ones. The cottage was purchased with bequests and gifts from Dr Nitschke's admirers.
The law bans helping people commit suicide, but not advising them. So Dr Nitschke explains how to use the lethal sedative Nembutal, how to obtain it, and how to test its purity. He also has canisters of nitrogen bearing the name of his company, Mad Dog Brewing, which can be used to organise death by asphyxiation. The gas is conventionally used for making home brew but Dr Nitschke's clients are unconventional. "The motto of the company is dispense or dispose ... if you see what I mean," he told the ABC. Police in Queensland and New South Wales are questioning Dr Nitschke over occasions in which the canisters have been found next to corpses.
He also has a mobile consulting unit packed with equipment so that he can inform people who cannot visit the clinic of their "options". He stresses that the gear is used only for information.
Even if assisted suicide is legalised in South Australia, Dr Nitschke does not intend to use the clinic as a thanatorium. "People prefer to die in their own homes," he says.
The clinic is controversial in Adelaide. "Let's bell the cat right from the start: Australia, like much of the Western world, has an ageing population," says Paul Russell, of Hope Australia.
"We must recognise the prospect of euthanasia becoming law in this country could effectively be aiding and abetting elder abuse by relatives. It's not hard to imagine a relative who has been systematically abusing an elder could see euthanasia as the final - and most profitable - card to play for personal gain. It's not hard to imagine someone who has been emotionally abused over time succumbing to the suggestion they 'do the right thing' once their frailty and ailments reach a certain point."
The first workshop on human uterus transplants will take place at the University of Gothenburg, Sweden, in February, led by Professor Mats Brännström. While a couple of transplants have taken place in humans, no live births have yet happened.
There are some serious ethical issues involved. There is a substantial risk for a live donor, more than for the recipient. The children would have to be conceived (at least initially) by IVF. The mother would have to take immune-suppressant drugs as long as she has the womb. There are weighty psychological and cultural issues to be negotiated. See the video for a discussion of this fascinating new technology.
Personal genomics company 23andMe is in hot water after a stern letter from the US Food and Drug Administration (FDA). The FDA stated that the company's Personal Genome Service - a cheap and user-friendly means of obtaining information about one's genetic data – has not been approved for marketing. Unless the necessary supporting documentation is supplied the product must be taken off the market.
The FDA says that 23andMe has failed to provide evidence that their tests are accurate and reliable: "we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses".
The personal genome service has already been used by hundreds of thousands of people around the world to access their genetic information. Customers provide a saliva sample to the company's laboratories and receive a comprehensive report on their DNA. This includes a list outlining 'probabilities' that they will develop certain diseases, whether they are carriers of an inheritable disease, and even what their ancestry is.
Critics of 23andMe have welcomed the FDA action. Cecile Janssens of Emory University believes that most diseases are not genetic enough to be identified in tests: "genetic testing for common diseases will never become as predictive as champions of genetic testing hope."
Similarly Nathaniel C. Comfort from Johns Hopkins University argued that 23andMe had deliberately oversold human genetics for the sake of profit: "Although 23andMe presents as a concerned company dedicated to the health of their clientele, they are also—and arguably primarily—dedicated to their stockholders."
Duke University bioethicist Nita Farahany defended the company, asserting that they provided accurate information about the meaning of DNA data: "A 23andMe report gives you probabilistic information about your genetic predispositions. It does not offer, nor does it purport to offer, a medical diagnosis of any condition."
The hot water into which 23andme has landed is just one of many simmering controversies about genetic testing. Earlier this year the American College of Medical Genetics released new guidelines about how much of the “incidental” information from a genetic test should be given to patients. This is information gleaned from a test for one genetic condition which is not related to it but which might be relevant to a patient’s health.
For example, a test for hereditary hair loss might reveal that you have a gene strongly correlated with an aggressive cancer. Should the doctor tell you? Do you have a right not to know this information?
The American College of Medical Genetics and Genomics (ACMG) made an abrupt change of policy earlier this year and decided that it would be unethical not to disclose all the incidental findings, even if a patient does not want to know. In other words, the patient’s autonomy comes second.
“We recognize that this may be seen to violate existing ethical norms regarding the patient’s autonomy and ‘right not to know’ genetic risk information,” wrote the authors of the ACMG recommendations. “However … we felt that clinicians and laboratory personnel have a fiduciary duty to prevent harm by warning patients and their families about certain incidental findings and that this principle supersedes concerns about autonomy.”
Is this a big deal? Why shouldn’t patients get as much information as possible?
It is a big deal: a commentary in JAMA declared that it had “profound implications for countless physicians and their patients”. The policy of the ACMG is that every genetic test evaluates 57 genes, so abundant “incidental” information is harvested. One of the flashpoints is how this affects children and adolescents. Previously, genetic counsellors could withhold information about conditions which might affect health – but might not, too. The tests can return false positives and could lead to needless anxiety, expensive and unnecessary screening tests and even prophylactic surgery.
Three prominent American bioethicists wrote in Science that “Starting down the path of unconsented testing and reporting in clinical genomics leads to grave difficulties, and should not be done without more careful analysis.”
Russia has banned all abortion advertising in a bid to address population decline. The new legislation, signed into law by president Vladimir Putin on Monday, is yet another blow to abortion providers. In 2011 the government passed radical legislation that barred abortions after the twelfth week of pregnancy and established a waiting period of at least 48 hours.
The head of the State Duma Committee for Family and Children welcomed the law, saying, "the problems of abortion prevention and the shift in public opinion towards abortion are currently very urgent. Although the number of abortions in Russia is falling, it still exceeds 5 million every year."
Abortion advocates have condemned the government, arguing that the law is part of a campaign to restrict women's reproductive rights. "This is not the beginning of the restriction of women's reproductive rights, but rather the continuation of a process begun in 2011," said women's rights activist Olgerta Kharitonova.