DEPP.F!TMC:NT OF tiEALTt-1. EDUCATION, AUD Vv'ELFARf

               PuaLic HEALTH SE-HVICE:
           NATIONAL INSTITUTfS. Or HPALT -I
               f3E.TtlESDA 'v1ARYLAND 20014

August 23, '1976

Daniel E. Koshland, Jr., Ph.D.
Professor of Biochemistry
University of Cal -ifornia
Berkeley, California 94720

Dear Dan:

Following your cal' today regarding the proposed Academy Forum on

It is extremely important that this meeting be structured with several
things in mind.
controversy over recombinant DNA research.  This includes the recommenda-
tions of an NAS Cormittee in 1974 to:
the time being, (2'1 ask NIH to develop guideline:i, and (3) hold an
international conference on the subject. Having sponsored the Asiloniar
Meeting, NAS then t\pproved and recomiended the temporary guidel ines
which resulted.

'$; Me? "Plasmid -- Engineerirg," I have mused further on its implications.

First is the historical role of the Academy in the

(1) defer certain experiments for

&JCOEJ   Second, there are the substantial developments which have occurred in the
Cofiko@fLt$ past year. These include:
obiqechcq  succeed those of Asilomar and which have been forwarded to the Academy
il"'&ctcto  with a request that they be considered and endorsed by HAS, (2) steps
QLF~..~   taken by NIH to foster greater awareness of the Smplications of these
J) s~qt   guidel ines by other government agencies , the private sector of research
3) Ed-@ , and development, and by the general public, (3) the Cambridge City Council

hearings, and (4) 3 considerable rash of comnients, letters, and articles
in the scientific and public media.  Within the next several weeks, NIH
will also publish 8 compendium of background material and public comnentary
relevant to its guidelines. We expect our environmental impact statement
on the guidelines will appear in the Federal Register of September 2, A
decision on patent policy concerning recombinant DNA will follow, probably
in early October.  During September avd October, an interagency cornmjttee
will develop recommendations for control of DNA research throughout the
Federal Goverment and throughout the nation.
Canada, EMBO, and possibly WHO and ICSU will also have made recommendations.

(1) issuance of the HIH guidelines which

In this same period,

Page 2 - Daniel E. Koshland, Jr., Ph.D.

I emphasize these developments because they all represent official actions
in regard to recombinant DNA which have been, and still are, matters
requiring full public awareness and debate. They offer substantive issues
about which further exposition and debate can be structured and thus
opportunity for elilvating discussion above the plane of personal prejudice
and passions where much of the discourse on plasmid engineering unfortunately
continues .

Third, there is the essentiality that the Forum provide greater evidence
of competence to achieve effective debate on delicate scientific questions.
The exercise on Huinan Experimentation, despite our hopes, failed to do this,
and we have to imp:..ove upon this example.  On the topic under ccnsideration
the Academy can crzate a public platform different from those used by NIH
to evaluate the measures evolving to contend with recombinant research.
This discussion, held on non-governmental territory, can be beneficial to
a1 1 concerned.

I stress, then, that events have moved far beyond the speculative days of
Asilomar.  Reasoned critique of these latter day actions are needed-outside
the government, as well as within.  The debaters must be held responsible
for making an informed analysis of these events. If this is so, the process
can be enormously helpful.
reiteration of adversary, personal speculations upon the benefits and
hazards of plasmid engineering will be destructive of public opinion of
the possibilities for rational  internal and external governance of science.

The mere provision of another stage for

f have several thoughts about details.  If you accept that the participants
(who should includ,p other than those of us in daily confrontation with this
problem) must be highly informed, time is critical.
Forum would be advisable.  You should carefully consider alternatives, such
as a date in February, which is the anniversary month of both the Asilomar
and the NIH DAC meetings.  The virtue inherent in an ideally prepared Forum
outweighs serving a preconceived schedule that forces premature development
of so difficult a topic.

A later date for the

Finally, I also believe it quite unwise to propose anything but a competely
open meeting.
The main purpose should be to offer opportunity for public airing of the
complicated matters involved.

Closure cannot be justified, given the nature of this subject.

%Page 3 - Daniel E. Koshland, Jr., Ph.D.

Recombinant DNA is no longer a field for practice scrimmage.
including the Acadcmy, can afford to fumble.
early September meeting, I understand that Maxine Singer will be there
and I hope Joe Perpich will be able to come, too.
cooperate fully with you, provide background information for all participants
and otherwise be as helpful  as we can.

         None of us,
Although I cannot make your

  Certainly we will

Best wishes,

Sincerely ,

VL-

Donald S. Fredrickson, M.D.

cc: Dr. Perpich

Dr. Singer
Dr. Robert Glhite