Document daeLD81wD4EEzR2p2LVZwm295

107 * ' Monsanto's .'early warning' * |! system How a major . [. chemital company manages ; - ! the risks and benefits in 1 ! technological progress John W. Hanley ! AA. - r\r% .; . Interviewed by ./ . C I David W. Ewing and ! Millicent R. Kjndle 1 Few potential conflicts between business and so-! ciety have created so much public concern as the risks inherent in scientific and technological advance. : One leading corporation i that has sought to reduce; this area of conflict is Monsanto. At various ; stages in the development of a new material or chem ical product, it brings to gether knowledgeable sci entists and engineers to ( " blow the whistle" on a ; new product concept that may introduce unaccept able hazards to users. Monsanto has organized task forces to analyze the role and effects of so- called " devil's chemical --ihat is, product and pro cess chemicals that may cause cancer. Moreover! with scientific advances taking place every day, ' the company seeks to de velop a realistic, up-to- date philosophy about the trade-offs between risks and benefits in technical progress. * Perhaps no one at Mon santo supports such efforts more vigorously than does its chairman ancTchief executive officer, John W. Hanley, the subject of the main interview in tls article. Formerly execu tive vice president at Procter ed Gamble, Mr. Hanley came to.Monsanto as chief executive in 1972. He is also a director of Citicorp and May De partment Stores, in addi tion to serving on various government boards con cerned with foreign trade. Following the interview with Mr. Hanley are short interviews witlj, three Monsanto executives who arc.intimatcly involved with efforts to assess the potential hazards in new and existing products. Curtis Elmer, manager of environmental staff in S formation, `describes a m assiv\ongoing project to collcctVIata on the im pact qf chemicals on the hehltlncf rhe company's 45,009. domestic and 20.000 overseas employees. Dexter Sharp, director of environmental sciences research for agricultural products, discusses efforts to assess possible carcino genic and qther-toxic ef- " facts of herbicides. And Dr. Roger F.olk, director of the environmental health laboratories, dis- . cusses his roup's philos op h y and approach in test* ing the effdets of the com pany's products on health and the environment. The four interviews were conducted by David Wt Ewing, managing editor of HBR, and Millicent R. Kindle, manuscript editor. Photographs courtesy of Monsanto Company. < * UH Harvard Business Review Interview with ' John W. Hanley HBR: What does it feel like to be chief executive of a giant chemicdl company dur ing a period when the word "chem ical" has'come to mean "cancer maybe" in the minds of much of the public?----------------- --- Mr. Hanley: I don't sense any appre ciable, difference in m y role from that of other chief executive officers of reasonably complex com panies. Because Monsanto and the entire chemical" industry are in the public eye, we're perhaps more 'sensitive to certain societal issues thdn sme of my counterparts. But I don't see that,as unproductive,' rather, I regard it as quite appropriate. The lacts are that Americans doip/have a very^good perception of the risks and the'benefits of chemicals. Our whole society is moving to ad dress itself to a. range of problems and opportunities, and the chemical industry has perhaps a dispropo^t tionateshare of those opportunities at the moment, but that doesn't bother me. I think we recogryzean DbUgimoh *ohelp educate the public, which is the solution to* the problem. I It must be hard to counter the pop ular impression of. chemical companies as risky places to work. The trouble is, there are a few schlock 'operators--complete with leaky valves and drip ping pipes--on the economic margins of the in dustry. Rightly or wrongly, they believe that they ; can't afford to have a safe process or a safe place to work. But for the vast majority of the industry, that's a Seriously distorted perception. M any observers believe that Monsanto has developed an effective approach to anticipating and handling the risks of new product . development, especially the potential hazards to health and th, e environme1nt*. How does this work? We try to eliminate bll of the pos sible surprises, and that's easier to do with new than existing projects. At every major stage of research and development, w& formally assess the possible hazards of a new material or process. W e look at things like the'-known orjexpcctcd impurities oha new product, its expected toxicity (what technical people call "acute" and "chronic" toxicity), fore seeable dangers in disposal, and the ability of cus- i 11 N ovcm ber-D eccm ber 1981 -i tomers to use the material properly and safely. So these are our preliminary assessments of the hazards --any effects on the health of workers, users, the * public at large, the natural environment, the chain of life. ( If the new product passes these early tests and goes into development, we hold tech nology risk reviews. This means that w e bring together the most knowledgeable people we can find--doctors, industrial hygienists, chemists, biol ogists, safety experts, epidemiologists, animal to x i cologists, and anyone jelse who is technically quali-. fied to see how, where, and when that material or process might cause trouble. W hat might go wrong? W hat exposure levelsjmight cause what risks? If the experts see potential hazards, the question becomes^ "C an those dangers be managed?" For example, can we change the pro duction methods to rdcycle the hazardous dust? Can we eliminate the risk by a special valve or some ' . other safeguard? If the answer is yes, we go ahead, assuming that the project makes econoiqic sense,* if it is no, then we stojp work on the project. Do these experts-- the "early whistle blowers"-- come from your own staff? ' M any of them do, but not all. It de pends. We don't claim to be the fountain of all 4 knowledge, and so we contact experts outside the company in universities and other organizations in the United States--in organizations all oyer the world, in fact. For instance, we may have a product that raises a question' about the effect of zinc in the metabolic system. We don't have experts here on . zinc metabolism, but we know where they are and we call on them; Dr. Bert Vallee at th Harvard Medical School is one. So we would ask him to ( come in and help us assess the risk w ith a zinq . ' metabolite. W hat happens if the experts don't agree? Then we are forced to take the most conservative posture possible. If the product would pose substantial risk in the judgment of one or more of the best qualified experts, we can't take a chance on it.' If there is uncertainty, we'll go out and try to get more data on the questions raised-- and then more judgments either refuting or con firming the experts' concern. People! here understand that if a proj ect ought to be stopped because of environmental risks, the earlier it is stopped, the better off we all are. W hat really hurts is going all the w ay through much of the research and developmdnt.and then 'Early warnins'jsystcm iII finding sombthing that invalidates all of that prior work. 1 Is it' a problem to keep this conOr servatism on potential health and environmental ri$ks firom dampening enthusiasm for research and n lw product development? ' * The conservatism I'm talking about; is' not in vcqturesoirieness; it's in being realistic .about a product's ultimate acceptability. W e1Want--- researchers and developers to do their homework' before new products are put to the market test. Th goallis to makenealth and environmental concerns an'integral art of our business thinking jusfas raw material and transportation costs, return, on invest-- ment, and other considerations are part of our,think ing/ Instead'pf being a deterrent to innovation, I see ur approach as a stimulant, for it means that.we /can proceediconfidently in the development and marketing of a new product because we know; it isses strict'medical and environmental tests. j It is true that when we put dkr in-v tcrnal review systems in place a number otyears ago, they met with resistance here. But those doubts have long since dissipated. N ew product develppers know that if it weren't for the internal checks {apd balances, they would he rolling the dice every time they committed time and money to a new product introduction. n il- ' How new is this early warning'.' approach at Monsanto? - In recent years we have expandt d and formaf&ed it, and I believe we practice it mop ' thoroughly than ever before, but the basic cor cept "isn't new. For instance, in the mid-ic)6os`we d<;- > , veloped a new organo-phosphate .insecticide,'which promised to'be very effective in controlling ce t a u r insects ip-cotton. After we tested this" product^ trade marked COLEP, in pur .labs, w e 'did some limbed | field testing under scientific supervision. Tke 1 ests' of acute toxicity.made by the medicardepdrtir :enl showed that the toxicity was-too difficult tb con-1 trol; there were too many circumstances in which the user could make a small .mistake and stjc cti . Himself or herself to an unacceptable risk, d t tie - :. produit was dropped,' the project was killed. | . *. In other* words, the principles w i're ' working on aren't new.'I think that what is new is ,, ' the comprehensiveness of our approach ribwl Th ',7 `reviews are more analytical and systematic, thley b begin easier, more experts are brought in. . f !-' ' .-'i . '"TV - . *.&i . . . W h y is the risk assessment process ( ^ easier for new products? / 110 Harvard Business Review Novem ber-Decem ber 1981 As I mentioned, environmental and' FDA. The bottle became the victim not of valid health risk studies are implicit in the development health and environmental concerns but of extreme, of every new product. The existing products, how unforeseeable, and inflexible government restric ever, have the potential for unexpected findings tions and interpretations fueled by the intense because when many of them were developed years political pressures and emotions of the time. We ago, what is today a normal, thorough range of said then, and we still believe, that the action studies was not done. And we are in fact taking our forcing this highly innovative product out of the newfound knowledge and looking retrospectively marketplace was unfair, unwarranted, and not in at these older businesses. the public interest. A well-known Monsanto example is . PCBs, or polychlorinated biphenyls. We made this The disappointment from the ban on class of beneficial chemicals for nearly 40 years, the Cycle-Safe bottle was enormous--to say nothing only to learn in tholate 1960s that they were bio of all those who lost their jobs. accumulating in the environment. Long before we understood the possible consequences, we volun It was unbelievable. It is unbelievable. tarily withdrew from PCB applications where we We gnashed our teeth and moaned and groaned and felt their discharge into the environment would be cried a lot; and then we said, "Okay, we've got to hard to control. And in 1977 we ceased production pursue this thing through the court to demonstrate entirely because of the public's increasing percep to the regulatory agencies that they cannot make tion that these chemicals presented an unacceptable capricious moves without being called to task." We Jlevel of risk. /` still don't have a reasoned, rational response from the FDA despite the fact that its basis for the ban Ho^successful has the early-whistle- was neither scientific nor proper and that it had to blower approach been in eliminating unpleasant reconsider what it did to us. surprises after a new product is launched? But we're out of that market now. The new plastic bottles you see on the shelves today are Technically, it has been very success- made from polyester and cannot be recycled or re ` jful^isorting numerous projects that were tempting filled. - beeafus^of the needs they could fill. Most of those- I'm still angry because it was a very . project^ I couldn't even tell you about because they large, important opportunity for Monsanto and, ^ were killed in early stages by our technical staff. when the whole story is written, it will be proved Politically, however, we have had one beyond the shadow of a doubt that there was no ' well-known disaster--the Cycle-Safe bottle. We must scientific basis for the ban. It was a mistake made by have spent more than $100 million on this pioneer the FDA. So what we want to do through our legal ing, recyclable plastic beverage bottle. You could pursuit of the matter is; in effect, to put a sign up grind it up and make another bottle out of it. We \ , on the bulletin boards of the regulatory agencies were even testing a version that could be washed \ saying: "Be careful. Make sure you're right before out and refilled. People thought it would help to \\ you make these moves." solve the nation's litter problem. *' \ O At every main step we asked the j\ What is Monsanto doing to overcome experts--both in and out of government--for their 1\ the setbacks caused by the ban? judgments on all the data that could be gathered about Cycle-Safe. We asked, "Do you agree it's' j On a broad scale, we've worked with safe?" At every point they said they did. If there had the Carter administration and now the Reagan ad been much negative opinion, we would not have ministration to try to bring some sensible guidelines proceeded. We even organized a scientific sympo into the relationship between industry and govern sium in Boston, that brought together both those ment. I personally have played a modest role in who opposed the concept of a plastic beverage bottle helping the.new administration address the pivotal and those who supported the idea. We went as far as a company could go in encouraging scientific peer review and criticism. I think it's fair to say that the issues in the regulatory process. Within our company itself, there are some people who feel that their whole existence scientific community considered our approach a has been frustrated by the government's unwar model qf what should be done. Officials of both the ranted action against Cycle-Safe. We've reassigned FDA and the EPA congratulated us on our profile of . them; we've tried to help them understand that we test data. v. i want to make something positive out of all this. We But a couple of years after Cycle-Safe emphasize that even if the FDA doesn't think of went on the market, it was banned in 1977 by-the Cycle-Safe as a success, we do. But I'm sure there - 'Early warning' system 111 arc wounds that have not yet healed--that will not heal--as a result of this unfortunate problem. 1 Do you make contingency plans when a new project goes into production, or do you have special teams of investigators ready to go intc action if something goes wrong? I can't think of a situation today where we would have contingency plans for a new product as it enters production. By that time, we would have reviewed environmental constraints to the point that the possibility of a surprise is almost eliminated. But.we're ready in case a possible, un expected problem'arises that involves one of our products or processes, and we'd investigate the allegations and develop our data or work with other producers to develop industry data. Then we'd make one of three decisions: to defend the product, to change our methods even though production costs may increase, or to drop the product. As part of our overall corporate ap proach, we established our environmental policy staff and the environmental policy committee, both headed by a senior vice president, in 1977. These new organizations provide corporate leadership and initiative for managing Monsanto's impact on the environment. They also serve as checks and balances to. eliminate crises as new projects go forward; they act as a "watchdog" internally and an early warning system externally. We've been talking mostly of new products and materials. What about investigating the risks in products that are already being marketed? Existing products need to be tested fo r. two reasons. First, some of them have been around * for a long time, and when they came out they were not subjected to modem testing methods. Monsanto studies a few such products--formaldehyde is a recept example--but usually, because the products are produced by manyi companies, they are assigned for testing to the Chemical Industry Institute of Toxicology, which is funded by the industry as a whole. Another reason is that new evidence may come to light indicating a health or environ mental problem not suspected before. .For example, some of our people are the world's leading experts on the genetic and other possible effects of acry lonitrile on animals and humans. When we leam something new about acrylonitrile--or any other subject of research--wd'll test any of-our products on the market that contain the chemical. I lI . ................................. ITT iTi nniillfirTTMlIl lIM Benzene is another example that has been around forever. Yet in the last ten years some toxicological data on benzene suggest that in certain circumstances it can be troublesome to humans. Monsanto is the world's largest user of benzene, I beliefe, and we are going to be testing this chemical for quite some time.- So surprises can come from new knowledge--new analytic capabilities--and we really don't know what all of that knowledge means. Discussions of chemical hazatd$ ) ^onfetimes center on "devil's chemicals." What^ are these? . ' Devil's chemicals are contaminants --usually highly toxic or carcinogenic--that are inadvertently formed in trace amounts during pro duction. Examples include the nitrosoamines,!the bioxins, and the furans. You have indicated that ma1|y uncer tainties exist about devil's chemicals. Does_this fact complicate Monsanto's job? i j I Yes. During the last two decades our national ability to measure and quantify has taken- quantum leaps forward, and this has changed much of our thinking and added a whole range of ques tions. A couple of decades ago we could measure chemical impurities fairly accurately in the range of parts'per million. If something was nofHetected in this rbnge, we considered the impurh existent,lero. But today we carpr^easure many trace Contaminants in parts per an idea of this technical achievement, one\ trillion is roughly the equivalent of a single grain of sugar in an Olympic-size swimming pool. Our increasing analytic capability has permitted us to measure things way beyond our ability to understand what the data rpean. And with . this greater measuring.ability, society is beginning to realize that there's no such thing as zero in this business of impurities-. Even fresh water has im purities, we now know. ; Ji :*t I Whose job is it. to identify and analyze devil's chemicals--the government's, the corpora tion's, of both? !; 0 -i 4 . Both. At Monsanto we have spent millions of dollars in this effort. We are not re quired by law to do so, but like other industry leaders, we consider it "our job. Our so-called deVil's 7 chemicals project is looking for trace contaminants ,r- in existing products, and we have now examined ,*> most of them. We have found no product contain- . l- lfe ,. ... _ j . j L j j f e ; 112 ing trace amounts even close to the levels that medical and toxicological scientists believe could cause harm. As for government, organizations like the FDA, EPA, and OSHA spend large sums assess ing devil's chemicals, and their staffs work in con tinuous contact with us. 1 S y ur devil's chemicals project related to the^arly-whistleblower approach? The two are independent of each other except when a new product or process is being examined. Then the presence or absence of a devil's chemical could enter into the decision whether to continue development of the product. How do you square the enormous ef fort and expenditure Monsanto is making to ana lyze devil's chemicals with the fact that you have lawsuits on your hands like the one filed in March 1981--a $ 1.7 billion/claim by a group of Monsanto workers in West Virginia who allege that they were exposed to paramfnobiphenyl and dioxin? Maybe this suit proves that there's no way to do your job in tiiisipdustry without having some brickbats thrown-Jtyou. PAB was used from ftthjrridyi940s to the mid-1950s in the Nitro, West >Vir-gvjfia plant to produce certain raw materials. In ' the mid-1950s, studies began suggesting'that pro- * longed exposure to PAB could cause bladder cancer. Once this was confirmed, we halted the use of PAB and put all employees who had been exposed to it on a long-term health monitoring program. That program, by the way, continues to this day. Monsanto's response was described in the medical literature as a model for other com panies and occupational medicine departments. I don't want to minimize the misfortune of those who may have become victims of PAB exposure. But it was the company that blew the whistle in this case, not a government agency--and certainly not the employees. How can society take these uncer tainties into account when it sets standards for health and safety? * . If we go looking for a trace amount of something, chances are we're going to find it in some minuscule amount at least. When we do find it, we must be prepared to take some action or be convinced that no\iction iti^needed. Again, what has happened is that our ability to detect substances in many cases has outstripped our ability to under stand what, if anything, their presence means. A growing body of evidence suggests that there's a Harvard Rusiness Review Novcm ber-D ccem ber 1981 threshold for all carcinogens--a level of use below which they are not hazardous--but that theory is not universally held. So we are far from hearing the last words on the significance of trace chemicals. In the meantime, what we've got to do is strike the bbst balance we can between possible risks and known rewards. \ In the media there are many accusa tions and much debate about the hazards of chem ical products. Is all this debate simply a result of the scientific uncertainties you have mentioned? Only some of it, and sometimes only a small part of it. The trouble is our tendency to confuse risk assessment with risk acceptance. They are two very different things, separate parts of the equation. Risk assessment is primarily a scientific exercise. It is an attempt at quantification--that is, determining that material X at exposure level Y presents Z degree of risk to animals or human beings. Risk acceptance is quite different. This is a judgment call, not a scientific measurement. If is a judgment that the risk, high or low, is acceptable or unacceptable. Who are the experts in assessing risks as opposed to those who decide whether to accept the risks? Risk assessment is the job of experts --toxicologists, analytic chemists, environmental specialists, doctors, and epidemiologists. Risk ac ceptance, on the other hand, is not for experts but society at large. It depends on the public's gnral feelings about risk as well as the credibility of the risk assessors, the role and influence of activist or ganizations like the Sierra Club and antinuclear groups, the activity of legislators, the reputation of regulatory agencies, and so forth. As a result of all these influences, risk acceptance becomes incon sistent at times, with high risks like cigarette smok ing being accepted and low risks, despite scientific assurances, being rejected. , One of the most intimate links I know between science and society is this bridge from risk assessment to risk acceptance. However, this link is the subject of a lot of confusion. Where do you see risk assessment and acceptance being confused? T All over. For example, a couple of summers ago the saccharin issue came bubbling up again. Well, before the scientific data were in on risk assessment, the question of acceptance was be ing debated on Johnny Carson's "Tonight" show, 'Early warning' system 113 in Congress, on the front page of the New York comparing some 3,700 male Du Pont chemists with Times, and in lots of other places. That's cockeyed. more than 19,000 male Du Pont nonchemists in the You can't reach a sound decision on acceptance same salary categories found a somewhat lowqrl. until the scientific data arc properly structured and cancer mortality`rate among the chemists. . analyzed. The data arc in on smoking, penicillin, and many pesticides, bin for an enormous number of products there are still no guidelines; or what ) During the last few years the media been giving much attention to problems in ever guidelines that do exist are under repair or chemical waste disposal. Is the early-whistleblower advisement. approach a way to head off that problem too? Let me give you another example. Regularly our plants are visited by a group of world- Yes and no. The technical reviews famous pathologists who bring their expertise to are useful in determining if a proposed product or bear on the question of what further improvements process can be modified to avoid creating any haz- might be made in the environment here. Sometimes -a'rtious waste, and ease of modification will bex*ne I sneak into the back of,the room and listen to their I of the factors in deciding whether to go ahead with discussions but, frankly,.their discussions arc gen i Ithe product. But the reviews don't deal directly with erally too technical for mc; they go right over my ^existing waste streams created by chemicals. Those head. One time I got them together at the end of streams are the subject of another effort under way. a meeting and said: "You know, we think our plants A hazardous waste study team is getting answers arc a safe place to work, but we're terribly con to such questions as: Where arc our waste strearns? cerned about health and safety and we want to do What are the existing treatment and disposal meth everything we can to make them better. What can ods? What do projections show about likely in-'j I do?" And they told me: "Outlaw smoking. Its creases or decreases in dangers? This tcan|will take danger to health is higher than everything else." another year to get the answers, and then-wc will So I talked about this with my asso complete a ten-year plan for handling hazardoujs ciates and discussed whether I should write a letter wastes. We may even develop a network of re to every employee sharing this scientific perspec gional facilities for disposal of wastes created b.y|! tive. We decided we should be very careful about plants in different areas. . any step like that. The data measuring the risk? of smoking arc one thing, but the acceptance of those Does this mean Monsanto won't have risks is another. Employees have the right to make to worry about creating "Love Canals"? that kind of decision themselves, except when smoking is hazardous because of working condi , We can't take anything for granted. tions. You sec "no smoking" signs in many areas Is thertyt warehouse somewhere filled with drums of the plants but not in offices. of chemical waste left over from some ompany- ! operation, of many years ago? We've been in busi How docs Monsanto ensure the safe ness for So years. We have surveyed all old closed ty and health of the public at hand--the employees? wasteVncs, and we don't think any of them could i / . become a hazard. Nevertheless, it is coriceivabld . We have an in-house medicaLand en that some site was used before the development of vironmental health department, which keeps close modern record keeping that we know nothing tabs on employees' health and safety through a about. So-we live with a certain risk from the past, computerized medical arid environmental health just as other generators of. hazardous waste do.` ' system that we call MEHI. And detailed epidemio As for the future, I'm confident that logical studies on Monsanto employees show they technology is the country's answer. Scientists in are healthier than a comparable sample of the gen every right-thinking company in our industry are eral population. Beyond that, three or four path being challenged to make products in such a wajy ologists visit our plants regularly and advise us on that they don't produce undesirable by-product! I how we could further improve plant safety for our think that 25 years from now there no longcrwill employees. 1 be processes that generate large quantities of haz Overall, w'vc set a new all-time safe ardous waste; the existing processes that do that ( ty record. It's kind of a theme; you sec signs all over will be phased out in favor of new systems that''; our plants about "the great safety race." In fact, won't. When I see people recoiling from technology National Safety Council data for 1979 show the U.S. because of pollution and hazardous side effects, chemical industry second f 43 industries in safety want to tell them: "The solution to those proble performance--more than ten times safer than non is also rooted in technology. We've got'.fo give sci military government service! And a recent study entists a chance to go to work." vm 114 Harvard Business Review November-December 1981 Could you tell us some of the ways Monsanto is trying to improve public awareness of the chemical industry's efforts to safeguard health and the environment? Wc started.back around 1975 with a program of public education, if you will, called "The Chemical Facts of Life" which, we think, has helped people see chemicals in their broadest perspective. On a mi)re personal level hundreds,anaybe thou sands,^ our employees are spokesmen for this public awareness effort. We cover everything from symposia and workshops to Rotary Club meet ings, and there are an enormous number of these smaller gatherings. Monsanto encourages managers up and down the organization to speak out in their areas of expertise--to help explain our operations, our positions, and our policies--and also to be available to answer the tough questions and the al legations when they are posed. / Do yoy View educating the public, then, as an opportunity to correct illusions about the dangers of chemicals? , and processes and our contribution to safeguard i n g the environment. Is it difficult to instill and maintain this philosophy in new employees? No, it isn't difficult at all. These men and women come from a social atmosphere--par ticularly evident on college campuses--in which en vironmental concerns are part and parcel of life. And they bring this attitude with them. , We find more difficulty in getting a few of our longer-term employees to appreciate the importance and integral nature of environmental matters. They have done business for so long in an atmosphere that did not place very great emphasis on these areas that some of them now have diffi culty changing the ways they do things--even the ways they think about things. We periodically monitor attitudes within the corporation, and surveys over the past few years indicate that we are making progress on environmental awareness. But there will always be room for improvement. We go further than that. We try to point out as clearly as We can the risks and the benefits of specific chemicals manufactured by Monsantovand then we show that life in total is . made up of chemicals and no chemical iscomplete-. ly safe all the time, everywhere. We want people to understand that. The problem has been largely the media's focus on the risks without quite rec ognizing that we really can't live in a contemporary way Without the contributions of chemicals. Yet peoplt^-tend to want to isolate the risks, and that can't be done. i What has been the impact on the chemical industry in general of this widespread public concern over environmental and health hazards from chemicals?I I don't think the public's concern has curbed the basic entrepreneurial spirit of the peo ple in our industry at all, nor do I sense any reluc tance on the part of young people to come in and cast their lot with us in terms of career develop ment. They, wanl to come in, and they understand that problems are solved through human effort. As I have said, j}ur ability to identify trace materials and their effect on human and en vironmental healthvhas developed very rapidly, al most astronomically. And whdT'Ehose skills we've been restfidying what we do, what we make, how it's used--and there are ertorrrious opportunities to improve the safety and ttffi'ciency of our products agencies have made a confusing tangle out of the business of risk assessment. Do you see any signs that government agencies are trying to untangle the mess that's been made? Yes, I'm an optimist, and there are signs of reason and rationality returning to the Potomac. The learning process of our whole society is continuing to advance, and people are realizing that there has to be an evaluation of all the factors involved--the benefits as well as the risks. For ex ample, chest X rays pose a risk of cancer, but since the benefits for detecting disease are great, most people accept that risk. When you start looking at products involving more potent carcinogens, the trade-off gets more debatable, but even in these cases society sometimes accepts the risks if it be lieves the benefits are worth the trade-offs. Afla- toxin--a naturally occurring substance--is one of the most potent carcinogens known, yet it is tolerated in foods by both consumers and federal regulators at levels that cause liver cancer in rodents. So I think people are beginning to see that life is a series of trade-offs. &v 'j . If society and government regulation arc so inconsistent, does it make sense to have much regulation at all? ipguiauun 01 suspected 'Early warning' system 115 exposure to them as much as possible. My plea is only to avoid snap judgments,.or our way of life is going to be threatened. We've got to make the best judgment calls we can make, and that means ad vancing our scientific knowledge. For instance, does aflatoxin cause liver cancer in humans? We don't know yet. Different species can be affected very differently by particular chemicals, and we lack direct correlations between cancer in animals and cancer in humans. We're working on that problem at Monsanto, but Monsanto can't do it alone. The work is going to have to come from industry, gov ernment, the universities, and other groups all working together. Regulation also makes sense in view of the fact that risk assessment is a judgment call. For example, if a very toxic pesticide is tightly con trolled in the workplace, with workers thoroughly educated in handling it, the health risk is small. But the hazards of that pesticide arc obviously greater and maybe unacceptable if much of the public is using it without the expert knowledge of how to handle it. I Do you view Monsahto's testing ap proach as proactive or reactive to government regu lation? ( We take the lead in testing. The exis tence or nonexistence of federal and state regulatory agencies has no relevance:at all to the need for our testing programs. We consider them a responsibility of being in this business, j Are there cases where Monsanto's standards are higher than those of government regu latory agencies? | 1 There are such instances in the United States, and outside the United States there are dramatic examples of this kind. In many foreign countries where we operate, we have thesame standards for worker health and safety as in . St. Louis, even though the governments of thosex nations do not require sucjh standards. Because of testing, is the chemical industry getting so expensive that small companies won't be able to compete? miracle herbicide in a garage tomorrow and have enough resources to pass the testing regimen re quired by the government. I think we've got to be careful ahout squashing the little guy by setting up requirements that aren't necessary, putting up hurdles tpat are unnecessarily high. Today's entre- preneii\^who can create tomorrow's Monsantos arc important to the country. * We understand that since the en vironmental policy^staff was organized, the irom- pany has benefited in lots of ways. v ) /'j, / 1 At the federal level, we have seeryoiir -suggestions affect the Clean Water Act amend-\_ /mfents, tfie OSHA labeling regulation, certain EPA ( air pollution regulations, and others. And as en vironmental regulation moves from the federal to the state level or even lower, we have been effec tive in influencing regulations in a number of areas, principally waste treatment and workplace , laws and regulations. We don't try to unnecessarily weaken laws or regulations but rather to achieve a better balance among government, industl^, ancH the public. ' ' Let me take the Toxic Substances Control Act, a piece of legislation that was debated for several years before enactment. The chemical industry was advising the legislators on the kind1of legislation that would respond to the problem, and the law is now passed with the full blessing of most members of Congress. We were heavily involved in it and think it's potentially very good. Now, that the law isin place, a whole range of regulations needs to*oe enacted to implement it. The existence of our environmental policy group allows us to deal constructively with the regulators, and that process is ongoing. Our data base of information regarding effects of our processes and products on the environ ment and health is helpful to the regulators and so, quite properly, industry and government are part-4 ners in-developing regulations designed to accom plish whatever the law-calls for. So we now have ' much more of a collaborative than an adversary1 relationship. * | T' ' You have mentioned some of the promising opportunities for joint ventures between industry and university research groups. Do you see this type of collaboration as ongoing? In some aretis it's getting to be very difficult for a small, youn^ company. Take herbi cide testing, for instance-kill the tests required to determine how the chemical affects the food.chain and ultimately human metabolism. It would be very unusual if the three of us could develop a Yes. So much, of the scieqtific com munity is in the academic world that we have tc be interested in what's going on there. In the past, business has had little incentive-to develop the dis coveries made on U.S^ campuses. For example,*say that a scientist at the University of Idaho develops 116 something relevant to caffeine in the metabolic system. He makes a worthwhile discovery, pub lishes, and it goes on the shelf. But General Foods and Procter & Gamble have little interest because that professor was funded by the government and so his invention, if it's patented, cannot be granted on an exclusive basis. Industry won't take on the commercial development job because, for.every dollagscientists spend getting to the invention, it'll take io or ioo dollars to get it to a practical appli cation. So because they don't have an exclusive shot at that invention, companies don't pursue it. Nowwe're trying to change that. We've tried to have a coupling of interests where we could mix skills and aspire to genuine syner gism. We agreed to take on the developmental re sponsibilities with Harvard Medical School right at the outset in exchange for some kind of proprietary interest in the joint ^discoveries. Right now we hap pen to be studying the nature of molecular mes sengers, which trigger the metabolic system and can feed tumors and start cancerous growths. If we can demonstrate that such col laboration can be profitable for the industrial part ner, we may encourage a whole series of like relat. tion.^hips around the world and thereby change that afu\nbling,-kincompletc process which involves the . ") transfer o'f academic research into products and pro.cesses that benefit society. Do you, then, see private companies supplementing the government by bankrolling campus scientists? Yes, I do. The government is clearly curtailing'the iTaturc of its investment in research and development, and I don't quarrel with that as part of getting our budgetary process back into some balance. But there is going to be a void, and I hope that the kind of experimentation going on will be so successful as to encourage other people, other industries to come in and help fill that need. The Harvard-Monsanto experience is only one degree on a circle of 360 degrees. 4 Harvard business Review Novem ber-Deccm ber 1981 Interview .with G ^ is^ E lm e r HBR: How long has Monsanto been collecting employee health information? 'Mr. Elmer, manager of Environmental Staff Information: We've just started formalizing collection of this data over the past few years with our MEHI--medical and environmental health in formation-system, but we've been working in that area for 40,50 years. We arc just beginning to use MEHI. The first step, to get a system and start it working, is over. Now we're on the second step of feeding the system data, and that will be ongoing. The third step of getting the data out so we can issue mean ingful reports is stif in the future. We have 45,000 Monsanto employe :s in the United States to deal with and 20,000 me c outside the United States. So you can imagine that the job of data collection and input is significant. Do you have safeguards to protect the privacy of employee information once it's entered into the MEHI computerized system? Most definitely. The process for medi cal data entry starts atia plant clinic where a doctor or nurse fills out two-part forms to recom employee health information. On the top line goes the em ployee's name,- on the second, the social security number and birth date. When that form is com pleted, it's torn off below the "top line, so the only thing that shows on the form that gets mailed to us is the social security number and birth date. Somebody who might accidentally open the envel ope can't tell much by that. And when it gets en tered into the computer, the programmer uses a specific program that scrambles the original into a totally meaningless jumble of letters and numbers. When the information is withdrawn, it has to go through that same program to unscramble the let ters and numbers. It's a tough code to break. Fur thermore, only.physicians can receive output with a person's name on it. ,-s :%i* Do you monitor for possible health effects from specific chemicals? Yes. We do studies for very specific purposes, either in a certain plant or for a certain chemical wherever it is used or made. Ten years' ago, our study data were less efficiently collected. < 'Early warning' system All we knew Was that someone was either exposed or not. For example, we had an accident at one of our plants in the late forties that exposed a few ^ ; hundred porkers to potentially hazardous levels of the chemicals being uscdat the time. The health statusjcJiVtnose workers has been carefully moni tored Iyer since. We followed-this particular group of employees--not because any government regula tion required it--but rather because we had no previous experience with that kind of exposure and didn't know what, if any, the lona-term health effects might be. As it turned out, we learned much laterpthat the highly toxic contaminant, TCDD or dkm n, was one of the substances involved in tn accident. Back in the forties, didxin hadn't even ^bcen chemically identified.' : Dioxin is one of the devil's chemicals, isn't it? ' Right--and it's much in the news late ly because of the Agent Orange controversy and other incidents. We're one of the few comj^niesv with documented expo'surc records with it^Now we don't know exactly how much the people Were ` exposed to during the accident because the science of industrial hygiene was not very sophisticated.30 years ago. But we do know who was exposed and what their symptoms were. We've recently-con ducted follow-up epidemiology studies on this group of workers and found no apparent excess in cause of death as a result of exposure some 30 years ago. Wc'rc/able to do studies like this with a great deal mos^detail now because we know more about the specific effects of exposures on people, both what and .how much. This is the kind of informa- tion we are putting into our MEHI system--any noticeable effects on th'c health of Monsanto em- . ployces that might be relevant to workplace ex posure. ' .-- ` 1 C./ Do you think tlieTDA sometimes overreacts when devil's chemicals are found as product contaminants in very small amounts? % The FDA's concern is not necessarily limited to the presence of devil's chemicals. The De laney Amendment to the Food'& Drug Act gives the FDA special problems and rigid guidelines. This amendment states specifically that nothing man made can be added to foods that has been shown to cause cancer in any test, of animals or people at any level. On the other hand, the FDA permits na turally occurring carcinogens in our food supply. Take aflatoxin, a potent human carcinogen. It is a naturally occuring mold that's formed on peanuts and other grain crops consumed by humans. The us FDA allows aflatoxins in U.S. foodstuffs, albeit at very low levels, because it has concluded that the benefits outweigh the risks. We simply feel that this same sort of rationale should be permitted with man-made ingredients. Do the regulators think there arc no safe levels for suspected carcinogens? iC r- 0 .: This is certainly the prevailing atti tude in.the-FDA. Other agencies like OSHA and the EPA are continually striving to reduce ex posures to the lowest possible levels. There is a substantial body of evidence that says there are safe levels for carcinogens. We know that many nutrients, essential for health and even life itself, have caused tumors when fed to rats at relatively high levels. Typically the regulators react to a high- dose animal test by issuing a new standard, let's say at 30 parts per million. Then another test comes along that shows a carcinogenic reaction at a lower dose level and then'll say, okay, let's reduce ex posure to 10 ppm and if 10 is good, 2 ppm would be even better and so on. Well, evgry time they go down another increment it raises the costs, some- ;ctimeq tremendously. And their reasons for what ".they do art! not always rational or clear. To reduce' exposure in a workplace from 10 ppm to'2 ppm on a particular substance may be justified. But if such a decision is based on unrealistic judgments, the net effect can be millions of dollars in additional costs to us and no real benefit to our workers. When this :happens, we're faced with a real dilemma. Is it worth it, or do we just fold up our tent and get out of the market--denying the consumer a benefit and some workers their jobs. With MEHI we hope to build a case based on hard data to counter the regu lators' arguments. Harvard Business RevieV^ November-Dcccmber 1981 Interview? with Dexter S|iarp HBR: We're interested in Monsanto's concept of early whistleblowing--that is, the or ganization of checks and balances designed to elim inate the possible hazards in a new project long be fore it ever goes on the market. Could you give us an example of how your section plays this role? f Mr. Sharp, research director, En vironmental Science, Monsanto Agricultural Prod ucts: Let's take Monsanto's well-known Roundup, herbicide. Roundup was first formulated as a dimethylamine salt, a formulation different from the product sold commercially now. Dimethylamine is a secondary amine and can form a nitroso com pound, or nitrosoamine. We blew the whistle,.point ing out that we would have had very serious prob lems defending the use of that product because of the remote chance that nitrosodimethylamine--a known carcinogen in animal tests--might form in ' the environment. So we developed a new formula tion using isopropylamine, which is a primary amine that cannot form a nitroso compound. And that is the formulated product that we know today. Nitrosoamines have a bad reputation. Would the Environmental Protection Agency have refused to register the first version of Roundup . if you hadn't made that change? At the time this happened, not many people knew about the hazards of nitrosoamines. We were not sure at all what the EPA's position would be. It may not have had that information then, though of course it does today. So what we did--like what we do today--was not only to antici pate what the EPA might do if it had the informa tion we had but, more important, to avoid placing on the market a potentially hazardous product. . *# I If the scientists hadn't been able to come up with the alternative formula using isopro pylamine, what would have happened? , ' %V' 1 . Our scientists would have continued their research until a suitable formulation was found. The work on Roundup would not have been stopped. The potential benefits of Roundup to agri culture were too great to have done otherwise, and we would have developed some other kind of for-, mulation. . 1 'Early warning' system i ' a U9 I: When you have tp put so much em phasis on the possible risks as opposed to the live ly benefits, is an atmosphere of excessive caution likely to be created? Naturally we try to avoid such an at-! mosljjlVrc, bht carcinogenicity is only pne p^rt of '' the equation*. For a chemical' to be a problem'; tie ' public as weil as^our employees have to be expbsed to it. If, using initiative and imagination, we can; ' find:ways to produce and use t|iat product so that lj the potential for exposure is remote, we woilld go : i . ahead with it. Also, by determining to the fullest !' extent possible the ultimate fate of a chemical/ ! J' nroughout the environment, we gain the broaoest technical base for assessing safety. . , L j v ^ Could you give an example of lin'w ^' Monsanto reduces the risk of exposure? I Suppose you use water in 'the mimu-i' facturc of a jnew product, and you pump-that water into the Mississippi. After the discovery and prpd-j uct development work--a dozen or so s ta s going from the research idea through synthesis, biological evaluation] research field tests, environmental _ 1 p chemistry, residue studies, and others--we ask if; f that water is so free of chemicals that there's no problem injsimply returning it to the river'. If the studies show chemicals, then we ask how the water might be cleaned up, and treatments wUl b e d e - j i veloped to remove the chemicals. And we m ay fyic that we* can even put tlie water back into the Mis sissippi cleaner than when we took it out. js \ Or suppose we find that^a chemical gets into tHe air when a pesticide isr'made. W zmea- sufe the Quantities in the1air, then^talk to the peppta involve in-'preduction-: "You 've got "to tighteuup your systeth. You can't have an open vat the :e; put a lid on it.f. So Manufacturing devises contrc Is or \ modifies equipment to eliminate that air em ssibnl ! You use animals for testing. H iw xonfident are you that tests of a cancer hazard oq arii- mals can be extrapolated.to humans?-; . I think these extrapolations ar 5rea sonable? T ley have built-in safety factors thatjailow-for variations when the-product is used byihu-' mans. Most people don't realize-that there are y plenty of natural products but there that are tumor inducers, and if it were the other w ay arouna-^if those natural products were tested on anima rst --they migIhtn'Ftobreeaxlalmowpeled^irne'pfoooitdedolrylasnoimmaelofeitjjeydh.a1 s tested on animals a naturaTsubstance in sassafras . tea and found it carcinogenic. Sassafras'-tea won't ; 120 P be banned because of this, yet that substance may end up being banned in man-made chemicals. In fact, now that testing methods have improved so much, natural products such as caffeine and other substances in plants are being looked at very crit ically for chemical manufacture'even though they' occur naturally in various foods. Such manufac tured natural products may have useful properties benefiW l to humans as fpod preservatives/for example. Doesn't all this testing delay launch ing a pesticideproduct on the market? Oh, yes. It may take 4^2 to 5 years to complete all the studies--toxicology [including car cinogenicity), identification of metabolites, effect of residues on crops, fate in the environment, and so on. All* these data go ifito a petition to the EPA to establish residue tolerances in support of food or feed use and. to grapt a-label, that is, precise direc tions for use. The data may be enormous--for Roundup, for example, the first label petition com prised 19 volumes stacked two feet tall. And then it takes the EPA from i& months to 2 years to re view all of th information. In parallel with the . ies (gathereds still more work to do--the stages of process'and product chemistry, engineering design, and manufacturing plant construction before actual production and marketing! And sales can't start until the EPA accepts our supporting data, estab lishes tolerances, and grants a label for the pesticide. Altogether we may be talking about 8 to 10 years or so from conception to manufacture and sales. Can this lengthy process really pay off? f1 Yes ; if we have found a new chemical that has unique biological'effccts and can solve a major agricultural problem, the process pays off. Furthermore,.if we can define th fate of this newly created molecule in complete terms--what happens when-it is consumed or lcachcd into the soil or changed by sunlight--we're going to be a lot better off. W'c,nccd that information to defend the prod uct uses and effectively communicate our knowl edge if pcople'begin to worry about the product. , Harvard Business Review^ / N ovem ber-Decem ber 1981 Interview with Dr. Roger Folk HBR: What is the aim of the Environ mental Health labs? Dr. Folk, director, Environmental.' Health Laboratories: First, we want to make sure that every product made by the company is safe for users. Secbnd, we want to make sure that company workers exposed to different chemicals in testing and manufacturing are safe. When you say "safe," do, you mean . in compliance with government regulations? A `j W c try to go a: lot farther than that. W c could ncycr keep the scientists here motivated if w c saw ouff.job as just checking out new products according tolstandard protocols.-That wouldbe rnes- mcrizing/it wouldbe like putting hubcaps on the assembly line in Detroit. If w c said, "W e 've got to weigh all those test animals and do it just like this, at the expense of other observations," we'd be trapped. ' How much farther can you go, then? . ,, * ` * W e want to fully understand the data w c generate. W e have more data on our ma terials and products than anyone else has, and we want to make sure we'know What those data are saying, regardless of whether the government or anyone else is concerned.- . Let's say we see something in the data that is a little bit different from what w e expected. - , W e don't pass it off and say, "W e don't have to ` worry about that." W e're interested becaus^ we're scientists and our training makes us interested in apparently minor discrepancies. The discrepancies may turn out to be the most important thing about a whole study. * * ! , Also, we're interested because such an approach will produce better risk analyses for the company. Finally, we're interested b e c a u s e *. we're professionals. l ean attract better people t6 the labs if we foster a spirit of inquiry here. There's always a big piece of every, scientist that has to hold onto the inquisitive attitude learned m school, and .1 want to encourage that innovative and entre- ` ' - preneurial spirit. .. .j D 0 these extremely talented people cause administrative problems? . ; .> 'Early warning? systan 121 Well, we can't put up with too hinny geniuses! Most managers, including myself, arc just not smart enough to manage them. But we've got to have W y good,scientists--some of .the best; ones arc maverkiks--and this can cause administrative problcms/lfm like a conductor. I make sure tnat all the p&ees play in harmony without restricting.indiyiduar&aicnts. * What are some of the major dii ci- plines represented in these labs? ' J i * ------ i \ ! We have toxicologists. Some a^ con- ccmed witji the effects of compounds given the/test U'rtfmals in:their food, others with the effects p r ^ /compounds in the air they breathe. The studies (onductediby toxicologists range from short, single- close experiments to lifetime administration ofja compound; to rats or mice. The latter is one of the most expensive kinds of study. It costs about \ S50o,ooo to do a lifetime feeding study to det brinine the potential of a compound to cause cancer in experimental animals. ! v : We have pathologists, clinical chem ists, and histologists who analyze the test an: mat's blood to determine red cell counts, white c c U! counts, and so on--everything you would havejdone if you wenjt in for a complete physical examination. We have pharmacologists who analyze what hap- pens to a `compound after it gets into the test ani mal's body--how long it stays there, h o w it is ex creted, how it is distributed among the organs! ; j W c have a genetic toxicology krpup. , These people study the potential of a compound to change th D N A in the nucleus and prqduce nfuta-` tions. Tlicjgenetic toxicology group'also studies the potential .effects of products oir reproduction, and the development of the fetus--a discipline we call tcratojogy. . j * i.- And we have pur own computer group that captures and manages reams and reams of data! Pdr instance; one of our standard studies is a 90-day feed or inhalation study. This ne study _ ' will invlge 160 rats or mice and willgenerate in excess of 40,000 pieces of data--and that's fairly .* small, by j)ur standards. I. b* i This is just a beginning--I couldd go on and ori.. . . 1 - j Is there a cutoff point on toxicity-- [that is, so(ne level above which a new product is considered too dangerous and dropped? i * j Ves, but there are no'rigid criteria ' because everything has somgdegree of toxic ityfff. given in large enough doses. W e start with large doses andishort'-term effects, working up to smaller I I ! :> 122 Harvard Business Review. Novem ber-D ecem ber 1981 doses given over long periods. We start drawing blood samples for the longer studies and stage by stage the.study intensifies. In each major stage we want to see some toxicity/ because anything you can think of--sugar, milk, vitamins--is toxic if a large enough dose is given. \ If the toxicologists see no adverse ef fects atgll, they feel very uneasy with the data. Was sometfmng done incorrectly? They'rfe not comfort able untiLthey know the no-effect levels and the levels at which toxicity occurs and cbmpare the lat ter with the highest levels any human user can get exposed to--and see if there is a good margin of safe ty. But there is no number or ratio of formula that is applied to give a go or no-go decision, because toxicity isn't a simple matter. 0 The wildness of science The essential wildness of science a$ a manifestation ot human behav ior is not generally perceived. As we extract new things ot value from it, we also keep discovering parts of the activity that seem in need of bet ter control, more efficiency, less unpredictability. We'd tike to pay less for it and get our money's worth -on some more orderly, businesslike schedule. The Washington planners^ are trying to be helpful in.this, and there are new programs for the cen tralized organization of science all over the place, especially in the bio medical field. t It needs thinking about. There is an almost ungovernable, biologic mechanism at work in scientific behavior at its best, and this should not be overlooked. animals engaged In savage play. When they afe near to an answer their hair stands on end. they sweat, they are ayfash in their own adrena lin: TogrSb the answer, and grab it first, is for them a more powerful drive than feeding or breeding or protecting themselves against the . elements. .It sometimes looks like a lonely activity, but it is as much the oppo-, site of lonely as human behavior can be. There is nothing so social; . so communal, so interdependent. An active field ot science is like an , immense intellectual anthill; the individual almost vanishes into the .mass of minds tumbling over each other, carrying information from place to place, passing it around at the speed of light... The open Jiociety. the unrestricted access to knowledge, the unplarjned and uninhibited association at men for its lurtherarjee - these are what may make a vast, complex, ever growing, ever changing, ever more specialized and expert technological world, nevertheless a world of human community. J. Robert Opp^nheimer Sc/enCe and the 'Common Understanding, 1953 The difficulties are more conspic- *. uous when the problems are very hard and complicated and the facts not yet in. Solutions cannot be arrived at for problems of this sort . until the science has been lifted through a preliminary, turbulent zone of outright astonishment. Therefore, what must be planned for, in the laboratories engaged in r the work, is the totally unforesee- able. If it is centrally organized, thej system must be designed primarily for the elicitation of disbelief.and the celebration of.surprise. * i Moreover, the whole scientific enter prise must be arranged so that the separate imaginations in different- human minds can be pooled, and this is more a kind of game,than a systematic business. It is irr,lhe abrupt, unaccountable aggregation of random notions, intuitions, known in science as good ideas, that the high points are made. There is nothing to touch the spec tacle. In the midst of what seems a collective derangement of minds in total disorder, with bits of informa tion being scattered about, tom to shreds, disintegrated, reconstituted, engulfed. In a kind of activity that seems as random and agitated as . .that of bees in a disturbed part of = the hive, there suddenly emerges', with the purity of a slow phrase of music, a single new piece of truth about nature... tt is instinctive behavior, in my view, and t do not understand how it. works. It cannot be prearranged in any precise way; the minds cannot be lined up in tidy rows and given directions from printed sheets. You cannot get it done by instructing each mind to make this or that piece, for central committees to'fit with the pieces made by other instructed minds. It does not .work this way. j' , The most mysterious aspect of difficult science is the way it is done. Not the routine, not just the titling, together of things that no one had guessed at fitting, not the making of connectionsMhese are merely the workaday details, the methods of operating. They are interesting, but not as fascinating as the central mystery, which is that we do it at all, and that we do it under such compulsion. What it needs is for the air to be ' made right, if you want a bee to matte honey, you do not issue pro tocols on solar navigation or carbor hydrate chemistry, you put him * together with other bees (and you'd better do this quicklyjor solitary. bees do not stay alive) and you do what you can to arrange the general environment around the hive. If the air is right, the science will come in . its own season, like pure honey. I don't know of any other human occupation, even including what I have seen of art, in which the people . engaged in it are so'caught up, so totally preoccupied Jso driven, beyond their strength and resources. From "Natural Science," In Th^Uves ofa Cell Scientists at work have the look of * by LewisThomas. creatures following genetic instruc- ` . 1973bytheMas38ctj(j$Glt3 Med!cal; lions; they seem to be under the influence of a deeply placed human Society. ' Originally appeared in/he New England . Journal ot Medicine. instinct. They are, despite their .* Reprinted by permisin ofV ttdng; efforts at dignity, rather like young Penguin Inc. \i -I am