ML20129J379
| ML20129J379 | |
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|---|---|
| Issue date: | 05/15/1978 |
| From: | Rubenstein D NRC OFFICE OF MANAGEMENT AND PROGRAM ANALYSIS (MPA) |
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Text
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A*""ACTIC L 1r7!?f 0F FrtAL REPOR~ 113 5*'3MI'""O ST 30MA3 7. FXiC 50, M.D.
Sy David Rubinstain Applied Statiscies 3rsuch Office of Management and
? ogram Aca17 sis IT.S. Nuclaar Regula:or7 Commission l
! B507220558 850524 PDR FOIA ALVAREZ85-309 PDR l
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! 3-l Is nr opinien the :ssul:s of nea 17 all .abulations and ana17sas
, given by the authors ars Largel7 subsu=ed. by de analyses per-'d -
I ing :o Tablas.11 and 23. 3ese :vo :ablas centrol for one-importan: variable,. age at death; day deal vi:h nucually a:cclusive groups and da statistical analysia is ra:her straight for card.
Tabla 11 (for males) and sN'a:17 Tabla 23 (for females) break.
. dcwn de al' certified deaths by groupings of radiacion deses and ages an dead. For each cat' defined 27 2 particular age group and radiation estego:7 .he percan: of cancs: deads is computad. The percen: of cancar deads is also c mputed for each radiacion group tocaled over ages. Le total group of Tabla 11 shows a rather consistant and app;sciabla rise in de percene of cancer deaths as one naves f: ur de :ero :sdiaciou subg oup :s de f00 -- centigsde subs: cup. 3e sa=a holds :: e for 70 + age group and :o lasser degrees or oc an all for other poups.
Eowever,, for no age group do he data suggese a :ensiacane devnvard
- sed. Le data is certsd-'7 consistanc vid an upward ::and for the higher age groups if all:wancas for pl.tusible s:aciacical
- variacion are cade. Tabla 23 providas si d's: :ssul.s.
I
- 4. -
- 3. Caveses on Section 2 and criticisms on the 71:a1 Recore. .-
-In -Ais see:1on I shall discuss sene aspects of .he data and the analysis which indicate a cautious approach :o de da:a and ther results of the authors. Se primary issue is dea:h races and cancer death races among workars a: risk rather than cancer death rates among deaths. *herefore a prospective type of analysis is preferable :o a retrospective analysis. Moreover
.I feel thac the logic of a prospec.1ve analysis is = ors direc and problems such as confounding are :mre apparen: and : se:able vid
, the prospective approach. Beyond the issue of prospec:17e vs retrospective analysis, I find tha: the da:a is ve.7 :: icky and -hat much of the ana17 sis by Mancuso ec. al. is see convincing. Sese vill be discussed with a few detailad ena=plas ra:her dan wi:h exhaustive cri:1cisn.
Confoundinst of see and esd12 fon dose.
The auchors poin: ouc repea:adly. da: :1=e rela:ed variablas such as calendar year, 7 ears before dead, and age are related to de respectiva dosages received or de proportion of verkars exposed.
I wish :n po1== clear 17 :o d e 314:1cuship becveen cumula:ive dosages at given ages and cancer death rates. Table 21 11s:s d e
= san cumulative dose by age for non-cancars and :vo selec:ad 3: cups of cancer. The mean cu=ulative dose for cen-canes:s rises fron aboue 10' con:1: ads a: icv ages to a **-- of abcut 30 :en irsds for ages of 50 years :o de :11-s1=:ias anddeclines is de sevse:Las.
. ~5-This rise and fall is repeated for tha two cabled cancer groups combined.
Unfortunately va do not ' cow da ;a::arn for other enncers whid. On de average (sea table 4 had icw mean cu=ulacite deses. Eovaver, .he non-csacers by themselves form .he overwhel-d g sejori 7 of cases and de trend for them 1.s very clear. In Table 11 we can see chac the cancer race of the non-exposed workers rises sharply :o the fif ties, reaches
=^= in the sixties, der"*es in the- seven:ias to a level roughly reached is the for: des. If one looks ac the cotal column de same patters is obsethed. An inspection of U.S. statistics fc= de year of 1970 yielded de same pac:ern but roughly ac :etce de races for Hanford workers. yor cue reason or another de sample of deceased Hanford workers is such dat deir mean cumulative doses are highes: at de ages ac which "catural" cancer deaths predoninaca.
The data of :able 11 are perhaps sore relevant since ther show da cumulative doses at death. To show de :enfounding rslacionship requires moderace17 i=volred analysis I have desea one based ou de ma17sia of contingenc7 : ables. Each call of Table 11 has an obserted frequenc7 of desch designated by de authors as"' fos'.' L a expec:ad frequencies for he cells a:e computed is such a sanner dac cor:ssponding cella of an7
- wo columna are proportional to che respectiva column :ccal, and vid idenci:21 propor:1onali:7 properties for :ws. '"he
. differences between o'oserved and expec:ad frequencias indica:a .he manner in which propor:141 assign =en: is riolacad. he ra:1cs of dese diffarances o de respec:1te expected frequencias sees :o 31te a good quanci:acite : essure of de shif:s 40 6
-S- -
f :m proporticnali:7 ~.able .t shows da: in age groups vid high :ancar rates (50-39, 60-49) de differseces are negative for icw radia:1cn groups and post:1ve for high. radiation groups _ h colloquial language dose eso age groups gen :: sore chan their fair share of high radia:Lon. Se opposi:e =end or a seu::a1 =end is apparent for the other age groups..
Table 11 which gives =ean ~ d2:1ve doses vs age bears further examina:1c'n as :s the pecit'2: cature of de confounding of =ean cumulative radia:1cu doses and age and the arra:10 nature of .his confounding. *e:
. us first icok agal: at de non-cancers. 3a: :he cumulative doses rise vi-2 age is ca:nral enough; de older a workar is the more chance he had :o ace.m21 ace :adia:1ca. 3ue why is :hore such l a sudden drep (377.) between .he ages of 65 and 707 Noce dat dese =eans i
are based respec:17e17 :n 1071 and 715 workers and prssumab17 ces:17 al'_
of -Je 716 verkers in de 70 year group are also 1 de 65 year g :up.
Among possibla explana:1cus are the ic11 wing:
(a) New workers vi-2 :o :sdia:1:n vere hl sd 2: ages above 65 chus diluting de =es=.
(b) S e mean cumulative doses are s ecus 17 i=fluenced by a. few workers vid ext:s=ely large doses.
(c) Se death rates becveen ages of 63 and 70 years ars strikingly l
higher for verkars vi:h odarate :2dl.atice deses .han for verkers vi d Iess :2dia:1:n (Note da: dese are sc=-cascar das es).
l (d) 3ere is some ;eculi.tr age related assiganen: of :2dla:1:n l
(
doses c verkars. -
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- 4h11e some of .hese amplanations sa7 be ver7 implausibia in .his concast and (d) appears perhaps to be che most plausibia, vi:h limi:ad, retrospective summ==M_as it is difficult to decide vid convic:fon.
We comparison of the :neen radiacion dose at death (99 ceneirads, see Table 2).*sid :he w'= mean radiacion dose of all ages (33 ceneirads) presents a shdiar problem.
- he mean cumulative doses for :he :vo cancer groups listed. i= Tabla 21.
also show very sharp changes is small age incarvals suggesting caution in incorpreting resul:s. For example for Ras 'Teoplass deads de mean e umalacive dose changes from 701 cancirads :s 34 caneirads in one year.
I do not wish, :s case doubn on :he accuracy of dose numbers; however I do suggest -Jtac such. sumbers akan a: faca value can sistaad. *he authors app 17 b11:he17 Studen:s :- :sse :o such numbers- (in Tabla 21 as elsewhers) and seen :s imply validic7 to :hese scacistical :sses.
An examination of analvses raistinz :s T.able 4 Table a presents an analysis somewhat diffarant fres dose discussed above.
De authors argue from de face dac for cancers for which de cancar raca
- of Hanford workars was high :e14:1re :o .he cancer :a:a of :he L 1.
population de sean cumulative doses vers also high. For exa=pla for myelomas de ratio of the raca of Hanford workers :s :he rz a of de A
U.S. population was highese a=cng al' cs cers the au. hors list in Table 4, and at the- sane :1=a de sean :- th:17e dose of Eanford workers dying 41,.h =7 ele =as vas also de highese. A=ong :he 13 cancer groups considered by the au: hors the relacienship be:veen Jean dose for :he cancers and the respective ra io is :oc perfec: but quite respec:abla as an exand a:Lon of *able i vill reveal. The co = ela:1on.
(Spear =en's rho) be:veen de dose and de ra:1o is .61 vid a one-sided P value of about .003.
The au: hors su=nari:e de rela:1onship by concasting :he observed deachs vid .he expec:ad dea:hs (based on 7.3 experiance scandardized to achieve 670 deads) for :vo groups of caccers,1.4. dose vi:5 high nean et=ula:17e doses and : hose vid low cu=u14:17e dose. Ter de high dose group de obse: red su=ber 391 is significan:17 larger dan .he expec:ad s :nber of 313.2., this diff arance as well as de above cocela:1cn sugges: at first i=pressica hat high cancer ra:es are associa:ed vi:h radia:1ce.
The sugges:ad rela:1onship is soc as si=ple as i: sigh see:2.
Iec us em-d e the i=plicacion of de sean dose of 773 can:1: ads for
yelomas the cancer group vid :he highesc ratio. First 14: us ga:her some fac:s. Table 1 indicaces de:e vere *.1 esses of nyele=as. 7:o
Table 3 so: reproduced here 1: can be infar ed cha: 3 of casa 11 cases
- sceived so :sdia:1on wha:sover. Final *.7 ve seed de ;er:en: ages of all cases in various radia: ion :acagorias :f Table il as well as :he percen: ages of ancers in ':hese ;;oups.
-9 Cases Cancers Jose No ._ ! No .
0 1136 33.0 226* 33.7 1-19 625 17.3 98 14.6 10-99 394 25 .4 194 29.0 100-499 5 12. 14.5 113 16.9 500 154 4.1 39 5.3 To al 3520 100 .(1) 670 100.0
}
- 226 = 16.9 x 1336 The najori:7 of al'. cancers coce from workars vi:h doses less -Aan 99 can:1: ads and :he overwhel=ing .ajori:/ froc workers vi.h doses less dan 500 cancirada. .! :7elocas follow de sa:e ;a::arn den de large average dose was caused by a few exceptional doses, in which case de observed ;henonenon is aberan: ra:her han :7pical.
If ex::ene observa:1:ns a s :uled ou: . hen .he deses af de 3 cases vid :sdiacion =us: cen:er en.abou: 900 canci:ada suggesti=g sece:hing like a :hrsshold ;hencuenen and :ha: lever radia: ions ars ;;ocac:17e.
Ie=enber .ha: nore dan 30% of ir:dadia:ad esses have doses '. ass 500 cen:L: ads.
The au: hors seen :s :sjecn the :hrasifold phenonenon and strongl7 endorse the hype:hesis of a linear relacionship (page 12. "de onl7 logical al:erna 1re") . In face : hey base : heir co=pu:a.1ons of de doubling dese and excess :or:ali:7 CISt, page '.3) on da: as s u=p tio:.. 3 de linear hypothesia 1.r : te and de racia of de intar:ap: :o de n
m t
O. Preliminaries.
The document under review is the Final Repor: 113 by Taomas T.
Mancuso, M.D. submi:ted under contrae: to ERDA.(ll. The sub-scantive part relating esacers :o :sdiation was wri::en by Thoems Mancuso, .tlica Stewart, and George Ineale. This pare has also been published is the Real-J. Physics Jcursal [1]. ~.2 this review the subsantive par: say be referred :o as the
. Final Report or the Mancuso Study.
Several ables era reproduced from :he Tinal Report and the able numbers of the Tinal Report are used. Toocuotes by .his reviewer have been added :o some of .hese tables. Tables developed by dis reviewer vill be labelad vid capi:21 letters.
Pages ci:ed is .his review :sfer :o .he page numbers of the Final Report.
- 1. !=credue:1on and spe-sach o review.
Is his summar7 of .he Final Repor: Mancuso stacas: "The stud 7 shows chac dere is a defd ':e rela:icuship between icw level tonizing radiacion and :he development of cancer." Wile he also scaces more de:211ed conclusions, *. shall deal prinard17 #.6 the quota as .he central issue because:
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a "'ha broad issue is of greatest concern to NRC.
h **o che extene dat da analyses of de 71 sal Repor: suppor its conclusions, his-in my viete cosas through 4: lease as forcefully for the general conclusion as for more specific conclusions.
In Section 2, I shall discusa che support for da relationship, faction I will deal selectively vid some short:enings of the data and analyses perforned by the- authors. Sec:Lon /* M.11 offer a sunenary view
- 2. Support for the relationship between cancer an low ivevel ioni:1st radiation.
Tabla 1 of the Final Report breaks down :he certifiad deaths (befors 1973) of Ianferi verkers by cancer deschs and non-cancer deaths. 2 shows respectively for desa two groups mean canulative radiation doses of 1.18 and 99 centirads, and propor:1ons of radia:1on exposed workers of 6o.0 and 61.1~.. M s apparen: association between cancar deaths and radiation suggests ac face value a causal relacionship. Many of tha succeediss :ablas and graphs presen: de same da:a broken down by finer classificacious such as exposures received in specif1: calendar years or ac specific ages or broken down by specift: types of cancers. As one vould expece desa :sfined breakdcuts :end :o show de sa=e essociation between cancer deads and ar;osure, and nei:her is i:
surprising ha: the assoc 12cion seems to be 3:ronger for sons subsets of the daca dan for others.
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slope of de seraighe 11:ss are proportional over cancer classifica-tions -den de =ean doses for all cancers should be de same. Even withouc dis :sserie:1on diffs:seces between mean doses on various
- 7 pes of cancer does soc see:a :o be a good measure of de : 14:1ve "riska" of cancer :7 pes :o radiacion.
Even though we car soc be abla :o find a plausibla explana:1co, for the scacistically significane cor:slacion between =ean doses and de racia observed :s espec:ed i: cert:s seca a::ention. One can duplicace the authors' analyses substi:uting de per:ss: age of exposed workers for the =ean etm.t14:1ve doses; the resui:s 4:s ;;ese::ed i "abla 3.
The differsuce beeveen observed and a=pec:ad for :he "high-riak" cancers becomes very s $" and :he cc::alation be:veen percent exposed and de racio has becoce slightl7 =egative (:ho = .05) . "he fac: da: :wo ec related =essures-percant exposed and =ean doses-71ald such sc:d'" gl7 differsne :ssul:s assis poin:s to the fac: dan de data is ::1:ky.
- 4. Su==at-r "t av b =7 op1:fon -"A of .he 71:41 Kaport iJ :oc relavas: or of questionabla validi:7 The ra al:dar of de repor: LJ 1argely subsu=ed by de analyses of Tables 11 and 23; especially on dose cacters of graa:ase concer: :o NRC. Bis leaves us vi:h ha issue how valid ara :hese a:alyses. Sase analyses are sc:scified (controlled) by ags ac desch and dersfors relative 17 1:vulnerabia :o confound 1:; fase vi d dis variable. Howeve ,
age at death is noe de on17 relavan: :1:e rala:ad variabla.
II I believe date of birth and scan allowance for lacanc7 art i or:anc.
A worker's date of bi::h decard es whechar he v11*. ::ach befors 1973 (cucoff date of stud 7), the ages i= vhich cancers deaths ::ach . heir highese proportions among deaths. Se :scher odd behavior of de mean cumulative dose as a function of age suggests : hat if la:ancy is accounced for the apparen: picture may change. ?inally,since the radiacion has been so scrongly confounded vi:h :ime : slated va: tables 1: seems plausibla dac it may al.so be :oufounded vi:h other variables.
In. facr differences is esdiation exposurs suggest diffarsucas in ,
occupaciou and cor slated charac:ariscies.
Sere are no goed sciancific guidelines to evaluate these possibill:ias The numerical rela:1onship of cancar incidence and lov level radia:1on, if te ever can be ceuvincingly demonst:stad, # nose likely be demonstraced by a painstaking prospec:17s study. Despt:a various reservations feel that .he :ssul:: of Tables 11 and 13 should noc be ignored is de fo=ulacion of :sgulatory pdlic7 until mora defint:a studies have been carr ed. cu:..
One more cemmenc, de rapid decline of de nean cunulative dose be:veen ages of 65 and 70 does suggest among 'other possibilities an increased death ra:a caused by radiation. Cat 11 or uniass bec:ar analyses art available NRC should soc be oblivious to $se suggestion.
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n References 1
i (1] nomas T. Mancuse. M.D. - 5tudy of Tifacime Heal:h. and Mor 211:7 l
Zzperience of Zaployees of Z20A Contrac: ors; iinal Reper: 113.
I Prepared f=r :he U.S. Inergy Research and Oevelopment F=d dstracion; i
September 30, 1977.
(,2 } ?. Mancuso, A. Seawart, G. K=eale - Radiation Imposures of 3anford
'4crkers Dytsg from Cancar and Other Causes. Heal:h ?hysics 33.5:
369-385, 1977.
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TABIZ Z -
LT -
External Radiatien Keeerds f== Three G =u=s o f Ncn-su rivers :
Cancers, : ten-cancers anc ence 3:.eci cea:ns t gg) Cumulative Mean. Radiati:n.I Exposed Radiacion I:qcsed Cases Ocse en-Survivors Wc kers Dose Wc kers in Centi: ads i Nos. Ncs. Conti: ads 1 A 3 ancers 670 442 92657' 66.0 210 13a en-Cancezz '
2350 1742 2S2961 61.1 162 99 11 Car-ified Oeaths 3520 2134 375613 62.0 172 107
-) Men vi:h one er == e ;csi:ive *:adge raadi .gs..
- 3) A = Mean c=ulative radiatica dese f : e:qcsed vc kars. .
3 = Mean ==ulative radiation dose f : allvc:Me$s.
t lavtawers connacc: Apparen:17 uncertifiad des:hs 2:a coc included is this tab!,a..
9e D
e 8
5
c -
, - 14 _
TABLZ 4 Chaerved and Expected Nt=hers of Specific Necelasms -Listed Acco rdanc :o Mean Cumula:17e Radia:Lon Mean Cu=ulative Radia:1:n Ccsa No. of Deaths II ,
Ratis Neoplasms ('*) Cantirads Cbserved Expected obs :Exp
- 1. Myelemas 775* , 11 7.s 1.45
- 2. P ancreas 253* 49 27.2 1.31
- 3. Brain 220' .
13 17.1 1.04
- 4. Kidney 187
- 21 15.0 1.40 l 5. Lung , 169*
192 144.4 1.31
- 6. Large , Intestine 135* 61 63.1 0.97
- 7. Myeloid Laukemia 122* 11 f.3 1.90 8.
Lymchemas 119
- 34 27.7 1.23 l .9. Rectum 99 19 29.6 0.64 LO . Mout.'. & Pha'ryn:t 89 24 *
.21.9 1.10 l ll. Other Genite-U ina$7 82 13 30.9 0 .49 l L2. Stemach. "
60 38 58.7 0.65
- 13. P :stata -
42 43 67.5 0.f4 i 14. Other 2ncastinal 22 13 ,17.3 1.00
- 15. Liver & Call 31 adde: 3L 13 12.5 1.44 l 16. Ly=pha:i: Lauksela 19 3 9.+ 0.31 1
- 1,7 . Other RE5 Neoplases 11 5 20.3- 0.25 l 13. Cther Solid 81 90 83.0 0.39 l-3 ,. 188* 397 313.2 1.25 t 9-13 65 -
273 351.7 , 0.73 l
I
'All Cancers 13'8 *- - 670 670.0 1.00 i
(1) Set Tabla 3.
(2) Chserved see Table 0,- expee ad see 1960 cancar deaths of whi:s U.S.
males in NC Menegraph 33. .
- = AbcVe :he maan valus f:: all c:::1fied daa:hs (13 7) , see Table 3.
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r" unaus 4A M^nn Cumulativo Coscs of Extn nal Radia' tion by stated Aces:
11 Non-Cancers, KI5 Nec=lasms and Other Selected Cancers'~y ancers RES Neoplasms Other Cancers ( cs. of Cases Age in 3 No n- RIS Other Tears R(') R t(3) R t Cancers Neoplasms Cancer 21 8 - -
39 '2. 3 43 1 5 22 7 2 -
39 3.1 87 2 7 23 9- 7 -
47 3.2 115 3 7 24 13 11 -
40 2.1 145 3 9 35 19 11 -
34
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177 3 11 30 38 37 -
40 -
~353 13 43 35 51 39 -
42 622 22 85 40 56 35 -
48
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370 30 125 45 59 6a -
56 -
1,093 34 175 50 73 116. -
105 2.0 1,302 33 20 5 55 33 230 2.5 154 3.2 1,39 7 20 213 60 80 211 2.0 130 1,326 2.1 25' 169 65 76 453 5.3 132 2.0 1,072 15 111 70 48 70L 9.2 30 716
, 3 59 7L 43 701 9.9 39 -
645 3 51 72 43 34 -
99 2.7 587 5 40 73 38 24 -
100 3.5 521 5 29 74 37 35 -
98 3.1 454 4 25 75 36 45 -
93 2.8 386 3 22 76- 35 45 -
115
, 3.3 233 3 16 77 35 45 -
112 3.0 173 '3 15 71 37 Sa -
119,, 2.5 221 2 10 (1) Cancers of tha cancraas, lung, brain, kidney, and larga in:astine (see Table 3) .
(2) A = Mean ,cumula:ive desa c ' external radia:ica.
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Contingenc-r Tabla: Age at Death 7s Radiation Doses 3ADIAT',CN DOSES .
Aga 0 1- 19 20-99 100-499 500+ . Totals:
obs 108 55 58 24 L 9 254 exp 96.4 45.1 64.5 36.9 n.1 25 4
<40 diff 11.6 9.9 -6.5 - 12 .9 ~2.1 diff/exp .12 .21 .10 ,
.35 .19 obs kSS 32. 137 74 17 495 exp '237.9 87.9 125 .7 71.9 21.7 495.1 40-49 diff -2.9 -5.9 11.3 2.10 -4.7 diff/exp .02 .07 .09 .03 .22 obs 331 137 200 155 58 881 exp 334.L 156.4 223.3 127.9 38.5 381 50-59 diff -3.1 -19.40 -23.30 27.1 19.5 diff/exp .01 .12
21 .51 obs 60 162 243 134 53 1007 exp 82.1 173.3 255.3 146.2 44.0 1007 60-69 diff p22.2 -16.3 -7.30 37.30 9.0 diff/exp .06 .09 .03 .26 .20 obs h5I 139 251 74 17 383 ex; 335.1 156.3 224.3 128.2 38.6 383 70* diff 16.9 32.2 26.7 -54.20 -21.50 diff/exp .05 .21 .12 .42 .56 2ota14: bs 1336 625 394 511 154 3520 exp 1236 625 394.1 511.1 153.9
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TA31Z 3 SELZu.ra SUMMARIES HCM 33LIS 3 AND 4 'JI'"E CANCE DIAGNOSES CRDEID 3? DECREASDTG PERCINT EX?CS E CASES ?X"O CBS/II? E.CT Cf 00SI CANCZRS MOSD CBSER7D EZ?EC .f.a 7ALUE ?xix VALU2 ?x;I Aactum 34.2 19 29.6 .6L 13.5 99 9 Lymphomas 82.4 34. 27.7 1.23 7 119 3 Large Intestise. 78.7 61 63.1 .97 11 135 6 Myelomas 72.7 12. 7.6 1.45 2 775 1 Stemach 68.4 38 58.7 .65 12 60 3 Lung 67.7 19 2 144.a 1.33 5 169 5 Kidney 66.7 23. 15.0 1.10 a 137 4.
Lymphatic LI 66.7 I 9.4 .31 17 19 17
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Other G.U. 66.7 15 30.9 49 16 32 11 Pancreas 63.3 49 37.3 1.31 6 15 3 1 3 rain 61 ' 13 17.3 1.04 9 220 3 Rasidua (Solid Tu= ors) 60.0 90 33.0 .59 13 al 11
, Residue (RES Neoplasms) 60.0 5 20.3 .25 13 1' 13 Mou:5. & Pharyn:e 33.3 24 21.9 1.10 3 89 10 Liver & Gall 31addar 55.5 13 12.5 1.44 3 31 15 Other Iaces-d=a.1 55.6 13 13.0 1.00 10 32 15
'd.yaloid Lauke:::ia 54.5 11 5.3 1.90 1 122 7
?:cstrate 48.3 13 67.3 .64 13.5 42 14-Totals: 'l-9 394 386.1 .
Totals: 10-13 276 233.6 All Cancars 570 670 tho wi:h ! Exposed .05 40 i:. . a
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