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  10:55:09 PM

More stem cell fraud allegations: why?

It would be hard to name a patch of science which involves more medical potential, scientific interest, ethical controversy and examples of misconduct than stem cell research. So how could a 30-year-old junior researcher at one of the world’s leading institutes report incredible stem cell results in the world’s leading science journal even though her paper contained dubious data?

Haruko Obokata’s career is in tatters after her employer, the RIKEN Institute, declared that she had engaged in scientific misconduct. (She denies this.) According to the Japanese newspaper, the Asahi Shimbun, Waseda University now also suspects that some portions of her 2011 PhD thesis may have been plagiarised.

This debacle highlights concerns in at least four areas.

Reckless editorial standards in leading journals. Stem cell biology has been plagued by fraud and error for years. So amazing claims ought to be subjected to an amazing level of scrutiny. Given that critics found holes in the paper by Obokata and her colleagues so quickly, it’s dismaying that Nature allowed itself to be stung. It’s hard to escape the suspicion that science journals, like other media, are so eager to scoop the competition that they lower their guard.

Deficient education in research ethics. In his apology, the president of RIKEN, Nobel laureate Ryoji Noyori, promised to “fundamentally rethink our provision of ethical education”. Apparently young researchers are not being steeped in a culture of scientific rectitude. The director of RIKEN's Center for Developmental Biology, Masatoshi Takeichi, admitted that “our systems for supporting the young scientists we have appointed into leadership positions were not effective in this case”. And the chairman of RIKEN’s investigating committee, Shunsuke Ishii, declared that, “I have never experienced this kind of carelessness” among junior researchers.

Pressure and competition. In the wake of the story, New Scientist conducted its own survey of 1000 stem cell scientists, of whom 110 replied. The respondents painted a picture of a highly competitive environment in which people were sorely tempted to take short-cuts. "There is a tremendous pressure to publish, in order to receive funding. Shortcuts are, therefore, not unusual," said one researcher. "I know of numerous instances where fellows with, at times, the knowledge of their mentors, have published falsified data," said another.

The peer review process. Headlines that “peer review is broken” are exaggerated, but its status as the guarantor of the reliability of research results – at least in the eyes of the public – must be questioned. "The review process has become a playground of promoting personal opinions, rather than evaluating the actual science," one researcher complained in the New Scientist survey.

The latest instalment of the stem cell saga need not tarnish the credibility of the scientific method. Only if an experiment can be replicated will a hypothesis be accepted by the scientific community. And in this case, suspicions arose precisely because no one could replicate it. This shows that “the scientific process of checks and balances actually works,” as Jonathan Garlick, a stem-cell expert at the Tufts University, told the Boston Globe. However, non-scientists could be forgive for feeling a bit less confident in the credibility of stem cell science after seeing its dirty linen. 

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  10:49:35 PM

What are the problems with peer review?

Here is a quick and helpful video overview of concerns with the peer review process. Scientists and journal editors comment at a conference organised by BioMed Central and BMC Biology last year. Greg Petsko, of Weill Cornell Medical College, the chair of the discussion says, “The thesis is that there is something seriously wrong with the scientific review process… which has become, if not outright broken, distorted to the point where it’s hindering people’s careers, and causing more problems than it is solving.”

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  10:42:13 PM

Australia recognises “non-specific sex” as legal option

Norrie, in Sydney. EPA, via London Telegraph

Because much of contemporary bioethics has to do with sexuality and personhood, legal wrangles over gender are quite relevant. This week’s episode comes from Australia where the High Court has ruled that people can be officially recognised as a non-specific sex.

After a four-year legal battle Norrie, a transgender person, won the right not to be identified as either male or female. The state of New South Wales, said the Court, should recognise a third category of non-specific sex in addition to male and female.

Norrie, who uses only a first name, was born in Scotland as a male and in 1989 underwent sexual reassignment surgery. For several years Norrie has campaigned to be identified officially as neuter.

The High Court’s decision supports a controversial 2011 move by the Australian Department of Foreign Affairs and Trade to allow transgender people to identify themselves as male, female or “indeterminate/unspecified/intersex” on their passports.

"For the most part, the sex of the individuals concerned is irrelevant to legal relations,” the Court declared. And "the chief, perhaps the only, case where the sex of the parties to the relationship is legally significant" is the – now contested and controversial -- legal status of marriage.

The judgement does admit that male and female are the only "registrable classes" of sex. But it sets down that this does not mean that people should be forced to choose between the two. They ought to have more options. "There is nothing in the [Births, Deaths and Marriages Registration] Act which suggests that the Registrar is entitled, much less duty-bound, to register the classification of a person's sex inaccurately as male or female”.

Most observers were delighted with the ruling. As Sydney University gender studies expert Jennifer Germon wrote in The Conversation, “understanding male and female in dualistic terms is a spurious endeavour and demonstrates how out of step the law is with scientific evidence”.

However, the New South Wales Registrar of Births, Deaths And Marriages contended in its submission to the High Court that:

“In the absence of a statutory definition of the terms ‘sex’ and ‘change of sex’, these words should be given their natural and ordinary meaning, unless the Act indicates an intention to depart from the ordinary meaning … The ordinary use of language supports the Registrar's construction of the term ‘sex’. Identification of people as either ‘male’ or ‘female’ is a practice which is deeply engrained and of very long-standing… Given the deep-seated assumption of two sexes, which sounds throughout the legal system, it is improbable that the legislature would overthrow fundamental principles or depart from the general system of law without expressing its intention with irresistible clearness.”
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  9:06:10 PM

Mexican authorities accuse Knights Templar of organ harvesting racket

Last Tuesday Mexican police arrested a senior member of the Knights Templar crime syndicate, alleged to have kidnapped children to harvest their organs. Police say that Manuel Plancarte Gaspar was part of an organ-trafficking ring run by the infamous cartel. The ring is said to have kidnapped children and taken them to rented homes with medical equipment where their organs were removed.

"We have several statements in open investigations that point to a network of several suspects who would identify people with certain characteristics, especially children, and kidnap them," said Michoacan state Public Safety Secretary Carlos Castellanos Becerra.

Following the arrest of Gaspar, the leader of a local vigilante group made a statement on radio supporting the police allegations. Dr. Jose Manuel Mireles of the civilian "self defence" group in Tepalcatepec said that several children had been rescued in his town while being transported in a refrigerated container inside a van. "They were inside a refrigerated box, tightly wrapped in blankets," he said in a morning interview with MVS, a local radio station.

The Knights Templar is a multifaceted crime syndicate that operates in the Michoacan region of Mexico. Whilst the cartel is heavily involved in drug trafficking, it current top sources of income are illegal mining, illegal logging and extortion. Authorities are investigating just how developed the group's organ-trafficking activities are.

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  8:18:24 PM

Rates of IVF continue to grow

A new healthcare analytics report has revealed just how big the IVF market is, and how big it is set to become. The report, produced by Allied Analytics LLP, estimates that the net worth of the IVF market at the end of 2012 was US$9.3 billion, a figure which is set to increase to $21.6 billion by 2020.

Delayed pregnancy in women is one of the key factors driving the increased use of IVF. Increased rates of infertility, due to stress levels, change in lifestyle and fertility related diseases, have also contributed to the growing popularity of the procedure. 

Researchers found that there has been a corresponding increase in egg donation. For instance, in the U.S., the number of egg donation cycles has increased from 11,000 in the year 2000 to 18,000 in 2010.

Medical tourism is providing an excellent opportunity for the growth of this market. The cost of IVF in New York is approximately around $10,000- $15,000 but the same treatment costs $6000 in Thailand. Developing economies are emerging to be the most preferred destination for IVF treatments with increasing focus on advanced technologies, improving health care infrastructure and favourable health care cost.

Less palatable statistics were released by the Human Fertilization and Embryology Authority in Britain earlier this week. It was disclosed that over 3000 IVF embryos are destroyed in UK clinics each week. Critics have described the figures as an indication of the indifference of these clinics to the fate of embryos. They treat embryos as "disposable life", one critic said.

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  7:58:44 PM

Clarifying the ethics of shame

Is it ever good to stigmatize? This question has received significant attention of late in many bioethical and medical journals.

Indeed, the International Journal of Obstetrics and Gynaecology recently published an editorial by two University of Tornoto bioethicists discussing stigmatization in healthcare. The article, entitled Reducing Stigma in Reproductive Health, criticises the continuing stigmatization of both users and providers of reproductive healthcare. The article focuses particularly on the ongoing shaming of individuals involved in abortions, be they doctors or patients:

Gynecologists who undertake lawful abortions, for instance, should be afforded the same respect as others, not denigrated as "abortionists," even when providing services in the private sector that public sector facilities decline to undertake. The role of creating stigma as a governmental public health strategy, for instance to reduce cigarette smoking, may remain politically contentious but, regarding patients and providers of reproductive healthcare, the judgment remains that "[s]tigma can without exaggeration be considered a barbarous and unacceptable form of regulation that a humane society must reject".

The significance of the article seems to lie not so much in the novelty of its comments on abortion stigmazation, but in its underdeveloped distinction between 'contentious' and 'non-contentious' examples of stigmatization. The authors claim that stigmatizing smoking may be an effective means of improving 'individual and public health', but stigmatizating abortion remains "barbarous and unacceptable".

Should stigmitization be based on a paternalistic attitude toward impacts on 'individual and public health'? The article seems to endorse a potentially "barbarous and unacceptable" practice, only to condemn it in the same breath. Whilst this is yet another contribution to a voluminous literature, it seems the topic warrants further attention.

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  7:25:20 PM

Transhumanism reaches Hollywood in new high budget film

Transhumanism is a movement receiving increasing attention on various levels of society. It has even sparked the curiosity of Hollywood. A new film by director Wally Pfister, Transcendence, warns of the dangers of the transhumanist project.

The film tells the story of an artificial intelligence researcher Dr Will Caster, who develops a sentient machine that combines the collective intelligence of the world with the spectrum of human emotions. The machine is intended to represent the transhumanist idea of 'the singularity'. After being pursued by anti-technology activists, Caster chooses to upload his own consciousness to the machine's mainframe. In his new computerised form, Caster embarks on an aggressive search for further knowledge.

Sci-fi fans are decrying the anti-transhumanist sentiment of the film: "Looks like a cool flick but seriously anti-transhuman and technophobic", commented one viewer of the official trailer. "I am genuinely afraid what people, especially young kids, will take away from this. We already have enough people out there who are weary of high tech and even more who are scientifically illiterate. Do we really need to aggravate them?"

Blogger Rebecca Taylor is looking forward to the exploration of what it means to be authentically human: "I am hoping it goes beyond simply the technological aspects of artificial intelligence but sparks a discussion about what it means to be an organic human, full of flaws and limitations, and yet sublimely beautiful at the same time. That is true 'transcendence'. The 'I can't feel anything' line is promising." 

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  6:01:17 PM

Why are we condemning sperm donor anonymity, asks bioethicist

Donor conception is often shrouded in secrecy. At age 7, only about half of children know that they were conceived with donor eggs; the figure for donor sperm is only about one-quarter. Legislation forcing IVF clinics to give access to the identity of the donors is spreading. In Sweden, Austria, the Australian state of Victoria, Switzerland, The Netherlands, Norway, the United Kingdom, New Zealand, anonymous donation has been banned.

But is this necessary? Writing in The Hastings Center Report, bioethicist Inmaculada De Melo-Martín says No. There is no desperate need for children to connect with their genetic parents. In fact, she says, a policy of non-anonymity may even be socially harmful.

She attacks supporters of the right to genetic information on three counts.

It is argued that secrecy could harm family relationships. But, she counters, the empirical evidence is ambiguous. “It is not clear that secrets are prima facie wrong or even that all secrets are in need of justification. Secrets can protect important aspects of human life, even when they can also invite abuse. Indeed, rights proponents are not proposing an end to all family secrets, or even to all secrets that relate to mode of conception.”

It is argued that children need to know their genetic origins for the sake of their health. But says Melo-Martín, this overstates the role of genetics and biology in a person’s life. Clinics screen donors for genetic diseases, so the process should be safe. In any case, “Even if people had accurate information about their genetic relatives, there is not sufficient evidence to conclude that access to family history improves risk prediction, changes people's risk perceptions, and leads to better health outcomes.”

It is argued that we have a natural need to know our genetic forebears and that people who do not know their genetic parents suffer from “genealogical bewilderment”. But, Melo-Martín, argues, there is no robust empirical evidence for this. In any case,

“even if many donor-conceived people had a very strong interest in knowing their genetic origins and suffered when they lacked that knowledge, depriving children of such information would still not be shown wrong. People have all kinds of interests that we would be reluctant to say must be satisfied. Unless one presupposes—problematically—that knowledge about genetic parentage is necessary to develop healthy identities, then it does not seem that the legitimate interest of donor-conceived people in identity formation is thwarted by lacking such knowledge.”

Furthermore, mandating non-anonymity could be socially harmful. People who do not know their genetic parents could be stigmatised. Such a policy could promote “genetic essentialism”, the controversial notion that we are determined by our genes. Worst of all, perhaps, says Melo-Martín, “Emphasizing the importance of genetic relationships might also encourage problematic beliefs about the superiority of biological families”. Non-biological families formed by gay and lesbian couples could be treated as “pathological deviations”. 

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  5:58:47 PM

“Therapeutic cloning” back on the boil

Shoukhrat Mitalipov

After a couple of years in hibernation, the notion of “therapeutic cloning” is once again in the headlines. The latest development comes from Shoukhrat Mitalipov, a Russian-educated researcher at Oregon Health and Science University.

In a paper in Nature, his team reports that they have successfully created embryonic stem cells using a technique which bypasses the need for egg cells. Instead, the nucleus from an adult cell and placed in an enucleated zygote at the two-cell stage (which is also called the interphase). For some reason this dramatically increases the chance of the new cell’s successful development.

Scientists had previously thought the interphase stage — a later stage of the cell cycle — was incapable of converting transplanted adult cell nuclei into embryonic stem cells.

Apparently Mitalipov and his team have succeeded because they carefully synchronized the cell cycles of the adult cell nucleus and the recipient embryonic cytoplasm. Both had to be at an almost identical point in their respective cell cycles for the process to work. "That was the secret," Mitalipov said. "When we did that matching, then everything worked." The next stage is using the same process in monkeys and after than, humans.

Reviving the powerful “therapeutic cloning” rhetoric of a decade ago, a university press release claimed that this was a great step forward for regenerative medicine: “Human embryonic stem cells are capable of transforming into any cell type in the body. Scientists believe stem cell therapies hold promise for someday curing or treating a wide range of diseases and conditions — from Parkinson's disease to cardiac disease to spinal cord injuries — by replacing cells damaged through injury or illness.”

Although the technique does seem to advance understanding of cell reprogramming, it still poses significant ethical challenges.

First, the source material. In the past, “therapeutic cloning” was not only difficult but impractical and expensive. It depended on access to a huge supply of human eggs. Extracting these is quite dangerous for women and potentially quite exploitative. A market in eggs would be needed.

However, Milatipov apparently envisages using “surplus” eggs from IVF clinics. There are hundreds of thousands of these frozen and stored in the clinics. Embryos will be far cheaper as a raw material for research than eggs – but also far more controversial ethically.

Second, although media reports and the university press release skirted around this issue, two embryos are destroyed in the process: the “surplus” embryo from the IVF clinic, and the cloned embryo created by the researchers, which is dissected for its stem cells.

Third, although media reports tiptoed around the “c-word”, Milatipov’s process is basically an elaborate form of cloning. It could also be used for human reproductive cloning. There are no hints of this in his paper, of course, but the easier it is to produce pluripotent human embryonic stem cells, the easier it will be for rogue scientists to produce human clones.

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  5:55:57 PM

Stillborn babies incinerated to heat UK hospitals

Government hospitals in the UK have been using aborted and miscarried babies as heating fuel in green waste reduction programmes, according to a Channel 4 investigation. Ten trusts (or divisions) of the National Health Service have admitted that they have been burning the remains of these children with medical rubbish, and two trust actually used the bodies in “waste-to-energy” plants to heat the hospitals.

At least 15,500 foetal remains have been incinerated by the 27 trusts over the past two years, according to the Daily Telegraph. Not all of the Trusts have been mixing foetal remains with medical waste. But one of Britain’s best hospitals, Addenbrooke’s in Cambridge, incinerated 797 babies below 13 weeks gestation at its ‘waste to energy’ plant. The mothers were told their babies had been ‘cremated.’

After the program aired earlier this week, the Department of Health immediately banned the practice. The health minister, Dr Dan Poulter declared that it was ‘totally unacceptable.’

A number of women told Channel 4 that they had been treated insensitively by hospital staff after a miscarriage. 'I asked one of the nurses what would happen to my baby and she said "it will be incinerated with the rest of the day's waste."' one woman told the Daily Mail. 'That was difficult to hear, to me it wasn't the day's waste, it was my baby. It would have been nice to mark that baby's life but there was nothing in the hospital that gave us that opportunity.'

Sands, a British charity which deals with stillbirth and neonatal deaths, said that cremation is the best policy, never incineration. A spokesperson said:

"Research has shown that the stage the pregnancy has reached when the baby dies is not an accurate predictor of the length and depth of the grief the parents will experience. Foetus is not a term that parents use or that should be used with them. From the day the pregnancy is confirmed they are expecting a baby. The death of a baby at any stage of pregnancy is a major bereavement with life long consequences. The care that parents receive cannot lessen their pain, but poor and insensitive care can and does make matters worse both in the short and the long term." 

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