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Thursday, October 17, 2002

Welcome and Opening Remarks

CHAIRMAN KASS:  Well, welcome to Council members, guests, members of the public to this, the seventh meeting of the President's Council on Bioethics.

I note the presence of Dean Clancy, the designated federal officer whose presence makes this a legal meeting.

I would like to announce that we have at long last added a lawyer to our staff.  Carter Snead from Ropes & Gray will be joining us starting in two weeks.  He will be at the meeting tomorrow.  I will introduce him at that time.

I would also like to announce that we now have at headquarters a members' office so that should you find yourself in town and need a place to sit and work and also to interact with our lively staff, there is a special office set aside fully equipped for your use.

Our cloning report in final version has been produced by the Government Printing Office and Public Affairs has produced the commercial version, copies of which are at your seats.

We have discussions of the report set up in the months ahead, and I know others of you are talking to Diane about arranging things on your campuses.

There will be a book forum at the American Enterprise Institute on the 29th of this month; a session in Baltimore sponsored by the law school of the University of Maryland and Johns Hopkins University on the 21st of November; and there are conversations underway at Georgetown, Princeton, and Chicago for further meetings.

Our next meeting is December 12 and 13 where we will have what's definite for that meeting is a presentation on the use of Ritalin and other stimulants in children; a couple of presentations on aging and longevity research; and Francis Collins of the Human Genome Project will be talking about uses of genetic technologies and the prospects for enhancement.

I would also, since as everybody knows this Council is charged with the monitoring of stem cell research, I would at least like at this point to make a very brief presentation, an update on the subject of the monitoring.

As I think everybody knows, since August 9th of 2001, federal funding has been available for research on embryonic stem cells subject to the particular restrictions announced by the President at that time.  The implementation of that policy which has fallen to NIH has yielded the following information for us.

There is a registry of cell derivations that meet the original criteria and the NIH has identified – 78 cell derivations that meet the original criteria.

The NIH has reviewed 13 grant applications involving human embryonic stem cells at its May 2000 Advisory Council session and 19 grant applications for its October 2002 Advisory Council sessions, and continues to receive applications each receipt date.

The NIH has also made available infrastructure grants to help developers defray the costs of providing cell lines, administrative supplements to encourage expansion of existing projects to produce preliminary data of human cells, and investigator initiated grant awards.

And so far the NIH has granted seven, 37, and eight awards in these respective categories.

Also, six of the NIH intramural labs are conducting research on human embryonic stem cells, and cumulatively there are over 45 researchers representing over 40 different research institutions receiving federal funds for research on human embryonic stem cells.

The NIH has also finalized four material transfer agreements with the commercial companies that have developed these lines.  They are Y Cell, the ESL International, BresaGen, Inc., and the University of California, San Francisco, associated with Geron.

Data on how many of these lines are presently available to be shipped is, however, not easy to get.  At present three developers have lines available for shipment totaling five different cell lines.

Finally, I'd like to mention one recent development that I think is pertinent to our ongoing deliberations.  Since the last meeting, researchers at the National University of Singapore funded by ESL have announced the successful culture of human cells on human feeder cell lines.

This is a newly derived cell line, and therefore under current policy, federal funding could not be used to do research with it.  All of the lines that are in the NIH registry were supported on animal feeder cells so that should human trials be required, these cells would at least at the moment not be available for use under the xenotransplantation regulations.

This new development, I think, will probably be important for us as the pressure might mount for work on these new lines that are potentially usable in clinical trials.

That just by way of an update.  Staff is working ahead on the monitoring of stem cells, and after the beginning of next year, we will have more to do with that at our regular meetings.

Questions or comments on that?

(No response.)

CHAIRMAN KASS:  Well, the two sessions that we have planned for this morning are on the topic of choosing the sex of children, the discussion of current technology and practice, and then a look at the demographics.

Our interest in the topic of sex selection is in part a continuation of questions that we touched on in the cloning report, namely opportunities to select in advance some of the genetic traits of children.

It also represents at least in part a use of biomedical technologies not for therapy, but for the satisfaction of client or patient desires.

This is also an interesting case in which the aggregated effects of choices that might be innocent in themselves might produce results such that even the people who use the technique might be unhappy with the result as a result of its being used by everybody.

And it is also an interesting case for us because there are international implications of biomedical technology where techniques developed for one purpose and one use and one country, say, in the United States, will be used for other purposes and in different ways abroad with consequences that may, in fact, come back to have an influence here at home.

We're very pleased to have with us this morning Dr. Arthur "Cap" Haney, who is the Roy T. Parker PROF. of Obstetrics and Gynecology and Director of the Division of Reproductive Endocrinology and Infertility in the Department of Obstetrics and Gynecology at the Duke University Medical Center.

Dr. Haney is a past President of the American Society for Reproductive Medicine, a researcher, and a leading authority in this area, and I'm very delighted that you could be with us, and especially after all of the travels that were required to make it possible.

We're in your debt, and we look forward to your presentation.

Thank you.

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