Document nkzz7Q2gZN01zEyYvZQLOgoOa

JtUSut crz: J\ <?//&* </A', <*/ /f'>-<ysz>S*-c/ /2^oftcy. rl ^C>r<yr/i?si <!yf ^(zffc * % CJ. *y N36893 DUP050312013 ER-8270-A REV. 3-64 ESTABLISHED 1002 E. I. d u Po n t d e Ne mo u r s &. Co mp a n y Wil min g t o n , De l a w a r e 19898 EMPLOYEE RELATIONS DEPARTMENT HASKELL LABORATORY FOB TOXICOLOGY AND INDUSTRIAL MEDICINE July 23* 1970 University of Illinois Medical Center 840 South Wood Street Chicago* Illinois 60680 - Dear Dr. Kellers I received the manuscript of your paper MBlood lead ih Pregnant Women and Neonate3" to' review and felt that because of our special relationship with regard to this paper, since the Du Pont Company had financially supported it, and the analyses had been performed in our laboratories, that I should writs to you directly concerning the publica tion of this paper. I feel very strongly that in its present form the paper* requires considerable revision and would offer the following suggestions. As set out in the abstract the purpose of the paper is said to be "to evaluate whether the increase in atmospheric pollution by lead increased the blood lead content of 410 pregnant females and 104 newborn infants. To onsvfer this question only two maximum blood lead values are given, one for patients having urban addresses and one for patients having rural addresses. To provide a satisfactory answer to this question at least the means and standard deviations for the two groups should be calculated and any difference in means tested by accepted statistical techniques for significance. If a significant difference is found, one possible explanation for the dif ference would be the air lead concentration to which the groups were exposed but other possible explanations such as differences in diet would have to be discussed and the actual air concentrations of lead in the area of the study measured or estimated. It is noted in the paper that com parisons were made of the influence of other factors than place of residence, such as stage of gestation, season of the year and sex of the infant, but none of this potentially very interesting data is offered in numerical form. BETTER THINGS FOR BETTER LIVING . . . THROUGH CHEMISTRY N36893.01 DUP050312014 J. M Keller, M.D. (Cont'd.) Pag 2 July 23* 3.970 It is stated that the lead level was somewhat higher in term pregnancies, hut there is no discussion of the problems of accurately measuring the lead levels in the blood of women with a changing fluid balance and red cell mass during gestation* Bi the preamble, reference is made to NegakIs s paper which claims an increased risk of abortion with blood leads exceeding 410 micrograms of lead per 100 grams of blood. It would seem to me that again a single figure is not suf ficient information and that one needs to know the mem blood lead as well as the range of values for the group, but that since you have introduced the subject of abortion some reference to the outcome of the pregnancies in your study should be made. Were there abortions, stillbirths, neonatal deaths or fetal deformities? If so, these should be documented and their statistical, significance assessed. In conclusion your reference to the "normal blood lead level" raises the problem that to many persons lead poisoning cun be diagnosed solely from a blood lead level, whereas lead poisoning is a clinical diagnosis to which knowledge of the blood lead level can make a significant and useful contribu tion. /`Normal" in the sense used here and in your paper means "commonly found" and being outside the normal range is not necessarily the same as suffering from lead poisoning. I hope these suggestions will be of value to you. It seems to me that tills study and others that we conducted at the University of Pennsylvania pointed to the complexities of carrying out longitudinal studies of lead levels in preg nant women and perhaps foiled pilot studies for a more definitive piece of research. Probably the only clear con clusion that can be drawn from the original data is that lead crosses the placental barrier to give essentially the same blood lead level In the fetus as in the mother. Sincerely, ORIGINAL SIGNED EST JOHN A. ZAPP, Jr. CJS/rlm 6. J. Stopps, M.B., B.S. Assistant Director DUP050312015 E. I. d u Po n t d e Ne mo u r s & Co mp a n y INCORPORATED Wil min g t o n , De l a w a r e 19898 EMPLOYEE RELATIONS DEPARTMENT HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE July 22a 1970 Robert JL Kehoe, M.D. Hhiverslty of Cincinnati Department of Environmental Health Kettering Laboratory College of Medicine Eden, and Bethesda Avos. Cincinnati, Ohio 45219 Dear Bobs I have Just returned from four weeks of vacation to find your, letter and the Keller manuscript on my desk. The paper arises from some preliminary studios which we sponsored gome years ago in trying to answer the Question; t!2s load mobilized from the maternal skeleton during the period of high calcium demand by the fetus in late pregnancy?'1 The .results of tills and some other studies we carried out at the University of Pennsylvania convinced me that without a spe cific interest in this particular problem by the clinical group involved and a much more sophisticated experimental design than could be undertaken in the conditions usually found in the outpatient department of an obstetrical service, fch question could not be answered. ' As X am sure you will appreciate far bettor than, most people the relationship between the. university person carrying out a piece of research and those responsible for partial or complete financial support can be a delicate one. Xn the case of Dr. Keller, personal relationships were always good, but it quickly became apparent to me that my original idea of how many mothers would need to be studied and the number of analytical samples required from each mother were inadequate and therefore X regarded the study by Dr* Keller purely as a pilot study and that to carry out a definitive study would require a much more sizeable effort than was feasible at that time. BETTER THINGS -FOR BETTER LIVING . . . THROUGH CHEMISTRY N36893.02 DUP050312016 Robert A. Kchoe, MX>. (ContM.) Page s uXy 22* 2970 Of course the results of the blood analyses were freely available to Dr<= Keller to use if he felt a useful contribution to the scientific literature could be extracted from them, I had hoped that the lack of any publication over the intervening years reflected Dr* Keller*s apprecia tion of the sketchy nature of the available data even if it were set out in full* but apparently this is not the case* X am glad you have expressed yourself firmly and forcibly on the merits of the paper since a similar ejspre.ssion of opinion on my part might be interpreted as an attempt to suppress publication* X am sorry that you have been bothered, by this matter and hope that in giving the background to the "studyu you will understand my position* With best regards* Sincerely* GJS/rlm o r ig in al s ig n ed it ? JOHN A. rfp, jt^ 0* xS * Stopps* Is*]S** ReO* Assistant Director DUP050312017