Therapeutic cloning: Researchers back bid to pay egg donors

The California scientists most likely to receive grants for making new cell lines were those who proposed comparing embryonic stem cell lines and induced pluripotent stem (iPS) cell lines, says Nature Reports Stem Cells in a piece dated 2 July (“What got funded: statistics on California’s new stem cell line grants”).

None of the grant applications submitted to the California Institute for Regenerative Medicine (CIRM) that sought to make lines using human eggs were funded, including three applications that proposed SCNT (somatic cell nuclear transfer), also known as therapeutic cloning. For SCNT applications, reviewers worried that researchers couldn’t get enough human eggs. (SCNT involves transferring the nucleus from an adult human cell into a human egg with the intent of creating stem cells from the resulting embryo. Such cells could potentially serve as a therapy genetically matched to the person who donated the adult cell.)

Somatic Cell Nuclear Transfer illustrated

On 11 June, Nature reported in an article (“Egg shortage hits race to clone human stem cells: Researchers back bid to pay donors”) that US stem cell researchers are calling for changes to state laws that prohibit compensating women who donate eggs for research. It took Kevin Eggan and Douglas Melton, of the Harvard University’s Stem Cell Institute, two years and US$100,000 in local advertising to secure a single egg donor for their attempt to develop embryonic stem cell lines to model diseases such as amyotrophic lateral sclerosis. Eggan says that although Harvard's highly publicised egg-donation programme received plenty of responses, many women decided against donating for research when they were informed that a fertility clinic would compensate them for the same procedure. Currently, laws in California and Massachusetts – two leader states in stem cell research – prohibit compensation for eggs. But with a shortage of available human eggs for research purposes, the issue remains a national sticking point to the progress of stem cell research and cloning science. (Time published an article dated 6 June 2006 titled “Why Harvard is Recruiting Egg Donors for Stem Cell Studies” which can be read here.)

The Scientist also took on this pressing issue when it reported on 27 March that the CIRM may be looking for ways to pay women for their eggs for stem cell research. The article (“CIRM to pay for eggs?”) says one idea that arose at a meeting of CIRM’s Standards Working Group on 28 February was to subsidise the cost of fertility treatment for women donating eggs, as is currently done in the UK. However, Eggan, a member of the CIRM standards group, told The Scientist that he doubts that CIRM can do much in its role as a regulatory agency within the existing legislation. He called on the US National Academy of Sciences (NAS) - which in 2005 recommended in its "Guidelines for Human Embryonic Stem Cell Research" that no payments should be provided for donating eggs, sperm, or blastocysts for research - to revisit the issue, stating that women should be compensated for providing eggs for stem cell research, just as they are for donating eggs to treat infertility and as they were in the early days of IVF research. "Clearly that's the expectation of these women for egg donation," he said. "Human research donors, which is what these women are, should be compensated for their time, their effort, and any duress they incur."

On 26 January 2006, The New England Journal of Medicine reported that Jonathan Moreno, the cochair of the National Academies committee and a professor of biomedical ethics at the University of Virginia, said in an interview that the NAS recommendations were justified by the sensitivity of egg donation for stem cell research and by uncertainties about the actual risk of severe complications in donors; but that John Robertson of the University of Texas School of Law at Austin (and currently chair of the Ethics Committee of the American Society for Reproductive Medicine) said the committee "made a political choice to get the field moving, not an ethical one grounded in sound analysis". Nature points out that Alta Charo, a lawyer and bioethicist at the University of Wisconsin Law School in Madison (and a member of the CIRM standards group), who liaised with the NAS committee that set the donor-compensation guidelines in 2005, says the move “was as much political as ethical”.

A Nature Special Report dated 10 August 2006, titled "Ethicists and biologists ponder the price of eggs", reveals that on 30 June 2006 the International Society for Stem Cell Research (ISSCR) task force released draft guidelines at its annual meeting in Toronto. The guidelines embrace most of the principles proposed by the National Academies in 2005. But differ on the issue of egg donation. The task force leaves the door open for a more liberal policy on compensation by stating simply that stem-cell research projects should be reviewed by a local oversight body, which must ensure "there are no undue inducements or other undue influences for the provision of human materials". What constitutes 'undue' is left to the local oversight bodies. (The ISSCR Guidelines for the Conduct of Human Embryonic Stem Cell Research can be read here.)

In respect of the UK, in July 2006 the Human Fertilisation and Embryology Authority (HFEA) granted the North-East England Stem Cell Institute (Nesci) - a collaboration between Durham and Newcastle universities - permission to recruit human egg donors; the donated eggs are being used in SCNT experiments to derive embryonic stem cell lines from patients with incurable diseases such as Parkinson's or Alzheimer's. Women donate eggs in return for cut-price in-vitro fertilisation treatment at the Newcastle Fertility Centre. The egg sharing programme has been criticised by opponents of embryonic stem cell research for creating disparity in the quality of care available to people who don’t have the money to undergo fertility treatments; but its supporters say it provides access to such treatments for more people. Alison Murdoch, who is leading the project at Nesci (and is a signatory to Declan’s petition to the UN on therapeutic cloning), said: "Nobody has done nuclear transfer and successfully made stem cell lines yet because of the difficulties of getting hold of human eggs." Nature Reports Stem Cells says Murdoch has so far collected more than 100 eggs.

As Declan and I have been sleeping in the same porch since 3 November 2006, despite that every night now we are under threat of arrest (see blog of 25 June “Police ‘No sleeping’ sign in the porch”), I probably sound too confident but I believe that our international campaign on therapeutic cloning and human embryonic stem cell research is in a unique position to call on the US National Academy of Sciences to revisit the issue of egg donation for research: the justification being that the NAS donor-compensation guidelines have a negative impact at an international level on progress in the field; and can be used by opponents to further restrict and prohibit this life-saving medical research – never mind the Centre for American Progress reporting on 16 July that “80 percent of the public wants medical researchers to have significant influence (39 percent “a great deal”/41 percent “a fair amount”) on stem cell research decisions”. My model for this letter will be a letter to the British Government dated 21 January published in The Times (“Stem cell research is vital and can save lives: The use of lawfully-obtained, anonymised cells must be permitted”), which was signed by almost 60 biomedical researchers and administrators, including four Nobel laureates (many of whom have also signed Declan’s petition).