. . . The telephone rang about nine- [it was] Bill Rutter (Professor of Biochemistry, UCSF) telling me that the Somatostatin
experiments (by H. Boyer in his department) were now "all o.k. with the University, a matter of some "sloppy paperwork"
having accounted for the earlier reports that no permission had been granted by the Institutional Review Board for the tour-de-force
of programming E. Coli to make this small peptide. The plasmid contained an artificial gene for B-galactosidase-Met-Somatostatin.
Thus the protein product had no biological activity (somatostatin having no Met, yet it could be easily split with cyanogen
bromide. No Memorandum of Understanding (MUA) had been sent to NIH because Genentech "had paid for it by contract",
yet there was this little matter of no MUA being completed and filed with the local IRB . . .
The hearings were held in Dirkson 5110, a room that was new to me, with its sail boats, model train, and other toys of commerce
in a case on one wall. The chairman, Senator Adlai Stevenson III, had sent an excellent letter of invitation, in which sensible
question followed sensible question, no tricks; indeed his orientation was my own, no proposal of excessive legislation like
that contained in S 1217 or HR 7897--the bills which had innocently begun in our Interagency Committee and then grown malignant
by the ambitions of Ted Kennedy or the well-meant excesses of the House Committee.
With Stevenson was the Senator-Astronaut, Harrison Schmitt from New Mexico, an engineer who was a staunch apologist for science
and forgiver of the sins of the practitioners yet his friendly asides today would not be enough to save us from Adlai's
utterly fair, persistent, legal briefs that edged slowly, persistently into the damning facts of the 'California Caper'.
The 'crime', mind you, was not Boyer's somatostatin, but Rutter's cloning of the insulin gene using a pBR320,
an uncertified E. Coli vector. How to explain the slow discovery of this--or the fast discovery and slow reaction, which
ended in the destruction of the clones and then the beginning all over again in with another vector in April 2? Or the mysterious
months of delay in telling the IRB at UCSF? The inadequate report of the IRB to NIH and our learning about this only because
Wade called us from Science--all this was what Adlai wanted to know.
The hearing began calmly enough, with Frank Press, the President's Science Advisor, accompanied by his Deputy, Gil Omenn,
as the first witnesses. Hardly off to a start, both veered off the road onto a soft shoulder and began talking about an "Administration
Bill" and about other alternatives. Frank invited me to sit with them and I soon found myself answering some of the
questions thrown to them. I noticed the Chairman's eyebrows indicating that he wished I had not accepted Press'
invitation. I got much more uncomfortable as I heard the Science Advisor plumping for legislation and suggesting that the
answers were all there in that "Administration Bill". Is it possible he didn't realize the good version of that
bill was dead and replaced by new bills far less benign? Frank had to leave and was accorded a "thank you" from
the Chairman that was less than effusive.
My turn next, I began reading from those few spots in my prepared testimony that did not already lie at the feet of the stenographer
shredded by previous testimony. As I went over the reasons why we rejected a regulatory agency role for NIH, Senator Stevenson
began to sigh. This sign of unrest was soon followed by gathering storm of questions about certification of plasmids, including
the exact wording in new and proposed guidelines concerning this process. Then he pursued with me intimate details of the
UCSF story, details I had not mastered for this hearing. . . I had determined not to try to excuse NIH at this hearing, emphasizing
that we were "going to demand a full report from UCSF about a story that however painful, had not resulted in any serious
biological consequences, only "injury to administrative process." We would never be able, and were determined not
to respond like a regulatory agency. Gartland with his staff of one, usually keeping no records of telephone calls, Hans
Stetten forgetting until October that he had a telephone call [from Rutter] about some plasmid in March, etc. , and all the
rest of the innocent peccadillo. We all knew instinctively that statutes or regulations would not work to govern laboratory
science. Now, however, we will be plagued for our innocent assumptions, for thousands of hours of painful meetings, the creation
of the EIS, the thoughtful poring over version after version of new guidelines, the necessity of keeping calm in the face
of the hysterical and the exploitative, and accepting the cries of scientists who hate all these processes. Is all of this
going to be for nothing because of one uncertified plasmid?
Our appearance is held up by a whistle-stop appearance by Margaret Mead, stick-in-hand, her fine head bowed over a hastily-prepared
and confusing text . . . a grand old scold railing away at "too much research, " "too little research", "a
world in danger", but exactly from what we are not sure. We return to the stand, Omenn still hanging with me.
I . . . know that someone must take the heat for the revealed misbehaviors in the university. It will have to be the NIH
Director . . . The Senators fuss with their notes, and one- by-one the sailboats in the case appear to capsize in the rising
wind. My diary will later record the rambling thoughts at the time, overblown phrases to the effect that this is the worst
hour of "proximal self-governance". . . and the "voluntary self- policing role of science".
We finally are released about 12:30. The staff who remained later told how Rutter and Boyer, in their turn, were taken through
a step-by-step account of what they had done. Sen. Stevenson's final admonition to them made clear that if this brings
regulation and laws, gentlemen, your actions will have brought this upon all of your peers.
I make several resolves after this, the most hostile and embarrassing hearing I have had so far. One is not to be driven
by depression into smoking again. A second is to deal with the heads of the universities on MDA's and the similar matters
on which rested the survival of the guidelines. Scientist-to- scientist understanding has led to a near defeat. We shall
have to sharpen implementation in the revised guidelines due in December. And we either must have some kind of benign preemptive
law in 6 months, or we will have to abandon this attempt to devise self-regulation. It's vain to place all hope in the
behavior of scientists.
Yesterday, Vie Cohn wrote a piece for the Post based on the EIS. It was, for him, a fair piece leaving the readers with a
sense that NIH was acting responsibly, if a bit deliberately, (considering that over a year has been spent in wrangling over
the revisions. At last the EIS is out, available for Justice to use in defending us against the Friends of the Earth (the
second circuit court in N. Y. C.) and Mack in Frederick, MD.
There were some interesting events after the Stevenson hearings. Philip Handler's public testimony before Stevenson adopted
the Quixote-stance of a First Amendment privilege for science. [ I had publically jettisoned this wistful theme earlier before
an audience of scientists at Columbia, only a few diehards like Gerhard Piel ever defend it anymore in public.] Then in camera
Handler went before the Executive Committee of Life Sciences to urge them to write a resolution demanding NIH to make a full
inquiry of UCSF. Robert Berliner telephoned and Norton Zinder came by later to tell me how close the Committee had come to
passing such a resolution. They had also queried Hans Stetten at the meeting. Hans had sought my opinion, and I urged them
not to take such action, because, while NIH might find it comfortable to make a spectacle of UCSF at demand of the Academy,
it would then be too easy for Senator Kennedy's staff or other hawks to use the NAS declaration to have a public inquisition,
with a resulting mass auto-de-fe of Boyer, NIH and voluntarism. Of course, Page 60
the anomalous NAS position of "no-law-is-needed, but take-the- grants-away-from-the-rascals" is an untenable one.
We will have to find a gentler way to achieve uniformity and one way is to get tougher in our revisions. Yesterday Halvor
Halvorsen sat across the 'Rembrandt Table' in my office. Hal was seeking the shadow of a window bar to keep the bright
sun from his blue Scandinavian eyes. His scruffy beard meets sideburns, giving him a somewhat seedy look, yet like someone
out of an Ibsen drama. Hal is ambitious to play a national role in this recombinant madness, and he has been very effective
this year. He's steadfastly stood up for reasonable legislation, and I agree with him. Page 60.
I think we must get Burke Zimmerman to rake through the ashes of bills previously drafted to learn if Paul Rogers will back
an appropriate kind of bill. Maybe we could get Harley Staggers [Chairman of the House Interstate Commerce Committee of which
Rogers Health Committee is a part] with him. We should try the Senate route (even with Kennedy?). Rogers was at NIH on
Monday. I brought him to my office and, over coffee, we chatted about centers. I did not raise the issues of Guidelines
or statutes. This weekend I had to turn to a paper on science funding--grants to centers--where there is a mounting need
for answers to some other complex problems.