JIM LEHRER: Next tonight, new rules for stem cell research. Jeffrey Brown has that story.
JEFFREY BROWN: President Obama came into office vowing to lift his predecessor’s restrictions on stem cell research and what the government was willing to fund. In March, the president issued an executive order directing the National Institutes of Health to set guidelines.
Now the agency has spelled out those rules. They allow more embryonic stem cell lines, as they’re known, to become eligible for federal funding. But to qualify, those lines must be derived from human embryos that were approved for research use by donors and originally created for in vitro fertilization, or IVF, but were not used for that purpose.
To help walk us through what this all means, we’re joined by Susan Dentzer, editor of the journal Health Affairs and a health analyst for the NewsHour.
SUSAN DENTZER, Health Affairs, editor: Nice to be back, Jeff.
JEFFREY BROWN: So, first, to try to explain what’s going on here, the biggest change from President Bush to President Obama in general terms?
SUSAN DENTZER: In general terms, it is, as you said, the number of lines that will now be eligible for scientists to work on and work on it with federal dollars, taxpayer dollars. That’s on one level.
On another level, though, this is another symbolic push forward for the research. And that’s, I think, how it was greeted broadly by the scientific community yesterday and today.
JEFFREY BROWN: Now, part of the issue in coming up with these guidelines was determining how exactly a particular line is derived. Explain what that means.
SUSAN DENTZER: Exactly right. Well, in the executive order that the president issued in March, he said that we wanted to — NIH was going to be allowed to fund research on lines that were responsibly created and would basically result in scientific advancement. So these guidelines are all about deciding what’s responsibly created.
As the guidelines went on to say today, there’s some degree of societal consensus, not complete, but some degree of consensus around the notion that, if you were involved in an assisted reproductive technology, like IVF, and that embryo was created for the purposes of reproduction, and if for various reasons it wasn’t used — you got lucky on the first one, you didn’t need a second one, you decided not to proceed, whatever — those embryos stack up in fertility clinics, and there are hundreds of thousands of them.
There’s general consensus, the guidelines say, around taking those discarded embryos, in effect, using them to derive the embryonic stem cells and growing lines from those, whereas the NIH has gone on to say there’s not consensus around embryonic stem cell lines created by other means, for example, what’s known as somatic cell nuclear transfer, cloning, in effect.
Mandatory informed consent
JEFFREY BROWN: So you can't create the line for the research?
SUSAN DENTZER: Well, and that is furthermore not allowed not because of anything that NIH or any administration, but Congress has systematically every year passed something known as the Dickey amendment which forbids anybody from creating or destroying embryos with federal funding.
So even these guidelines don't allow a scientist to take federal tax dollars, go into the lab, and create a new stem cell line. What this does allow them to do is take a line that somebody else has already created and work on it with federal tax dollars, assuming that this line was created, again, through IVF, through very clear, informed consent of the donors who were donating the embryos and so on.
JEFFREY BROWN: Yes, explain the informed consent, because that's another key part in coming up with these guidelines, right?
SUSAN DENTZER: Yes, indeed. A value of these guidelines in the eyes of the scientific community is now there is a very clear roadmap for how an ethical line, in effect, will be created.
You have to basically present to the donors an informed consent document. You have to say, "This is what we're going to do with these embryos if you discard them. Research will be done on them. It may be the case that this will lead to scientific breakthroughs. It may be the case that somebody will make money off of these scientific breakthroughs."
All of that has to go to the donor in the form of a document, with one exception. There was a great deal of concern that some pre-existing embryonic stem cell lines were not put through this ethical sieve, in effect, but still might be able to be worked on.
For example, some of the original lines that even were authorized under the George Bush policy, so NIH has also created a separate avenue where you can go to a new working group and demonstrate your line and say...
JEFFREY BROWN: Your intent to get the consent or something?
SUSAN DENTZER: Well, was this somehow created in an ethical fashion under rules that applied very differently, say, 10 years ago? And the working group has the freedom to decide, yes, this is, in effect, an ethical line.
Implications for the future
JEFFREY BROWN: All right, so what are scientists saying is the practical impact here, in terms of the number of lines, in terms of research going forward?
SUSAN DENTZER: The practical impact is really just to open up to many, many more embryonic stem cell lines, many that were created in the intervening years outside of the federal funding process, others that may be created in the future. Lots of assisted reproductive technology is going on all the time.
And now if somebody really wants to sit down and create a line through discarded embryos, through IVF procedures and so on, again, there's a very, very clear roadmap, how to do it where it will just not be equivocal whether or not this line could be used in a federally funded context.
So that's considered to be the great advantage of this. It's now very, very clear what can get funded and what cannot.
JEFFREY BROWN: And in terms of who's happy and who's not, some researchers wanted to go further.
SUSAN DENTZER: Very much so. Many researchers wanted to be able to work on lines that were created through this other procedure, somatic cell nuclear transfer. They were not made happy.
Others wanted to be able to work on lines that were created through another procedure, pre-implantation genetic diagnosis. This is when you create an embryo ahead of time and then test it to see if it has genetic defects. Sometimes it does. People don't want to implant it. Some researchers wanted to be able to work on that. They got the ability to do that in these guidelines.
So there was a little bit of a give-and-take. In the end, nobody was completely happy on either side, but a lot of the scientists got what they wanted.
JEFFREY BROWN: But those opposed to the research from the beginning...
SUSAN DENTZER: ... remain very much opposed. The NIH received 49,000 comments on its draft guidelines from all parties, pro and con embryonic stem cell research. There were people who wanted in the informed consent document a clear indication that these embryos would be, quote, "destroyed." They were not satisfied by the guidelines. The guidelines, in fact, said, no, the documents don't have to say that.
So it remains clearly a very, very ethically contentious issue. And many in the right-to-life community and others opposed to embryonic research still are very unhappy about this.
JEFFREY BROWN: All right. Susan Dentzer, thanks again.
SUSAN DENTZER: Good to be with you, Jeff.