Childless working couples and singles who cannot afford to take extended leave are increasingly shipping embryos to IVF clinics in India to be implanted in the wombs of surrogates.

A 40-year-old US man who wants to become a single parent recently sent an embryo to IVF Melbourne in Gujarat, after hiring an American egg donor. Dr Manish Banker, from the clinic, said: "He has already finalised a surrogate from options sent to him on e-mail and will come only to sign the legal papers. We will transfer the embryo in the surrogate and if pregnancy occurs, he will come back to take the child.”

The embryos are frozen and stored in medical straws, then sealed, packed in liquid nitrogen and kept at -196 degrees. The courier’s trip is about three to four days long, and costs between 50,000 and 60,000 rupees depending on the country from which it is being sent. Doctors have said the process is far cheaper than the conventional process – as it eliminates the travel costs for two people as well as accommodation expenses for the 7-10 days it would usually take for the process to be completed. It also eliminates the need for prospective parents to take leave from work to travel to India.

Dr Banker has four embryo-shipping cases set for surrogate mothers – including an embryo from an Australian couple. He says: “This practice of getting IVF treatment in their own countries and then sending embryos is set to grow as it saves both time and money."

Dr Naina Patel, from Anand’s Akanksha Infertility Clinic (a burgeoning surrogacy hub close to IVF Melbourne), has noted a sharp rise in enquiries about this new infertility treatment. "We receive a growing number of embryos shipped from all around the globe from couple who can't come here for initial stages of treatment. While we prefer to pick up eggs and do embryology if the couples come here, many couples have genuine problems of getting extended leaves (sic). If the embryos are shipped, they have to come here only for a day or two to complete the legalities," she says. ~The Times of India, Aug 29; Slate, Aug 23

A British doctor who cut a rugby player’s lip so that his team could substitute a better player in a crucial game has been scolded by the General Medical Council, but allowed to continue practicing.

Dr Wendy Chapman, 46, told a disciplinary hearing that she had succumbed to "huge pressure" from a player for one of England’s leading teams, the Harlequins, after he had bitten into a fake blood capsule. Officials immediately suspected that the blood oozing from his mouth was a charade and he pleaded with her to cut his lip.  She made a small nick and the blood flow was stanched with gauze and pressure. A specialist goal-kicker was brought in to win the game.

It later turned out that the Harlequins had used this stunt on at least four previous occasions to enable tactical substitutions. “Bloodgate” became a media sensation and was investigated by the European Rugby Cup. At an ERC hearing, Dr Chapman falsely backed up the player’s claims, along with the team’s physiotherapist and director of rugby – but not under oath. At the later GMC hearing, however, she freely admitted that she had colluded in the deception and subsequently lied about it. However, she pleaded that she was under immense stress at the time and depressed.

Dr Chapman admitted that what she had done was "completely wrong" and she was "deeply, deeply ashamed". The GMC has now cleared her to continue practicing medicine as an accident and emergency doctor. She had been suspended for a year by the GMC. "You do not pose any risk to patients or the public. The panel accepts that there is a public interest in retaining the services of a good doctor," said the chairman of the GMS panel. By the way, the Harlequin specialist kicker missed the goal and his team lost 6-5. ~ Telegraph, Aug 31

The US Justice Department has requested District Judge Royce Lamberth to delay the implementation of his decision banning federal funding for human embryonic stem cell research until it is appealed to a higher court. White House spokesman Reid Cherlin says that hESC research is important for the Obama Administration. “We’re going to do everything possible to make sure to avoid the potentially catastrophic consequences of this injunction.”

The director of the National Institutes of Health, Francis S. Collins, says that the decision will waste a colossal amount of money and work expended since 2001. The NIH has invested more than $546 million and the "anticipated financial loss to NIH and the taxpaying public is enormous and would include the hundreds of millions already spent on interrupted projects and the administrative costs of shutting down and restarting the NIH funding,” a spokesman declared.

Dr Collins also pointed out that adult stem cell research has numerous drawbacks despite its successes, research expertise will be lost, and young scientists will go overseas. “The momentum that has finally been established in the hESC field will be lost,” he said in a statement to the court. He lamented that “the greatest loss, however, will be for the millions of Americans suffering from diseases current under study with hESC.” ~ Washington Post, Aug 31

The media is taking a closer look at the star clinical trial with human embryonic stem cells – a privately-funded project by the biotechnology company Geron for curing spinal cord injury. In July the US Food and Drug Administration notified the company that a Phase 1 trial can begin. If the trials fail, private investors would be spooked at a time when private funding is essential. Apparently no one has been enrolled in the trial yet.

"There's a lot of angst around these trials," Evan Y. Snyder, of the Sanford-Burnham Medical Research Institute in San Diego, told the Washington Post. "There's going to be this perception that if the cells do not perform well, the entire field will be illegitimate." This is particularly true now that a federal court judge has banned federal funding for the controversial field.

Bioethicists also worry about whether a recently paralysed young motorcyclist can really give informed consent to an experimental procedure. He might agree to anything which promises to save him from a lifetime of paralysis. However, says Hank Greely, a Stanford lawyer and bioethicist, "If human embryonic stem cells are going to be useful in treating humans, someone has to be the first one to try it. They need to have their fingers crossed and hold their lucky rabbit's foot and be really careful in their preparations, because before you try something in humans you never know what's going to happen." ~ Washington Post, Aug 29

Sicilian police have questioned staff at a hospital where a baby boy was born with heart problems and suspected brain damage after a row between two doctors attending his mother allegedly took place as she went into labour. The 30-year-old woman, Laura Salpietro, was given a hysterectomy following the birth which, according to her husband, was almost an hour and a half late. He told police that after a heated exchange, one of the doctors grabbed the other by the neck and shoved him into a wall. He said the other doctor reacted by punching a window which shattered, injuring his hand.

Both doctors have been suspended, and four separate investigations are taking place over the incident which occurred at the Policlinico hospital in Messina last Thursday. One of the doctors involved and the hospital’s head of obstetrics have denied any link between the fight and the complications. However the woman’s husband, Matteo Molonia, said there had been no previous signs of complications. Health Minister Ferruccio Fazio visited Ms Salpietro in the hospital on Monday to apologise. "I tried to give her words of hope, and above all I tried to tell her that the government was with her and her family at this time," he said. ~ BBC News, Aug 30; Guardian, Aug 20

University of Minnesota bioethicist Carl Elliott has written a stinging article in Mother Jones magazine about how pharmaceutical companies allegedly abuse clinical trials to market their products. He has based it on the 2004 suicide of Dan Markingson, a 26-year-old man struggling with paranoid schizophrenia, while enrolled in a trial for anti-psychotics at the University of Minnesota.  

“The Nuremberg Code stipulates that an ‘experiment should be such as to yield fruitful results for the good of society,’ and ‘the degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.’ But what if a research study is not really aimed at producing genuine scientific knowledge at all? The documents emerging in litigation suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to ‘generate commercially attractive messages’?...  

“If these experts are right, then the study in which Dan Markingson committed suicide was not simply a matter of inadequate informed consent, or financial conflicts of interest, or even failure to monitor a subject’s care. The ethical breach was built into the study from the start. It is one thing to ask people to take risks for science, or the common good, or to help other people. It is another thing entirely to ask them to risk their lives for the marketing goals of AstraZeneca.”

It is a fascinating and challenging article – although it is one-sided and passionate, and suffused with the author’s “sting of shame” that his own university had apparently treated this patient and his mother so badly. ~ Mother Jones, Sept-Oct

Here’s something you probably don’t know about car safety. Developing better seat belts and airbags has always depended upon testing car crashes with cadavers. Ford, for instance, has been promoting the use of inflatable seat belts in its 2011 Explorer. “It’s still very important,” Priya Prasad, a former top safety researcher at Ford, told Wired magazine. “Even though we have very good math modeling of dummies, human modeling hasn’t reached that state yet.” The National Highway Traffic Safety Administration funds university tests on cadavers every year and many universities also receive grants from car manufacturers.

The researchers attempt to treat the cadavers with respect. Their heads are swaddled and their limbs are bound. Sensors record the forces exerted on various body parts. After a simulated crash, the corpses are X-rayed and autopsied. The universities are experienced in dealing with informed consent, so they ensure that the relatives of donors are informed and that the bodies will be disposed of appropriately.

The car companies would like to eliminate the need for cadaver tests. They use virtual modelling extensively because it is cheaper and raises few ethical issues.  But testing with real bodies is still necessary to capture how human tissue responds to catastrophic injuries. There are other needs as well. Cadaver tests are being used to design football helmets to decrease the danger of concussion and how to protect soldiers from traumatic brain injuries. ~ Wired, Aug 31

A small group of medical specialists has spoken out against euthanasia in the lead-up to a Quebec-wide conference on the controversial procedure, warning that past attempts at legislation in other countries have been failures. A provincial legislature committee is set to travel to 11 cities in Quebec to confer with the public on the controversial practice, in which terminal patients ask doctors to help them die.

The province’s Federation of Medical Specialists has given public support for government legislation on euthanasia for “exceptional circumstances”, saying that the procedure is already happening throughout Quebec. A small group of medical specialists based in Montreal, however, disagrees.

"I think that ultimately, we're going to go down a slippery slope, where eventually, what patients purport to want, which is autonomy of decision-making, will be lost," Paola Diadori, a pediatric neurologist at the St-Justine Hospital, said last week. "Patients need care. And we need to be responsible for providing the care that they need. I don't think that it's good medicine to have physicians end these people's lives. That's not caring for them. That's basically just getting rid of a person."

"What's going to happen is by euthanasia, we give doctors the power to kill," José Morais, a geriatrics specialist, added. "I think there are consequences to that. Patients would start thinking, or questioning the intentions of their doctors.” He added that proper palliative care can be a reasonable option for the terminally ill.

Doctors worry that the public is ill-informed. "It could work for a while, but then it will be trivialized, and that is the slippery slope," warned Dr Joseph Ayoub, a Montreal palliative care oncologist. "We've seen that happen in Holland." ~ CBC News, Aug 26

The 62nd Emmy Awards saw Al Pacino named outstanding lead actor in a miniseries or movie for his performance in the Jack Kevorkian TV movie biopic “You Don’t Know Jack”. As reported in BioEdge in April, the impossible has become possible – the HBO film has not only depicted the doctor responsible for well over a hundred mercy killings as a martyr but has been lauded for it as well. ~  San Francisco Chronicle, Aug 29; BioEdge, Apr 9

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.”