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[6/10/1997 - 7/21/1997] [Cloning]
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41052040
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[6/10/1997 - 7/21/1997] [Cloning]
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RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Donna I. Coleman ( CN=Donna I. Coleman/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME:10-JUN-1997. 16:10:39.00
SUBJECT: Phone Message from Angie
TO: Clifford J. Gabriel ( CN=Clifford J. Gabriel/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
CC: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
CC: Sybil Francis ( CN=Sybil Francis/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
CC: Lisa M. Duffey ( CN=Lisa M. Duffey/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Contact: AngieCompany: AESOP EnterprisePhone: (202) 675-4511FAX: Message: Terry Nipp would like to set up a
teleconference on cloning. Participants include Roger Wyse and Ron Phillips. Nipps office will call again with
possible date (probably 6/13) and time.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:10-JUN-1997 13:00:30.00
SUBJECT: Re: Cloning video
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
Thanks - can we borrow the video for awhile before you have to return it?
(a day or 2 at most)
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Daniel L. Goroff ( CN=Daniel L. Goroff/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME:10-JUN-1997 17:54:08.00
SUBJECT: nbec
TO: eemanuel ( eemanuel @ nih.gov @ inet [ UNKNOWN ])
READ:UNKNOWN
TEXT:
Hi Zeke,
Congratulations on a tough job well done with the Cloning Report! Yes, I
am over here at OSTP for a while.
You had mentioned trying to have a meal together in DC sometime. Let me
know what works. Best regards to all,
Danny Goroff
202-456-6003
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:11-JUN-1997 10:02:52.00
SUBJECT:
TO: [email protected] ( [email protected] [ UNKNOWN ])
READ:UNKNOWN
TEXT:
To fellow NBAC Commissioners,
I want to say thank you to everyone for such a tremendous effort on the
cloning report. I especially want to thank Harold--I have no idea ow you
could do all the work on the report and fulfill your Princeton
duties--amazing!
Having re-read the report I am confident in the next few weeks as people
digest the contents and substance the insights and conribution will really
shine.
Thanks again everyone.
Ezekiel J. Emanuel, M.D., Ph.D.
Dana-Farber Cancer Institute
Harvard Medical School
National Institutes of Health
(617) 632-2267--Boston
(773) 327-1763--Chicago
(301) 496-2429--Bethesda
(617) 632-2270 fax
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Holly L. Gwin ( CN=Holly L. Gwin/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME: 09:10:00.00
SUBJECT: Re: today's analysis
TO: rnishimi ( rnishimi @ gwvi.gov [ UNKNOWN ])
READ:UNKNOWN
TEXT:
hmm, I like that way of thinking. BTW, I have scammed you a copy of
cloning that may become very valuable because it's print quality
identifies it as one of the first 2 books off the production line. I'll
bring it tonight; I'm also bringing a book I got for you to take to HI
and then stupidly left on the table at home when I came in Memorial Day.
rnishimi @ gwvi.gov
06/11/97 11:48:00 AM
Record Type: Record
To: hgwin
cc:
Subject: today's analysis
You and POTUS are the only humans on the face of the earth to have been
present at the release of reports from his Committee/Commissions on the
subject matter circles that we all generally move about in!! Seems pretty
clear to me that the conclusion here is stick with Gwin to travel in the
company of the leader of the free world.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:11-JUN-1997 11:17:57.00
SUBJECT: Web activity on cloning
TO: Jeffrey M. Smith ( CN=Jeffrey M. Smith/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Check this out - one group is already running with the issue.
http://www.all.org/cloning.htm
Skip Stiles
Democratic Legislative Director
House Committee on Science
822 OHOB
Washington, DC 20515
(202) 225-8483
(202) 2260983 (fax)
committee home page - http://www.house.gov/science_democrats/
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:11-JUN-1997 10:47:01.00
SUBJECT: Re: Cloning Event
TO: Jonathan Foster ( CN=Jonathan Foster/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
ok thanks
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN ])
CREATION DATE/TIME:11-JUN-1997. 10:22:22.00
SUBJECT: Re: the president's legislation
TO: [email protected] ( [email protected] [ UNKNOWN 1)
READ:UNKNOWN
TEXT:
>I also thought that Carol, who was upset by the slip in the original
>title of my draft bill, would be really delighted to see this called the
>Cloning Prohibition Act!!
>
>Alex
>
You guessed right alex, after I saw the title of clinton's bill i thought
yours was wonderful in comparison.
Perhaps this title might change if we asked nicely?
:)
Carol
Carol Greider, Ph.D.
Cold Spring Harbor Laboratory
P.O. Box 100
Cold Spring Harbor, NY 11724
Phone: (516) 367-8808
Fax: (516) 367-8815
E-mail: [email protected]
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN ])
CREATION DATE/TIME:11-JUN-1997 15:29:54.00
SUBJECT: Tip o' the hat
TO: [email protected] [email protected] [ UNKNOWN ])
READ:UNKNOWN
TEXT:
I concur with Zeke (with special awe at Harold's editing and Kathi's
manifold labors), and I agree we will get some praise for the way the
material is laid out even if more time would have "been our ally" on the
writing end. I hope we are also prepared for more criticism, esp. from
the right-to-life end, but also, judging from the comments by Annas et al
from the bioethicists who think we weren't sufficiently "ethical."
I also hope that the security of now having a "long life" ahead of us
means that, with similar guarantees of stable (and more generous?) funding
(doesn't someone owe us to replace the funds used on cloning report--even
if they can't replace the hours of wear and tear--so we can complete the
rest of this year's mandate?) will mean that the necessary staff can be
hired promptly to make sure that future reports are less hectic and
burdensome both for the commissioners and for our over-worked existing
employees.
Alex
On Wed, 11 Jun 1997, Ezekiel Emanuel wrote:
> To fellow NBAC Commissioners,
>
>
I want to say thank you to everyone for such a tremendous effort
on the > cloning report. I especially want to thank Harold--I have no
idea ow you
> could do all the work on the report and fulfill your Princeton
> duties--amazing!
V
V
Having re-read the report I am confident in the next few weeks
as people > digest the contents and substance the insights and conribution
will really > shine.
>
V
Thanks again everyone.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ([email protected] [ UNKNOWN )
CREATION DATE/TIME:11-JUN-1997 11:07:29.00
SUBJECT: CLONING
TO: Jeffrey M. Smith ( CN=Jeffrey M. Smith/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Jeff,
We are working on the issue up here and I wanted to pass on a few items.
First, your west wing conversation has prompted a series of phone calls
to us from the leg staff trying to figure out what is going on and
whether George Brown will cosponsor the bill! Good Work.
A read of the bill shows that it probably will not even come to our
committee. It looks like a Commerce and Judiciary bill in the House
(the latter due to the penalties). You might want to think about
sponsors on those committees as well.
But the issue of sponsorship gets complicated by the right to life issue
- if I am Phyllis Schlafley, I want this bill to move. First, there is
nothing now putting a ceiling on the private sector - without this bill
they can do anything they want. So, I want to move the bill but (Second
reason) I want to define what it means to "create a human being" as
mentioned in Section 5. The chance to define the moment of creation is
too good to pass up. Also, I do not want the private sector to be able
to create humanoids without the "intent of transfer to the human womb or
create a human being" (again section 5) - something that would be
allowed under this bill. (A paranoid right-to-lifer can envision
biotech companies growing human embryos in culture and allowing them to
develop to the point that they can be harvested for their pre/neonatal
cells to be used in human therapies. This would be allowed under this
bill - since the bill deals with somatic cell transfer and involves an
intent to create a human being. So if I am the paranoid person above, I
start messing with this bill to stop that.) Anyway, if these folks get
fully engaged, you lose some Democrats (Dingell comes to mind) who are
sensitive on these issues.
But, we need to probe this a little farther. First, we are discussing
how and whether to raise these issues at our hearing tomorrow on the
issue. We may want to start flagging these points for people - or we
may want to just stay away from them, I don't know at this point.
Second, we are not sure whether Morella wants to move the Ehlers bill
along and whether anyone has an idea of how it plays after we move the
Ehlers bill (which is a federal funding ban) or what Ehlers wants to do
to broaden his bill (he has mentioned in the press that he may want a
wider ban to include the private sector).
I am meeting with a biotech person in a few minutes to get some
intelligence from the private sector. The university folks need to be
felt out on this as well.
Anyway, this is a very complicated issue and needs some thought and
discussion before we move forward to introduction. We need to figure
our way back from the end game and try to guess what the opposition
might do. Lets share some ideas tomorrow morning.
Skip Stiles
Democratic Legislative Director
House Committee on Science
822 OHOB
Washington, DC 20515
(202) 225-8483
(202) 2260983 (fax)
committee home page - http://www.house.gov/science_democrats/
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:11-JUN-1997 15:31:26.00
SUBJECT: Re: the president's legislation
TO: [email protected] [email protected] [ UNKNOWN )
READ:UNKNOWN
TEXT:
On Wed, 11 Jun 1997, Carol Greider at Cold Spring Harbor Laboratory wrote:
>
>>[ also thought that Carol, who was upset by the slip in the original
> >title of my draft bill, would be really delighted to see this called
the > >Cloning Prohibition Act!!
»>
> >Alex
> >
>
>
> You guessed right alex, after I saw the title of clinton's bill i
thought > yours was wonderful in comparison.
>
> Perhaps this title might change if we asked nicely?
> :)
>
> Carol
Once the White House has lined up sponsors for the Bill, we can work with
them to get amendments considered. If we know early enough who that is,
the modifications might be made in the language before it is introduced;
more likely, we'll have to try to get the sponsors to put forward
amendments in the mark up process in the committee. Some people on the
hill think that this is an attractive "hot button" issue for some
conservatives, so the legislative process may move quickly; others note
that Congress is tied in knots over bigger issues, this issue may get
stalled. Of course, Im hoping for the latter!
Alex
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP. [ OSTP ])
CREATION DATE/TIME:11-JUN-1997 16:28:08.00
SUBJECT: Thanks and a request: Re: VP Excerpted Remarks during Science and Math Presidential Awards
TO: Roger V. Salazar ( CN=Roger V. Salazar/O=OVP @ OVP [ UNKNOWN ])
READ:UNKNOWN
TEXT:
Thanks! Dr. Gibbons is also interested in obtaining a copy of the VP
remarks at the NBAC Cloning Event on June 9 - is it possible for you to
email me that? Thanks in advance. Susie Bachtel
P.S. it just occurred to me - if you have an email listserve for VP
releases may I be added? [email protected]
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Timothy L. Newell ( CN=Timothy L. Newell/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:11-JUN-1997 12:41:36.00
SUBJECT: Another request for Cloning Report
TO: Jeffrey M. Smith ( CN=Jeffrey M. Smith/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
This looks like your bailiwick
Forwarded by Timothy L. Newell/OSTP/EOP on 06/11/97
12:41 PM
Kevin S. Moran
06/11/97 10:41:30 AM
Record Type: Record
To: Timothy L. Newell/OSTP/EOP
cc:
Subject: Another request for Cloning Report
Tim We are getting requests for on-line versions of the cloning
report. Is that something that your office has available for us to put on
the web?
Forwarded by Kevin S. Moran/WHO/EOP on 06/11/97
10:41 AM
WEBMASTER @ Al
06/11/97 10:09:00 AM
Record Type: Record
To: Kevin Moran, Lori Anderson
cc:
Subject: Another request for Cloning Report
ATTACHMENT 1
ATT CREATION TIME/DATE: 0 00:00:00.00
TEXT:
From: [email protected]@INET@EOPMRX@LNGTWY
*To: webmaster@A1@CD@LNGTWY
Date: 6/9/97 11:56am
Subject: White House WWW Comments
[Connection Information]
CLIENT:
EXPRESS.SSCTR.BCM.TMC.EDU[128.249.27.60]
BROWSER:
Lynx/2.7 libwww-FM/2.14
URL:
http://www.whitehouse.gov/WH/html/briefroom-plain.html
[Sender Information]
PERSONAL-NAME:
David
EMAIL-ADDRESS:
[email protected]
ORGANIZATION:
RELATIONSHIP:
[Message Information]
PURPOSE:
Suggest an improvement
TOPIC:
Content
AFFILIATION:
Private Citizen
SUBJECT:
Cloning report
[Message]
Would it be possible to make available on this website the
full text of the cloning report? I understand that it's about
100 pages or so, but, still, it would be nice to have it
available in HTML format. Thanks.
END ATTACHMENT 1
ATTACHMENT 2
ATT CREATION TIME/DATE: 0 00:00:00.00
TEXT:
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Errors-to: The Postmaster <[email protected]>
Keywords: WWW-Correspondence; ; Suggest an improvement; Content; Private
Citizen;
Comments: Forwarded from White House WWW
END ATTACHMENT 2
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:13-JUN-1997 11:23:30.00
SUBJECT: Re: [XOTA:409] OTA Reports Available
TO: kirsi ( kirsi @ worldnet.att.net [ UNKNOWN ])
READ:UNKNOWN
CC: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP @ EOP [ OSTP ] )
READ:UNKNOWN
CC: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Dear Kirsten: Rachel Levinson, OSTP's Assistant Director for Health/Life
Science, is desperately seeking hard copies of the Biotech Report Series -
papers 1-5, esp. Public attitudes toward biotech, Ownership of tissues and
cells, etc. Would be a big help to us - she is our point person on the
National Bioethics Advisory Commission that overlaps with these issues.
Thanks a million. Let me know. Susie Bachtel (202) 456-7116. (am sure
we can arrange to pick them up to save you cost of mailing - or we can
reimburse you)
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:13-JUN-1997 11:02:01.00
SUBJECT: Re: Denver Communique
TO: Laura L. Efros ( CN=Laura L. Efros/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Looking at this morning I realized that it still has problems, such as the
title. Just called Elizabeths and we would rppose something along the
lines of new cloning technology and adding genetic to replication of human
individuals. And correcting the typo on "closing"!
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] [email protected] [ UNKNOWN )
CREATION DATE/TIME:13-JUN-1997 15:22:46.00
SUBJECT: proposed federal legislation
TO: [email protected] [email protected] UNKNOWN )
READ:UNKNOWN
TEXT:
A few comments on the proposed legislation
I agree with Alta and others who pointed out that (deliberately or not?)
section 3(a) leaves open the interpretation that cloning embryos for
research would be covered by the phrase "create a human being". From
the Commission's standpoint, we made it clear that we were addressing
only live births, so I would favor changing the language to something
like: "to prohibit any attempt using somatic cell nuclear transfer
cloning to create a child." This would be consistent with the language
we use in the report, and in my mind, is sufficient to distinguish
"child" from "embryo."
Section 4(c), definition of "somatic cell nuclear transfer": in the
report, on page one of the Executive Summary, we define this as "using
nuclei derived from somatic cells other than those of an embryo or
fetus" (which I like; I had concerns at the last meeting to include
embryo and fetal-derived cells in the definition, but decided not to
prolong the discussion on that point). Should we recommend using the
report's definition? Are we prepared to deal with the implications of
using one definition versus the other?
Section 5: language on "or in any other way creating a human being." I
recommend either deleting this phrase, or changing "human being" to
"child," for the same reason as stated above.
Section 6(1): I would replace "the use of somatic cell nuclear transfer
or other cloning technologies" with "cloning technologies". This would
match the definition of "cloning" in section 4(a). So the revised
section would read: "(1) cloning of molecules, DNA, cells, and tissues;"
The next sentence would be unchanged.
larry
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Jeffrey M. Smith ( CN=Jeffrey M. Smith/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME:13-JUN-1997. 09:08:30.00
SUBJECT: Cloning legislation
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
Rachel -- would you be good enough to send JHG (with a cc to me) a
nutshell description of the 6/12 Morella hearing, what might be
anticipated at the upcoming Frist hearing , and the legislative outlook
for the days ahead? He may be meeting with press next week and should be
kept informed so he can be responsive to any questions. Or, if you
prefer, tell me, and I'll knock out a paragraph or two. Thanks.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Laura L. Efros ( CN=Laura L. Efros/OU=OSTP/O=EOP [ OSTP )
CREATION DATE/TIME:13-JUN-1997. 10:13:11.00
SUBJECT: Denver Communique
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Rachel,
Have you seen the cloning paragraph for the Denver Summit? It's at the
end of this message.
Laura
Forwarded by Laura L. Efros/OSTP/EOP on 06/13/97
10:12 AM
Sherman G. Boone
06/13/97 09:25:24 AM
Record Type: Record
To: Elizabeth Drye/OPD/EOP, dhohman @ os.dhhs.gov @ INET @ LNGTWY, Laura
L. Efros/OSTP/EOP
cc:
Subject: Denver Communique
Proposed re-writes for Denver Communique. Please let me know IMMEDIATELY
if you have any problems with these paragrpahs. Thanks.
Infectious Diseases
26. Infectious diseases, including childhood pneumonia, diarrhea,
tuberculosis, malaria, and HIV/AIDS are responsible for a third of all
deaths in the world. They pose significant challenges to the health,
security and financial resources of the global community. In many parts
of the world, infectious diseases and deaths from infectious disease have
risen sharply in the last decade for a variety of reasons, including the
emergence of drug-resistant microbes and the increased movement of people
and products. In the coming year, our governments will promote more
effective coordination of international responses to outbreaks; promote
development of a global surveillance network, building upon existing
national and regional surveillance systems; and help to build public
health capacity to prevent, detect and control infectious diseases
globally. Central to this work will be strengthening and linking existing
activities in and among each of our countries, in other fora, and through
the World Health Organization.
28. Preventing the transmission of HIV infection and the development of
AIDS is an urgent global public health imperative. While other prevention
and treatment methods must be pursued, in the long term the development
of safe and effective vaccines against AIDS holds the best chance of
limiting, and eventually eliminating, the threat of this disease. We will
work to provide the resources necessary to accelerate AIDS vaccine
research, and together will enhance international scientific cooperation
and collaboration. Cooperation among scientists and governments in the
developed and developing world and international agencies will be
critical. We call on other states to join us in this endeavor.
29. The Joint United Nations Program on HIV/AIDS (UNAIDS) must help
expand the scale and quality of the response to HIV/AIDS. As a group and
with others, we will work to assure that it has resources adequate to
fulfill its mandate.
Reproductive Human Cloning
39. We have taken note of recent successful cloning of an adult sheep,
which could open the way to the use of closing for the replication of
human individuals While recognizing the considerable benefits for basic
research, agriculture and human health from cloning technology, we regard
the deliberate cloning of human beings as ethically unacceptable. We are
encouraged by the serious attention being given to the ethical
implications of this technology by both national and international
bodies. This will enable a measured approach to the debate on which uses
of this technique are, and which are not, unacceptable. We support
international cooperation to enforce common aspects of national policies
on the use of cloning to create human beings.
RECORD TYPE: PRESIDENTIAL (NOTES MAIL)
CREATOR: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME:13-JUN-1997 09:39:12.00
SUBJECT: Re: Sorry, but could you put your clips request in writing?
TO: Teresa Wildman ( CN=Teresa Wildman/OU=WHO/O=EOP @ EOP [ WHO ])
READ:UNKNOWN
CC: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
Teresa - any feedback yet? I had to scrounge fast last weekend for a clip
from the NYT that the POTUS wanted that day for the cloning event. We
would appreciate starting the weekend clips/WH magazine asap. With much
appreciation! Sue
Forwarded by Susanne Bachtel/OSTP/EOP on 06/13/97
09:37 AM
Susanne Bachtel
06/06/97 01:09:53 PM
Record Type: Record
To:
Teresa Wildman/WHO/EOP
cc:
Jodie R. Torkelson/WHO/EOP
Subject:
Re: Sorry, but could you put your clips request in
writing?
Dear Teresa: Thanks for your note. Sorry for the delay in response; I
was awaiting some feedback from one of our staff.
This is Dr. Gibbons's request:
1. Cancel the WH daily clips addressed to Ernie Moniz
2. Change the WH daily clips addressed to Tim Newell -
readdress them to Dr. Gibbons - send to
Dr. Gibbons's office - Room 424 OEOB (Dr.
Gibbons's office)
3. Add WH weekend clips - address to Dr. Gibbons - send
to Room 424 OEOB
4. Add WH magazine clips - address to Dr. Gibbons - send
to Room 424 OEOB
Many thanks, Susie
Bachtel, Ext 6-7116
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN ])
CREATION DATE/TIME:16-JUN-1997 10:50:40.00
SUBJECT:
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Thank you so much for finding the time in your busy schedule to meet with
my students on Friday. They very much appreciated the chance to talk to a
"real person" who is involved with the cloning issues and other
biological issues. They asked me to ask you whether there are
internships possibilities working with your office since most of them are
biology majors and some are interested in medical careers -- but not
simply as doctors. They are all deeply interested in issues of science
and society, and they are eager to learn.
Perhaps your schedule will become less hectic and you and I might meet at
some point. I am in and out of town this summer, serving as "science
advisor" for Congressman Matt Salmon, then will be here most of the
fall and next spring. My job is to increase communication between
Washington and Arizona State, and I could learn a lot from you -- if you
have time at some point.
Thanks again. Jane Maienschein
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:16-JUN-1997. 08:50:37.00
SUBJECT: Re: [XOTA:409] OTA Reports Available
TO: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Am not sure I have any of the biotech reports but will check and let you
know
Kirsten
At 15:27 13-6-97 +0000, you wrote:
> > > > > > > > > > > > > >
>Susanne Bachtel
>06/13/97 11:27:23 AM
Record Type: Record
To: kirsi @ worldnet.att.net
cc: Rachel E. Levinson/OSTP/EOP, Susanne Bachtel/OSTP/EOP
> > > >
Subject: Re: [XOTA:409] OTA Reports Available
Dear Kirsten: Rachel Levinson, OSTP's Assistant Director for
>Health/Life Science, is desperately seeking hard copies of the Biotech
>Report Series - papers 1-5, esp. Public attitudes toward biotech,
Ownership
>of tissues and cells, etc. Would be a big help to us - she is our point
>person on the National Bioethics Advisory Commission that overlaps with
>these issues. Thanks a million. Let me know. Susie Bachtel (202) 456-
>7116. (am sure we can arrange to pick them up to save you cost of mailing
>- or we can reimburse you)
>
>
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME:16-JUN-1997 16:13:18.00
SUBJECT: see text
TO: Jeffrey M. Smith ( CN=Jeffrey M. Smith/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
The following is on h:\lifesci\cloning.tec
On June 12, Rep. Morella (R-MD) chaired a hearing of the House Technology
Subcommittee to review the recommendations of the National Bioethics
Advisory Commission regarding cloning of human beings. The Commission
concluded that &at this time, it is morally unacceptable for anyone in
the public or private sector, whether in a research or clinical setting,
to attempt to create a child using somatic cell nuclear transfer
cloning,8 the technology used in Scotland to create Dolly the sheep.
Members of Congressional supported the Commission,s conclusion and
recommendation to enact federal legislation to enforce the existing ban on
the use of federal funds for cloning human beings. However, some, Reps.
Sensenbrenner and Ehlers, in particular were critical of the proposal that
such legislation sunset after a period of time in which the ethical and
scientific issues more thoroughly explored. The Administration,s bill,
introduced on June 7, the day NBAC,s report was released, tracks closely
the Commission,s recommendations, including the sunset provision. The
Administration proposed NBAC would complete a status report and review of
the ethical and scientific implications six months prior to a five-year
sunset. Even some who oppose on ethical grounds the creation of children
via somatic cell nuclear cloning endorse a sunset because new benefits may
alter the equation in the intervening years.
When asked his view of the procedures that would or would not be captured
in the definitions of the Administration bill, Dr. Harold Varmus indicated
his satisfaction with the bill language. In supporting a sunset clause,
he noted that future advances in science might restricted and justify
revising the legislation.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:16-JUN-1997 10:14:00.00
SUBJECT: Re: [XOTA:409] OTA Reports Available
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
FYI re the OTA reports.
Forwarded by Susanne Bachtel/OSTP/EOP on 06/16/97
10:13 AM
kirsi @ worldnet.att.net
06/16/97 08:45:13 AM
Record Type: Record
To: sbachtel
cc:
Subject: Re: [XOTA:409] OTA Reports Available
Am not sure I have any of the biotech reports but will check and let you
know
Kirsten
At 15:27 13-6-97 +0000, you wrote:
ДДЛЛЛЛЛД
V V V V V V V V V V V V V V V
>Susanne Bachtel
>06/13/97 11:27:23 AM
VVVVVVVVV
Record Type: Record
To: kirsi @ worldnet.att.net
cc: Rachel E. Levinson/OSTP/EOP, Susanne Bachtel/OSTP/EOP
>
Subject: Re: [XOTA:409] OTA Reports Available
>
>
>
Dear Kirsten: Rachel Levinson, OSTP's Assistant Director for
>Health/Life Science, is desperately seeking hard copies of the Biotech
>Report Series - papers 1-5, esp. Public attitudes toward biotech,
Ownership
>of tissues and cells, etc. Would be a big help to us - she is our point
>person on the National Bioethics Advisory Commission that overlaps with
>these issues. Thanks a million. Let me know. Susie Bachtel (202) 456-
>7116. (am sure we can arrange to pick them up to save you cost of mailing
>- or we can reimburse you)
>
>
>
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Audrey J. Lee ( CN=Audrey J. Lee/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:16-JUN-1997 11:24:40.00
SUBJECT: cloning
I've finished the background summary for cloning and will begin work on the background summary for global-scale
issues.
Audrey
TO: David Heyman ( CN=David Heyman/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Sarah S. Knight ( CN=Sarah S. Knight/OU=WHO/O=EOP [ UNKNOWN 1)
CREATION DATE/TIME:16-JUN-1997 16:12:57.00
SUBJECT: Cloning
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
Rachel,
Can you help me update the Cloning form letter? Thanks. Sarah x65514
This is what we had before:
Cloning form letter
Thank you for writing to me regarding the issue of cloning. I
appreciate knowing your views on this matter.
The recently reported breakthrough in animal cloning brings with
it both promise and concern. That is why I asked our National
Bioethics Advisory Commission, headed by Princeton University
President Harold Shapiro, to conduct a thorough review of the legal
and ethical issues raised by this new cloning technology and to
recommend possible actions to prevent abuse of the technology. I look
forward to receiving the Commission's report.
On March 4, I issued a directive that bans the use of any federal
funds toward cloning human beings or research related to cloning of
humans. I also strongly urged the private sector to follow suit with
a self-imposed moratorium on human cloning research, ensuring that, as
the scientific community continues its work, we will carefully weigh
the concerns of faith, family, philosophy, and values, and not merely
those of science alone.
I appreciate your interest in this important issue.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Laura L. Efros ( CN=Laura L. Efros/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:17-JUN-1997 17:59:31.00
SUBJECT: more Denver Summit stuff
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Rachel,
I just received a copy of a fact sheet on cloning for the Denver Summit.
I assume you've seen it. (I imagine you probably wrote it.) If not, do
you need a copy?
We also just received a request through the NSC system for Q&A's for the
President's press conference on Sunday. They are due by noon tomorrow.
Let me know if you want me to send anything down with the EID stuff.
Laura
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:17-JUN-1997 21:46:54.00
SUBJECT: Re: Sheri Alpert and genetic privacy
TO: [email protected] [email protected] [ UNKNOWN ])
READ:UNKNOWN
TEXT:
OK I'll bite:
And I agree with alex/larry/steve that genetic information not a distinct
species of information.
I will need to look at Sheri Alpert's proposed paper again in more detail.
But it seemed to me to be mostly a theroetical treatment of genetic
privacy in general, rather than specific to the stored tissue issue. I
think i'd need to be reminded of the papers that we have already asked for
to understand where this one fits.
Didnt we say we would like to see an analysis of the various positions and
aurguments regarding stored sampels that are already out there in the
literature? did we get someone to do this?
Is Sheri's proposed paper covering an area we had set out to cover? or
should we ask her to focus on one of those area specifically where we felt
we needed more info? Sorry I do not have the list of papers to commissions
that we decided earlier at hand here at home.
Carol
PS Steve- sure I'll talk about cloning with you. what is there left to say?
Carol Greider, Ph.D.
Cold Spring Harbor Laboratory
P.O. Box 100
Cold Spring Harbor, NY 11724
Phone: (516) 367-8808
Fax: (516) 367-8815
E-mail: [email protected]
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN ])
CREATION DATE/TIME:17-JUN-1997. 21:35:10.00
SUBJECT: the cloning report and the Web site
TO: [email protected] ( [email protected] [ UNKNOWN ])
READ:UNKNOWN
TEXT:
Hi everyone,
I appreciate that others, like me, are just now digging out from under the
piles of paper that accumulated during the Dolly days (Dolly daze?).
But I would really appreciate it if the Cloning report were on the web. I
have told many people that it would be up by the end of last week, and
they keep bugging me about it.
thanks very much.
:)
Carol
Carol Greider, Ph.D.
Cold Spring Harbor Laboratory
P.O. Box 100
Cold Spring Harbor, NY 11724
Phone: (516) 367-8808
Fax: (516) 367-8815
E-mail: [email protected]
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Audrey J. Lee ( CN=Audrey J. Lee/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME:17-JUN-1997 09:20:28.00
SUBJECT: Cloning Issue
I am working with Dave Heyman on providing background information on the cloning issue for the Carnegie Meeting.
I was wondering if you have any information on Congressional action/debate on this subject since March. If so, please
let me know, and I can come to pick it up.
Thank you,
Audrey Lee
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ([email protected] [ UNKNOWN 1)
CREATION DATE/TIME:17-JUN-1997 21:25:02.00
SUBJECT: Re: Sheri Alpert and genetic privacy
TO: [email protected] [email protected] [ UNKNOWN ])
READ:UNKNOWN
TEXT:
agree with alex/larry, re: genetic info not a distinct species of
information. also agree with larry that issue of stored samples,
particularly those collected in routine pathological procedures (which
will consititute the "future stored tissue samples), if driven by setting
public benefit vs. other interests of which privacy is but one which
then leads into the kind of analysis alex embarks on in the latter half of
his memo.
anyone want to talk about cloning?
-steveAt 02:32 PM 6/17/97 1000, you wrote:
>Tom Murray wrote:
Dear colleagues,
» This is directed especially to the members of the Genetics Subcommittee,
but
» I welcome comments from all commissioners. Sheri Alpert has been
detailed
» to the Commission from another federal agency until
September.
She
is
most
» knowledgeable about public policy with respect
to privacy. In speaking
with
» her about what she could do to help the Genetics Subcommittee, we
agreed » that a background paper on aspects of genetic privacy would be
useful
What
» follows is her brief description of the proposed paper. I
would appreciate
»
your comments on her proposal.
» Tom
» (from Sheri Alpert):
» Privacy interests in genetic information
»
V
V
I propose to look at some of the various privacy interests at
stake
» in personal genetic information. As articulated by various court
decisions,
» the judiciary has generally recognized three separate privacy
interests -
» autonomy, freedom from intrusion, and informational privacy. I would
»
propose to start with that framework, expanding the interests
implicated as
» need be. For instance, to capture the notion of "being wronged" (as a
negative privacy interest), I would probably expand the framework to
include
» issues of justice. (To a large extent, the justice and autonomy
interests
are where issues of "group privacy" will arise.) Within each of the
» interests articulated, I will also describe the practical mechanisms
used to
mitigate possible infringements on these interests (e.g., informed
consent
addresses some of the autonomy interests; "fair information practices"
»
address some of the informational privacy interests; etc.), as well as
some
»
of the public policy mechanisms currently in place to implement
them (e.g., » 45 CFR 46). Whether these mechanisms and policies are
adequate for genetic
information is the key set of public policy issues. (Whether that is
something I explicitly address in the paper, or defer on, is up to you,
although that evaluation could be very useful.)
>
>
What this means for the paper I would do for the NBAC is that I
will start with a broad overview of the privacy interests in genetic
»
information generally, and move that discussion into the contextual
setting
»
of stored tissue samples. Depending on the time necessary to
complete the » analysis, it might also be useful to look at an
organization that is in the
»
process of considering how to address the
privacy interests in a tissue
»
banking context. For instance, I could
approach officials at the National
»
Center for Health Statistics (the agency which administers the NHANES
»
surveys). NCHS is currently in the process of designing NHANES-4, and
is
»
explicitly considering the privacy issues at stake in the collection
and
»
storage of tissue samples, particularly for future genetic analysis.
(There
» are also NIH institutes or other CDC components that could be
approached, » although their tissue storage efforts are probably not as
broad in scope
and
coverage as NHANES.)
V
V
It is also important to recognize that many of the privacy
interests at stake, particularly with genetic information, are highly
»
contextual in nature. For instance, the sensitivity of these interests
will
» intensify dramatically, as genetic information is computerized (e.g.,
as
» part of the patient medical record or in a linked research protocol).
»
However, this whole issue may be fodder for another paper that
addresses
more generally issues of the management of personal genetic
information.
» (This would also be an appropriate paper in which to
discuss
the
merits
of
» treating genetic information as another part of a
patient's general medical
»
information, or treating genetic information
as
distinct.
At
least
some
of
»
the pending legislation in Congress sees
genetic information as distinct
e.g., S. 422, "The Genetic
Confidentiality and Discrimination Act of
1997.")
Thomas H. Murray, Ph.D.
»
Center for Biomedical Ethics
»
School of Medicine
»
Case Western Reserve University
»
10900 Euclid Avenue
»
Cleveland, OH 44106-4976
»
Phone: 216/368-6206 Fax: 216/368-8713
»
[email protected]
>[ agree with Alex on not treating genetic information differently from
>other medical information, and that was the general conclusion that the
>commission had (informally) reached. However, I have no objections for
>providing alternative analyses in the paper, since, if we continue to
>believe there should be no difference, we should be up to challenging
>the analysis and conclusions. On the public policy aspects, I would
>expect the paper to address them; otherwise, the analysis would be
>incomplete for our purposes.
>
>My larger question is the place of this proposed analysis in our work on
>stored tissue samples. Privacy is important, but only one issue.
>Perhaps it has been too long since we were on the topic, but I am
>primarily interested in where we are going on stored tissue samples, and
>how we are going to get there. I guess the primary purpose of the
>journey is on: 1) how to maximize the public benefit derived from use of
>stored tissue samples; 2) with an important aspect being the rights and
>benefits/harms to the people from whom the tissue samples were taken
>(including relatives, related groups, etc. who are affected). Privacy
>would fall in the latter category of issues, which I would classify as
>an important consideration, but not the primary objective of our
>journey. Am I being clear? We want to derive maximum public benefit
>from use/research of/on stored tissue samples, while remaining cognizant
>of the potential benefit/harm to the individuals from which they are
>derived, and protecting/benefitting as best we can the individuals
>affected.
>larry
>
>
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:17-JUN-1997. 14:38:40.00
SUBJECT: Re: Sheri Alpert and genetic privacy
TO: [email protected] [email protected] UNKNOWN
READ:UNKNOWN
TEXT:
Tom:
Thanks for sharing Sheri's proposed research with the full NBAC.I would be
happy to discuss the following with Sheri if she wishes. I think her
outline is interesting, but do have comments on two aspects:
I. SHOULD WE TREAT GENETIC PRIVACY AS DISTINCT FROM OTHER MEDICAL PRIVACY?
I seem to recall that NBAC discussed the issue that Sheri gets to at the
end of her outline--whether genetic information is distinct from other
medical information--and I THOUGHT we were inclined not to go for the
"distinct" view. Perhaps I misremember. In any case, I would urge that
nothing we do--or that we have her do--commits us to the "genetic info is
distinct" position, which at this point I believe to be mistaken and
potentially harmful.
Two arguments against the "distinct" approach:
1. It is a waste of effort trying to figure out what information is
"genetic" in the first place.
2. The impulse to have separate rules comes from a phenomenon I labelled
long ago as the "genecity" of topics like this--the tendency of the novel
"genetic" aspects to elevate concerns. Like some of the public fear of
cloning--which derived from its novelty-- a good deal of the concern about
genetic information also steps from novelty; part of our objective could
be to show that it is the general risk of medical information becoming
"unprivate" that is troublesome not genetic information specifically.
II. THE "AUTONOMY" ASPECTS OF "PRIVACY"
I would caution Sheri NOT to get confused, under the "autonomy" heading by
the Supreme Court's former use of "privacy" to mean constitutionally
protected decisional freedom (which now is more likely to be described as
a protected liberty interest). The privacy label stemmed, I think, from
the facts of GRISWOLD V. CONN.
There is also--as I think she may be getting at--an older notion (somewhat
inchoate in the cases, but there in philosophical analysis of the
interests involved) that maintaining control over information about
ourselves is part of the way we maintain autonomy in our lives and thereby
determine the kind of people we are. This is a more sophisticated notion
than the other way in which (unwanted) disclosure of information
interferes with autonomy: when someone (say an insurer) has access to
information they may act towards us in a way we don't like and prevent us
from carrying out a choice we have made (such as, to buy insurance).
The more sophisticated "autonomy" interest does not depend on such direct
acts contrary to the person's interest, but instead relates to the way
that information "shapes" a person. One somewhat novel aspect here is the
way in which information that is thrust upon a person (from a genetic
test, for example) may shape them in ways they don't want to be shaped.
In that case, the "information" has two aspects: that which is HIDDEN in
the person's genes already and that which is contained in the report on
what is shown by the analysis of the genes. Even if the latter
information (the test results) are kept "private" (ie not disclosed to
others, such as insurers, with whom the person does not want to share the
information) the person may still feel that a breach of "privacy" has
occurred when the "hidden" (ie, noi scientifically known) genetic
information is revealed even to the person him or herself. I would be
interested to know whether Sheri finds any "legal" materials that take
account of this interest (which, again, is not unique to the "genetic"
realm at all).
I hope these comments are helpful to the genetics group and to Sheri,
Alex
* Alexander M. Capron
[email protected]
*
*
Henry W. Bruce Professor of Law
(213) 740-2557 (voice)
*
*
University Professor of Law and Medicine (213) 740-5502 (fax)
*
*
University of Southern California
(213) 740-0149 (fax)
*
*
Los Angeles, CA 90089-0071
*
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:18-JUN-1997 09:50:22.00
SUBJECT: Re: more Denver Summit stuff
TO: Laura L. Efros ( CN=Laura L. Efros/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
I will attach the Qs and As we did for the cloning event last week. I
have cleared off on the fact sheet which poor Sherman Boone did over the
weekend. This guy has worked the last four weekends in a row and is
somewhat fried. Treat him gently.
ATTACHMENT 1
ATT CREATION TIME/DATE: 0 00:00:00.00
TEXT:
Unable to convert ARMS_EXT:[ATTACH.D23JMAIL41206386K.116 to ASCII,
The following is a HEX DUMP:
END ATTACHMENT 1
Qs and As on Cloning
June 9, 1997
Q.
What did the Commission recommend?
A.
The Commission recommends legislation to prohibit anyone in either the public or private sector from
attempting to create a child using the cloning technology that made possible the creation of
"Dolly" --so-called "somatic cell nuclear transfer" technology. The Commission also supports a
continuation of the current moratorium on federal funding of creating a child by cloning while the
legislation is pending. NBAC is also asking the private sector to comply with the voluntary
moratorium President Clinton called for in March, pending the legislative prohibition. Finally, NBAC
also called for continuing public dialogue on these issues to further understand the ethical and social
implications of this technology.
Q.
What exactly does the President's legislation ban?
A.
The President's legislation prohibits the use of somatic cell nuclear transfer to create a human being
(specifically, "with the intent of introducing the product of that transfer into a woman's womb or in any
other way creating a human being").
Q.
How will the prohibition be enforced?
A.
The legislation gives the Attorney General authority to seek injunctive relief, impose civil fines up to
$250,000 or twice the profit from a violation of the Act (whichever is greater), and seize any and all
property used in violating the Act (including entire laboratories).
Q.
Why doesn't it make cloning a criminal act and impose jail time?
A.
We think the penalties in the bill provide an effective deterrent. In particular, they make it clear no
one will profit from this activity. It is appropriate to be cautious about criminalizing any activity, and
at this point we don't have any indication that we need the threat of criminal sanctions to deter this
activity.
Q.
But what if Congress wants to impose criminal sanctions?
A.
We have seriously considered this option and would be willing to look at it again.
Q.
Why is there need for a "sunset" provision?
A.
NBAC recommends --and the President supports --a sunset provision, combined with review by an
advisory body prior to the sunset date. There are several reasons to take this approach. First, a
Automated Records Management System
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sunset provision provides a strong incentive for Congress and the Administration to renew the national
debate on cloning within several years, ensuring continued attention to the ethical questions; second,
there is a possibility that we will get the precise legislative language wrong the first time around, given
our limited understanding of the science, the difficulty of defining terms, and the vagaries of the
legislative process; and third, there has been little time to fully consider the moral issues, and it is
possible that convictions may evolve.
Q.
But if you think cloning is morally wrong now, won't it be morally wrong for all time?
A.
Even if one thinks cloning is morally wrong, a sunset provision still makes sense. As I just noted, it
will force a renewed national debate within several years and will keep the ethical issues squarely in
view. A sunset provision will also make sure we revisit how we've defined the ban and ensure we
have done it exactly right.
Q. Why ban the cloning of humans?
A.
It is morally unacceptable for anyone in either the public or private sector to attempt this type of
cloning. NBAC found it is simply unsafe; knowing that "Dolly" was the only successful case in 277
attempts, there is no doubt that there would be substantial risk to the potential child.
And the
possibility of replicating ourselves raises other ethical and religious concerns about the implications of
this technology for our society. These issues need further discussion before the technology is used.
Q.
Why not ban all cloning? What are the potential benefits of cloning research?
A.
There are legitimate and beneficial applications of cloning cells, DNA, tissues, and animals: including
the development of medicines, and therapies for diseases such as cancer, cystic fibrosis, and diabetes.
Cloning also furthers our knowledge about developmental biology that may one day lead to such
advances as regeneration of tissue in severe burns and spinal cord injuries.
Q.
Why is any additional legislation necessary? Why not extend the President's moratorium?
A.
The President's moratorium covers only federally funded activities. In March, President Clinton called
for a voluntary ban on privately funded activities. Legislation is necessary, however, to ensure that
the privately funded research and clinical centers comply with the proposed prohibition on cloning of
human beings using the somatic cell nuclear transfer technique.
Q.
With the proposed legislation, are we interfering with people's reproductive freedom?
A.
No.
We don't think people should have the "freedom" to do this activity. It's unsafe and ethically
objectionable.
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Hex-Dump Conversion
Q.
How will the recommendations and legislation affect research?
A.
NBAC found that a ban on human cloning will not impede any important research at this time.
research in such areas as animal husbandry and drug development will continue. Similarly, basic
research using somatic cell nuclear transfer technology to study, for instance, the potential for
regenerating tissues and organs will continue. However, under current federal restrictions, human
embryo research using federal funds will remain prohibited.
Q.
Why would you (or the Commission) support a total ban on cloning people, but not on creating
embryos using cloning technology for research?
A.
The issue of embryo research is an important but separate question. NBAC found that the
technology that created Dolly doesn't raise new questions related to embryo research. By contrast,
the use of somatic cell nuclear transfer technology to create a child raises a host of new and different
ethical issues relating to safety, individuality, and family integrity. The President's legislation is
directed at these concerns. Further, the President has prohibited the use of federal research funds to
create an embryo for research purposes --whether through cloning or any other means.
Q.
If human embryo research is bad, why not ban it in the private sector as well?
A.
Whether to ban privately-funded embryo research is a question that needs careful deliberation, as
such research may offer medical benefit, particularly with respect to treating infertility. We simply
need further discussion about regulation of this activity in the private sector before pursuing
legislation.
Q.
Does the Federal Government have any jurisdiction over privately funded research with human
embryos?
A.
If the research is part of an effort to develop a drug, biologic, or medical device, the research is subject
to regulation by the Food and Drug Administration. Otherwise, it is unregulated.
Q.
What happens to human embryos created for research? If they are not implanted, isn't that
tantamount to abortion, or even murder?
A.
Creation of human embryos for research is a prohibited use of federal funds. The extent of such
research under private sponsorship is unknown; therefore, we have no reliable information on the fate
of human embryos used in this way.
Q.
How will this affect childless couples who see cloning as their only chance to have genetically
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related offspring?
A.
Prohibiting this technology will have little practical effect on such couples. Currently neither the
science base nor safety considerations make it possible to produce a child by somatic cell nuclear
transfer.
Q.
Is
the United States acting unilaterally on this issue? Are we treating this issue any differently
than other countries?
A.
Some European countries have already established legal prohibitions on the cloning of humans. To
the extent that there are common aspects to our respective policies, we will certainly cooperate with
these nations regarding enforcement.
Automated Records Management System
Hex-Dump Conversion
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] [email protected] [ UNKNOWN ])
CREATION DATE/TIME:18-JUN-1997 16:18:13.00
SUBJECT: Re: Sheri Alpert and genetic privacy
TO: [email protected] [email protected] [ UNKNOWN ])
READ:UNKNOWN
TEXT:
Alex,
I can say for certain that I find your comments very helpful. Thanks.
Re genetic exceptionalism: We agree, and reading your comments it seems
for very similar reasons, that genetic information ought not to be treated
as distinctive for most purposes. But I am reluctant to impose that as a
conclusion this early in our deliberations. So, when Sheri suggested
including it in her paper for us, I thought that might be a useful way to
get an independent read on the merits.
Thanks for your comments.
Tom
>Tom:
>
>Thanks for sharing Sheri's proposed research with the full NBAC.I would be
>happy to discuss the following with Sheri if she wishes. I think her
>outline is interesting, but do have comments on two aspects:
>
>I. SHOULD WE TREAT GENETIC PRIVACY AS DISTINCT FROM OTHER MEDICAL PRIVACY?
>
>[ seem to recall that NBAC discussed the issue that Sheri gets to at the
>end of her outline--whether genetic information is distinct from other
>medical information--and I THOUGHT we were inclined not to go for the
>"distinct" view. Perhaps I misremember. In any case, I would urge that
>nothing we do--or that we have her do--commits us to the "genetic info is
>distinct" position, which at this point I believe to be mistaken and
>potentially harmful.
V
>Two arguments against the "distinct" approach:
>1. It is a waste of effort trying to figure out what information is
>"genetic" in the first place.
V
>2. The impulse to have separate rules comes from a phenomenon I labelled
>long ago as the "genecity" of topics like this--the tendency of the novel
>"genetic" aspects to elevate concerns. Like some of the public fear of
>cloning--which derived from its novelty-- a good deal of the concern about
>genetic information also steps from novelty; part of our objective could
>be to show that it is the general risk of medical information becoming
>"unprivate" that is troublesome not genetic information specifically.
>
>II. THE "AUTONOMY" ASPECTS OF "PRIVACY"
>
>I would caution Sheri NOT to get confused, under the "autonomy" heading by
>the Supreme Court's former use of "privacy" to mean constitutionally
>protected decisional freedom (which now is more likely to be described as
>a protected liberty interest). The privacy label stemmed, I think, from
>the facts of GRISWOLD v. CONN.
>
>There is also--as I think she may be getting at--an older notion (somewhat
>inchoate in the cases, but there in philosophical analysis of the
>interests involved) that maintaining control over information about
>ourselves is part of the way we maintain autonomy in our lives and
thereby >determine the kind of people we are. This is a more
sophisticated notion
>than the other way in which (unwanted) disclosure of information
>interferes with autonomy: when someone (say an insurer) has access to
>information they may act towards us in a way we don't like and prevent us
>from carrying out a choice we have made (such as, to buy insurance).
>
The more sophisticated "autonomy" interest does not depend on such direct
>acts contrary to the person's interest, but instead relates to the way
>that information "shapes" a person. One somewhat novel aspect here is the
>way in which information that is thrust upon a person (from a genetic
>test, for example) may shape them in ways they don't want to be shaped.
>In that case, the "information" has two aspects: that which is HIDDEN in
>the person's genes already and that which is contained in the report on
>what is shown by the analysis of the genes. Even if the latter
>information (the test results) are kept "private" (ie not disclosed to
>others, such as insurers, with whom the person does not want to share the
>information) the person may still feel that a breach of "privacy" has
>occurred when the "hidden" (ie, noi scientifically known) genetic
>information is revealed even to the person him or herself. 1 would be
>interested to know whether Sheri finds any "legal" materials that take
>account of this interest (which, again, is not unique to the "genetic"
>realm at all).
>
>I hope these comments are helpful to the genetics group and to Sheri,
>Alex
>
>* Alexander M. Capron
[email protected]
*
>*
Henry W. Bruce Professor of Law (213) 740-2557 (voice)
*
>*
University Professor of Law and Medicine (213) 740-5502 (fax) *
>* University of Southern California
(213) 740-0149 (fax) *
>*
Los Angeles, CA 90089-0071
*
>
>
>
Thomas H. Murray, Ph.D.
Center for Biomedical Ethics
School of Medicine
Case Western Reserve University
10900 Euclid Avenue
Cleveland, OH 44106-4976
Phone: 216/368-6206 Fax: 216/368-8713
[email protected]
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected]@INET@LNGTWY ([email protected]@INET@LNGTWY[
UNKNOWN )
CREATION DATE/TIME:18-JUN-1997 14:56:11.00
SUBJECT: Re: URGENT need info!
TO: Rachel E. Levinson@EOP ( Rachel E. Levinson@EOP [ OSTP ])
READ:UNKNOWN
TEXT:
best as i can remember, uk has a law that probably applies and is being
tightened up to make sure it applies; argentina recently passed a law to
prohibit it; and china's research council has come out against it and that
is a de facto prohibition tho not de jure prohibition on it.
hope this helps.
also note that council of europe, european commission and w.h.o. have all
cone out against it but no specific law was passed. council of europe's
resolution may have binding force on its members, tho.
At 02:47 PM 6/18/97-0500, you wrote:
>Message Creation Date was at 18-JUN-1997 14:47:00
>
>Your phone is busy. Can you tell me which countries currently have bans
that
>are known to apply to SCNT cloning? The Knoppers paper lays out which
>countries have laws on the books that may or may not apply but I don't
know
>which countries have actually passed anything yet that is specific.
Your
>help is much appreciated
V
>
V
r. alta charo, j.d.
associate professor, law & medical ethics
school of law
tel: 608.262.5015
univ of wisconsin
fax : 608.262.5485
madison, wi 53706
email: [email protected]
ATTACHMENT 1
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RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME:18-JUN-1997. 14:42:27.00
SUBJECT: URGENT need info!
TO: racharo ( racharo @ facstaff.wisc.edu @ inet [ UNKNOWN ])
READ:UNKNOWN
TEXT:
Your phone is busy. Can you tell me which countries currently have bans
that are known to apply to SCNT cloning? The Knoppers paper lays out
which countries have laws on the books that may or may not apply but I
don't know which countries have actually passed anything yet that is
specific. Your help is much appreciated
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] [email protected] [ UNKNOWN ])
CREATION DATE/TIME:19-JUN-1997. 13:11:46.00
SUBJECT: Re: Sheri Alpert and genetic privacy
TO: [email protected] [email protected] [ UNKNOWN )
READ:UNKNOWN
TEXT:
For the record, I do not believe that our tissue sample report can be
ready before December. To put that another way, I think December is a
reasonable goal for completion of the report. I also believe that the
Commissions ought not of necessity be the primary authors of reports.
Kathi Hanna did a terrific job for us on cloning. But we should have
ethicists and perhaps others on staff who can shoulder the burden of
writing, with the guidance of the Commission.
Tom
>Tom:
>Thanks for the note. Yes, I agree with your plan, as I noted a few
>moments ago in responding to Larry's e-mail in which he said that we
>ought to have see if our tentative conclusion holds up in the face of
>contrary arguments.
>
>BTW, I also agree with Carol and Larry on the need for the scientific
>papers and hope those can be arranged. After an exhausting experience
>like the cloning report, it is hard to throw oneself immediately into a
>new task, but I'm sure that your subcomm, like the HSSC, finds the Oct.
>deadline looming awfully large already.
>
>As a general comment--especially for Harold's eyes--I want to plead for
>as rapid (and high quality, of course!) outcome on the hiring of the Exec
>Dir. and other professional staff, as I don't think it is either feasible
>or wise to place the primary production of our future reports on the
>shoulders of the commissioners to anything like the degree we did, of
>necessity, with the cloning report.
V
>Best,
>Alex
V
V
>On Wed, 18 Jun 1997, Tom Murray wrote:
V
Alex,
» I can say for certain that I find your comments very helpful. Thanks.
» Re genetic exceptionalism: We agree, and reading your comments it
seems for » very similar reasons, that genetic information ought not to
be treated as
» distinctive for most purposes. But I am reluctant to impose that as a
» conclusion this early in our deliberations. So, when Sheri suggested
» including it in her paper for us, I thought that might be a useful way
to
» get an independent read on the merits.
» Thanks for your comments.
» Tom
Tom:
»
>
» Thanks for sharing Sheri's proposed research with the full NBAC.I
would be
» >happy to discuss the following with Sheri if she wishes. I think her
>outline is interesting, but do have comments on two aspects:
>
» >I. SHOULD WE TREAT GENETIC PRIVACY AS DISTINCT FROM OTHER MEDICAL
PRIVACY?
>
» >I seem to recall that NBAC discussed the issue that Sheri gets to at
the
» >end of her outline--whether genetic information is distinct from
other
» >medical information--and I THOUGHT we were inclined not to go for the
» >"distinct" view. Perhaps I misremember. In any case, I would urge
that
» >nothing we do--or that we have her do--commits us to the "genetic
info is
» >distinct" position, which at this point I believe to be mistaken and
» >potentially harmful.
>
» Two arguments against the "distinct" approach:
» >1. It is a waste of effort trying to figure out what information is
» >"genetic" in the first place.
»
>
» >2. The impulse to have separate rules comes from a phenomenon I
labelled
»
>long ago as the "genecity" of topics like this--the tendency
of
the
novel » >"genetic" aspects to elevate concerns. Like some of the
public fear of » >cloning--which derived from its novelty-- a good deal
of the concern about » >genetic information also steps from novelty; part
of our objective could » >be to show that it is the general risk of
medical information becoming » >"unprivate" that is troublesome not
genetic information specifically.
V
» >II. THE "AUTONOMY" ASPECTS OF "PRIVACY"
V
» >[ would caution Sheri NOT to get confused, under the "autonomy"
heading by
» >the Supreme Court's former use of "privacy" to mean constitutionally
»
>protected decisional freedom (which now is more likely to be described
as » >a protected liberty interest). The privacy label stemmed, I think,
from
>the facts of GRISWOLD V. CONN.
>
»
> There is also--as I think she may be getting at--an older notion
(somewhat
» >inchoate in the cases, but there in philosophical analysis of the
»
>interests involved) that maintaining control over information about
»
>ourselves is part of the way we maintain autonomy in our lives and
thereby » >determine the kind of people we are. This is a more
sophisticated notion
» >than the other way in which (unwanted) disclosure of information
»
>interferes with autonomy: when someone (say an insurer) has access to
»
>information they may act towards us in a way we don't like and prevent
us
» >from carrying out a choice we have made (such as, to buy insurance).
»
>
»
The more sophisticated "autonomy" interest does not depend on such
direct
» >acts contrary to the person's interest, but instead relates to
the way » >that information "shapes" a person. One somewhat novel aspect
here is the
» way in which information that is thrust upon a person (from a genetic
» >test, for example) may shape them in ways they don't want to be
shaped.
» >In that case, the "information" has two aspects: that which is
HIDDEN in » >the person's genes already and that which is contained in
the report on
» >what is shown by the analysis of the genes. Even if the latter
» >information (the test results) are kept "private" (ie not disclosed to
» >others, such as insurers, with whom the person does not want to share
the
» >information) the person may still feel that a breach of "privacy" has
» >occurred when the "hidden" (ie, noi scientifically known) genetic
» >information is revealed even to the person him or herself. I would be
» >interested to know whether Sheri finds any "legal" materials that take
» >account of this interest (which, again, is not unique to the "genetic"
» >realm at all).
»
>
» >[ hope these comments are helpful to the genetics group and to Sheri,
» Alex
»
>
» >* Alexander M. Capron
[email protected]
*
» >* Henry W. Bruce Professor of Law (213) 740-2557 (voice) *
» >* University Professor of Law and Medicine (213) 740-5502 (fax) *
»>* University of Southern California
(213) 740-0149 (fax)
*
» >* Los Angeles, CA 90089-0071
*
»
» >
» >
» >
>
»
V
» Thomas H. Murray, Ph.D.
» Center for Biomedical Ethics
»
School of Medicine
» Case Western Reserve University
»
10900 Euclid Avenue
»
Cleveland, OH 44106-4976
»
Phone: 216/368-6206 Fax: 216/368-8713
»
[email protected]
» > > >
Thomas H. Murray, Ph.D.
Center for Biomedical Ethics
School of Medicine
Case Western Reserve University
10900 Euclid Avenue
Cleveland, OH 44106-4976
Phone: 216/368-6206 Fax: 216/368-8713
[email protected]
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:19-JUN-1997 13:41:26.00
SUBJECT: Re: Sheri Alpert and genetic privacy
TO: [email protected] [email protected] [ UNKNOWN ])
READ:UNKNOWN
TEXT:
On Thu, 19 Jun 1997, Tom Murray wrote:
> For the record, I do not believe that our tissue sample report can be
ready > before December. To put that another way, I think December is a
reasonable
> goal for completion of the report. I also believe that the Commissions
> ought not of necessity be the primary authors of reports. Kathi Hanna
did a > terrific job for us on cloning. But we should have ethicists and
perhaps > others on staff who can shoulder the burden of writing, with the
guidance of > the Commission.
Glad that we agree on the "report drafting" question and I trust that
with appropriate staffing in place in the not too distant future (!?!)
this will turn out to be the case.
On the question of deadlines (such as the tissue report by Dec.?), I think
it might be helpful for all of us to hear from Harold what his
expectations are about the issuance of various reports over the coming
8-12 months. Now that we have an extension at least through Oct. 1999, we
ought to be able to plan more sensibly. On a recent "informal" HSSC
conference call, I played the role of Simon Legree, pushing the staff very
hard to have both Phase I and II of the federal agency review process
completed by the projected completion date of the first HSSC report in
Oct. That date reflects an expectation in our charter, but the other
dates are more for us to set and then to meet.
Alex
* Alexander M. Capron
[email protected]
*
*
Henry W. Bruce Professor of Law
(213) 740-2557 (voice)
*
*
University Professor of Law and Medicine (213) 740-5502 (fax)
*
* University of Southern California
(213) 740-0149 (fax) *
* Los Angeles, CA 90089-0071
*
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:19-JUN-1997 12:43:08.00
SUBJECT: Re: Sheri Alpert and genetic privacy
TO: [email protected] [email protected] [ UNKNOWN ])
READ:UNKNOWN
TEXT:
Tom:
Thanks for the note. Yes, I agree with your plan, as I noted a few
moments ago in responding to Larry's e-mail in which he said that we
ought to have see if our tentative conclusion holds up in the face of
contrary arguments.
BTW, I also agree with Carol and Larry on the need for the scientific
papers and hope those can be arranged. After an exhausting experience
like the cloning report, it is hard to throw oneself immediately into a
new task, but I'm sure that your subcomm, like the HSSC, finds the Oct.
deadline looming awfully large already.
As a general comment--especially for Harold's eyes--I want to plead for
as rapid (and high quality, of course!) outcome on the hiring of the Exec
Dir. and other professional staff, as I don't think it is either feasible
or wise to place the primary production of our future reports on the
shoulders of the commissioners to anything like the degree we did, of
necessity, with the cloning report.
Best,
Alex
On Wed, 18 Jun 1997, Tom Murray wrote:
> Alex,
V
> I can say for certain that I find your comments very helpful. Thanks.
V
> Re genetic exceptionalism: We agree, and reading your comments it seems
for > very similar reasons, that genetic information ought not to be
treated as
> distinctive for most purposes. But I am reluctant to impose that as a
> conclusion this early in our deliberations. So, when Sheri suggested
> including it in her paper for us, I thought that might be a useful way
to > get an independent read on the merits.
>
> Thanks for your comments.
V
> Tom
V
> Tom:
> >
> >Thanks for sharing Sheri's proposed research with the full NBAC.I would
be
> >happy to discuss the following with Sheri if she wishes. I think her
> >outline is interesting, but do have comments on two aspects:
> >
> >I. SHOULD WE TREAT GENETIC PRIVACY AS DISTINCT FROM OTHER MEDICAL
PRIVACY?
»
> >] seem to recall that NBAC discussed the issue that Sheri gets to at the
> >end of her outline--whether genetic information is distinct from other
> >medical information--and I THOUGHT we were inclined not to go for the
> >"distinct" view. Perhaps I misremember. In any case, I would urge
that > >nothing we do--or that we have her do--commits us to the "genetic
info is
> >distinct" position, which at this point I believe to be mistaken and
> >potentially harmful.
»
> Two arguments against the "distinct" approach:
> >1. It is a waste of effort trying to figure out what information is
> >"genetic" in the first place.
> >
> >2. The impulse to have separate rules comes from a phenomenon I
labelled > >long ago as the "genecity" of topics like this--the tendency
of the novel > >"genetic" aspects to elevate concerns. Like some of the
public fear of > >cloning--which derived from its novelty-- a good deal of
the concern about > >genetic information also steps from novelty; part of
our objective could
> >be to show that it is the general risk of medical information becoming
> >"unprivate" that is troublesome not genetic information specifically.
> >
> >II. THE "AUTONOMY" ASPECTS OF "PRIVACY"
> >
> >I would caution Sheri NOT to get confused, under the "autonomy" heading
by
> >the Supreme Court's former use of "privacy" to mean constitutionally
> >protected decisional freedom (which now is more likely to be described
as > >a protected liberty interest). The privacy label stemmed, I think,
from
> >the facts of GRISWOLD V. CONN.
»
> > There is also--as I think she may be getting at--an older notion
(somewhat
> >inchoate in the cases, but there in philosophical analysis of the
> >interests involved) that maintaining control over information about
> >ourselves is part of the way we maintain autonomy in our lives and
thereby > >determine the kind of people we are. This is a more
sophisticated notion
> >than the other way in which (unwanted) disclosure of information
> >interferes with autonomy: when someone (say an insurer) has access to
> >information they may act towards us in a way we don't like and prevent
us > >from carrying out a choice we have made (such as, to buy insurance).
»
» The more sophisticated "autonomy" interest does not depend on such
direct
> >acts contrary to the person's interest, but instead relates to the way
> >that information "shapes" a person. One somewhat novel aspect here is
the
> >way in which information that is thrust upon a person (from a genetic
> >test, for example) may shape them in ways they don't want to be shaped.
> >In that case, the "information" has two aspects: that which is HIDDEN
in > >the person's genes already and that which is contained in the report
on
> >what is shown by the analysis of the genes. Even if the latter
> >information (the test results) are kept "private" (ie not disclosed to
> >others, such as insurers, with whom the person does not want to share
the
> >information) the person may still feel that a breach of "privacy" has
> >occurred when the "hidden" (ie, noi scientifically known) genetic
> >information is revealed even to the person him or herself. I would be
> >interested to know whether Sheri finds any "legal" materials that take
> >account of this interest (which, again, is not unique to the "genetic"
> >realm at all).
> >
> >I hope these comments are helpful to the genetics group and to Sheri,
> > Alex
> >
>
>
>* Alexander M. Capron
[email protected]
*
>
>* Henry W. Bruce Professor of Law (213) 740-2557 (voice)
*
>
>* University Professor of Law and Medicine (213) 740-5502 (fax) *
> >* University of Southern California
(213) 740-0149 (fax)
*
>
>* Los Angeles, CA 90089-0071
*
>
>
>
>
>
>
>
>
>
>
> >
> Thomas H. Murray, Ph.D.
> Center for Biomedical Ethics
> School of Medicine
> Case Western Reserve University
> 10900 Euclid Avenue
> Cleveland, OH 44106-4976
> Phone: 216/368-6206 Fax: 216/368-8713
> [email protected]
>
V
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Yolanda L. Comedy ( CN=Yolanda L. Comedy/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME:19-JUN-1997 13:35:34.00
SUBJECT: Re: National Bioethics Advisory Commission
TO: Sltaylor33 ( Sltaylor33 @ aol.com [ UNKNOWN ])
READ:UNKNOWN
TEXT:
I have forwarded your request to the appropriate person. Please let me
know if there is any difficulty in getting the information. Yolanda L.
Comedy
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:19-JUN-1997 15:46:26.00
SUBJECT: RE: the cloning report and the Web site
TO: [email protected] [email protected] [ UNKNOWN ])
READ:UNKNOWN
TEXT:
We are working on getting the report on the Web ASAP and are looking at
early next week. Our office move plus vacations, family deaths,
pregnancies, etc. has slowed us down a bit. In the meantime we have
plenty of copies of the report - it would be best to ask people to fax a
request to us at 301-480-6900. We fill requests within 24 hrs.
Sincerely yours,
Henrietta
From: Carol Greider at Cold Spring Harbor
Laboratory[SMTP:[email protected]]
Sent: Tuesday, June 17, 1997 9:34 PM
To: NBAC Members E-list
Subject:
the cloning report and the Web site
Hi everyone,
I appreciate that others, like me, are just now digging out from under the
piles of paper that accumulated during the Dolly days (Dolly daze?).
But I would really appreciate it if the Cloning report were on the web. I
have told many people that it would be up by the end of last week, and
they
keep bugging me about it.
thanks very much.
:)
Carol
Carol Greider, Ph.D.
Cold Spring Harbor Laboratory
P.O. Box 100
Cold Spring Harbor, NY 11724
Phone: (516) 367-8808
Fax: (516) 367-8815
E-mail: [email protected]
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME:19-JUN-1997. 13:42:58.00
SUBJECT: Re: National Bioethics Advisory Commission
TO: Yolanda L. Comedy ( CN=Yolanda L. Comedy/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
You're in luck - we just received a bunch of copies that are located in
room 436. Help yourself.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:19-JUN-1997 12:55:35.00
SUBJECT: PARIS and FERMI
TO: Deanna M. Behring ( CN=Deanna M. Behring/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
1. Are there any handouts that JHG will want to take to Paris, e.g.,
cloning report, etc., that need to be mailed in advance?
2. Holly is also curious about the Martha Krebs/FERMI request--not
sure why JHG should be doing this
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:19-JUN-1997 15:34:09.00
SUBJECT: Susan Wolf
TO: [email protected] [email protected] [ UNKNOWN 1)
READ:UNKNOWN
TEXT:
Susan Wolf of the U Minnesota bioethics center has an (unconvincing) OpEd
piece in the Minneapolis Star Tribune today, "Why the Bioethics Commission
is wrong to seek a ban on cloning" (text below, or as attachment) in which
she really objects that IF Congress enacted a ban that went beyond
babymaking to ban all embryo research and IF it were not time limited, it
would be a bad statute (obviously, such legislation is inconsistent with
our recommendations). She says instead that we should have followed the R
AC model of regulation by an expert panel (Difference: that was an
activity, namely human gene therapy, which was ACCEPTABLE--not burdened by
serious, unresolved ethical issues, as repro. cloning is-- and in which
the only questions related to safety of each individual case, not the
whole technique). She suggests in passing that human subjects rules would
prevent anyone engaging in cloning-babymaking now on safety grounds
anyway, but later says that privately funded research isn't covered, so
that we should "consider fixing the existing federal rules on human
subjects" (which we've already said we favor in principle, and will be
trying to do in our first full report on human subjects).
Alex
Commission suggests
ban on human cloning
Published Thursday, June 19, 1997
Commentary: Bioethics Commission
wrong to seek ban on cloning
Susan Wolf
Last week the National Bioethics Advisory
Commission
recommended a federal ban on using cloning to create a child.
President Clinton agreed and proposed a
five-year ban by
federal legislation.
They're wrong.
It's true that cloning packs an emotional
wallop. It conjures up
images of xeroxed humans. It seems another
attempt to play
God. It certainly warrants regulation.
But should it be banned? No other bioethics
controversy has
been addressed by a ban this broad.
This goes beyond prohibiting the use of
federal funds (which
the president had already done). It goes
beyond the federal
regulations on human subjects research, which
already would
make cloning impossible (because it is still
unsafe) in
universities and other institutions covered
by those regulations.
Instead, the cloning ban would reach all
public and private
institutions whether or not federal money is
involved. It would
threaten them with fines of at least a
quarter-million dollars.
And the ban would be imposed by Congress
itself, not a
regulatory body ready to respond to new
developments in the
technology.
That's both new and unwise. It turns cloning
into a political
football for Congress.
Past congressional imbroglios over the
related areas of embryo
research and abortion predict the same
trouble ahead for
cloning. This means that although the
president and the
commission have called for a ban reaching the
private sector
only on application, not research, Congress
is likely to go
further and ban research too.
And though the president and commission
focused on banning
only somatic cell nuclear transfer (the
technique used to clone
Dolly the sheep), Congress may well rope in
other cloning
technologies, such as embryo splitting,
despite its potential
value in treating infertility.
Even if Congress miraculously enacts the
limited ban the
commission recommended, research may well be
chilled by the
specter of legal investigation and penalty
any time a researcher
arguably clones with the wrong intent (in the
president's bill "the
intent of introducing the product
into
a woman's womb or
in any other way creating a human being").
In addition, a federal ban of all public and
private cloning may
well violate constitutional guarantees of
academic freedom for
researchers and procreative liberty for
infertile couples, as well
as exceeding the limits on federal power.
Some may respond that banning cloning remains
the right
course -- that no good can come of it. But
there is potential
good we need to consider.
Within an infertility treatment program,
cloning in the forms of
induced twinning may save a woman from
repeated exposure
to drugs that cause superovulation, and may
thus reduce her
risk of ovarian cancer later.
Even Dolly-style cloning has potential uses.
Consider, for example, a woman whose genetic
material would
likely inflict a serious disorder on her
child. Cloning also may
allow her to avoid using genetic material
from an egg donor and
thus may keep the reproductive process
between the woman
and her partner -- something of value to many couples.
A federal ban, depending on how broad it is,
would shut down
or threaten these possibilities. Especially
if the five-year ban
that Clinton now favors results in a
longer-term avoidance of
cloning.
There is a better way. The commission,
president, and
Congress should consider the model we have
followed with
human gene therapy: regulation by an expert
panel able to
respond to improvements in the technology
over time and more
insulated than Congress from partisan
politics. Indeed, lessons
we have learned in using that model could
lead to better
refinements.
They also should consider fixing the existing
federal rules on
human subjects. Because any cloning of human
beings now
would be considered experimental, those
regulations would
offer important protections. But those
regulations apply only to
research underwritten with federal funds and
in any institution
that has assured the federal government its
research will
comport with federal rules.
Some researchers remain outside these rules,
a problem that
should be addressed.
Finally we need a reevaluation of regulations
on assisted
reproduction generally. Though progress has
been made in
recent years, state-to-state inconsistency,
problems with
federal reporting requirements, and conflicts
of interest inherent
in industry self-regulation merit careful examination.
A ban may seem a simple and safe solution.
But the questions
raised by cloning are far from simple. We
have to balance the
promise of research and the potential
benefits against the need
for regulation and caution.
We have to do better than a ban.
-- Susan Wolf is associate professor of Law
and Medicine at
the University of Minnesota Law School and a
faculty member
in the University's Center for Bioethics.
) Copyright 1997 Star Tribune. All rights reserved.
Commission suggests
ban on human cloning
- wolf
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HEIGHT="16" ALIGN="left" BORDER="0"><FONT SIZE="2" FACE="Arial,Geneva">Commissi
on suggests ban on human cloning</FONT></A><BR CLEAR="all">
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TD VALIGN="top" ROWSPAN="2"><P ALIGN="left"><A HREF="/cgi-bin/stOnLine/section?
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</P><FONT SIZE="1" COLOR=#636363" FACE="Arial,Geneva">Published Thursday, June
19, 1997</FONT>
<BR>
<H2>Commentary: Bioethics Commission wrong to seek ban on cloning</H2>
<STRONG>Susan Wolf</STRONG><P>
<P>Last week the National Bioethics Advisory Commission recommended a federal b
an on using cloning to create a child. President Clinton agreed and proposed a
five-year ban by federal legislation.</P>
<P>They're wrong.</P>
<P>It's true that cloning packs an emotional wallop. It conjures up images of X
eroxed humans. It seems another attempt to play God. It certainly warrants regu
lation.</P>
<P>But should it be banned? No other bioethics controversy has been addressed b
y a ban this broad.</P>
<P>This goes beyond prohibiting the use of federal funds (which the president h
ad already done). It goes beyond the federal regulations on human subjects rese
arch, which already would make cloning impossible (because it is still unsafe)
in universities and other institutions covered by those regulations. </P>
<P>Instead, the cloning ban would reach all public and private institutions whe
ther or not federal money is involved. It would threaten them with fines of at
least a quarter-million dollars. And the ban would be imposed by Congress itsel
f, not a regulatory body ready to respond to new developments in the technology
.</P>
<P>That's both new and unwise. It turns cloning into a political football for C
ongress.</P>
<P>Past congressional imbroglios over the related areas of embryo research and
abortion predict the same trouble ahead for cloning. This means that although t
he president and the commission have called for a ban reaching the private sect
or only on application, not research, Congress is likely to go further and ban
research too. </P>
<P>And though the president and commission focused on banning only somatic cell
nuclear transfer (the technique used to clone Dolly the sheep), Congress may W
ell rope in other cloning technologies, such as embryo splitting, despite its p
otential value in treating infertility. </P>
<P>Even if Congress miraculously enacts the limited ban the commission recommen
ded, research may well be chilled by the specter of legal investigation and pen
alty any time a researcher arguably clones with the wrong intent (in the presid
ent's bill "the intent of introducing the product
into a woman's womb or
in any other way creating a human being"). </P>
<P>In addition, a federal ban of all public and private cloning may well violat
e constitutional guarantees of academic freedom for researchers and procreative
liberty for infertile couples, as well as exceeding the limits on federal powe
r.</P>
<P>Some may respond that banning cloning remains the right course -- that no go
od can come of it. But there is potential good we need to consider. </P>
<P>Within an infertility treatment program, cloning in the forms of induced twi
nning may save a woman from repeated exposure to drugs that cause superovulatio
n, and may thus reduce her risk of ovarian cancer later. </P>
<P>Even Dolly-style cloning has potential uses.</P>
<P>Consider, for example, a woman whose genetic material would likely inflict a
serious disorder on her child. Cloning also may allow her to avoid using genet
ic material from an egg donor and thus may keep the reproductive process betwee
n the woman and her partner -- something of value to many couples. </P>
<P>A federal ban, depending on how broad it is, would shut down or threaten the
se possibilities. Especially if the five-year ban that Clinton now favors resul
ts in a longer-term avoidance of cloning. </P>
<P>There is a better way. The commission, president, and Congress should consid
er the model we have followed with human gene therapy: regulation by an expert
panel able to respond to improvements in the technology over time and more insu
lated than Congress from partisan politics. Indeed, lessons we have learned in
using that model could lead to better refinements.
<P>They also should consider fixing the existing federal rules on human subject
S. Because any cloning of human beings now would be considered experimental, th
ose regulations would offer important protections. But those regulations apply
only to research underwritten with federal funds and in any institution that ha
S assured the federal government its research will comport with federal rules.
</P>
<P>Some researchers remain outside these rules, a problem that should be addres
sed. </P>
<P>Finally we need a reevaluation of regulations on assisted reproduction gener
ally. Though progress has been made in recent years, state-to-state inconsisten
cy, problems with federal reporting requirements, and conflicts of interest inh
erent in industry self-regulation merit careful examination.</P>
<P>A ban may seem a simple and safe solution. But the questions raised by cloni
ng are far from simple. We have to balance the promise of research and the pote
ntial benefits against the need for regulation and caution. </P>
<P>We have to do better than a ban.</P>
<P>-- Susan Wolf is associate professor of Law and Medicine at the University o
f Minnesota Law School and a faculty member in the University's Center for Bioe
thics.</P>
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END ATTACHMENT 1
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Yolanda L. Comedy ( CN=Yolanda L. Comedy/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME:19-JUN-1997. 13:31:38.00
SUBJECT: National Bioethics Advisory Commission
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
Please respond. Thanks, Yolanda
Forwarded by Yolanda L. Comedy/OSTP/EOP on 06/19/97
01:40 PM
Sltaylor33 @ aol.com
06/19/97 12:31:30 PM
Record Type: Record
To: ycomedy
cc:
Subject: National Bioethics Advisory Commission
Can you please help me locate a copy of the report to the president given
by Dr. Harold Shapiro on 6/9/97 regarding the committee's work on the
issue of Human cloning. I am a student at the University of New Mexico in
Albuquerque and I am taking a summer class in Genetics. I would like to
discuss the committee's opinions and findings to my class. Your help
would be greatly appreciated.
Thank you
Susan L. Taylor
[email protected]
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:22-JUN-1997 12:10:15.00
SUBJECT: Re: Sorry, but could you put your clips request in writing?
TO: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Forwarded by Susanne Bachtel/OSTP/EOP on 06/22/97
12:10 PM
Susanne Bachtel
06/22/97 12:15:09 PM
Record Type: Record
To:
Teresa Wildman/WHO/EOP
cc:
Subject:
Re: Sorry, but could you put your clips request in writing?
Do you think you could ask Jodie about this - as you know the written
request went in a couple of weeks ago - can you get a verbal go ahead.
The clips will be well used - we are one of the 4 policy offices - like
Reed, Sperling, Berger, etc., and the weekend/magazine clips will help a
lot. Thanks for anything you can do - I have a family funeral to attend
on Monday first thing - back early p.m. Thanks Susie
Forwarded by Susanne Bachtel/OSTP/EOP on 06/22/97
12:05 PM
Susanne Bachtel
06/13/97 09:43:03 AM
Record Type: Record
To:
Teresa Wildman/WHO/EOP
cc:
Susanne Bachtel/OSTP/EOP
Subject:
Re: Sorry, but could you put your clips request in writing?
Teresa - any feedback yet? I had to scrounge fast last weekend for a clip
from the NYT that the POTUS wanted that day for the cloning event. We
would appreciate starting the weekend clips/WH magazine asap. With much
appreciation! Sue
Forwarded by Susanne Bachtel/OSTP/EOP on 06/13/97
09:37 AM
Susanne Bachtel
06/06/97 01:09:53 PM
Record Type: Record
To:
Teresa Wildman/WHO/EOP
cc:
Jodie R. Torkelson/WHO/EOP
Subject:
Re: Sorry, but could you put your clips request in
writing?
Dear Teresa: Thanks for your note. Sorry for the delay in response; I
was awaiting some feedback from one of our staff.
This is Dr. Gibbons's request:
1. Cancel the WH daily clips addressed to Ernie Moniz
2. Change the WH daily clips addressed to Tim Newell -
readdress them to Dr. Gibbons - send to
Dr. Gibbons's office - Room 424 OEOB (Dr.
Gibbons's office)
3. Add WH weekend clips - address to Dr. Gibbons - send
to Room 424 OEOB
4. Add WH magazine clips - address to Dr. Gibbons - send
to Room 424 OEOB
Many thanks, Susie
Bachtel, Ext 6-7116
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:23-JUN-1997 17:31:41.00
SUBJECT: Back on line
TO: [email protected] ( [email protected] [ UNKNOWN ] )
READ:UNKNOWN
TEXT:
I returned this afternoon to find only 39 messages. Till I started
reading the email I was worried about our health -- but everybody seems
okay. At a Goals of Medicine meeting in Naples nobody asked about
cloning. Do they know something we don't?
Eric
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN ])
CREATION DATE/TIME:24-JUN-1997 10:32:55.00
SUBJECT: Cloning Bill
TO: [email protected] ( [email protected] [ UNKNOWN )
READ:UNKNOWN
TEXT:
Rachel:
i'll be sending you, if you haven't alreay gotten it, BIO's analysis of
the President's cloning bill. great concern over ambiguities (re: a human
being) and regulation of the intent rather than the actual production of
the new being. both might serve to "chill" allowable research.
i think that the best way to go is to go back to the drawing board and
redraft the bill w/o reference to the technology AT ALL: regulate the
"product" not the "process".
basically: it shall be illegal to create, by any means, a new human
individual essentially genetically identical to another human individual
who currently exists or previously existed.
for purposes of the bill, a "human individual" shall mean a member of the
species homo sapiens who has been born and lived post birth but shall not
include any embryo or fetus of the species homo sapiens that was never
born and lived post birth.
this would outlaw cloning people by Wilmut-cloning as well as serial
twinning by blastomere separation and nuclear transplantation of embryonic
nuclei. it would leave alone blast separation and embryonic nuclear
transplantation twinning if the second twin is not serialized.
this also has the virtue of getting away from the issue of embryo
research. if people want a bill to regulate that, they should draft a
second bill.
just a thought.
-steve
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Angela Phillips Diaz ( CN=Angela Phillips Diaz/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME:25-JUN-1997 12:36:40.00
SUBJECT: NBAC Report for PCAST
TO: Yolanda L. Comedy ( CN=Yolanda L. Comedy/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
Angela Phillips Diaz ( CN=Angela Phillips Diaz/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TEXT:
Yolanda:
I would recommend that we get copies of "Cloning Human Beings"
report & recommendations of the NBAC for PCAST. Prior to sending it to
them, we should pull the PCAST letter to POTUS & POTUS response & meet w/
Gabriel, Gwin, & Levinson to determine what action if any we want to
assign to PCAST in the cover transmittal letter. I would welcome your
thoughts/proposals on how to proceed also.
Thanks.
Angela
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Cathleen A. Campbell ( CN=Cathleen A. Campbell/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:26-JUN-1997 10:58:25.00
SUBJECT: nbac report
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Rachel,
Can I get a copy of the NBAC report on cloning to give to the Russian
Embassy S&T officer???
thanks,
cathy
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ([email protected] [ UNKNOWN 1)
CREATION DATE/TIME:30-JUN-199720:27:53.00
SUBJECT: Stars & Surprises
TO: [email protected] [email protected] [ UNKNOWN 1)
READ:UNKNOWN
TEXT:
OUR STARS. Two NBACers starred in last week's Interagency Human Subjects
Conference on Genetics Research and Human Subjects: The Changing
Landscape. First, DAVID COX gave a remarkably fresh, clear, illuminating,
and witty presentation on the Human Genome Project: Implications for
Future Research. I heard several people say that they wished he had been
their teacher in college -- I share that sentiment. Then, while keeping
her eyes on the clock so she could catch her plane, ALTA CHARO offered a
most lucid (even though rapid!), pentrating, and insightful discussion of
NBAC's work on human subjects, genetics, and, yes, of course, human
cloning-- I found her presentation quite stimulating, particularly her
important and difficult questions, raised in the context of our work and
report on cloning, about the relation of ethics and politics in public
bioethics. I hope we can discuss these questions sometime. As the first
speakers, David and Alta really got the fine two-day conference off to a
great start.
SURPRISE. Earlier last week I decided to drop in on a conference on the
Moral Challenge of Cloning Technology, sponsored by the (quite
conservative) Center for Jewish and Christian Values, particularly to see
what arguments would be offered against our report. I was also interested
because the conference was being held in the U.S. Capitol, SC-5, with
Senator Lieberman introducing the discussion and Rep. Ehlers participating
in one of the panels, and because it was focusing on theological-religious
arguments about a third of the time. The panel on religious perspectives
was intended to provide diverse religious views all united in their
opposition to human cloning. You can imagine the surprise and chagrin the
sponsors experienced when Rabbi Byron Sherwin (Vice President of Academic
Affairs, Spertus College of Judaica) generally agreed with NBAC's report
and, on grounds somewhat different from Rabbis Tendler and Dorff (in
appealing to the extended commentary over the centuries on a Talmudic
story about the creation of an anthropoid), supported the possibility of
human cloning once the safety factors are surmounted (as he is confident
they will be). He argued at one point: "In my opinion, we have more to
fear, for instance, from computers than from cloning. A computer can wipe
out any trace of our very existence, whereas a clone could help perpetuate
it." Rabbi Sherwin further noted that little opposition to human cloning,
beyond the safety issues, has emerged in Orthodox Judaism and Conservative
Judaism, both of which appeal to legal precedents, but that some Reform
Jews have expressed opposition in "vague" terms such as respect for
dignity. Having expected to present a more united front against human
cloning, and perhaps one more critical of NBAC's report, the organizers of
the conference had to watch much of the subsequent discussion focus on
Rabbi Sherwin's paper rather than on the more critical Protestant (Ben
Mitchell of Southern Baptist Theological Seminary) and Roman Catholic
(John Grabowski of CU) papers.
See you in a couple of weeks.
James F. Childress
Kyle Professor of Religious Studies &
Professor of Medical Education
University of Virginia
Cocke Hall
Charlottesville, VA 22903
Tel. (804) 924-3741
Fax (804) 924-1467
e-mail: [email protected]
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ([email protected] [ UNKNOWN
CREATION DATE/TIME:30-JUN-1997. 19:41:33.00
SUBJECT: HSSC Mtg
TO: [email protected] [email protected] [ UNKNOWN 1)
READ:UNKNOWN
TEXT:
To: NBAC Members
From: Jim Childress
Subj.: HSSC Mtg
The HSSC will meet all day Tuesday, July 15, beginning around 8:00 AM and
ending around 4:00 or 4:30-- we hope that most members of the whole
commission will be able to join the discussion. Your suggestions have
already been most helpful in developing the tentative agenda that follows,
and I would appreciate any additional suggestions you might have:
First, we will discuss our federal agency report with attention to patterns
that have emerged in the phase I (structure) and phase 11
(process/implementation) interviews, the direction of the final report,
and a rough schedule for drafting and reviewing its different parts
(Freeman, Feinstein, and Mangel).
Second, we will devote a large block of time to a serious and sustained
iscussion of possible guidelines for cognitively or decisionally impaired
research subjects. Everyone should read carefully Rebecca Dresser's
excellent contract draft paper on this subject; we will discuss it with
her to see whether we have suggestions for additions, changes, etc. We
will also discuss with Jonathan Moreno, who will be working closely with
the HSSC over the next several months, some background materials for a
possible report on this topic. In addition, we will hear from from Nina
Schooler, Adil Shamoo, and an as yet undetermined representative from NIMH
on ethical issues that arise in research with cognitively impaired
subjects and on the kinds of guidelines, if any, that should be
developed. Finally, Paul Appelbaum will discuss his (and his colleagues')
studies of competence measurements for use in treatment and research
decisions. We have circulated a large body of materials on this topic
since December; please review these materials again along with the
transcripts of our meetings. Other new materials will include Trish
Backlar's paper on advance directives for research.
Third, we will discuss the issues and proposals Alex Capron raised in his
memorandum of May 30, 1997 (circulated in conjunction with our June 7
meeting) regarding the lack of data in federal research oversight. We'll
send early next week, along with other materials for the meeting, another
copy of Alex' earlier emorandum in case it got misplaced in all the
cloning materials.
Fourth, we will seek to set priorities for our work, in light of our
extended life expectancy, and determine how we might proceed with topics
that we have selected or that have been assigned to us, including
compensation for research-related injuries, which we hope to complete this
year, and the use of children and adolescents in research, which we have
discussed working on early next year. I will provide an update of the
progress of the two IRB studies that are underway so that we can determine
what else we might need to do to provide the kind of report on IRBs that
the administration has requested (see Building Public Trust). We will talk
about current and possible additional contract papers.
Finally, please bring your calendars for the next two months so that we
can determine when it might be possible to have another HSSC meeting,
prior to the next scheduled NBAC meeting, if we find that we need to do so.
Please give me your thoughts and suggestions. I look forward to seeing
you in two weeks.
James F. Childress
Kyle Professor of Religious Studies &
Professor of Medical Education
University of Virginia
Cocke Hall
Charlottesville, VA 22903
Tel. (804) 924-3741
Fax (804) 924-1467
e-mail: [email protected]
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME: 1-JUL-1997 10:52:21.00
SUBJECT: Fireworks and cloning
TO: JoAnn Ward ( CN=JoAnn Ward/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Barbara Walton ( CN=Barbara Walton/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Mary Kay Vaske ( CN=Mary Kay Vaske/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Franklin F. Urteaga ( CN=Franklin F. Urteaga/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Ben L. Trachtenberg ( CN=Ben L. Trachtenberg/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Sandra J. Toomey ( CN=Sandra J. Toomey/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Sheri A. Thornton ( CN=Sheri A. Thornton/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Jeffrey M. Smith ( CN=Jeffrey M. Smith/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Frances Sharples ( CN=Frances Sharples/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Daniel Rochberg ( CN=Daniel Rochberg/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Steven M. Rinaldi ( CN=Steven M. Rinaldi/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Maria R. Reff ( CN=Maria R. Reff/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Andrea 1. Razzaghi ( CN=Andrea I. Razzaghi/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Malini Ramanarayanan ( CN=Malini Ramanarayanan/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Donald Pryor ( CN=Donald Pryor/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Angela Phillips Diaz ( CN=Angela Phillips Diaz/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Lori A. Perine ( CN=Lori A. Perine/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Barbara A. Panko ( CN=Barbara A. Panko/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Elaine R. Padovani ( CN=Elaine R. Padovani/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Timothy L. Newell ( CN=Timothy L. Newell/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Irwin Nepo ( CN=Irwin Nepo/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Stephen G. Moran ( CN=Stephen G. Moran/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Ernest J. Moniz ( CN=Ernest J. Moniz/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Mary E. Mogee ( CN=Mary E. Mogee/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Joann Miller ( CN=Joann Miller/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Monisha M. Merchant ( CN=Monisha M. Merchant/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Jerry M. Melillo ( CN=Jerry M. Melillo/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Alicia McKay ( CN=Alicia McKay/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Deborah J. McGovern ( CN=Deborah J. McGovern/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Jerold R. Mande ( CN=Jerold R. Mande/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Jonathan T. Makler ( CN=Jonathan T. Makler/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Bruce W. MacDonald ( CN=Bruce W. MacDonald/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Martha A. Livingston ( CN=Martha A. Livingston/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Audrey J. Lee ( CN=Audrey J. Lee/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Cecilia D. Lafoe ( CN=Cecilia D. Lafoe/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Jason Y. Kim ( CN=Jason Y. Kim/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Gerald P. Kiernan ( CN=Gerald P. Kiernan/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Henry C. Kelly ( CN=Henry C. Kelly/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Brian G. Kahin ( CN=Brian G. Kahin/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Kerri A. Jones ( CN=Kerri A. Jones/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Carolyn S. Huntoon ( CN=Carolyn S. Huntoon/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Jefferson Hofgard ( CN=Jefferson Hofgard/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Mark D. Hodge ( CN=Mark D. Hodge/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Cheryl E. Hill ( CN=Cheryl E. Hill/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Donald Hillebrand ( CN=Donald Hillebrand/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: David Heyman ( CN=David Heyman/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Beverly K. Hartline ( CN=Beverly K. Hartline/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Gerald J. Hane ( CN=Gerald J. Hane/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Holly L. Gwin ( CN=Holly L. Gwin/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Daniel L. Goroff ( CN=Daniel L. Goroff/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Clifford J. Gabriel ( CN=Clifford J. Gabriel/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Thomas A. Fuhrman ( CN=Thomas A. Fuhrman/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Sybil Francis ( CN=Sybil Francis/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Jonathan Foster ( CN=Jonathan Foster/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Miriam A. Forman ( CN=Miriam A. Forman/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Roxana E. Folescu ( CN=Roxana E. Folescu/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Ruth A. Fisher ( CN=Ruth A. Fisher/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Barbara A. Ferguson ( CN=Barbara A. Ferguson/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Tanya M. Felder ( CN=Tanya M. Felder/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Gerald L. Epstein ( CN=Gerald L. Epstein/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Laura L. Efros ( CN=Laura L. Efros/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Marjorie R. Dial ( CN=Marjorie R. Dial/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Thomas M. Cronin ( CN=Thomas M. Cronin/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Gregg P. Cramer ( CN=Gregg P. Cramer/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Yolanda L. Comedy ( CN=Yolanda L. Comedy/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Sandy L. Cole ( CN=Sandy L. Cole/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Donna I. Coleman ( CN=Donna I. Coleman/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Daryl E. Chubin ( CN=Daryl E. Chubin/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Cynthia M. Chase ( CN=Cynthia M. Chase/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Christina M. Chase ( CN=Christina M. Chase/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Cathleen A. Campbell ( CN=Cathleen A. Campbell/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Rosina M. Bierbaum ( CN=Rosina M. Bierbaum/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Mark Bernstein ( CN=Mark Bernstein/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Deanna M. Behring ( CN=Deanna M. Behring/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: Susan L. Bassow ( CN=Susan L. Bassow/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Samuel F. Baldwin ( CN=Samuel F. Baldwin/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Peter W. Backlund ( CN=Peter W. Backlund/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TO: Lorena E. Ahumada ( CN=Lorena E. Ahumada/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TO: John W. Ahlen ( CN=John W. Ahlen/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TEXT:
Thought that would get your attention! Willing to trade a copy of the
best-selling report "Cloning Human Beings" by the all-time great group,
National Bioethics Advisory Commission, for access to the fireworks for
Science Division intern, Monisha Merchant, and my wonderful
brother-in-law. Also willing to entertain other requests for copies of
the report in exchange for GOOD cloning jokes.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Laura L. Efros ( CN=Laura L. Efros/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME: 1-JUL-1997 10:56:02.00
SUBJECT: Re: Fireworks and cloning
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Rachel,
I believe that last year all the interns were allowed in as a group.
Someone in Admin should be making sure that our interns are included with
the White House interns. As for your brother-in-law, maybe he should
bring a saxophone and pretend he's with the band.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Mark D. Hodge ( CN=Mark D. Hodge/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME: 1-JUL-1997 10:59:24.00
SUBJECT: Re: Fireworks and cloning
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
OK
Rachel E. Levinson
07/01/97 10:53:00 AM
Record Type:
Record
To:
All OSTP Users
cc:
Subject:
Fireworks and cloning
Thought that would get your attention! Willing to trade a copy of the
best-selling report "Cloning Human Beings" by the all-time great group,
National Bioethics Advisory Commission, for access to the fireworks for
Science Division intern, Monisha Merchant, and my wonderful
brother-in-law. Also willing to entertain other requests for copies of
the report in exchange for GOOD cloning jokes.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Susanne Bachtel ( CN=Susanne Bachtel/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME: 1-JUL-1997 11:06:47.00
SUBJECT: Re: Fireworks and cloning
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
I'm already overbooked on my pass, but last year I think they would have
let you in with a couple of extra people. (altho I don't want to be
responsible if they don't make it!)
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Beverly K. Hartline ( CN=Beverly K. Hartline/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME: 1-JUL-1997 11:22:54.00
SUBJECT: Re: Fireworks and cloning
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
Thanks for trying to help Monisha. Unfortunately I won't be in town. Is
there anything else I could do to earn a cloning report?
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN ])
CREATION DATE/TIME: 1-JUL-1997 13:21:31.00
SUBJECT: Re: RE: PCW September Event
TO: RMorgan%[email protected] ( RMorgan%[email protected] [ UNKNOWN 1)
READ:UNKNOWN
TO: [email protected] ( [email protected] [ UNKNOWN ])
READ:UNKNOWN
CC: [email protected] ( [email protected] [ UNKNOWN 1)
READ:UNKNOWN
CC: Bruce W. MacDonald ( CN=Bruce W. MacDonald/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
CC: [email protected] ( [email protected] [ UNKNOWN ])
READ:UNKNOWN
TEXT:
Howard, Tiny, Bruce, Peter et al,
Got the note on the change in the kickoff event for September. I for one
am happier -- thought the other room a little too sterile.
Any other details, send 'em along.
Hugh
PS -- Howard, what about a triple cloning?
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Angela Phillips Diaz ( CN=Angela Phillips Diaz/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME: 1-JUL-1997 11:25:03.00
SUBJECT: Re: Fireworks and cloning
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
wish I could help, but I wont be here; sorry.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Yolanda L. Comedy ( CN=Yolanda L. Comedy/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME: 1-JUL-1997 16:46:14.00
SUBJECT: Cloning
TO: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TO: Clifford J. Gabriel ( CN=Clifford J. Gabriel/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
CC: Angela Phillips Diaz ( CN=Angela Phillips Diaz/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TEXT:
Rachel, Cliff,
May we meet regarding a possible response from PCAST on the NBAC report?
I propose Tuesday afternoon, July 8 (since it looks okay on everyone's
calendar). However, instead of a meeting, you may want to give me
feedback on whether or not PCAST should respond with another letter to
POTUS, and if so, what you think the response should be. Thanks much.
Yolanda
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Yolanda L. Comedy ( CN=Yolanda L. Comedy/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME: 2-JUL-1997 11:32:47.00
SUBJECT: Re: National Bioethics Advisory Commission
TO: Sltaylor33 ( Sltaylor33 @ aol.com [ UNKNOWN 1)
READ:UNKNOWN
TEXT:
Ms. Taylor,
I am sorry that your request was not answered. The most expedient way to
get the report is to call or send a fax to the National Bioethics Advisory
Commission, 301-402-4242 (phone) or 301-480-6900 (fax). The report is
called Cloning Human Beings: Report and Recommendations of the National
Bioethics Advisory Commission.
Yolanda L. Comedy
President's Committee of Advisors
on Science and Technology
Sltaylor33 @ aol.com
07/02/97 11:16:01 AM
Record Type: Record
To: ycomedy
cc:
Subject: Re: National Bioethics Advisory Commission
Dear Ms. Comedy
I thank you for your response to my request for Dr. Shapiro's report of
June 9, 1997 regarding the subject of human cloning
I have not received information from the individual that you indicated may
reply.
I would appreciate your assistance or direction.
My genetics class is hoping to use this information to have a lively
discussion on ethics.
Thank you for your time and guidance.
Susan L. Taylor
[email protected]
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN ])
CREATION DATE/TIME: 2-JUL-1997 11:17:05.00
SUBJECT: Re: National Bioethics Advisory Commission
TO: Yolanda L. Comedy ( CN=Yolanda L. Comedy/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TEXT:
Dear Ms. Comedy
I thank you for your response to my request for Dr. Shapiro's report of
June 9, 1997 regarding the subject of human cloning .
I have not received information from the individual that you indicated may
reply.
I would appreciate your assistance or direction.
My genetics class is hoping to use this information to have a lively
discussion on ethics.
Thank you for your time and guidance.
Susan L. Taylor
[email protected]
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] [[email protected] [ UNKNOWN 1)
CREATION DATE/TIME: 3-JUL-1997 17:38:51.00
SUBJECT: ABAC Report Introduction
TO: [email protected] [email protected] [ UNKNOWN 1)
READ:UNKNOWN
TEXT:
> Ban Human Cloning: Report of the American Bioethics Advisory
>
Commission
>
(Click here for full text)
>
Introductory letter:
>
>
June 21, 1997
>
William J. Clinton
>
President, United States of America
>
>
Washington, DC
>
Dear Mr. President,
>
>
The field of genetics is exciting and promising, but brings with
>
it some serious challenges. The promises and challenges of the field
>
were brought to public attention very dramatically in February this
>
year, with the report from Scotland of successful cloning of a mammal.
>
If the experiment at the Roslin Institute can be repeated, it would be
> an event of immense importance.
>
>
The excitement and joy of this scientific breakthrough (if the
V
experiment can be repeated) may be overshadowed by legitimate and
V
grave concerns about the future, unless this nation and indeed all
V
nations move quickly to protect legitimate science and to ban
V
dangerous and irresponsible abuses. Fortunately, with regard to
>
cloning, the line between the two is very clear: we should encourage
>
responsible experiments in animal cloning, but ban all human cloning.
>
The bright line dividing legitimate and exciting scientific research
V
and development from dangerous and dehumanizing manipulation is easy
V
to see: it is the line between animals and humans.
>
V
To be sure, animal cloning has some hazards, and human cloning
> has some attractions. But the hazards of animal cloning (such as
> possible threats to biodiversity) can be handled responsibly, and the
V
attractions of human cloning (human embryo research) can be foregone.
>
Seeing the bright line, and ensuring that all scientists see it and
>
respect it, will protect legitimate scientific endeavors while
> preventing assaults on human life and dignity.
>
The American people and indeed all people everywhere have a right
>
to the legitimate excitement and joy that accompanies scientific
>
breakthroughs. But the report from Scotland raised grave concerns
>
about the future of humanity. Many people have compared the promise
>
and threat of cloning to the promise and threat of nuclear power. For
>
the good of the nation and the world and science, we must embrace what
>
is good and reject what is evil.
Science and technology throughout the United States and the world
>
will operate under a cloud of suspicion unless we can explain clearly
>
how to distinguish real benefits from momentous harms. Scientists and
>
bioethicists have a grave responsibility to understand the
>
distinctions, to respect them, to articulate them fully, and to
>
communicate them to the general public. Conversely, if any scientist
>
or bioethicist should overlook or blur key distinctions, that person
>
would be doing immense disservice to the nation, the world and to
>
science.
>
In February 1997, you asked the National Bioethics Advisory
>
Commission to help you and the nation to think through an appropriate
>
response to the report of sheep cloning and the prospect of human
>
cloning. They have worked to respond to your request. At the same
> time, the American Bioethics Advisory Commission was established to
>
ensure that the voices of grassroots Americans would also be
>
represented in national debates, and we have also worked to understand
>
how to separate the good from the evil. We are pleased to present this
>
report to you and to all interested individuals. Our advice is very
> simple:
1. Encourage responsible animal cloning.
2. Ban human cloning immediately, completely and permanently.
It is not often in the history of science that a breakthrough
>
brings dramatic promise and grave dangers of the magnitude associated
V
with mammalian cloning. It is the task of the leaders of this nation
> and of the world to embrace the benefits and avoid the calamities. The
V
dividing line is obvious, and we urge you to protect that line
> scrupulously.
>
Throughout the history of this nation, people have pondered te
V
wisdom found in Scripture, including the sharp challenge in the words
> of Moses. He said that the command of God is not mysterious or remote,
>
that it was not up in the sky or across the sea. Rather, it is very
>
near to us, in our mouths and in our hearts; we have only to carry it
>
out. Moses said (Deut 30: 19-20):
"I call heaven and earth today to witness against you: I have set
> before you life and death, the blessing and the curse. Choose life,
> then, that you and your children may live, by loving the Lord, your
> God, heeding his voice, and holding fast to him."
V
>
Mr. President, with regard to the promise and danger of cloning,
>
there is a bright line between the blessing and the curse. Encourage
>
animal cloning, but ban all human cloning immediately, completely and
>
permanently. Hold the line.
>
>
C. Ward Kischer, PhD, University of Arizona, Chairman, American
>
Bioethics Advisory Commission
>
>
Paul A. Byrne, MD, President-elect, Catholic Medical Association
>
>
Ronda Chervin, PhD, Sedona, AZ
>
>
William F. Colliton, MD, Bethesda, MD
>
>
Donald J. DeMarco, PhD, St. Jerome's College
>
>
Eugene F. Diamond, MD, Chicago, IL
V
> Rev. Joseph Howard, Shreveport, LA 71101
>
>
Bernard Nathanson, MD, New York, NY
>
> Dr. Joseph Pastorek II, MD, Louisiana State University Medical Center
>
> Prof Charles Rice, Notre Dame Law School
>
> Dr. Jerome T.Y. Shen, MD, FAAP, University City, MO
http://www.all.org/clon-rep.htm
<BASE HREF="http://www.all.org/clon-rep.htm">
<HTML>
<HEAD>
<!-- Created by AOLpress/1.2 -->
<TITLE>ABAC Report - Introduction</TITLE>
</HEAD>
<BODY>
<HI>
Ban Human Cloning: Report of the American Bioethics Advisory
Commission
</HI>
<P>
<H4>
(<A HREF="clon-txt.htm">Click here for full text</A>)
</H4>
<P>
<H4>
Introductory letter:
</H4>
<P>
<P>
June 21, 1997
<P>
<P>
William J. Clinton
President, United States of America
Washington, DC
Dear Mr. President,
The field of genetics is exciting and promising, but
brings with it some serious challenges. The promises and challenges of the
field were brought to public attention very dramatically in February this
year, with the report from Scotland of successful cloning of a mammal. If
the experiment at the Roslin Institute can be repeated, it would be an
event of immense importance.
The excitement and joy of this scientific breakthrough
(if the experiment can be repeated) may be overshadowed by legitimate and
grave concerns about the future, unless this nation and indeed all nations
move quickly to protect legitimate science and to ban dangerous and
irresponsible abuses. Fortunately, with regard to cloning, the line
between the two is very clear: we should encourage responsible experiments
in animal cloning, but ban all human cloning. The bright line dividing
legitimate and exciting scientific research and development from dangerous
and dehumanizing manipulation is easy to see: it is the line between
animals and humans.
To be sure, animal cloning has some hazards, and human
cloning has some attractions. But the hazards of animal cloning (such as
possible threats to biodiversity) can be handled responsibly, and the
attractions of human cloning (human embryo research) can be foregone.
Seeing the bright line, and ensuring that all scientists see it and
respect it, will protect legitimate scientific endeavors while preventing
assaults on human life and dignity.
The American people and indeed all people everywhere
have a right to the legitimate excitement and joy that accompanies
scientific breakthroughs. But the report from Scotland raised grave
concerns about the future of humanity. Many people have compared the
promise and threat of cloning to the promise and threat of nuclear power.
For the good of the nation and the world and science, we must embrace what
is good and reject what is evil.
Science and technology throughout the United States
and the world will operate under a cloud of suspicion unless we can
explain clearly how to distinguish real benefits from momentous harms.
Scientists and
bioethicists have a grave responsibility to understand the distinctions,
to respect them, to articulate them fully, and to communicate them to the
general public. Conversely, if any scientist or bioethicist should
overlook or blur key distinctions, that person would be doing immense
disservice to the nation, the world and to science.
In February 1997, you asked the National Bioethics
Advisory Commission to help you and the nation to think through an
appropriate response to the report of sheep cloning and the prospect of
human cloning. They have worked to respond to your request. At the same
time, the American Bioethics Advisory Commission was established to ensure
that the voices of grassroots Americans would also be represented in
national debates, and we have also worked to understand how to separate
the good from the evil. We are pleased to present this report to you and
to all interested individuals. Our advice
is very simple:
1. Encourage responsible animal cloning.
2. Ban human cloning immediately, completely and
permanently.
It is not often in the history of science that a
breakthrough brings dramatic promise and grave dangers of the magnitude
associated with mammalian cloning. It is the task of the leaders of this
nation and of the world to embrace the benefits and avoid the calamities.
The dividing line is obvious, and we urge you to protect that line
scrupulously.
Throughout the history of this nation, people have
pondered
te wisdom found in Scripture, including the sharp challenge in the words
of Moses. He said that the command of God is not mysterious or remote,
that it was not up in the sky or across the sea. Rather, it is very near
to us, in our mouths and in our hearts; we have only to carry it out.
Moses said
(Deut 30: 19-20):
"I call heaven and earth today to witness against you:
I have set before you life and death, the blessing and the curse. Choose
life, then, that you and your children may live, by loving the Lord, your
God, heeding his voice, and holding fast to him."
<P>
Mr. President, with regard to the promise and danger
of cloning, there is a bright line between the blessing and the curse.
Encourage animal cloning, but ban all human cloning immediately,
completely and
permanently. Hold the line.
C. Ward Kischer, PhD, University of Arizona, Chairman, American Bioethics
Advisory Commission
Paul A. Byrne, MD, President-elect, Catholic Medical Association
<P>
Ronda Chervin, PhD, Sedona, AZ
William F. Colliton, MD, Bethesda, MD
<P>
Donald J. DeMarco, PhD, St. Jerome's College
<P>
<P>
Eugene F. Diamond, MD, Chicago, IL
<P>
<P>
Rev. Joseph Howard, Shreveport, LA 71101
<P>
<P>
Bernard Nathanson, MD, New York, NY
<P>
<P>
Dr. Joseph Pastorek II, MD, Louisiana State University Medical Center
<P>
<P>
Prof Charles Rice, Notre Dame Law School
<P>
<P>
Dr. Jerome T.Y. Shen, MD, FAAP, University City, MO
</BODY></HTML>
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Angela Phillips Diaz ( CN=Angela Phillips Diaz/OU=OSTP/O=EOP [ OSTP ])
CREATION DATE/TIME:14-JUL-1997 11:41:15.00
SUBJECT: NBAC Report for PCAST
TO: Yolanda L. Comedy ( CN=Yolanda L. Comedy/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
Angela Phillips Diaz ( CN=Angela Phillips Diaz/OU=OSTP/O=EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
let's discuss @ our weekly
Forwarded by Angela Phillips Diaz/OSTP/EOP on
07/14/97 11:40 AM
Angela Phillips Diaz
06/25/97 09:43:40 AM
Record Type: Record
To:
Yolanda L. Comedy/OSTP/EOP
cc:
Subject:
NBAC Report for PCAST
Yolanda:
I would recommend that we get copies of "Cloning Human Beings"
report & recommendations of the NBAC for PCAST. Prior to sending it to
them, we should pull the PCAST letter to POTUS & POTUS response & meet w/
Gabriel, Gwin, & Levinson to determine what action if any we want to
assign to PCAST in the cover transmittal letter. I would welcome your
thoughts/proposals on how to proceed also.
Thanks.
Angela
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:15-JUL-1997 16:30:17.00
SUBJECT: US comments on dr doc, "Econ Aspects of Biot & Human Health"
TO: [email protected] ( [email protected] [ UNKNOWN ])
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TEXT:
Many thanks, Rachel, for transmitting to us the initial US comments on the
draft document, "Economic Aspects of Biotechnologies related to Human
Health". We note that further comments from FDA (via yourself) are to be
expected shortly (18/21 July), but to maintain momentum we are immediately
starting work on the matters raised in your communication of 10 July. (A
week-end and "Bastille Day" have intervened since its arrival).
This covering note is to acknowledge receipt of your communication; to
transmit it (as an attachment to this memo) to members of the Steering
Group (with your agreement, as confirmed by 'phone to-day - thanks); to
make some general comments in response to the points raised; and to
indicate that we are starting on the revisions and additions through
which we propose to meet the concerns expressed. We shall await the
receipt of your remaining comments before dispatching (or placing on the
Electronic Discussion Group) the proposed revised text.
For ease of reference, we have numbered the 25 paragraphs of your memo
(excluding titles), i.e.
Introductory / covering memo: I-4
Comments on Full Report: 5-7
Comments on Revised Exec, Summ. + Linkage Elements: 8-13
Brief Comments on Other Components of the Report:
- Outline of Outreach Policy Doc: 14-16
- Section I: 17
- Section II: 18
- Section III: 19-22
- Section IV: 23-26.
General comments
2) & 3): here and elsewhere, the general question of fulfilment of
objectives requires us to examine the original agreed statement of
objectives. These are summarised in para 13 of the Executive Summary of
the Part I report:
"13. For the first phase of the project, reported in this volume, four
specific objectives were formulated:
1. provide an up to date review of current and forthcoming
developments of
biotechnology in the health care sector, defining some of the key
questions;
2. identify methods currently available to policy makers for the
economic
evaluation of new medical biotechnologies;
3. determine whether there are methodological inadequacies in the
existing
systems of economic evaluation of new biotechnologies, and consider their
implications for the process of innovation;
4. determine whether the use of the various techniques of technology
assessment and economic appraisal is effectively integrated into overall
systems of health care planning and delivery."
The implication that biotech is inherently or inevitably more expensive is
certainly not the intended message; rather, the papers make clear that in
some cases (e.g. EPO), the cost may be more, but it also delivers more -
e.g. in quality of life - for needs previously unmet or less than
adequately treated. In other cases, costs in early stages of an innovation
may be apparently high, but particularly at such stages are not an
adequate basis for confident economic evaluation. (See chapters by
Drummond & Mason, and by Kobelt).
4) As suggested here, we shall seek to met the US points by
modifications
to the Executive Summary and Linkage pages.
Full report
5)-7) The criticisms of excessive length, stylistic inconsistency and
perhaps of disproportion, we hope to meet by the preparation of the two
"Policy Reports" based on the full papers. Regarding disproportion, and
later comments on the length devoted to genetic testing, a general problem
of balance was presented by the impossibility of covering in depth all the
many areas of potential application of biotechnology to health care. Our
selection of case studies was considerably influenced by the prospect of
availability of sufficient documentation. We acknowledge the importance
of subjects such as cloning and fertility treatments, and
xenotransplantation; however, evcaluation did not yet seem possible. At
the same time, the introductory paper on the science and technology was
intended to give a broader "waterfront" coverage of the potential. This
made it more difficult to link this chapter with the case studies selected
for inclusion.
Executive Summary and Linkage Elements
9) We shall add some wording to bring out more clearly the rationale
and
focus of the report.
10) "Some of the roles described for industry seem unrealistic" - this
criticism probably has more force in sone OECD countries than others; we
shall qualify the statements accordingly, using some of the language in
the US comment.
11) We shall reduce the section of the Executive Summary referring to
the
genetic testing.
12) We shall bring forward to an earlier point in the Executive Summary
some
of the related points.
13) The points about greater riskiness are supported by nmaterial in the
Kobelt paper, some elements of which could be inserted in the Executive
summary. The increasing length of time, and cost, of developing and
securing registration for a new product are widely documented, and create
risks for small companies in terms of the greater "lumpiness" of the
business. Recent volatility of stock prices of biotech companies in
response to disappointing results of late-stage (Phase III) trials have
illustrated this. These subjects are treated extensively in Part II
(please see EDG pages).
Outline of Outreach Policy Document
14) Source and context will be clarified.
15) In drafting the full text of the Policy Document, the points about
the
various impacts of biotechnology products on costs will be clarified.
The Science and the Technology
16) It is true that this paper has been drafted separately from the
other
papers; it aims at a reasonably comprehensive overview, whereas the case
studies are selected, and few in number. Also, a major criterion in the
selection was the availability of sufficient historical data to make some
evaluations and judgements; thus militating against the inclusion of
leading edge areas such as gene therapy, for which it could not yet be
realistic to carry out serious economic evaluation except in the broadest
terms (e.g. of scale of unmet need). Some sentences to clarify the
relation between the first and subsequent sections will be added in the
Executive Summary.
Section I
17) Agreed - this section is fundamental to the whole report, and we
shall
examine whether this could be more clearly emphasised in the Executive
Summary or first Linkage pages.
Section II
18) We feel that the comment is not entirely fair to Murray's paper.
The
section is not seeking to provide an overview and appraisal of the state
of development of recombinant vaccines, but does address a number of other
important economic / policy issues, where there is a large unmet need,
predominantly in developing countries; and where the number of companies
participating in development work is obviously greater than the likely
number of "winners" in terms of successfully arriving at a commercially
viable product. We shall seek in the linkage pages to clarify the
rationale and relevance.
Section III
19) et seq: The length devoted to this topic may in part reflect the
interests of the authors - but Dr Battista by background, present
responsibilities, and his presidency of ISTAHC highly qualified to make
these judgements, and as Secretariat we were therefore reluctant to fight
strongly against them, the more so given the high public and political
interests shown in these applications of modern biotechnology.
22) Historically and currently, most clinical applications of genotypic
diagnosis have been applied for single-gene disorders which have high or
100% prognostic reliability. More recently, there has arrived a number of
genes more associated with propensity, or forming only partial or
contributory factors, e.g. in multi-factorial phenomena. It is indeed
this shift from patterns of "inevitability" to a more complex and
troubling proliferation of information relating to propensities which
gives rise to harder problems of economics, ethics and clinical
counselling practice, and hence of policy. These complexities of course
partly explain the length of this chapter.
Section IV
23) See remarks above about selection of case studies for which
documentation was available.
24) Biotechnology augmenting quality of life - we agree with this
point, and
will seek to augment the Executive Summary to strengthen this further.
25) IPR aspects are treated in Part II of the report; we shall consider
incorporating a suitable cross-reference to this.
26) We acknowledge that there may be some redundancy with Drummond &
Mason's
short paragraph on GCSF; but here it facilitates the reading of the
chapter as a coherent whole.
We await your further comments, which we shall seek to address also, and
then distribute a revised (marked) text via the EDG.
Date: Tue, 15 Jul 1997 21:41:00 +0200 (MET)
From: "Mark CANTLEY, STI/BIO"@mr.oecd.org
Subject: Comments on Economic Aspects of Biotechnologies
MIME-version: 1.0
Content-type: TEXT/PLAIN; CHARSET=US-ASCI
Posting-date: Tue, 15 Jul 1997 00:00:00 +0200 (MET)
Al-type: DOCUMENT
E-mail from Rachel Levinson of US Office of Science and Technology Policy
to M. Cantley and E. Ronchi of OECD, also to C. Nee of US Delegation to
the OECD
Object: Comments on Economic Aspects of Biotechnologies
Message Creation Date was at 10-JUL-1997 16:00:00
1) The attached document represents our initial comments regarding the
draft document, "Economic Aspects of Biotechnologies Related to Human
Health." I will receive another set of comments but felt that it would
be appropriate to forward these, given time constraints. The FDA expects
to finish its comments by the end of next week. Their initial comments on
the introduction are very positive.
2)I am most concerned that the current document does not accomplish the
goal we originally set, that is, in an international context, how do human
health products produced through biotechnology rate when compared to
other, more traditional forms of therapy.
3) The current document, in some cases, perpetuates the notion that
biotech is more expensive, without supporting documentation, or implies
that safety concerns justify a more rigorous ( and thus more expensive)
regulatory review.
4) I believe that certain adjustments addressed in detail in the attached
comments can help to improve the document and correct certain
misperceptions or inaccuracies. As I have discussed with Elettra and
David Harper, it is my understanding that such corrections would
accomplished via the Executive Summary and the linkage pages, rather than
editing the contract papers. I hope that it will be possible to take an
intermediate approach that will improve the final document without taking
such a long time that its usefulness is diminished. I realize that I have
been tardy in delivering comments and apologize to you and the WPB.
U.S. Comments on the OECD Report on
!&The Economic Aspects of Biotechnologies Related to Human Health!8
Comments on the Full Report
5) In its present state, the report is a compendium of papers developed by
numerous contractors. As a consequence, it is much too long, gives
disproportionate emphasis to some subjects, and provides insufficient
discussion of others. It could greatly benefit from the attention of an
editor with an understanding of the report!,s objectives and content, who
can impart brevity, substantive balance, and stylistic consistency.
6) Implied in the stated objectives of the report is the notion that it
will allow policy makers in OECD member countries to improve their own
approaches to the assessment and economic appraisal of new technologies.
Yet, the treatment of economic issues is actually quite superficial and
the report contains little quantitative analysis, and thus may be of
limited utility to those who must study these issues thoughtfully.
7) In addition, considering all of the products and activities that the
!&new!8 biotechnologies have yielded, the report focuses
disproportionately on genetic testing. Genetic testing is a significant
development fraught with ethical and scientific considerations, but it is
certainly not the most important development from an economic point of
view. Some attention is given to gene therapy, monoclonal antibodies, and
vaccine development, but these discussions seem limited relative to the
portion of the document devoted to genetic testing. Regarding these
products, the emphasis of the report is on their economic impact relative
to disease management and prevention, and almost no attention is given to
the other ways in which these products benefit national economies, such as
through the revenues associated with their patenting, licensing, and
sale. Other products of biotechnology with important health and economic
consequences and promise are virtually ignored, including reproductive
technologies (e.g., cloning, fertility treatments), genetically-engineered
tissues for transplantation, genetically-modified animal models for human
disease, animals engineered to yield xenotransplantable tissues and
organs, and so on.
Comments on the Revised Executive Summary and Linkage Elements (Dist.
02-May-1997, doc # 51579)
8) One goal of the Executive Summary should be to convey succinctly the
content of the full report, which it does successfully for the most part.
Although it mirrors some of the problems described above, it also corrects
some of the imbalance within the individual papers, many of which provide
excessive content on scientific and ethical considerations. The Executive
Summary gives the reader a stronger sense of the objectives of the project
and its economic focus than does the sum of the individual papers.
9) It would be helpful if the summary could give more attention to the
rationale for the focus of the report. In other words, it should explain,
!& Why biotechnology?!8 An underlying concern seems to be that the
products of biotechnology are somehow more costly than other forms of
technology used in health care, and therefore countries should give
special attention to their costs when considering their approval or
reimbursement for their use. One could argue, however, that the most
expensive health care interventions generally have little to do with the
!&new!8 biotechnologies as defined in this report. The report does
suggest that biotechnologies have a harder time getting approved due to
concerns over safety, but this observation does not speak directly enough
to relevant economic questions. Thus, some additional justification for
the report!,s focus would be useful.
10) Drawing on the Drummond and Mason paper, the Executive Summary
suggests some roles for government and individual companies in developing
economic evaluations of biotechnology products. Some of the roles
described for industry seem unrealistic. For example, one bullet in
paragraph 55 states, !&governments should ensure that biotechnology
companies, particularly the smaller ones, are aware of the potential need
for economic evaluations [of biotechnology products] and are well
prepared.!8 In fact, many companies would argue instead that, in a free
market, the only reasonable economic considerations relate to the demand
for those products and whether they will recover their development costs
and make a profit, given whatever prices the market will bear. It is
probably not reasonable to expect companies to have macro-economic
considerations in mind when developing new products. The reasons for the
emphasis on !&small companies!8 and the meaning of being !&well
prepared!8 as used in the sentence cited above are both completely
unclear.
11) Because it reflects the imbalance of the full report, the Executive
Summary focuses excessively on genetic testing, and delves further into
issues of discrimination and privacy than is warranted for a paper on
economic matters. Much attention is given to the conceptual framework for
considering various types of genetic tests (and the diseases they
identify), which might indeed be useful in a different sort of paper, but
is once again too far removed from the supposed thrust of this piece. In
addition, genetic testing takes place in both clinical and research
settings, with different implications relevant to each. The lengthy
classification scheme does not address this distinction.
12) The segment on genetic testing is then followed (beginning with
paragraph 86) with a section titled, !&Is the biotechnology industry
under-estimating risks, and over-estimating success? Who pays for
innovation?!8 This important and very globally-stated question seems
like a non sequitur after the protracted and very specific discussion of
genetic testing. The subsequent text then presents a very limited and
unsatisfying discussion. A broader discussion of this question belongs
somewhere earlier in this report.
13) The Executive Summary is followed by a series of !&Linkage!8 pages
to other sections of the report. The purpose of these pages in terms of
the overall organization of the report is not clear. The first linkage
page asserts that !&the pharmaceutical business has become more risky, !8
yet the report doesn!,t support this statement in any way. Do company
financial statements or stock prices bear this out? Drug development has
always been considered a process entailing a high degree of risk, but one
could argue that new techniques (combinatory chemistry) and new strategies
(developing !&me too!8 drugs) have increased the yield and lessened the
risk of drug development somewhat. It is generally the !&new!8
biotechnology pursuits of these companies, I believe, that inject an added
element of risk, but this phenomenon is not explicitly addressed in this
section.
Brief Comments on Other Components of the Report
!&Outline of an Outreach Policy Document!8 (Dist. 29-Apr-1997, doc. #
51466)
14) M Page 6, Figure I This purports to show !& The total biotechnology
industry by market segment,!8 but the context is not clear. Does this
chart portray the situation for the U.S. or the world?
15) M Page 10, paragraph 16 The assertion made here (as is often made in
other settings) is that new technologies increase the costs of medical
care expenditures. While this is true of some technologies, particularly
those associated with end-of-life or heroic treatments, the specific case
of biotechnology is different and needs special consideration. One goal of
biotechnology, for example, is to enable large-scale production (generally
through genetically modified bacteria) of pharmaceutical products that ot
herwise would be produced synthetically in much smaller quantities, and
thus more expensively.
!&Biotechnology and the New Revolution in Health Care and
Pharmaceuticals: The Science and the Technology!8 (Dist. 01-Apr-1997,
doc. # 50237)
16) M This paper presumably is intended to provide the background on the
scientific aspects of the !&new!8 biotechnologies to allow lay readers
to understand the types of technologies being discussed. Yet, it seems to
have been drafted in isolation of the other papers, and thus the topics do
not correlate well with those discussed in the rest of the report. For
example, it describes much of the science behind somatic cell therapy, the
economic consequences of which are barely discussed elsewhere. Somehow
this paper need to be better integrated with the other papers (or
vice-versa).
!&Section I: Economic Evaluation The Challenge, the Need, and the
Problems!8 (Dist. 01-Apr-1997, doc. # 50239)
17) M This section is seems to be reasonably well prepared and presents
the thrust of what the paper as a whole should be about. Proportionately
more attention should be given to this material than to the other sections
of the report.
!&Section II: Economic Evaluations of Immunisation Programmes: The Case
of Hepatitis B Recombinant Vaccine!8 (Dist. 03-Apr-1997, doc. # 50344)
18) M The report would be strengthened if recombinant vaccine development
were addressed more generically, and less attention were devoted to this
case example (or the case were placed in an appendix). It may simply be
that the state of recombinant vaccine development is such that there just
isn!,t enough generalizable knowledge in this area to discuss it at
length. Nonetheless, this paper is longer than it needs to be.
!&Section III: Using Genetic Information: In Testing and Diagnosis!8
(Dist. 02-Apr-1997, doc. # 50290)
19) M As stated at length previously, disproportionate emphasis is given
to this topic, and this paper should be much shorter. It is also requires
better organization and editing for accuracy and redundancy.
20) M Page 2, paragraph 5 states !&the issues surrounding genetic testing
are rife with potential conflicts of interest.! While this is an issue
fraught with ethical considerations, !&conflicts of interest!8 are a
minor consideration compared to issues of privacy and discrimination (all
of which are tangential to the subject of this report).
21) M The Introduction (pages 5 to 7) does not provide very useful
information.
22) M Page 8, paragraph 35 states, !&genotypic diagnosis is inherently
prognostic.!8 In fact, the opposite is true, and this is in part why
genetic testing presents so many ethical dilemmas. There is concern that
clinicians and patients will make treatment decisions and other important
choices based on clinically equivocal genetic information. A case in
point is the BRCA-1 gene, which was initially presumed to a fairly high
degree of prognostic significance. Additional studies have shown,
however, that the presence of BRCA-1 is much less predictive than
originally believed, and thus its utility in clinical decision-making is
in question.
!&Section IV: Lessons from the Process of Adoption of Two Biotechnology
Breakthrough Drugs: EPO and GCSF!8 (Dist. 02-Apr-1997, doc. # 50291)
23) M As with other case examples, this one should be shorter and/or
included in as an appendix item.
24) M This paper appropriately devotes attention to quality of life, which
is difficult to measure, and yet one of the most vital considerations in
determining the value of new technologies. Many technologies,
particularly those that prolong the end of life, not only lead to
tremendous cost, but add little in terms of quality of life. The promise
of many biotechnology products is that they do augment quality of life,
but insufficient attention is given to this in the Executive Summary and
in the other cases.
25) M Page 9 gives attention to the important issue of intellectual
property. More attention could be devoted to this topic elsewhere.
26) M Pages 22 to 23 provide unnecessary and redundant information on the
science behind CSF technology.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ([email protected] [ UNKNOWN ])
CREATION DATE/TIME:16-JUL-1997 20:12:33.00
SUBJECT:
TO: [email protected] ( [email protected] [ UNKNOWN ] )
READ:UNKNOWN
TEXT:
Please be apprised that as of today all requests for the cloning report
should be forwarded to
Robert Tanner
NBAC
6100 Executive Blvd * Suite 5B01A
Rockville, MD 20892
fax: 301.402.0906
email: [email protected].
Thank you for your cooperation.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN ])
CREATION DATE/TIME:17-JUL-1997. 18:24:09.00
SUBJECT: Re: your mail
TO: [email protected] ( [email protected] [ UNKNOWN 1)
READ:UNKNOWN
TEXT:
Rob:
What is the status of getting a "printed" (and bound) version of the
report (and in smaller than 8.5 X 11" format)?? Is that still going to
happen or just duplicate the "pre-print version" forever?
Alex
On Wed, 16 Jul 1997, Tanner, Rob wrote:
> Please be apprised that as of today all requests for the cloning report
should be forwarded to
Robert Tanner
> > > > > > > > > >
NBAC
6100 Executive Blvd * Suite 5B01A
Rockville, MD 20892
fax: 301.402.0906
email: [email protected].
Thank you for your cooperation.
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: [email protected] ( [email protected] [ UNKNOWN 1)
CREATION DATE/TIME:18-JUL-1997 09:13:40.00
SUBJECT: Ehler's Bill Markup
TO: Jeffrey M. Smith ( CN=Jeffrey M. Smith/OU=OSTP/O=EOP [ OSTP ])
READ:UNKNOWN
TEXT:
Jeff,
The Technology Subcommittee will be marking up the Ehlers bill to ban
cloning using federal research (HR 922, "None of the funds made
available in any Federal law may be expended to conduct or support any
project of research that involves the use of a human somatic cell for
the process of producing a human clone." - the active phrase in the
bill) The legislation is referred to the Commerce Committee and the
Science Committee, and the Commerce Committee apparently has no plans to
move at this time.
We would like your input on what you would like to have done with this.
Also, does this go beyond the EO already in force = what is the
additionality of this legislation? Let me know.
Also, we are moving the computer security bill in the Technology
Subcommittee as well that day - HR 1903.
Mike Quear is the contact on cloning and computer security (225-6917).
Hasta
Skip Stiles
Democratic Legislative Director
House Committee on Science
822 OHOB
Washington, DC 20515
(202) 225-8483
(202) 2260983 (fax)
committee home page - http://www.house.gov/science_democrats/
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Gerald J. Hane ( CN=Gerald J. Hane/OU=OSTP/O=EOP [ OSTP 1)
CREATION DATE/TIME:18-JUL-1997 11:10:38.00
SUBJECT: Dr. Mori's visit with JHG
TO: David Heyman ( CN=David Heyman/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TO: Deanna M. Behring ( CN=Deanna M. Behring/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TO: Laura L. Efros ( CN=Laura L. Efros/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TO: Cathleen A. Campbell ( CN=Cathleen A. Campbell/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
TO: Kerri A. Jones ( CN=Kerri A. Jones/OU=OSTP/O=EOP @ EOP [ OSTP ])
READ:UNKNOWN
CC: Gregg P. Cramer ( CN=Gregg P. Cramer/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
CC: Gerald L. Epstein ( CN=Gerald L. Epstein/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
CC: Rachel E. Levinson ( CN=Rachel E. Levinson/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
CC: JoAnn Ward ( CN=JoAnn Ward/OU=OSTP/O=EOP @ EOP [ OSTP 1)
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CC: Bruce W. MacDonald ( CN=Bruce W. MacDonald/OU=OSTP/O=EOP @ EOP [ OSTP 1)
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TEXT:
From 8:30 -9:05 am Dr. Mori visited with Dr. Gibbons in room 424. Dr.
Mori was accompanied by Japan's Science Counselor, Mr. Kuramochi.
Three subjects were discussed, 1) the Carnegie G7 meeting which Dr.
Gibbons did not attend, 2) the timing of the JHLAP and JHLC meetings in
1998, and 3) Dr. Mori's desire to press certain medical science issues in
Japan.
CARNEGIE G7
CERN/LHC
Dr. Mori noted that CERN and the LHC was an "important" subject of
discussion. European representatives expressed concern that they did not
have enough money to complete this project and were asking for Japan and
the U.S. to increase their contributions.
Dr. Gibbons noted that we had just finished working with Congress to
secure the funds that we had promised. He noted that Congress was keeping
close scrutiny of U.S. participation and was particularly interested in
ensuring some sort of a quid pro quo.
-
ITER
Dr. Mori indicated that ITER was not a major topic of discussion. He
noted that both Italy and Canada, which had expressed interest in being an
ITER site earlier (?) were rather subdued. (Japan, as you know, as
postponed any major increases in funding for about three years.)
Dr. Gibbons noted the importance of keeping fusion energy alive as an
option for the future.
-
Human Cloning
Dr. Mori noted that Ministers agreed that cloning a "human" was not
acceptable science. They did feel, however, that cloning human cells was
important for medical research. The French Minister raised the idea of
all nations agreeing on a law to ban human cloning, but others responded
that this would be best addressed within the context of each nation.
Dr. Mori noted that he has suggested to Prime Minister Hashimoto that
Japan establish a Bioethics Commission to examine this and other issues.
The Prime Minister was supportive, but the bureaucracy has been slow to
move.
Dr. Gibbons noted that the selection of individuals on such a Commission
was very important in the U.S. to ensure its credibility. He also noted
that Harold Shapiro of Princeton might be a useful source of advice for
Japan on this matter.
-
Natural Disasters
Dr. Mori said that natural disasters were also discussed at some length,
particularly earthquakes. Bob May of the UK was still optimistic about
the future of earthquake prediction.
-
Science Summit
Dr. Mori reported that they discussed the idea of a "Science Summit" to
give the meeting more visibility and impact. He noted that the down side
would be that this would formalize the meeting and participants would lose
some ability to have free discussions.
Dr. Gibbons said that he was intrigued by this idea and that it deserved
further discussion. He sensed value in increasing the visibility of this
event. He also noted that we should work to more fully integrate science
in the leaders meetings, such as G7, and pointed to the inclusion of
emerging infectious diseases in the last G7 summit.
JOINT HIGH LEVEL COMMITTEE (JHLC) /JOINT HIGH LEVEL ADVISORY PANEL
Dr. Mori noted that although he had hoped to have the Advisory Panel
meeting before the October JHLC meeting, the Ministry of Foreign affairs
balked at this idea. He said that they are now hoping to convene the
advisory panel early next year and conveyed the hope of the Ministry of
Foreign Affairs that the U.S. would host the JHLC meeting next
spring/summer.
Dr. Gibbons said that we would consider this.
EXPANSION OF COOPERATION IN HEALTH/DISEASE
Dr. Mori commented that he was in the U.S. now for the U.S.-Japan Medical
Sciences Agreement, which has a 30 year history of promoting successful
collaboration. He also noted that Prime Minister Hashimoto has a
particular interest in the area of health and proposed a Human Caring
Society activity in the G7 (this includes EIDs and aging at this time as
well as consideration of how to ensure the welfare of the people.) Dr.
Mori would like to build stronger cooperation with the U.S. in this area.
He thinks that the activities of the U.S.-Japan Medical Sciences Agreement
could be used as a core of this more highly visible initiative, and asked
for Dr. Gibbons' support.
Dr. Gibbons expressed his support and agreed to help as needed.
END
RECORD TYPE: FEDERAL (NOTES MAIL)
CREATOR: Donna I. Coleman ( CN=Donna I. Coleman/OU=OSTP/O=EOP [OSTP])
CREATION DATE/TIME:21-JUL-1997 12:15:31.00
SUBJECT: Re: Phone Message from Bill Raub
TO: Alicia McKay ( CN=Alicia McKay/OU=OSTP/O=EOP @ EOP [ OSTP 1)
READ:UNKNOWN
TEXT:
Alicia,
I am assuming this message is for Rachel. Am I correct?
dic
From: Alicia McKay on 07/21/97 11:39:12 AM
Record Type: Record
To:
Donna I. Coleman/OSTP/EOP
cc:
Rachel E. Levinson/OSTP/EOP
While You Were Out
While You Were Out
Contact:
of:
Phone:
FAX:
Bill Raub
DHHS
202/690-5874
Message:
Contact: Bill Raub
Company: DHHS
Phone: 202/ 690-5874
FAX:
Message: Would like to speak w/ you Re: the mark-up on Rep. Ailer's (sp)
cloning bill.