_ “Enough to Make Your Hatr Stand Up"

7 The Industrial Bio-Test Caper

ae ae a ee SEITE EAE I SSS ere
by Pat Merrelt ing, “What we found there is enough to make your hair
. stand up."5
a. “lestrad of changing the summary to more accurately Science teported that an fav:

estixation of LOT was begun

reflect the data, hinvever, the data ha atal Protection Agency, the

more accurately reflect the wmmory.” National Cancer fnsiitute, and the Irspa ctor General af “he
~ Fued & Deroy Athainisteation offic ial Adrian Department of Health, Eulucation & Welfare,

Gross, de-cnt ap data toh Heatien by GU. Searle & Co, yp dn 1078, the Washington Pst reposted that “fevers in.

involving drug Fragyl Srence FO8-1228. Dec. 23,1977, fvestirators say they have evidence that the

ef Been changed ta by the FDA, the Envirnnine

Htivn’s bipyest

see ee fomunrrcial teeing Jaburatary deliberately Calsified data
submitted to the Reveroment on potential curcinopens and
Twat heeitant todo the Industrial Bio-Test tory becanse btiat at Ieast four metion pesticide tannfacturers were
i loobed the y by tromlew pit—L- stincly remember say- faware of the problem. ' The Post said EPA and FDA had

. ing tbat—and 1owas recht. Industria Bio-Test tsa Urefersed seuults of their Invest Hens ta the fustice Denar

+ | Pandera’s Raw, Writers who have known of the story for ment, anit quoted “hres ledgeabbe federal rep latory 0
. I seur have ducked it because ef the enormity of facts aml ciais” as saying audits of HHT data “turned op far moe
. if oats tavolved. troblenss than invastigators had originally expeeted.”

ah * tr fosteial Bie Test Laboratories, tne., a subsidiary of “At the beginning of this thing, we th
i un Chem ral Co, is the nation’s largest commenial {dea ing with problems confined te je

anht we we +
stone thice-year pei.

to colorical tecting company, id” said a senier official invaleeil in the probe. “Nowy we

© Onc the wears,

chemicals. On] as suspeat.” Acconing tu the Puct, the extent of a preb.
We basic HIRD data, bon freds of Prowucts have been rep-| lem caused by the Leis allewedd dita tampering, was ce~
ttered as safe for ue with pevernment agencies by com] sctibel ty a senien official invedvesd in the inwest

TUBE to develop the data, See] “whe said the Weorkd Heat

Pectial "ety ut pa steeiete piedutly invetved following this
stery) .

te,
th Organization, which sets ia.
tera stional safety expry te standard: far potentiolly basa

fal chemicals vind peeticistes, ten tried heavily on data
on 19-7, she soveennent learned that IBT hal been} fem WE"

fslatving test reculte on a massive scale, Al feast four laine! The Poo suid INT chanel its top man
chem d companies Loew that dita hal been Calsified for
frente prodncts

© Sace that time, geveroment hrc dere little te
the trys AU chemi ah iovedved are stili repistece

mint after the
data tampering teat Phe, Some tampering tock the fore
cf Substitutions of healtay animals Lept by HVT at the labe
cleanup for animat, that boron iff during the tects * Investigators
Dive ase alse stiscoveredt that IBT seeearchers fated in soutit cases to
Che tL: arad pevernment ofticials stand silent as chemnj- my mber test animals, a abing it impossible to tell which
Cl companies reps Hedy refer to pacermernt tenistration were alfected by test substances
rantce of preabict calety, The Woll Street Jounal «
ork the Canadian and US, keveraments have volved “slipups that} may
i Ave ino men ET tshnician toll ot
wwernment has. Tave years ball rats Cer autopsy,
six chemicals asa dhrect te. truth, hes.

aid inepalarities ot HC in
haw. beca detihaate "A fae
“osiculepice’s pretembag bo
fo evanting a drug's eliscton them; in
aid, the rats iad alre uly died of neptert ov of ex

ered the IE caper +

posure to the drag, bot the autopsy findings didn't reflect
; THe stony of hew the (BT sandal was discovered ts ine this: The techiveian fi wes that the pactense was cited ai
H teresting. Atcerching te Seacnce Tagazing, “ite 1978, Food y Conceating inadequate aninsal care or fing: the high death

& Dre Administration offn iate received a tip trom an em: } rate among animals expored to the vrug. or beth"
Cheyer of Senter Coup 4 drag. manufacturer in Califor) One study, the IBT tulinician said, was tecnedl
nia, that Hare were problems with tests tha! Syntex had! gic pens shady” becae complete blond analysrs ape
scbeatied to the PA, An FDA othcial, instead ef pulling | pearcd in the finat Tepert, even though most of the analy-
afle es Syate, pulled one by mistale on inducteial Pio-! ses bad never been peclormed, Chevron Chemical {nin
Test. an independent Uburatory that had dune a study fos | also under investigation by the Judice Departinent) “cone
Sintex on an antionthritic thug called Naprosyn. Ca teade| cluded that the INT cat stinly had tasted just 16 menths,
. ing it. he found enough deficiencies 10 warrant en Inspec-¢ and that six months of fabricated dat had been added to
tien, ...7 Adrian Gross, then associate director of nonclin- the final report.” (The stutly involved the insecticlde Or-
ical stucbes in FDA's Bureau of Drugs, was quoted as say-/ thene, marketed by Chevron.)

2

he ena-

NCAP NEWS ¢ WINTER Ioar

Syatex Corp. filed.a lawsult far unsperified
against INT because of problems they had discove
the tests on Naprosyn. According to Syntes,
serious shertcomings in tests: In
of tumors that didn’t appear |

corded as having died twice, and other animals whove
welnhls continued ta be logned along with other test ants
tals fang aftcr they had been listed as tlesd
The fusmal said, “the wpe ee gerw louder... when (BT
j psid that Mr. brisque HiT sf ciner president} had inadver~
teetly eodfered the shredding of hundreds of records te.
“quested by the TPA. Amo B Ube sheousledd data were seven
hang-lerm studies on the cancer caucing potential of sul
{ Manees uced in plastics, herbicide
t sweeleners.
Uy November, 3

damages
red with
there were
complete records, evidence
in the final sepest, fats ree

SRST ww 2 RESIS

Rape, the renistrant fuhemical cemtrany] will be te yuired ta
Hit the data paps ay soon as peeuble, aad in caves of minor
data paps, the Paps «all be filled through the Hecastration
Standard Dats Callan Prowse” fa process th,

“ hat takes up to
five years before a Company is even requested to begin rew

Stes vary of the actual number of tate
s, atl cyclamates, the ay. hy WT Sand other tahel which all base tote cecone. But
the Wall Street Journal sepurted that EDA ic abirg 235
chemical comparice to reeasmine EMOSIET tele that were
crocialin obtaining federal Clearance to market 483 dhrter-
ent pesticides. § The cest to industry to setest the sutpct
1 Pestivides discovered co far was totem ated ot $100 millon
robles, by Or, Aloe Mornson, head of Canada’s leteral be sith
protection branch!

. . . - And the problem docsn't end s ith staches performed &
: Tests for birth defects —76 percent invalid the IRT, ENA spokesman Bm Sit igen said the agency z

Tests for mutations--52 percent invalid: auditing test results from “nine oF tin inhorat bea:
_* Fests on tone elfeets te the nervous system —S0 per- f DE OF Ta HoPorateney becauye
trnt invalid;

# Tests to ditermine the toxicity of chemicals if swat. '
inwed, breathed eg absorbed through skin—30 percent in-
voli: and
© Riedie ters teste
jlnvatd ,

tetfurmed

82, a Canadian seporter had learned
from EPA oficial De, Diana Reisa that nearly 250 cf 609
studies done by INT —and later rev irwed by US, and Ca:
uation autharities—were found invalid." Reica said 69 pes
cent of lorp-teem studies were invalid. Other p
MPS ate:

How Low-Can You Go,
Monsanto?

fora vasiety of effects — 50 percent

Last issue, NCAP NEWS tepedted that diwrepan-

One vexing thing about the INT fiaseu is the rontinuing cies between summanes cf Mencanto Corpor Ron's

secrecy. It is nearly inspossibte to determine what studies tsade secret reeisteation data en herhir ide Reandup

are valid for inslividesal chemicats, the wicrmation thal and independeoily. perlormed sedes hid raised
would be mast useful te Fersens desiring to pretect thom. “Brave questions abeut ach

quacy of new posticidte

Sites frou the chemicals’ effects. EPA's Reisa, whe hay registration procedures adrunistered by the FIA 7

beer assinnrd to other duties since Rranting her interview Alter thet story was publuted, } SCAP iecined that
with the Canadian twpester, said “only che companies virtually al! of Morsanto’s Rourdup toric desi al
manufacturing the produnts would he notilied of problems Fegistration data resulted from stuhes performed ty
with specific chemvicals,"? . the duceedited Industrial Bio-Test Laboratories, Inc.

At one tame. TPA imposed a imoratorium on agency az. Many of thee studies cestelate closely with studies
jun involving pesticides supported by IBT data, But by that EVA has required Monsanto to duply ate (Fater-
Jaly, 1980, EPA had announced that under a new policy, al Reguster, Vol. 43, Na. 235, Tuesday, Dec. 5. 1978),
“10 Cases whe virtually the entire date base is invalid and

there iv a strong Possibility of substantial health risk, the NCAP has a list of the invalidated lests.
Agency will consider cancellation, tn cases of

NCAP NEWS # WINTER i381

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