Document gaQe3OpRpak0KgB2OYMaNRM9a

FILE NAME: Exxon (EXX) DATE: 1979 Dec DOC#: EXX052 DOCUMENT DESCRIPTION: Journal Article - The Scientist and Health Information: Responsibility of the Scientist, by Robert Eckhardt, M.D. The scientist and health information: respon sibility of the scientist R O B E R T E. E C K A R D T , M .D., Ph.D. C o n s u lta n t 7355 E. Clarem ont Street Scottsdale, A Z 85253 This has been, perhaps, one of the most dif ficult papers I have ever attempted to put together. At first I thought the assignment would be easy, but the more I thought about it, the more difficult it became. As a result, an empty pad of paper has been sitting on my desk top for weeks, waiting for thoughts to gel. As a starting point, I think the first respon sibility of the scientist is to himself. Throughout recorded history, scientists have been persecuted and even executed, because what the facts that they saw told them was considered heretical by others, or by society in general, because others did not know the facts known to the scientist, were incapable of understanding the significance ofthe facts, or refused to accept the facts for religious, superstitious, personal or a great many other reasons. Whatever the reasons, however, the scientist had to keep testing hypotheses with properly designed experiments and from the facts so developed construct concepts whether popularly received or otherwise. I don't believe the responsibility of the scien tist has changed all that much over the years. I still believe that the first responsibility of the scientist is to himself, but obviously his responsibilities do not end there. I did not have the privilege to see what Dr. Reingold would be saying in his keynote address (this symposium), but the differences which arise between scientists do not arise, in most cases, over whether facts should be developed, but only in their interpretation and "misinter pretation. " It is probably fair to say that we will never produce enough health information. We can always use more, so that we will have to be prepared to extrapolate, introduce judgmen tal decisions, and otherwise arrive at inter pretations of the significance of health infor mation based on inadequate and incomplete data. We further must operate on the assumption that what is accepted as fact to day may well become tomorrow's fallacy. I remember very well that at the time I was finishing my medical residency training, it was almost considered malpractice not to an ticoagulate a patient who had had a coronary occlusion. This was based on a cooperative study coordinated by Dr. Irving Wright of Cornell-New York Hospital. Everyone thought that Dr. Wright's data were foolproof and ironclad. Yet today, as a result of the development of additional data, it would probably be considered malpractice to an ticoagulate such a patient. It is this continu ing flux of new facts and information, which leads to our having to do an about face perhaps once, or even more often, within a single lifetime which makes the health field so dynamic and interesting. Man began to use energy for his own com fort and safety and probably also to his own detriment, before there was such a thing as a scientist, let alone a health scientist. He found that fire could be used to keep him warm, cook his food, and at times scare off animals that might be menacing his well be ing. But at times it smoked up his cave and made him choke and cough, and in light of what we know today probably had long-term effects on his health that he was totally un aware of, or perhaps because of his short sur vival time, he did not live long enough to develop those long-term effects. The greatest need for health information in relation to energy production is good, sound epidemiologic data on humans. All of us know, I believe, how difficult this is to come by. The famous CHESS studies carried out 1136 Am. Ind. Hyg. Assoc. J. (40) December, 1979 spon e of health infor i and incomplete operate on the ;epted as fact toDrrow's fallacy. I t the time I was ency training, it ractice not to an id had a coronary on a cooperative Irving Wright of >ital. Everyone ita were foolproof s a result of the data, it would ^practice to anit is this continuformation, which > an about face 3 often, within a s the health field for his own comy also to his own such a thing as a th scientist. He sed to keep him t times scare off icing his well beup his cave and 1, and in light of ly had long-term e was totally un3 of his short sur long enough to acts. th information in n is good, sound nans. All of us it this is to come idies carried out 10) December, 1979 /13-17, 1978 Iby EPA were well intentioned and well con ceived, but still came up far short of the goal of providing us with sound and reliable epidemiologic data upon which sound deci sions could be made without a judgmental component. Perhaps the state of our epidemiologic basic science, or knowledge, is such that we may never be able to develop the epidemiologic information we need from general population studies. We may then be forced to go to limited population studies, in which limited groups in the population are studied for health ef fects. My epidemiology friends tell me that such studies can be very dangerous because biases may be introduced into them, which may go unrecognized. One such limited group, of course, is the occupationally ex posed group, hi spite of the fact that many people refuse to acknowledge the usefulness of data obtained from the occupationally ex posed worker, very helpful data have in the past arisen out of careful observations on this group. Obviously certain precautions need to be observed when using such data, not the least of which is an awareness of the so-called "healthy worker effect." Nonetheless, many environmentally caused health effects have first appeared in those occupationally ex posed, including asbestosis, lead poisoning, gynecomastia in males excessively exposed to estrogens, and others. Often the diagnostic procedures useful in defining a particular dis ease, and therapeutic measures have first been developed in this group and subsequent ly applied more broadly. I am well aware of the fact that the occupational medicine record of the past has left much to be desired in some cases, but in other situations imporj tant progress was first made in this field. I am not claiming that such data are a panacea. I am only suggesting that where good data ex ist, they are not to be overlooked or ignored completely. More and more companies today are establishing well-qualified medical departments which may contain, in addition to physicians, toxicologists, industrial hygienists, and epidemiologists. I predict that out of these departments, more and more useful information will come in the future, and there will be less and less cause to American Industrial Hygiene Association JOURNAL (40) 12/79 The LAST Sth Life Sciences Symposium, September 13-17,1978 look at such data with skepticism and dis belief. Industry, I think, has learned a very" useful and bitter lesson from its past at tempts to hide or cover up health difficulties that have developed among its employees. Further, occupational physicians, through* their major professional society, the American Occupational Medical Association, have written themselves a code of ethics, which hopefully will overcome some of the difficulties they have encountered in the past. It is interesting that the American Management Association, in its publication, The Forum,(1) took cognizance of this code of ethics. This article also states that several oc cupational physicians have had to quit their jobs over ethical disputes, indicating that the code may be having some of the desired ef fects anticipated from it. Distressing to the occupational physician, at least, in this publication is the observation that medical policy is determined in the company board room, and maybe not all companies will be willing to accept and adopt this code of ethics for their physicians. If this be so, then the oc cupational physician, whom I class with the scientist, has a responsibility to mount an educational campaign that will convince most corporate boards that a code of ethics like this is truly in the corporation's best interests. If general population studies or studies of limited population groups do not produce the necessary health information, then we shall have to rely solely on the results of animal studies, hi today's world, it is likely that any major change or new development will have been subjected to at least some animal testing. In many cases this may be inade quate animal testing in terms of quantity, and sometimes even of quality. If the animal toxicological studies have been designed by a nonhealth (or nonbiologically) oriented in dividual they most assuredly will be deficient. This is particularly true if they are designed by the engineer, chemist, or scien tist responsible for the new development. There are many reasons for this, but over the years I have become convinced that the most important is that the developer wants to make his new development as profitable, 1137 either for himself or for the corporation for has been some reluctance on the part of some whom he works, as possible. He therefore looks on toxicological data as an increased people to embrace immediately all such tests, I think it is understandable. Dr. Ames and development cost, the necessity for which, his coworkers, for instance, use several because of his background, he cannot fully modified strains of Salmonella, and over the C 1 comprehend. years their recommendations as to which ] The toxicologist, or other biologically oriented individual, who is advising the modified strain or strains should be used have changed. It is my understanding that 1tt developer of a new idea or product, first needs to sit down with him and accumulate of a lot they are still working on additional modifica tions of strains, so it can be anticipated that 1 1 of information himself. What is the nature of the new development (or product)? How will their recommendations will continue to change in the future. Others use a series of fc it be made? What chemicals and/or catalysts will be involved? Are there intermediary strains of E. Coli. Still others use Neurospora. Some tests which are positive f chemicals involved, and if so, what happens to them? What is the size of the potential with Salmonella are negative with E. Coli or Neurospora and vice versa. If this is true, and cc market? How will it be used? Are there waste products, and if so, what will be done with if all bacteria have the ability to mutate, and there are perhaps a million differerit bacteria, c 1 them? How does it react with other chemicals or materials? What happens to it when it is it is easy to see why some people are reluctant to embrace such tests with impassioned fer s t subjected to heat?--and many other ques tions. In other words, the biological scientist vor. I am sure that in time these problems will be resolved, but I think scientists have a t 1 needs to know as much as is known about the new development or product, and may even responsibility to recognize that such problems do exist, and not be overcritical of t t have to suggest that additional information those who may be moving more cautiously. i. be developed. Based on this information, the biologically oriented person can then begin to It used to be that when toxicological (or health) information was developed nobody b r design animal and/or other toxicological heard about it or knew of it. True, some of it studies, which are adequate in both quantity was published in the literature, particularly if v1 and quality. As I outlined in the American Journal of Public Health,w the extent and it was important that a company warn its customers, its intermediary handlers, or ti: nature of such toxicological testing will vary depending on the various factors outlined perhaps even its competitors, if they were in the same business. Actually customers and t t above. In addition, since 1970 new tox icological testing has been developed as a intermediary handlers could be informed through product information brochures, but fi ti result of advances in basic science as outlined by Dr. Kraemer (this symposium). Such ad often a section on toxic properties or hazards was left out of such brochures. Competitors in vances are going to continue into the future the same business were often told verbally at and an additional responsibility of the trade association meetings. But if these data biological scientist will be to keep abreast of were interpreted to be negative, it was quietly these new developments. As warranted, ad filed away and no one heard of it but the com ditional or modified tests will have to be add pany that developed it. Some scientists1 S' ed to those which previously were considered thought that this was not a desirable practice t; standard. After thalidomide, teratogenesis tests were added in some circumstances. and there was much talk at one time of a "Journal of Negative Results." The principal w b Many laboratories, including those in in journals that were used, if publication did oc n dustry, are evaluating a whole new battery of cur, were the American Industrial Hygiene s! toxicological tests including various Association Journal, the Journal of Oc o mutagenic tests with bacteria, direct- or host- cupational Medicine (then called Industrial o mediated, cell transformation, DNA damage Medicine and Surgery), and the Archives of o and repair mechanisms and others. If there Environmental H ealth. (which has gone ca rC OB <u CL. "O 1138 Am. Ind. Hyg. Assoc. J. (40) December. 1979 Ar LASL 6th Life Sci. Symp. 9/13-17,1978 i on the part of some liately all such tests, able. Dr. Ames and tance, use several onella, and over the ations as to which ns should be used understanding that additional modificabe anticipated that will continue to :hers use a series of Still others use which are positive itive with E. Coli or a. If this is true, and nlity to mutate, and >ndifferent bacteria, people are reluctant ;th impassioned ferime these problems ink scientists have a )gnize that such ot be overcritical of lg more cautiously. en toxicological (or developed nobody f it. True, some of it ature, particularly if . company warn its diary handlers, or tors, if they were in tally customers and could be informed ition brochures, but iroperties or hazards ures. Competitors in ften told verbally at ?s. But if these data native, it was quietly rd of it but the comt. Some scientists a desirable practice k at one time of a ults." The principal TIpnudbulsitcraitailonHdyigdieonce>en cJaolulerndaIlndoufstrOiac-l md the Archives of (which has gone up.J. (40) December, 1979 9/13-17.1978 through numerous name changes over the years). Today, numerous other journals have appeared, not the least of which is Toxicology and Applied Pharmacology (the official jour nal of the Society of Toxicology, which was not even in existence then). About the mid50s, under pressure from the government, much more extensive labeling, and much more extensive information on the label began to appear on almost every product. In fact, there were those who predicted that over-labeling would defeat the original pur pose of labeling, and I have no doubts that in some situations this did occur, and still does occur. Intensive campaigns by FDA and others helped this situation some by en couraging people to read the label. Today, however, with the passage of the Toxic Sub stance Control Act, it is going to be necessary to report all data, positive and negative, to the government. Additionally, the data will be reviewed by others, presumably disin terested parties, for their adequacy in quan tity and quality. What does worry industry, including the biological scientists in industry, has been alluded to earlier in this paper. No matter how many data we have, we will never have enough so that decisions can be made without judgmental inputs. It therefore could be very easy for governmental regulators to insist on more and more data to the point that new developments are stifled. There are those who believe such has occurred in the field of new drug development in this coun try. Whether the charge is justified or not, I am not in a position to evaluate. It is, however, a factor that must not be ignored, and the regulators in Washington or elsewhere must be made aware that at some point they will have to make judgmental decisions even in the face of what may be con sidered incomplete data. Obviously some of these decisions will be contested because they will find respectable scientists supporting both sides of the argument. Such dichotomy may be perfectly sensible, and scientists should be able to recognize the legitimacy of other scientists who do not agree with their own interpretations. I think a good example of this is the dispute that has raged for several years now about the use and/or dangers of use of oral antidiabetic drugs. The results of the cooperative university study suggest that diabetics who use such drugs suffer a higher mortality than those who use insulin, or who control their diabetes by diet alone. Almost to a man, the diabetologists have disputed the findings of this study and defended the use of some of these oral an tidiabetic agents. Can it be that all of them are wrong? Or is it more likely that there may be some legitimate grounds for disagreement. Perhaps only time will answer those ques tions. but I do not believe that name-calling will add much to the solution. Thus, I think scientists have a responsibility at least to listen respectfully to other scientists who may not share their views. As I pointed out in a re cent editorial in the Journal of Occupational Medicine,(8) there is a tendency on the part of some regulators to force their own decisions through three tactics, which scientists should avoid. These approaches are: obfuscation of the facts, smear tactics, and the creation of strawmen. Summing up, then, I would say the scien tist has several responsibilities. First, he has a responsibility to himself. Second, he has a responsibility to design meaningful, epidemiological studies, recognizing fully their limitations and shortcomings. Third, if epidemiological studies seem impossible or impractical, he has a responsibility to design meaningful animal, or other organism, tox icological studies of adequate quantity and highest quality. Fourth, he needs to interpret such studies and their significance in an un biased and honest fashion. Fifth, he needs to keep up with the newer developments in his field, acknowledging when such develop ments may have their own limitations and deficiencies. Sixth, he needs to review his data and interpretations with other scien tists, soliciting their differences of opinion when compared with his own. Finally, he must acknowledge that other scientists are going to disagree with him, that such dis agreements may be perfectly legitimate, an he must resist the temptation to name-call. American Industrial Hygiene Association JOURNAL (40) 12/79 The LASL Sth Life Sciences Symposium. September 1317, 978 1139 ^iv ren ces , r Hlth; Toxlootogl J`RU6' - 3' (OZ TT U^ r*7 ^ S0**" H'i*0O"s-n"er't5c AL Lit discussion epidemiologic d l^ a re T o ra v I iia b ir'N M a t0 6Xists where adequate human Perhaps the scientist is at fault. The s c ie n t is f u ^ h ^ ar lackin9 in the literature and 2 T n0t toxico,9y per se. Even a thrle ievel toxici!VelS * understand some biological arget organ in the animal, he can loo for lo w in g the 1140 AmJ " dc, ^ g-Assoc- J- ffl) December, 1979 WSL L|fe Sci. Symp. 9/13-17, 1978 me pri abc anc disc ttohai mar : the setg mai thos> rathe ihnartdh At L appli . reseai we've aretr when perhaj are get peer re tain if moving You pany w work fc compan workers 10% o f: on we ft than sin that is, out in te: a need policyhoi trol thei. would, in jury and < sairliecaosriesacl Liberty *4 AmrearicauaIU*