Gene, 7 (1979) 173--178 173 © Elsevier Scientific Publishing Company, Amsterdam -- Printed in The Netherlands

Book Review

Symposium: Biotechnology and the Law: Recombinant DNA and the Control of Scientific Research

Southern California Law Review, Vol. 51, September 1978, No. 6, pp. 969--1573. The Law Center, University of Southern California, Los Angeles, CA 90007 (USA) $10.00, 612 pp.

reviewed by w. SZYBALSKI

McArdle Laboratory for Cancer Research, University of Wisconsin, Madison, WI 53 706 (USA)

The "Symposium" presented in the special issue of the Southern California Law Review actually was never held, but just represents an assembly of arti- cles which were solicited by the s t u d e n ~ t o r s of the Gould School of Law. The difficulty the non-scientists have in dealing with scientific issues is illu- strated by the somewhat pessimistic and maybe biased tone set in the Pre- face by the anonymous Editor who summarizes the fears and scenarios of a specific group of intransigent and sometimes irrational critics of the recom- binant DNA technique, specifically R. Sinsheimer, E. Chargaff, G. Wald and J. Beckwith. This is followed by a Prologue by A.M. Capron, who assigns the origin of the debate to th~ 1973 letter of Singer and $611, assumes that the imaginary dangers of recombinant DNA are real and summarizes the views of several participants of the Sympositmi. He discusses mainly how the "dangers" should be regulated, but never considers that there might be nothing significant to regulate and that regulations of imaginary dangers could create real dangers and thus harm society. The Preface and Prologue are followed by the Introduction by M.H. Shapiro, which again starts with quoting Sinsheimer's apprehensions and then discusses mainly the ethics of clinical research, human engineering, democracy versus liberty, and the legal aspects of research. As the previous contributors, he believes that there are true dangers of recombinant DNA and does not consider the possibility that the apprehensions are purely imaginary or insignificant ones, as discussed only briefly in one of the final chapters by Zilinskas.

These three prologues are followed by seven sections, namely I. Description of recombinant DNA research

II. History of the recombinant DNA research debate III. Philosophical, ethical~ and social implications IV. Constitutional issu~ and persl:~ective V. Tort liability

VI. Regulatory aspects VII. A role for the public

174

A significant omission is the absence of any chapters on the evaluation of the "risks" of the recombinant DNA technique or their absence, which indi- cates either the bias of the organizers of the Symposium or the normal atti- tude of certain jurists or ethicists who assume that all science must be dan- gerous and are mainly interested in due process and little in the actual scien- tific issues. The lucid and factual description of the recombinant DNA tech- nique and some of its applications (by Baker and Clough, pp. 1009--1016) is followed by a 60 page history of the recombinant DNA debate. The latter starts with a description of Pollack's 1971 apprehensions about th °- possible cloning of SV40 DNA using Xdv vectors. What a lack of insight and imagina- tion, negativism and shortsightedness! The scientifically correct and positive reaction of Pollack should have been to advocate the recombinant DNA technique as a much safer way to propagate and handle welklefined seg- ments of viral DNA. The historical survey is generally rather accurate and fairly presented, although there are some errors and important omissions. The latter include the role of the Administration in the legislative action, the i'wst shortrlived Kennedy legislative proposal based on the Administration draft, the bills proposed late in 1977 and early in 1978, the 1977 resolutions of the three Gordon Conferences and the letter to all members of the Con- gress signed by about 1000 scientists. These resolutions had a crucial impact on the demise of the legislative efforts, especially since they emanated from basically the same group as the original 1973 letter signed by Singer and $511. Also, the sole emphasis on Curtiss' disabled E. ¢oli K-12 mutants is mislead- ing, since the safe EK2 vectors based on bacteriophage ~ were developed, certified by the Recombinant DNA Committee, and put into use several months before Curtiss' host and California plasmids combination. Despite these omissions, and though the authors appeared not to directly participate in the 1971--77 recombinant DNA debate, their account rather fairly repre- sents the gist of the historical developments, even stressing the crucial point that the 1976 Guidelines were drafted and promulgated without first as- sessing the "risks" which they were supposed to regulate, contrary to the original charge to the Recombinant DNA Committee (RAC) and to common sense. The manifold reasons for this serious distortion of the due process, which included some ignorance as to the role of RAC, imposed haste, and political considerations, were not discussed in the chapter.

The following 120 pages are devoted to seven chapters on the philosophi- cal, ethical and social implications of the recombinant DNA technique, start. ing with the excellent essay of C~rl Cohen, Professor of Philosophy, who di- vides the arguments of opponents of recombinant DNA research into "heavy questions" (or "loaded questions") and "arguments by metaphore" and dis- counts all of them as irrational rhetoric and not compelling enough as to abridge the freedom of inquiry. He summarizes the opponent's demands as follows (see p. 1112):

"Show cause why you shall not be made to desist from this destructive colonial war- fare against nature. Prove that self4ggrandizement does not taint your motivation es you pursue this research. Demonstrate that nothing of serious consequence can happen in the

175

course o f the inquiry before y o u begin it. Do n o t ask for guidelineG in doing the research, however, s i rce we know beforehand tha t wha t y o u propose to do is satanic. You may ex- per iment , surely, (we honor f reedom of inquiry) bu t do not per turb nature in the process. We realize tha t yours is a mission o f arrogant and aggressive destructiveness, o f course -- bu t y o u may proceed af ter y o u have proved t h a t your hands are clean".

R. Neville discusses the freedom of inquiry in relation to the liberal and critical political philosophies and participatory democracy, assuming that re- cGmbinant DNA activities "pose special dangers to the public".

Joseph Fletcher, ethicist, presents thoughtful arguments in favor of con- tinued research, and concludes that "dangerous knowledge is never half as dangerous as dangerous ignorance". H.T. Engelhardt Jr. discusses the role of the public in assessing risks, again assuming that there are real dangers. L.F. Cavalieri, an acknowledged critic of the recombinant DNA technique, equates basic science with technology, since the research on cloning of the somatostatin and insulin genes may be commerciaLly exploited. He also makes a surprising statement that only work published in scientific journals could be cited; such a requirement would prevent any press reporting, as based on the scientific meeting, and citing unpublished data even with per- mission of the authors. A large part of his contribution is an unfounded per- sonal attack on the President of the National Academy of Sciences. He also criticizes the present research and its reliance on sophisticated instrumenta- tion. He concludes with the statement that "society will have to control scientists" if they do not accept the burden "to consider the social implica- tions of what they are doing".

H.O. Halvorson dismisses the concept of "dangerous knowledge" and dis- cusses the possible misuses of research results or of the unfounded opinions presented as scientific c e ~ t i e s . He briefly reviews the legislative efforts, the role of scientific societies and the preemption clause that was contained in several legislative proposals. He concludes that a code of ethics must apply not only to scientists but also to politicians dealing with scientific affairs, who "must strive to acquire as much objective information as possible about issues on which they need to act".

C. Grobstein evaluates issues of regulations of basic research. He poses many questions both legitimate and "heavy" ones (see Cohen's chapter, p. 1082), but the answers are very ambiguous. He both advocates regulations and warns against dangers of regulations. He says that only "clear and pre- sent danger" justifies regulation, but then indirectly implies that the bio- hazards of the imaginary risks of the recombinant DNA technique represent such a danger. In conclusion, he recommends a still wider debate and "more than a jerry.build regulatory agency" to establish the just regulations of basic research, since "[r] egulation without full consideration may, in this context, be more dangerous than no regulation" (p. 1200).

The section on constitutional issues is about 150 pages long and contains two very detailed, highly legalistic and excellent analyses by J.A. Robertson and R.G. Spece Jr., both professors of law. Although the discussion might have been biased by the incorrect assumption that "DNA research poses . . .

176

risks of staggering magn i tude . . . " (p. 1289), this statement is tempered by pointing out that the probability of such risks was ' ~ m v ~ l e " . Both authors independently arrived at similar conclusions that basic research is protected under the U.S. Constitution. Its "content" cannot be regulated ex- cept in very exceptional circumstances, while regulation of its %~ne, place and manner" of research requires the S ta~ to provide "compening" reasons. Regulation by funding has to meet the criteria of the "doctrine of tmconsti- tutional conditions" since the Supreme Court has firmly established that "the government may not deny a public benefit for the purpose of creating an incentive enabling it to achieve what it may not command directly" (427 U.S 347, 360--61, 1976). In the section on tort liability, J.M. Friedman suggests that individ,al~ and institutions should be liable without fault for any mishaps caused by use of the recombinant DNA technique, and the Government should compensate the victims.

The regulatory aspects are discussed in five articles (120 pages). Susan Wright, a perennial critic of recombinant DNA research, complains that the biomedical community had too much influence on decision making. She uses "heavy question" and '~netaphor" arguments (CQhen, p. 1082)and advo- cates that in order " to avert further blind development of recombinant DNA and other emerging technologies, it is essential to fred ways to insulate the decision areas from competitive pressures", which by innuendo most prob- ably means the scientific community. M.S. Yesley, a former staff director of the National Commission for the Protection of Human Subjects, believes that all the above problems could be solved by appointing a new Public Ad- visory Commission for Recombinant DNA Research, with diverse member- ship. R.B. Dworkin, on the other hand, discusses the Science Court and anal- yzes the Expert Town Meeting as a means to cope with the social issues of the recombinant DNA technique.

R.A. Zilinskas, a Doctoral Candidate, evaluates briefly the risks of recom- binant DNA research, which he cites to be less than one l e ~ r i o u s acci- dent per one million years (p. 1486), discusses the international agreements and suggests that the researcher should (1) simply file a research design with an international body such as the W.H.O., (2) invite comments from inter- ested parties and (3) file the final report or resulting publication. P.B. Hutt, the former chief counsel of the F.D.A., reviews the regulatory issues, with- out considering the constitutionality of such regulations. He specifies three kinds of risks: (1) to the individual laboratory worker, (2) unleashing of epi- demics, and (3) serious misuse of information gained. He stresses that the un. ce~zinty imposes the burden on the scientific community to prove that (i) the risks have been reduced to the lowest level that can be reasonably achieved, (ii) the risk to the public is extremely small, and (iii) the potential benefits are significantly greater than those risks. He does not acknowledge that the risks were already shown to be insignificant and that the benefits are already rapidly accumulating, rather than being potential. He specifies the current public policy that "[all new] substances are presumed unsafe until

177

they are proven to be safe", and by implication extends it to the recombi- nant DNA technique. He states that "current public policy is not a statement of scientific facts, but rather a statement of public policy emanating from scientific uncertainty". Hurt suggests that new legislation is unnecessary since section 361 of the Public Health act provides adequate statutory autho- rity, if one assumes [incorrectly] that recombinant DNA creates the real danger of "introduction, transmission or spread of communicable diseases". He stresses that the NIH "guidelines" are really regulations and wisely sug- gests that they should "incorporate a procedure for the granting of exemp- tions or variances", assuring "instant flexibility". He criticizes procedures which led to the adoption of the guidelines and advocates substantial public participation in "nonscience issues".

The role for the public is discussed in the final two chapters. The first ar- ticle is by H.R. Holman and D.B. Dutton and starts with a discussion of a "desirable or ideal [maybe utopian] relationship between science and socie- ty" where "partnership of scientists and lay persons (a) set[s] direction and priorities for scientific inquiry, (b) design[s] and conduct[s] scientific stu- dies, (c) evaluate[s] the outcome of those studies, and (d) appl[ies] scien- tific and technological products to social purposes". The discussion "focuses more on ends than on means", and neither dangers of these utopian ideas nor the possibility that it could deteriorate into a thoughtless bureaucratic relationship are considered. The authors present a large number of proposals which would ensure public participation, e.g., "requirement by law or by government policy that educational and research institutions undertake cooperative projects with local citizens, as a condition for continued funding" (p. 1523). M. Lappe and P.A. Martin assert that "science is a social activity involving risks to m~rnbers of society such that the principles of democratic institutions mandate public involvement". Using unrelated ex- amples (i) from clinical research (informed consent and fetal research) and (ii) the right to reply to personal attacks and political editorials on radio or television, they "conclude" that the public has a right to decide on scientific issues, and how research involving the recombinant DNA technique "is to be conducted", especially since research affects "society's social, psychological, or intellectual character" (p. 1554).

In general, it is a sociologically interesting and relatively inexpensive ($10 per about 600 pages) symposium volume, in which the majority of the con- tributors are non-scientists. There are only a few articles by scientists, mainly administrators of science. With perhaps one exception (Halvorson is director of a laboratory in which the recombinant DNA technique is sometimes em- ployed) none of the contributors had any first~hand laboratory experience with the recombinant DNA technique, and thus they should be neutral. Several contributors, however, are known as persistent detractors of scien- tific research in general and of the recombinant DNA technique in particular. It is maybe characteristic that some of those who had little talent to signifi- cantly contribute to the progress of science elected to criticize these impres-

178

sive achievements of the human intellect o r t o promote their careers by try- ing to regulate, organize, philosophize about, politicize and impede scientific research progress. Achmlly, at present there are only a of unre~ formed critics of the recombinant DNA technique, but their visibility and vocal input, especially at meebkq~ concerning regulations and guidelines, is st~i high.

One ~ feature of this volume is the number of "historical accounts" of the recombinant DNA debate and, as in the famous Japanese Rashomon, each account represented the personality a n d convictions o f the individual authors. Some articles are quite long, ponderous and dull, but per- sonally I was most m u s e d and sociologically educated by the essay of Carl Cohen (pp. 1081--1118) on the "arguments by heavy questions and meta- photo".

I wonder how many more symposia of this kind will be held or published [see, e~., Research with Recombinant DNA, National Academy of Sciences, Washington, 1977, and review in Gene, 126 (1979) 329--333], un~3 the organizers and participants will realize that the original anxieties were un- founded, that the risks are insignificant, that many other really important areas of concern abound, and that spending time and effort on discussing regulations of imaginary risks is both wasteful and embarrassing.