Document KxLJMRvb6Q9d2n17516o4r9x

October 11, 1952 Mr. Manfred Bowditch Lead Industries Association 42o Lexington Avenue liow York City 17 Dear Manfredt It appears that something in the nature of a tempest has developed, whether In a teapot or perhaps in some large receptacle, over the somewhat inadequate but veil-intended information supplied to you by my friend and colleague, Doctor Robert Kotte, concerning come unfortunate results which attended the use of Calcium Disodium Versenate (5 cc ampules supplied by Hiker Laboratories)in the treatment of two infants suffering from lead poisoning. Odder the circumstances it seems best for me to clear the atmosphere by a statement of the facts, so far as I have them, since every one Involved in the matter seems to be touchy, suspicious or otherwise upset. It even appears that I am suspected of sabotage in the matter, and of being constitutionally opposed to the development and use of specific therapy in lead poisoning, although I find it difficult to believe that anyone has seriously entertained any such idea. At any rate, while X am willing to do any required penance for my sins, I do not accept quietly indirect queries concerning my medical and scientific attitudes, and therefore in the not unalloyed role of peacemaker, I am prepared to accept the intermediate position which Invites any blows Intended for myself or others. The situation, with respect to the use of EDTA in the treatment of lead poisoning came about here some months ago, when it was first suggested publicly that this agent might be useful. As is well known, X should think, I have had only a mild concern about the * treatment of the usual case of lead poisoning in the adult, although we have subjected a number of types of therapy to rather rigid investigation. Moreover, Z have Inveighed, as vigorously as I know how, against the substitution of therapy for the preventive measures that are available and demonstrably effective, against industrial lead poisoning. On the other band, I have been deeply concerned, for many years# over the serious problem of the development of adequate treatment for tvo types of lead poisoning which give rise to high incidence of fatalities, namely, lead encephalopathy in the infant and small child, and tetraethyl lead poisoning in the adult, which, if exposure is sufficient, is uniformly fatal The former is a public health N22330 Mr. Manfred Bovditch - (2) - October XI# 1952 problem of rather serious proportions# which, at present# is not wholly preventable# and which# therefore# requires and will continue# until It is solved# to require effective treatment. When it appeared that EDIA might be useful# Z obtained all of the information I could get# together with a supply of the material, and conferred with the group here In Cincinnati with whom I have collaborated for many years in the diagnosis of cases and In the study of the problem. Z strongly reooraoendcd the use of the product in the treatment of selected cases of grave illness# and found complete agreement that the highly unfavorable prognosis justified the trial of the preparation. A means of following the cases# to determine the extent of the clinical benefits and to observe the effects upon the lead metabolism# was agreed upon# well before the time of year when such cases can be expected to reach their peak Incidence. (V/e had somewhat in excess of twenty cases In 1951# with a mortality of about one third# and ve are quite certain of seeing several serious cases, some of which are destined to be fatal# during the summer months of any year.) Meanwhile you (Bovditch) and Doctor Wheat ley had been in more or less continuing communica tion with Doctor Sot to on the matter of lead poisoning as well as other types of illness among children# and ve complied with your request to make such suggestions as ve could for a form of report and an outline of procedures indicated-for demonstrating the results of therapy. Our own procedure differed somewhat from that which was regarded .as essential and that which could be carried cut in certain other places # with particular reference to the analytical regimen. In this ve followed our own counsel, since I have not been favorably impressed by the critique, or I should say, the lack of critique# on either the clinical or metabolic effects of the use of remedial agents in recent years in lead poisoning# because of the almost complete disregard of the known facts concerning the metabolism Of lead in health ahdUIscase. and the^reliability of the methods required to establish the facts in the Individual case# on the part- of most of those who have: undertaken such observations . Suoh methods were not available in the nineteen twenties# and there was no serviceable information on the subject until after the late thirties. There are ouch methods now and some data# but neither the methods nor the data have been taken seriously by more than a very few people. Consequently, I may be forgiven# perhaps, if I considered that it would be necessary for us to answer questions on the metabolic aspects of the matter for ourselves. ho suitable cases , of lead encephalopathy among children were available for treatment until the late summer of this year# but two such cases appeared thexv and treatment was initiated with EDIA in the Cincinnati General Hospital (I misinformed Lanxa in an earlier letter# by saying that these were in the Children's Hospital). Z was away at the time,but Doctor Kotte felt that it was vise to infora you (Bovditch) of what had occurred. The cases were not his own# and he had no direct or delegated r Hr* Manfred Bovditch * (4J - October 11, 1952 vere desperately ill and several others required hospitalisa tion and radical caro* That there vere no further fatalities may not he attributed to the beneficial effects of the use of BIX/A, a supply of vhich v&a taken along, and further supplies obtained from Dr* Foole {whose accidental death, some days later has shocked all of us). However, the drug vas veil tolerated by these patients, and observations were made as veil as they could be under the circumstances to determine the metabolic effects of the use of the drug'in certain of these cases. (Some vere treated vith BUT A, others were not,) The analytical data on something over tvo hundred samples of blood and urine have not been obtained entirely, nor has it been possible to study them in relation to the therapeutic regimen, but all of these data vlll be available shortly, and they should show whether or not this agent is capable of Influencing the behavior of tetraethyl lead and/or Its decomposition products in the human body* It does not follov, of course, that these facts will have any Important bearing on the problem of lead poisoning from inorganic poisoning, but they vlll have some significance, I hope, in relation to TEX* poisoning* v/e shall continue to make use of EDTA in an experimental study of the therapy cf lead poisoning In the adult, and, in all likelihood, ve shall be able to resume trial use in selected cases of 'lead poisoning In the child* Our experience, although as yet inadequately reported, fully justifies the position taken by the group that this preparation should not be distributed for general use, until such a time as adequate evidence can be obtained concerning its possible benefits and dangers * The incident and the hubbub about it also demonstrate clearly that the applica bility of a proposed new remedy needs to be examined in an attitude of unhurried objectivity, rathe:* than in an aura of enthusiasm based on theroretloal considerations however exciting they may be. -' I ha've given this letter as vide circulation as seeded necessary at tills time* In view of the fact that I have gone somewhat outside my own professional province in reporting incomplete and inadequate information on patients who vere not under my care, l must ask that this information be handled with appropriate professional discretion until the facts have been released by the responsible physicians* Sincerely yours. Robert A. KohoqM. D. KAK ef CC j Dr. A. J. Lanza - Dr* Thomas L. Shipman - Dr. Harriet llardy Dr. Elston L. Belknap - Dr. George N* Wheatley