Synbio is a diverse field with diverse applications, and the different contexts (e.g., gain-of-function research, biofuels) raise different ethical and governance challenges. The objective of this course is to increase learners’ awareness and understanding of ethical and policy/governance issues that arise in the design, conduct and application of synthetic biology. The course will begin with a short history of recombinant DNA technology and how governance of that science developed and evolved, and progress through a series of areas of application of synbio. Content will be presented in many forms, including not only reading and lectures, but also recorded and live interviews and discussions with scientists, ethicists and policy makers. Learners will have the opportunity to think, write and talk about the issues and challenges in their own work and in real-life case examples. A final project will engage students in the development of governance models for synbio.
Interview: Dr. LeRoy Walters (Part 1)
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From the course by Johns Hopkins University
Engineering Life: Synbio, Bioethics & Public Policy
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From the lesson
Recombinant DNA Technology: Science and History
We start the course by learning a bit about the history and context of the development of recombinant DNA (rDNA) technology in the 1970s, the ethics and policy issues raised by that science, and how those issues remain with us today in synthetic biology. The work of the week includes lecture videos, readings, and an interview with LeRoy Walters, who was involved in the discussions and debates about rDNA in its early years. The week will conclude with a quiz.
Meet the Instructors
Debra JH Mathews, PhD, MAAssistant Director for Science Programs
Berman Institute of Bioethics
[MUSIC]
We're going to have a conversation with LeRoy Walters,
who is an Emeritus Professor at the Kennedy Institute of Ethics in
the Department of Philosophy at Georgetown University in Washington, DC.
LeRoy was part of the early debates and discussions around
Recombinant DNA that we've talked about in week one of the course.
And I am thrilled to have you here to talk with us about this.
If you want to say a little bit more about who you are, and
then we can start talking about Recombinant DNA.
>> Well, I came to Georgetown in the summer of 1971.
>> Mm-hm.
>> Having finished a graduate program in religious ethics at Yale University.
>> Mm-hm.
>> My dissertation topic was the just war theory from
the 13th century through the 17th century.
I looked at five classic just war theorists and
tried to see how the theory evolved during those centuries.
What wars the theorists were talking about?
And also, whether they came out on different sides of the same war.
I never have a formal course in Medical Ethics.
And the term bioethics wasn't being used very much in 1971.
I did hear Paul Ramsey lecture at Yale in 1969.
And those lectures went into his books, The Patient as Person, and Fabricated Man.
But I remember when I interviewed for the position, I told Andre Hellegers,
the Director of a New Research Institute,
that I had never had a formal course on medical ethics.
And his reply was, that's fine, you can learn on the job.
>> [LAUGH] >> So I did learn on the job for
39 years, and I'm still learning in retirement.
>> Mm-hm.
>> I very much enjoyed my time at Georgetown and at the Kennedy Institute.
And right away, we started to gather materials on what
we conceived of as the field of biomedical ethics or bioethics in 1971.
Most of the topics are still being discussed.
End of life care, research involving human subjects,
genetics in general, the beginning of life reproductive technologies.
But basic research was not within our agenda,
it was not on our video screens at that time.
And I would say, it was only a very gradually in
the mid 1970s that the topic of basic research
with Recombinant DNA began to emerge as a theme for
the field of bioethics as well as for public policy.
>> Mm-hm, and do you remember when you first became aware of
Recombinant DNA research?
>> Those of us in the field had to keep up with science and nature.
And perhaps- >> The journals.
>> The Medical Journal.
>> [LAUGH] >> Couple of medical journals as well,
the New England Journal and JAMA in particular.
And so we were vaguely aware that in 1973, Maxine Singer and
Teacher Zo, had written a letter coming out of the Gordon conference.
But I would say that, that really didn't make much of an impression.
My friend Charles McCarthy at NIH and I worked in the Fall of 1975 to
plan a series of seminars on questions of biomedical ethics.
And we invited Dewitt Statton, who was in Chair of the Rack, to come and
speak to one of the first sessions.
>> Mm-hm.
>> I remember that I asked a few questions of him at the end of the session,
because I was curious about Recombinant DNA research.
And I think it was because of that contact with Dewitt Statton.
That I was then invited to come to the big director's advisory
committee meeting in February of 1976.
>> Mm-hm.
>> Where first major draft of guidelines for Recombinant DNA research
was discussed with the director's advisory committee and
several additional consultants to the committee.
So at that time, I had to really begin an education for
one Recombinant DNA research, molecular biology, microbiology.
I'd gone as far as I could in college, in science and math.
But it had been a long time since I had done botany, and zoology, and physiology.
So I remember asking my colleague, Leon Kass,
what's the difference between a bacterial virus and a bacteriophage.
And he kindly didn't laugh but said, well, they're the same thing actually.
>> [LAUGH] >> And so he directed me, I think,
to molecular biology of the gene.
And I began a crash course in molecular biology and a little bit of microbiology.
To try to get ready for participating in discussions of Recombinant DNA research.
>> Mm-hm, so the Asilomar happened at the beginning of 75.
>> Yes.
>> And there was quite, I mean, my reading of it,
there was quite a bit of media attention.
>> Yes.
>> Around the Asilomar,
there was activity going on in Cambridge.
There was a lot of public engagement.
[LAUGH] Or not public engagement, public discussion about the science.
Were you involved in any of those conversations?
Were you sort of aware of those conversations?
Were you in advance of the NIH seminar series that you co-organized?
>> Well, there were other things going on at the same time in the field of
bioethics.
>> [LAUGH] Absolutely.
>> And so the National Commission for the protection of human subject was the public
policy body that was most on the minds of I would say, most people in bioethics.
>> Right, of course.
>> There was first of all, the initial effort
to do a report on research involving the human fetus.
And then the commission went on to look at the general principles underlying
all research involving human subjects, and that was another big topic.
I had also worked with Charles McCarthy and
James Childress on a report on the compensation of injured research subjects.
And that produced several volumes which have been gathering dust ever since.
>> And it remains unresolved in the United States.
>> It does, right.
>> [LAUGH] >> So I would say that the field as
a whole was very much focused on research involving human subjects.
>> Mm-hm.
>> And basic laboratory research using E coli or
viruses was just very foreign to the field of bioethics.
And I guess, we had to be convinced by Asilomar whether it was
just minimal involvement by several attorneys.
>> Right. >> Nobody with formal training in ethics.
And so we were aware of debates and discussions going on.
But there were other things that captured more of our attention,
I would say, until early 1976.
76 turned out to be a pivotal year with the guidelines and
also the public debates reached their height in Cambridge,
Massachusetts, during that year.
And then with a bit of a lag in 1977,
I would say that Congress really got involved in this topic.
And I would say there is a tug of war between on rage and the Congress
about who was going to oversee the field of Recombinant DNA research.
>> Right, right, and this was pivotal time for you too as a scholar.
I mean, you finished your PhD in 71, right?
>> Right.
>> And became assistant professor in 75.
Right at the time, I mean,
you were really just launching your career as all of this was happening.
>> Right, right.
>> It's severing to think that this was more than 40 years ago.
I feel fortunate to be alive and to have an intact memory too.
>> [LAUGH] >> And many of the leading figures in this
debate have unfortunately passed away since that time.
>> Mm-hm, but you are here.
>> I am here, yes.
>> [LAUGH] >> I have to admit that I went back and
looked at some documents to try to refresh
my memory of what issues were being discussed.
Who the various players were?
>> Mm-hm.
>> What was happening at NIH?
And what was happening on Capitol Hill in particular.
>> Right, right, so you went to the directors' meeting.
And shortly thereafter, you were asked to join the Rack, right?
>> Yes, I was.
I think it was September of 1976 that I was invited to join the Rack.
And I think that I was able to join for the September 1976 meeting.
I learned afterwards that there had been some trouble getting my
name through downtown as they talked about it.
And that was in the Department of Health Education and Welfare.
It was- >> Now,
the Department of Health and Human Services.
>> Right, it was a Republican administration.
And Caspar Weinberger was Secretary of HEW.
And my name was associated with the Kennedy Institute of Ethics.
But there probably wasn't much love lost between Senator Kennedy and
Secretary of HAW, Caspar Weinberger.
And so I think there was a little resistance to my name, but finally,
it all worked out.
>> Mm-hm, and- >> So then I did have a four year term
on the Rack from 76 through 1980.
And I would say by 1980, the debate was basically finished.
>> Mm-hm, but in 75, so you at the beginning of 70.
No, at the beginning of 76,
you started giving yourself this crash course, you said.
>> Right. >> So
by the time you joined the Rack later in 76,
what was view of Recombinant DNA research.
>> I guess I'm a technological optimist.
>> Mm-hm.
>> And therefore, very open in principle to new areas of biomedical research.
And I think the burden of proof is on those who are arguing
that there's a serious risk or
a serious problem with the research or the technology.
So just to choose some other examples,
some people in the field of biomedical ethics
were concerned about genetic techniques.
For example, there is a lot of discussion about genetic engineering of human beings.
>> Mm-hm.
>> But I thought that was a frightening term, and
what was technically feasible was much less than genetic engineering.
And that gene therapy might be a good thing.
>> Mm-hm.
>> And so, basically, I was open and
I was skeptical of the critics, like Leon Kass or Paul Ramsey.
Similarly, with the new reproductive technologies.
There hadn't been a baby born with the assistance of in vitro fertilization
in the mid 70s.
But I thought if this technique can help people with infertility,
then it's something to be welcomed.
Whereas, other people in the field were worried about
making reproduction into manufacturers, something like that.
So there were technological pessimists in the field, and
I usually wound up on the other side.
And I tried to keep an open mind so
I wanted to learn more about what this field of research involved.
I mean, the technical knowledge that one has to get was formidable.
>> Mm-hm.
>> I mean, people would throughout determine like a baculovirus,
that's a virus that infects insects.
But I had no idea that insects could be infected by viruses.
And then you had plant people at the table, and yeast people,
and plasmid people, and bacteria phage people.
And they, I think, were learning from each other at the same time I was trying to
learn from all of them.
>> Mm-hm, and you were in the first group
of non scientists added to the Rack.
>> Yes, the first person who was added to kind of
make the Rack a bit more pluralistic was a young biologist named
Elizabeth Cutter from Evergreen State College.
She was, I would say, more critical of science in general
than most of the original senior scientists on the Rack.
And then early in 76, a person in public policy,
Emmet Redford, was added to the Rack.
And that was the third person added to try to make the Rack a bit more diverse.
>> Mm-hm.
>> Three of us were, of course, very small minority on the Rack.
But I don't think, I think we were all trying to learn from each other.
>> Mm-hm, and what was sort of the tenure of those conversations?
I mean, I know you can't possibly know whether the tenure of the conversation's
changed prior [LAUGH] to your addition versus post year addition.
But what were those conversations like?
>> Well, there were two major types of containment for
the research that were being discussed.
One was physical containment.
>> Mm-hm.
>> What kind of laboratory facility did you have.
And at that point, we talked about P1, P2, P3, and P4.
There's only one P4 lab in the whole country,
at Fort Dietrich in Frederick, Maryland.
>> Wow, yep.
>> There were several P3 labs.
They were somewhat less secure in terms
of anything escaping from the lab.
We really didn't know in the early days whether there was the danger,
first of all, to the laboratory personnel.
That would have been a sort of local and contained problem.
Could someone in the lab get sick?
What was more worrisome was the notion of some
kind of andromeda strain escaping from the lab.
And infecting all of Cambridge Massachusetts or
even all of the state of Massachusetts.
We didn't know whether something that would be created.
They know for in the lab using this technique of splicing together,
pieces of DNA, would produce some kind of very
virulent infectious pathogen or not.
As time went along, and people stepped back and
thought about the whole history of evolution.
Well, probably a lot of pathogens were tried in evolution,
and failed, and died out.
And we knew about the ones that had survived.
And what was the probability that we would create something new that hadn't been
tried before?
So from an evolutionary standpoint maybe it wasn't as risky as we thought.
But we did have the case of radiation
in the laboratory as a possible precedent.
And we know what happened to Madame Curie
over time because of her exposure to radiation in the lab.
We knew about the technological application of
radiation in the atomic bomb and the hydrogen bomb.
And so some critics of Recombinant DNA were afraid that we
might be on the threshold of something similar to radiation.
Where we ought to be concerned about the immediate risks and
also about the long term technological applications.
But we didn't know what the best metaphor or analog was to Recombinant DNA research.
>> Right.
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