Friday, March 7, 2003

CHAIRMAN KASS: Mr. Doerflinger, welcome back.

MR. DOERFLINGER: Thank you.

I found myself nodding in agreement with Dr. Annas until he said something nice about the British system. So I wanted to comment on that.

I've been involved in the debates about federal funding of IVF and embryo research for some 20 years. From my perspective, the reason why IVF remains one of the most under regulated industries in the nation is that proponents of regulation always started out by assuming that when you regulate it you have to use the British system. That is, in order to regulate, you have to fund.

In the British system it's all or nothing. There is no private sector in embryo research, and so either you ban it or you have the government actively support and sponsor and license it, which means that in order to regulate abuses, you have to first make a decision that we have a sufficient consensus to provide active government support for this.

Now, in the British system where socialized medicine is the norm, that's not necessarily taken as a moral decision, but in the United States because of our less socialized system, it is.

And there are a great many issues where the way in which our society has dealt with matters of moral ambivalence, matters where there is not sufficient consensus to ban but there is not sufficient consensus to give positive approval, is precisely to allow something to happen in the private sector, but not to fund it.

One might interpret our Supreme Court's decisions on abortion along those lines, that the Court said you cannot ban abortion, but that states and the federal government may use their funding power to express a preference for childbirth over abortion and actually to discourage abortion short of actually placing active barriers in its way.

Now, I think that system, though I disagree with the Supreme Court's decision about that in the context of abortion, that flexibility, shows respect for the pluralism of our society, where a lot of different things are in those gray areas-- either because they really are morally ambivalent, or because gray is what you get when you mix together ASRM's view of the embryo as important tissue and my view of the embryo.

That pluralism and that flexibility should not be lost. I think the reason why we don't have regulation now of IVF is that the insistence has been we have to give our positive approval relating to some of it in order to prevent the worst of it.

I don't think that works necessarily as a matter of practice, because it simply means that you give a baseline and then private funding is used to do all the stuff the federal government is too hesitant to provide funding for.

The private sector then moves back in and says, "why don't the federally funded researchers get with the program now that we've established the new baseline, and begin providing funding?"

I certainly don't think self-regulation is the answer. I think the ASRM ethics committee is an example of a group that is ethically actually willing to go beyond what many of its own members might be comfortable with. The chairman of the ASRM ethics committee, John Robertson, has written at length that people have a constitutional right to do reproductive cloning. I think that's not a widely held view among many. And when the Norfolk, Virginia IVF clinic announced it was creating embryos solely for research purposes, to the great consternation of many ethicists and members of Congress, the first announcement that came out in that report was that the ASRM found this to be consistent with its own ethics standards.

There has been a great deal of commentary in the bioethics literature about industry ethicists telling industry what it wants to hear, and that being the reason why they're hired in the first place.

So between the extremes of self-regulation left untrammeled, and the British system where there's no flexibility, no middle line between federal funding and implied federal approval versus complete ban, I hope this council can find its way to respect the intricacy of the American system and find a way to set restraints on some of the worst abuses in a way that people like me, for example, would not have to oppose because it involves actively approving some of it.

Thank you.

CHAIRMAN KASS: Michael Sandel, do you?

Mr. Doerflinger, would you come back? Mr. Sandel would like to ask a question.

PROF. SANDEL: Did I understand you correctly to suggest that you would favor or support a compromise that might regulate, federally regulate embryo research, even though you might oppose that research, provided it were not federally funded, or did I misunderstand?

MR. DOERFLINGER: Well, I think a federal regulation that said, for example -- and I don't know how you would have to find the federal jurisdiction to do this, perhaps through the interstate commerce clause -- a federal law that said -- well, there's a federal law proposed right now that has passed the House that says you may not do research involving cloning of embryos. That leaves the field of both privately and publicly funded research involving so-called spare embryos completely alone.

I consider that, from the total field of embryo research, that's a regulation. It's a law against one of the worst abuses that involves positively creating embryos for research, possibly in great numbers, and leaves the rest of the field alone.

Leaving the rest of the field alone is not by itself a mark of moral approval. It may just be a decision that there's no sufficient consensus to act against it.

And I'm something of a fan of Thomas Aquinas, who said there is a large area of moral wrong, that it may not be feasible or even appropriate to pass civil laws against.

So there are a lot of opportunities. The FDA is one model in which, by achieving a consensus on one particular area that goes beyond the societal consensus one is not necessarily approving, but only leaving for another day, things that go short of that.

Does that make sense?

CHAIRMAN KASS: I think the comment raises for us, I think, a difficulty that when we're at the point where we would want to offer recommendations we would have to face the various obstacles that George Annas alluded to, various parties on all sides who, on the one hand, don't want the kind of opening that would lead to certain curtailment and, on the other hand, don't want to pronounce with public blessings those things that they regard to be a moral problem we will have to grapple with.

Let me thank once again our guests. Let me thank members of the council for your loyalty and stalwart participation, members of the public for joining us. Safe travel and godspeed. We'll see you --

PROF. GEORGE: Could I just take one moment before we break to fulfill a promise to President Didier Sicard of the French Bioethics Council?

CHAIRMAN KASS: Please.

PROF. GEORGE: Yes. I was received very graciously representing the council and the United States at the 20th anniversary of the Comite Consultatif National d'Ethique, the French Bioethics Council. President Sicard asked me, in particular, to convey regards and compliments to Chairman Kass and to the council.

He and a number of other representatives who were there representing various nations from Japan to Luxembourg indicated that they had read with considerable interest our report on human cloning, and we were congratulated consistently by people for the thoroughness of the report and for its analytic rigor.

And people in particular noted that this was true across the range or spectrum of opinions represented on the report.

I did get the -- I hope I'm not deceiving myself -- but I did get the very clear sense that this was not simply polite talk or "politesse."

There was a certain amount of diplomatic nicety going on in other regards, I think, pertaining to my being there at this time as a representative of the United States, but with regard to the compliments that were paid to the cloning report, as I say, my impression was that they were very sincere.

So it really is a pleasure for me to fulfill this promise to President Sicard and to convey compliments and regards to the council and to Chairman Kass.

CHAIRMAN KASS: Thank you.

The meeting is adjourned.

(Whereupon, 12:06 p.m., the meeting in the above-entitled matter was adjourned.)