Magnus: Do We Need More Guidelines?

"Too little, too late." That's what Stanford ethicist David Magnus has to say about the recommendations released last week concerning embryonic stem cell research.

The proposals came from the International Society for Stem Research. But Magnus asked, "Do we really need another set of guidelines."

Writing in the San Jose Mercury News, he said:

"The ISSCR group missed a real opportunity to address many new challenges that stem-cell researchers and oversight committees face -- challenges that have had little attention.

"All of the guidelines to date focus on bench research. But Menlo Park biotech company Geron has already announced that it intends to start clinical trials using differentiated embryonic stem cells for patients with acute spinal cord injury. Yet we have almost no guidance on how oversight committees should evaluate these trials or what should go into informed consent forms. Astonishingly, neither the NAS nor ISSCR has said anything about the right of subjects who may oppose stem-cell research to know that the cells placed in their bodies for research come from embryonic stem cells."

Magnus also said that the "one really novel stand" from the group concerned payment for eggs for research. He continued:

"The ISSCR group says local oversight committees should determine the appropriate policy: no payment, reimbursement of direct expenses, or substantial compensation for time and suffering. The problem with this recommendation is that it seems to fly in the face of virtually every law in place. The NAS guidelines call for a prohibition on payment of egg donors beyond direct expenses. Proposition 71 has a similar ban in place. Many other states and countries have made it unlawful to pay women more than a token amount or to pay anything beyond their direct expenses.

"Many researchers are worried that they will have a difficult time getting access to the eggs they need. But offering standards that cannot be followed by any of the major players in stem-cell research is a recipe for irrelevance."

The recommendations have been praised by John M. Simpson, stem cell project director for the Foundation for Taxpayer and Consumer Rights, who said:

"We are pleased the international guidelines stress public benefit and we will continue to insist that California's regulations provide affordable access to any discoveries or cures resulting from research funded by the state program. Too often stem cell advocates have hyped the immediate benefit of stem cell research. I'm delighted to see the call for realism. The Scientific Strategic Plan for the California Institute For Regenerative Medicine already reflects that realistic approach."

Reporter Terri Somers of the San Diego Union-Tribune quoted Larry Goldstein, an ESC researcher at UC San Diego and a member of ISSCR task force, as saying.

“Realizing that stem cell research is an international community, we have to be able to share cells and our scientific methods across borders with some confidence that we have been doing our work to some agreed-upon ethical standards.”

Stem Cells and 'Things that Go Bump in the Night'

What's going on with those CIRM scholars, those folks whose education is being assisted by the California stem cell agency?

Reporter Bradley J. Fikes of the North County Times in San Diego County wrote about 32 of them, including some from fields such as bioengineering, bioinformatics and chemistry. Among other things, Fikes said that ethical training occupies one-third of the curriculum in this particular program.

Fikes quoted Larry Goldstein, director of UC San Diego's stem cell program, as telling the scholars that they have an obligation to become missionaries – not Goldstein's word – for ESC research. Goldstein said:

"Some of you have been studying fish and flies and things that go bump in the night. It's not always obvious to the public how this relates to humans. For better or worse, the world is watching us, not just in San Diego, but in California."