In the great tradition of American litigation, will the fate of human embryonic stem cell research be decided in the courts? Earlier this week, US District Judge Royce Lamberth granted an injunction banning Federal funding for the research. This overturns not only President Barack Obama’s relatively liberal guidelines for research on embryonic stem cells, but also President George W. Bush’s more restrictive ones.

The Department of Justice has announced that it will appeal the decision.

The news has appalled supporters. A New York Times editorial described the injunction as “a huge overreach” of judicial power which would be “a serious blow to medical research” if it succeeds. The head of the National Institutes of Health, Francis S. Collins, said that it pours sand in the engine of medical progress.

His agency has already declared that 50 pending requests for new funding will not be considered. About a dozen other requests for US$15 million to $20 million which were likely to be approved have been frozen. Another 22 grants of about $54 million which are due for renewal in September will be cut off.

The decision was criticised as politically inspired. Jonathan Moreno, a University of Pennsylvania bioethicist with close ties to the Obama Adminstration commented disgustedly: “What the opposition to this legitimate and globalized field has been unable to do through science and the ballot box they are trying to do through the courts.” Slate columnist William Saletan was so disconsolate that he moaned: “I never thought I'd say this, but I'm starting to miss George W. Bush.”

The lawsuit was brought by two researchers who work exclusively on adult stem cells, which do not involve the destruction of embryos. James L. Sherley, a biological engineer at Boston Biomedical Research Institute, and Theresa Deisher, of Ave Maria Biotechnology Company contended that the Dickey-Wicker Amendment, which was first passed in 1996 and has been renewed every year since as a rider to appropriations bills for the Department of Health and Human Services, forbids funding for hESC research.  

President Bush and President Obama differed on their views on the destruction of human embryos for research. But they did agree that destroying them and using the by-products were two entirely different issues. All subsequent regulation has rested upon that assumption. No Federal funding has ever been made available for the destruction of embryos, but work on embryonic stem cells was supported by both presidents, albeit in different ways.

But Judge Lamberth firmly declared that this assumption is wrong.

“Despite defendants’ attempt to separate the derivation of ESCs from research on the ESCs, the two cannot be separated. Derivation of ESCs from an embryo is an integral step in conducting ESC research… If one step or ‘piece of research’ of an ESC research project results in the destruction of an embryo, the entire project is precluded from receiving federal funding by the Dickey-Wicker Amendment.”

True, two Presidents and Federal agencies have been interpreting the Amendment differently for nearly a decade, but Judge Lambert says that this is clearly mistaken: “as demonstrated by the plain language of the statute, the unambiguous intent of Congress is to prohibit the expenditure of federal funds on ‘research in which a human embryo or embryos are destroyed’”.

What happens now?

If an appeal fails in the courts, the whole embryonic stem cell debate will go back to Congress. Whether the Obama Administration will have the stomach for leading the charge in a new battle is anyone’s guess. With the Democrats facing stiff headwinds as mid-term elections approach, they may decide to defer a highly polarizing stem cell debate, leaving many biologists very down in the dumps.  

Embryonic stem cell research will not grind to a halt – it is still being funded by private investors, state governments, and universities -- but it could slow to a very slow walk.

There is a potential winner in this: California, which has hundred of millions of dollars of funding to splurge on researchers based in the state. The president of the California Institute of Regenerative Medicine, Alan Trounson, declared that the “deplorable” injunction was not altogether deplorable for California: “This decision leaves CIRM as the most significant source of funding for human embryonic stem cells in the US.”

There is more spin in discussions of embryonic stem cells than in the average gyroscope. Even eminent scientists tend to glide over the disadvantages of their preferred cell type. But quite consistently throughout years of debate, four uses for these cells have been mentioned: curing dread diseases, testing drugs, doing genetic research, and benchmarking performance. What no scientist in favour of using them has ever mentioned is that someday they would no longer be needed.

Until now. Dr Rudolph Jaenisch, a leading and often-quoted researcher at the Massachusetts Institute of Technology, told the New York Times that scientists currently need embryonic stem cells to benchmark the performance of adult stem cells and induced pluripotent stem cells. But then he admitted that this would not be the case for ever. “Things are very much in flux,” he said. “We will probably need human embryonic stem cells for a while. And then we probably will not need them anymore.”  ~ New York Times, Aug 25

 

Here’s another new film about the perils of genetic engineering. Information about Jim is sketchy at this point – it will be released in October – but it has something to do with corporate control of science. The protagonist takes frozen eggs to Lorigen to have them genetically engineered. The commercial for the company is a tour de force of creepy commercialism.

A technique used in half of American IVF births causes many infertile fathers to pass on their infertility to their sons – sometimes along with other genetic defects, according to an article in the Boston Globe.

A million babies around the globe have been born with ICSI. But hundreds, and perhaps thousands of the boys will be born infertile.

“Thanks to IVF and ICSI many babies have been born who wouldn’t have otherwise existed, and this has brought happiness to countless families. But unlike any other kind of medical intervention, which can be tested for safety and efficacy on the population it will affect, fertility techniques by design can’t be tested on the resulting babies until after they are born. To put it bluntly, we’ve chosen as a society to carry out a big safety experiment on the first generation of children we’ve created with these methods.”

US medical guidelines urge doctors to suggest that men with very low sperm counts be offered genetic tests before ICSI. But very often these guidelines are not followed. And many infertile men do not want to be tested, anyway.

What are the ethics of this, asks Sylvia Pagán Westphal.

“Infertility is, at the very least, a medical condition that causes significant emotional distress and, when fertility treatments are sought, puts the woman, and often her male partner, through medical procedures that are not without risk. Is it ethical to knowingly pass down this condition to a child? Does a couple’s right to reproduce trump that of their future children?”  ~ Boston Globe, Aug 8

The UK fertility regulator may radically commercialise IVF to enable British women to be paid thousands of pounds for donating their eggs. The supply of eggs and sperm for infertile couples dried up as soon as the government removed donor anonymity in 2005. Now there are long waiting lists and many couple resort to IVF clinics overseas.

Regulations might also be relaxed to allow one man’s sperm to create up to 20 children despite the danger of unwitting incest. The current limit is 10.

"We want to remove obstacles to donation," an HFEA spokeswoman said. "There are waiting lists of various lengths for people wanting to get access to treatment with donor eggs or sperm. We want to see if our policies are contributing to an unnecessary delay."

A public consultation on a market in gametes will begin in January 2011 and will run for three months. The results will be made available in May 2011.

Professor David Jones, director of the Anscombe Bioethics Centre in Oxford, and an adviser to Catholic bishops told the Guardian: “The church finds IVF ethically problematic and donor conception is worse… because it means the mother and father of the child won't be its biological parents. So when you start to pay people for it, it's even worse because you are encouraging, in the crudest kind of way, people who aren't going to be involved in the rearing of children to donate sperm or eggs.

“It's not just the church – a lot of people find the idea of payment problematic, because it's demeaning to procreation, that you should pay someone to take their child from them biologically."

Researchers have discovered that adult stem cells from the brain could be used to restore movement to paralysed patients. Experts say the breakthrough could lead to the creation of a spare set of matching cells which could then be used to “repair” damage to the spinal cord.

The study, conducted by researchers from the Nara Institute of Science and Technology, Japan, involved transplanting “neural stem cells” (NSCs) to mice with severe spinal cord injuries. They were then administered valproic acid, used to treat epilepsy. The acid promoted the transplanted stem cells to generate nerve cells rather than other types of brain cell.

According to Prof Kinichi Nakashima, who led the study, the method could be developed as an effective treatment for serious spinal cord injuries. “The body’s capacity to restore damaged neural networks in the injured… is severely limited,” he told the Telegraph. “Although various treatment regimens can partially alleviate spinal cord injury, the mechanisms responsible for symptomatic improvement remain elusive. These findings raise the possibility that (stem cells)… can be manipulated to provide effective treatment for spinal cord injuries.”

Tamir Ben-Hur from Hadassah Hebrew University Medical School, Israel, said that despite the study’s “impressive” results, further work was necessary “before it can be determined whether this approach will work in human patients”. ~ Telegraph, Aug 17

British scientists claim to have turned stem cells from spare IVF embryos into red blood cells in a project with the goal of manufacturing synthetic blood on an industrial scale. It has been said to be the first time in Britain that human embryonic stem cells have been used to produce human red blood cells.

The £3m project is aimed at developing an alternative source of O-negative blood, the universal blood type that can be used by most people without fear of rejection.

The project has used over a hundred embryos left over from IVF procedures to establish several hESC lines. One of the lines, called RC-7, has been converted from embryonic cells into blood stem cells and then into functioning red blood cells containing the oxygen-carrying pigment haemoglobin.

The project is in its very early stages, with the first clinical trials of synthetic blood made from ESCs planned to occur within the next five years. The plan is to then scale the manufacturing process to produce over two million pints per year using industrial bio-reactors.

Professor Marc Turner, director of the Scottish National Blood Transfusion Service in Edinburgh and leader of the project, said synthetic blood produced on an industrial scale would eliminate the problem of blood shortages and the transmission of infections between donors and recipients.

Some fundamental issues remain to be resolved. For example, scientists have to ensure that the cells are cultured with laboratory reagents that have not come into contact with animal cells, because these could contaminate the blood cells with animal diseases. The project is also yet to gain regulatory approval. In addition the use of hESCs themselves has been the subject of widespread bioethical debate. ~ Independent, Aug 16

A quadriplegic man who made a public plea to Hong Kong’s leader for the right to die six years ago has changed his mind. Tsang Sui-pun became paralysed from the neck down after he fell while rehearsing for a gymnastics display in 1991, badly injuring his spine. In 2004, using a chopstick in his mouth to type, appealed to the chief executive and legislators of Hong Kong for assistance in committing suicide.

Now he is going home. Mr Tang, now 41, smiled at reporters as he left hospital in a wheelchair. He said he had faced many difficulties since the accident and was happy to be on his way home. Carers will attend to him, and the monthly rent for his specially-adapted public housing flat will be paid by the government.

Assisted suicide is illegal in Hong Kong, and widespread debate and media coverage followed his moving statement. Donations flowed in to pay a taxi fare for his father’s daily visits to the hospital to feed him his favourite soup. Later on, Tang changed his mind and decided he wanted to life, although he is adamant that the choice of life or death is a basic human right. ~ BBC News, Aug 20

There are so many developments on the euthanasia front in the UK this week that they are best grouped together.

Former BBC producer Ray Gosling made the dramatic claim earlier this year that he had euthanased one of his numerous gay lovers more than 20 years ago. “I killed someone once. He was a young chap, he had been my lover and he got AIDS… I picked up the pillow and smothered him until he was dead. The doctor came back and I said ‘He's gone’. Nothing more was ever said.”

There was a great hoo-haa in the media over his teary reminiscences and the police immediately interrogated him. It turns out that probably Mr Gosling did no such thing and he will be charged, not with murder, but with wasting police time. A Crown Prosecution Service spokeswoman said there is “sufficient evidence” to prove he was lying. The Police are said to be furious that the BBC did not check out the story. ~ Daily Mail, Aug 20

An 84-year-old retired Scottish doctor will not be prosecuted for assisting a suicide. Dr Libby Wilson, a member of Friends At The End (FATE), was arrested last September after multiple sclerosis sufferer Cari Loder, took her own life using a helium cylinder and a hood. Police indicated that Dr Wilson did give the woman some advice but that it was not significant in carrying out the suicide. Dr Wilson was “unrepentant” and jeered, “What jury would have convicted me?” ~ Scotsman, Aug 17

A new right-to-die society has sprung up in the UK. The Society for Old Age Rational Suicide (SOARS) wants to press the case for assisted suicide for people who are not terminally ill. “After eight or nine decades, many people rightly decide that their lives have been fully lived, and now they have a life which, for them, has finally become too long,” its website declares.

The leader of the group is 79-year-old Michael Irwin, who is now being dubbed “Dr Death” by the British media. He is a controversial figure who was deregistered as a doctor after he helped a friend to die in 2005. He admits having helped several people to commit suicide. ~ London Telegraph, Aug 16

A clear North/South divide is emerging in attitudes towards male circumcision. In May the Dutch Royal Medical Association became the first national medical group to declare that the procedure is both medically unnecessary and an abuse of the rights of the child, in the same way as female circumcision, or female genital mutilation.

However, the Dutch have decided to actively discourage circumcision rather than to ban it, as that could drive the procedure underground. About 15,000 boys are circumcised each year.

On the other hand African countries are actively encouraging circumcision because trials in 2007 in Kenya, Uganda and South Africa showed that it dramatically reduced the risk of infection with HIV/AIDS. According to a report in the BMJ, 14 countries in southern Africa are promoting circumcision with radio and television campaigns.

In Swaziland, where HIV prevalence is 45%. circumcision is even regarded as “crucial to the survival of the state”. Botswana plans to circumcise all boys by 2012. Even Rwanda, where HIV prevalence is only 3%, is promoting it as a cost-saving public health measure.

However, the Dutch doctors are sceptical of the African data. They believe that while it might delay infection, it will not prevent it. They also say that there are some complications which cannot be ethically justified for a “medically futile” procedure.

In the UK, Australia and the US, the trend is away from circumcision. The Australasian Association of Paediatric Surgeons,  for instance, describes circumcision as "inappropriate and unnecessary" but allowable in children over 6 months old when parents "hold a very strong opinion.” ~ BMJ, Aug 17