Republished by the LSU Medical Reseach Law Project

DAY TWO: OPENING REMARKS

DR. SHAPIRO: I apologize for our late start because we have been trying to accumulate appropriate materials for our discussion this morning in a way that would enable it to proceed in some kind of orderly fashion. We have a number of things this morning that I'd like to touch base on before continuing. First of all, some of you may have noticed earlier this morning, Henrietta's with us and was, at least, sitting in the back. Henrietta, are you there?

MS. HENRIETTA D. HYATT KNORR: Yes.

DR. SHAPIRO: Yes. I really want to thank you very much for all the work you've done for NBAC, and we'll try to record in our minutes our great appreciation for all that you've done for us. So thank you very much, and thank you for being here today.

PRESIDENT CLINTON'S REQUEST RE: EMBRYONIC STEM CELLS

DR. SHAPIRO: Turning to our business this morning, I think we should allow an opportunity with respect to responding to the President's letter. We take on a set of issues where some of us may have conflicts regarding possible future regulations or other public policy issues involved. And so I think it's healthy for us to just go around the table and if we do feel that there are any conflicts that any of us may have in this area, we should simply put them on the table and we'll proceed from there. I don't think there's any significant problem, judging by the comments that were made yesterday. So now let's just go around the table and see what conflicts you may have. Bernie, you want to start?

DR. LO: I don't have any direct conflicts. (Unintelligible)

DR. SHAPIRO: Thank you. Rhetaugh?

DR. DUMAS: I have no conflicts.

DR. SHAPIRO: David?

DR. COX: Harold, I misunderstood your directive in terms of what we're conflicted about.

DR. SHAPIRO: Well, we are going to be giving advice over the next months, and indeed in the letter we might send today to the President, regarding public policy issues or issues that might affect something we're involved in. And it's a question of whether you think that gives you any conflicts or not.

DR. COX: I hear you. So with respect to this letter, I have no conflict. Except that I can sign it.

DR. SHAPIRO: We'll try to get along with that. Alta?

PROF. CHARO: Thank you. As I mentioned yesterday, I've had some involvement with the experiments at Wisconsin that were done by Jamie Thompson and published in Science. I spoke with Jamie before he began this research on the meaning of separating one cell from any form of Federal funding in order to make sure that he did not violate the ban. I did not serve on the IRB that reviewed Jamie's work, but I do serve on a university Bioethics Committee that looked at his work after it was completed on behalf of the university and that has made recommendations about licensing restrictions that should apply when his cells are made available to other researchers. And obviously, being at the university, it has economic implications for the University of Wisconsin if Jamie's patent is granted, but that does not affect me personally.

DR. SHAPIRO: Arturo?

DR. BRITO: I have no conflict.

PROF. BACKLAR: As far as I know I have no conflicts.

DR. CHILDRESS: I'm not aware of any conflicts.

DR. SHAPIRO: I don't believe I have any direct conflicts; however, as president of Princeton University, it's quite possible that there are members of the faculty and others who might have some interest in this area and may have some interest in the way public regulation works out in that respect. Tom?

DR. MURRAY: I have no conflicts on this that I'm aware of.

DR. GREIDER: I'm currently at Johns Hopkins University, where some of the work on the human embryonic stem cells was done, reported by John Gearhart in PNAS. And although I do not know John Gearhart, again, because I'm at Johns Hopkins University, that would be the only potential conflict.

DR. SHAPIRO: Eric?

DR. CASSELL: I have no conflict.

MS. KRAMER: No conflicts.

DR. SCOTT-JONES: I have no conflicts that I'm aware of.

DR. MIIKE: No conflict.

DR. SHAPIRO: Steve?

MR. HOLTZMAN: Less conflicts than you think. I'm a member of an industry organization where members of the industry are performing this kind of work, although my company is not. I'm co-chair of the committee of the industry organization that requested the President to ask NBAC to look into the issue. And in a former life I founded a company that did active work in this area, although I no longer have any interest in that company.

DR. SHAPIRO: Thank you, thank you all very much. Let me indicate what the business is before us. We will adjourn at noon today, or at least no later than noon, which gives us an awful lot to do this morning. I want to spend the bulk of the time on the Human Biological Materials Report, since we might be able to begin thinking about sending that out for public comment. However, we have a couple of issues left over from yesterday. We are currently typing out, or will distribute shortly, the recommendations from our Capacity Report that has been revised as we approved yesterday. As far as I know, there are no changes in that beyond what we approved yesterday, but we'll look at that in a few minutes; there might be some small changes we want to point out to you as we go through those. That will happen shortly. We then, of course, have the letter to the President, which is going through a draft right now, and we'll take a look at that and see where we are in that area. We may or may not be able to get that letter done today in the sense of reaching a satisfactory conclusion. If we do not, I will work on that letter in the next day or so and will communicate by fax as necessary, so we'll just have to see how that goes.