Philip Morris
Safety First How A Device to Aid in Breast Self-Exams If Kept Off the Market Other Nations Approved It But U.S. Demands Proof Simple Pad Isn't Risky Nine Year Battle with the FDA
Fields
- Author
- Bowers, B.
- Area
- NICOLI,DAVID/OFFICE
- Type
- NEWS, NEWS ARTICLE
- Attachment
- 2046936886/2046936889
- Named Organization
- Earl Wright
- FDA, Food and Drug Administration
- Intellectual Property Owners Property
- Inventive Products
- Justice Dept
- Maui Clinic
- St Joseph Medical Center
- Decatur III
- FDA, Food and Drug Administration
- Named Person
- Alley, K.
- Alpert
- Alpert, S.
- Gorman, M.
- Katterhagen, G.
- Palmore, M.
- Redmond, P.
- Richardson, G.
- Withers, J.
- Wright, G.
- Xxearl
- Alpert
- Document File
- 2046936725/2046937271/Missing
- Request
- Stmn/R1-072
- Stmn/R1-079
- Litigation
- Stmn/Produced
- Author (Organization)
- Wall Street Journal
- Master ID
- 2046936726/6992
Related Documents:- 2046936726 Table of Contents
- 2046936727 A
- 2046936728-6731 FDA's Legally Suspect Actions Invite Challenge
- 2046936732-6735 FDA Paralysis Raises Health Care Costs
- 2046936736-6739 the Real Problem with Health Care in America: While Dr. David Kessler's FDA Fiddles, Medical Approvals Lag and Americans Die
- 2046936740-6743 What the FDA Doesn't Want You to Know Could Kill You
- 2046936744-6751
- 2046936752-6759
- 2046936760-6762 Guide to Medical Device Regulation FDA Issues First Warning Letter Citing Gmp Problems Under New Cpg
- 2046936763-6766 the Vitamin Uprising
- 2046936767-6780 Losing the Edge Overseas Patients Reap the Benefits of U.S.Research While Those Here Wait
- 2046936781-6783 Losing the Edge
- 2046936784 Feds: Toughen Regulation, Promote Research Improvements Needed, and They Are on the Way
- 2046936785-6786
- 2046936787-6789 Challenging FDA Authority
- 2046936790-6793 Speakeasies in A New Age of Prohibition
- 2046936794-6798 Who Is Happiest Politician in Washington Over Whitewater? Alfonse D'amato - Newt Gingrich - David Kessler?
- 2046936799-6800 Pro-Free Enterprise Group Challenges FDA's Authority to Regulate Drug Companies' Speech
- 2046936801-6802 Wlf Off-Label Use Suit Heats Up
- 2046936803-6805 Just Call Me 'doc'
- 2046936806-6810 Food and Drugs and Politics
- 2046936811-6813 Science and Technology Getting the Lead Out
- 2046936814 Forbes Fear of Falling 5 Ways to Protect Yourself in Scary Times
- 2046936815-6816 Book Burning
- 2046936817 If A Murderer Kills You, It's Homicide If A Drunk Driver Kills You, It's Manslaughter If the FDA Kills You, It's Just Being Cautious
- 2046936818-6820 Frustration for Medical Innovators
- 2046936821 Block That Innovation
- 2046936822-6823 Getting Even
- 2046936824-6826 Biotech Pipeline: Bottleneck Ahead
- 2046936827-6829 Consuming Interest Are We Safe From the FDA?
- 2046936830-6839 Saying Yes to Drugs Policy Analysis
- 2046936840-6858 Deadly Overcaution: FDA's Drug Approval Process
- 2046936859 B
- 2046936860-6861 Litigation Update Wlf Wins Suit Against FDA to Stop Overregulation of Heart Valves (Washington Legal Foundation V. Shalala)
- 2046936862-6863 Litigation Update Wlf Opposes FDA Efforts to Dismiss First Amendment Lawsuit (Washington Legal Foundation V. Kessler)
- 2046936864-6867 Dickinson's FDA Review
- 2046936868-6869 Wlf Urges Appeals Court to Enjoin Federal Policy Restricting Human Heart Valve Transplant (Washington Legal Foundation V. Shalala)
- 2046936870-6871 FDA Problems Slow US Andas
- 2046936872-6873 Taking the Heat An Aids Patient Champions A Risky Blood Treatment Banned in the U.S.
- 2046936874-6876 New Study Says Breast Implants Are Not A Health Risk
- 2046936877-6878 Wlf Sues FDA to Overturn Policy Restricting Information on Off-Labels Uses of Approved Drugs and Devices (Washington Legal Foundation V. Shalala)
- 2046936879 Ex-Inspector of F.D.A. Is Convicted of Bribery
- 2046936879A FDA Has No Position Yet
- 2046936880-6881 M-D-D-I Reports - 'the Gray Sheet'
- 2046936882 FDA Halts Test on Device That Shows Promise for the Victims of Cardiac Arrest
- 2046936883 Law Concerning Medical Devices Is Often Ignored
- 2046936884 Dairies, Drugs and Accusations
- 2046936884A FDA to Launch Campaign on New Labels for Food
- 2046936885 Probe of Three FDA Officials Sought Industry Ties Before Approval of Bovine Growth Hormone Are at Issue
- 2046936890-6892 Who Will Regulate the Regulators? If You Make A Mistake, Shouldn't You Own Up? Not If You're the FDA, Epa, or Ftc
- 2046936893-6894 None - A - Day Is the FDA Out to Take Your Vitamin?
- 2046936895 Will A New Government Program Net the Bad Fish?
- 2046936896-6897 FDA Responds to Wlf Petition Regarding Off-Label Drug Use by Indefinitely Postponing Issuance of Regulatory Guidelines
- 2046936898-6905 FDA Research: Overview
- 2046936906-6910 Government Report Finds Levels Safe Pesticide Residues in Your Children's Food
- 2046936911-6912 Wlf Urges FDA to Rescind Policy Restricting Information Flow on Off-Label Uses of Approved Drugs and Devices
- 2046936913 Regulatory Chokehold FDA Red Tape Dooms Transplant Drug
- 2046936914 FDA Called Lax in Overseeing Medical Sterilizers, Disinfectants
- 2046936915 FDA Sets Labeling Rules for Dietary Supplements Nutritional Data, Support for Health Claims Required
- 2046936916 Chemicals That Taint Seafood Concerns Continue Over Safety of Methylmercury Inspection Processes
- 2046936917 Lifesaving Devices Languish at the FDA
- 2046936918-6919 Wlf Sues FDA to Enjoin Federal Policy Restricting Human Heart Valve Transplants (Washington Legal Foundation V. Shalala)
- 2046936920 What's in Food? Answers Differ at 2 Agencies Manufacturers Fight to Keep FDA Label Rules From Encroaching on Ftc Ad Rules
- 2046936921 Reform the FDA
- 2046936922 Legal Beat FDA Approval Shield Firms in Injury Suits
- 2046936923 Water From A Bottle
- 2046936924 Commentary FDA and Our Split Medical Persona
- 2046936925-6926 FDA Assailed for Slow Testing of New Drugs
- 2046936927 Andrews Office Products Capitol Heights, Md (K)
- 2046936928-6947 Statement by David A. Kessler, M.D. Commissioner of Food and Drugs Before the Committee on Energy and Commerce Subcommittee on Health and the Environment U.S. House of Representatives
- 2046936948-6961 Filthy Food,Dubious Drugs, and Defective Devices: the Legacy of FDA's Antiquated Statute A Staff Report
- 2046936962-6968 Gao Reports on FDA-Related Topics 860000 to Present
- 2046936969 D
- 2046936970-6985 Statement by Louis W. Sullivan, M.D. Secretary of Health and Human Services Before the Committee on Labor and Human Resources U.S. Senate on the Final Report of the Advisory Committee on the FDA
- 2046936986-6992 Proposed Remarks of Dr. Charles Edwards Before the Senate Committee on Labor and Human Resources
- Characteristic
- ILLE, ILLEGIBLE
- Site
- W6
- Date Loaded
- 05 Jun 1998
- UCSF Legacy ID
- fnt92e00
Document Images
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rI'I!E,'-;UAY, APRIL 11-1, 19414
r wm i;.S ;'er ombed ana sh~t ,
rvara: Scrh rrlior'al~ct:hirles at;. .r,"
;hat v'cre Mr;vin, inu the ti:n of Goraztte.
lrl;er !r the day, Serb al t.l!c'1)' ' itelted
;;era dr. 7ea'-i!'; a.n,:' Ser" 'orc - , hcr^
in Bo;ria iitnite~ the :noveme:^ts U.N.
~
°a ekes^er ;;nd re. .. wa:kers, L.S. at-
rpt politicai len3ers in
r uI minur.i Production
\nnuul ruu, ,c milllnr: nf tw,rc u,
'C :TG Y+)'ait£I) Ser!: t;osittr:nn; in
sov,lr
cust^rn ;J',sr.ia for e~ day.
,orr i,,osnia unc Scroia w:re unsuccessfu;, a
U.S. official said. (Article on
Clinton s'mii he talked hrV tri<phorte
S:r,ria,u nipht With Russia's Yeltsin, who rr7:rrssed co;tcern atrr the intticl Lo;nb
:;7r, and the fart lha' `,fosc'ou' didr,'t know
.. ~'!/ E: it c'i,a17cc.
tiA'I:'LSS RAGED throul;L Rw'anda's
cLpltsl and spread into the rc,tr~ry'.,ide.
F;;;ht'.ng imensi,c i )etw+'
rm}' and .ebr and tnru nc's of
t'pses were r,~portec to ^ii..1 ,, ,
Rel;ef' ~'ls esti mated ,
many is 2n.~u(''.p pect'dt nav,~ ;ied to
ti' ali
,ilo rie ir, five da';s at eth.^, s!^:~ghter. In. = Rward^'s secon^;-larg^s' dr , Butare. rrft!-
`eesf:'oti:.'L'iai'.I'?:S('JiCirrr^,p^'1^ gttr;'l
it' tba.t were se'tin; f:re te vii!aces ani `aci:inK
4'a residents to aeat .;.tost reliei ar:encies
-uliea forei;n ctaf`e-~ o::; of the Z'acC'.a.hac'r:C' -tn' an
}'. l'ft~'r'i?'O r2 ~C^h'r,' ECi~ latc'CP17e Itte i,
rcb~ ~ a*d l ;r ; . , 't,; ,'rz rc5e';; ~~ .,,
scd ;c r:r,^t a-. 1-<. . ,
The Clistons pa., S:3.^ ir, bac:. ;L
:al and state taxes and Vmt? est ^ft't
lin; to renor
, a SoA:S cana2i sriin in t: c
'Otilrrts The rr_'S:den:'S De~-
nt sonal attorney said the capiai gair, re
suited from c mmalities tra~ing by ~ ir<.
Clinton. (Articie or Page A20)
x
..
A forrner denltty prirne ^?ir:steremerged
as an unexpected contender to become Ja-
rans next leader. Michic Watanabe. ~C, ~
member of the oooos:tion Libcra: Demo.
cr:t`-ic Party, declared his interest :n jc r,in2
'ith some e!em:ents of the ruiinfl coaiition in
:rder, to succced P:im^_ Minister N'^so-
t:aw'a. r:'-rtrcie on oa,;e AI2.
* * X.
`r Israel has _7*e^d to re!ez,:e 2,5^ Pales-
'is tinian rrison^.'; tvo dG°c after " s;s at. accord',,-ith the PLO on 1--racl's
nu:ic'-tt:`~D:n',
Gaza and .ier -..."i.^.In,f.' to .. _ _l
negotl^tnr in Cairc. . he LL;tt,d-av; _: scr;;rd, I
to ri~ na!1v due tc .,. ,ne~ to;~..rre. at the
;a:esf, . ow is =x~ecte.: to be +'ras~oe> ao
by the end cf ,..., ncat:,.
enra'l:;' n'-:vtI1s "'~ ,-!^L' IC) r c.' te than
orerno t n
~e. of br ce:ls a.^_ ccrnection:.
:we_ ?i c .: °ced s en
. on ~a>e .
on :..,. (Artic o
?overtv is i^_re asL z dramaiicaliy
ar.:on, ,he natio^'s in.`anue and toddiers,
according to a cor,gressional study that said many of these children are 1.~cked o:7'
...cf fr(t," . ++c! ^~irt ~;iot r,r>,°rr1)c
ever to serve in the
White House. In the
process, she also
has become the
most powerful chief
of staff that the East
;
ALUMINUM PRODL'CTIO\ in the I.T.S.
fell to a^ PnnuRl rate of 3,371,658 metrtc
tons in March from 3,401,096 metric tons in
February, the Aluminum Association re-
por`s'
,5'ing - the first
] programs in 19?7 and 19S`:, now drops them can get: two sealed plastic sheets with
£ 27St1 ClCG~%~S 1 71~,JiLte i 'orlackofworkerinterest; many people just lubricant in between. It
is laid over a
leave at lunch to smoke, or smoke at home, woman's breast like a cloth durin~ cr
1 i I says spokeswornan Deanna Frautschi. Bell examination, to reduce friction.
R?"ii 6gS ~Y ei.v C' -,. i Atlantic, whict institut d a smoke-free ~''L^nda Richardson thilt; s;[ p
robabiy
._ . worknlace in 1988, also stops paying for spared r,er death from br east cancer. Johr
7
_
~ ~~
f * r ' .'bP U S ~ ~ /
" ~
i dvs domain at the
~~rCSI lllt OvCr 'Hlliarvii il(11.
i
~'::z1;!C Vi~il3r'i); i~ili:15
`, Powcr Conlc_ at ^ Pric,~ ,
By Mir'.HAEL K. :l2ItiR1
cti'ASHIINGTC,N - h:arraret Williams
has resumed wri'in,g poe,r'y again, a pas-
'::ne shc eave up ~ear: af;o. "The oaly
th;nvou have toMld on to is w'; at's inside
"Tney can rant and rave
about what I*ve done, or what they think
I've 3cne."
And just what has she done, the 39-
year-old chief of staff to Hillary Rodham
Clinton? By all accounts, Ms. }Villiams-
known as Maggie - has become the most
povrerful African-
1'RI\t'IM)\, i`IE\l' ,1F:If.tiF:1'
2Q4693sS86
7d ( . . FNT S
~~'~~ ~,~,~~~ Safety First
L
I A Special News Report on Peoplei How a Device to Aid
And :'heirJobs in OfCces, In Breast S»lf_ExG[";5
(
°m)l n: cess.^.tion pro.-ams, as does Cor-
s lio itc ui i/::pers, G','isconstn Rapids, Wis.
rJbac ;xraire n.talnr d Cas of
;JCtrark: :'C.d., thcu;, ;, helps swntc 3,370
rmp:ouces who sl.aoke - c'F% of its trcrk
torre-lhroug,^ American CancFr sor',tu
! andotherprcvtramti.
By BKBNT BUwEfLti
Staf( hoprrrtrr uj-1'nr. wni.t. Sn+ta;r Jur,+vn:.
It is aboutas simple as a medical device
v;;.het~, a snrFecn it .i,.: Maui C:-,r ,,
LlaaI,, says it i:. o,: ;, ", or st effectl^e
weapons against breast ^.ncer in years.
And Patricia Redmond, a New ','cr}: rad;o;
oo st, says it "can abso:,rtely save lives."
Out don , try buyind it in the U.S.
Though ;nany d.nctors and cancer spec!al-
IT'S STILL THE BACK of the p:ane for R1 ea'Ct:*n ;~'7 ~v ar '~- ~~4 I
most busine:;s tta.velers. w}Lle the FDA 'r-eeps msny med Za-
The er,d of the recessio^ hasr(t brought vice proc:ucers in Iiwith long delnye
much more first -ciass ;ravel for executives, ' ir. approving ne^, nrnduclvt, it can alno
ccmaanies say. Electronic Data Systers, tE.:c away spproval,~c;;es ,%i:: de+r<.
which ended such perks in 19?1, pays for first tating *eeatR. Bn-crprise, page tDE.
class only if a cr,t;cal contract is at stake.
.american General. a Houston insurer, re- i ists hail the Sersor Pad as a usefui tool in
serves the wide seats for its executive v:ce detecting the disease that many women
presidents and unit presidents. , fear rnost, and though it years ago sailed
Home builder Centex Corp. and others ' through approval processes in countries in
i ban first-class travel unless executives use ~ Europe and Asia, the Food and Drug
freauent!lier certificates. Most companies Administration won't let Inventive Prod
let executives keep their miles, then trade ucts Inc. sell it in this country.
them in for free flights or upgrades. Encore ; Gr ant Wright, the president of Inven
Computer, Plantation, Fla., reimburses em- I tive Products, and his father, Earl, the
plovees half of the discounted rate for any pad's co-inventor, have been fighting for
flight in ',,,)ich personal frequent-flier miles ~ nine years to get clearance for the product.
are used. What be~an as an FDA recuest for more
infermat:on has degenerated into a long,
G.t. YRETIREES soon will have their own 1 debititatinn strug,!e and allegations that
retiremen:community. the Wrights viola:ed federal So ftus-
The Palms of Manasota, a 2C=r-ila com- trated did the .Vrights become abollt the
plex, is on the drawing boards outside j burea'!cratic maze that six years ago the.,
who is building the started selling the pad to U.S. hospitals
Sarasota
Fia Bill Ia1ng
,
,
,,;tite House - has ; p,operty. is still searching for tha right site, without FDA clearance. That
triggered a
er seen; ir status- I,ut expects to f;r:d it soon. He already has court battle that they lost in
19:'2. Now they
conscious V+ashinb- I receil'ed more tha.n. 300 inquiries after ads in i are back to tr'inF to v+in
FDA blessng for
,on. it is Axts'eme!y ~ Scy N,,blications such as 10 Percent and the I the pad.
i,!m pir Ll'i1.[iams s,gn``tcar`t that i+ls. Advocate tout The First Alternative Retire ; Stffl Ilo
Innov3tion'
',V11:ams's ovm of- i ment Home."
`
the dispu,hoisnt resolved saon,
ce is located in the ;' ; i:e House's ~Vest There is r.othinc in the country like this, But i
',~inb. nolesbianst one, says r2tireme iirn. t Lahomeing, home" wfor gays and I Grant W i,htsays, ,
wiI dos? his Deca
^ But Y:ere are '?~:es`ions about whaf ,o pians to tur, IIL, company, which ccsL about Si,oP,
,r
Ms. ' ';:Pams has done regarding a month the vex ncfude a pei';uanent ca e home for 'esi hroush
S 5B~C00 in legal has fiy bl)rre';
.c,nt.rrcersy ove- P.'esiect anc' rilrs. I dents unab:e to co^k and handie aaily , ',V. teiater
~ wife and three?:ids," he sa s. '. v'e goC to
a: ~'s nvestilent R w ch0;'es. ~'J11at about heterosex:al appli .
Dece:ocme^t /'. .^,ture ! ao so,et;:ng w:L, m'y llfe."
°a es'a' "e , cznts? "1f Iget straight peop,e who want to I
Ler t~ss, hav^::i' been vie use as an con e in, I cannot bv law keep them out," he ir' 1r.ght's
strug~le, in the cyes of
inspirat:on for w-omen, s increasin£le por- says. "But they must'r.now that it's going to some, is
more than just he tale of a
trayed in the press as an uptight lawyer I be made upef gty and lesbian people." I small-town
entrepreneur's tangle with far
^ is at the center of many of the ti r, [ning says he is plcasanQy sur away bureaucrats; it is more,
too, than a
administration's problems. Ms. Williams p;!p,d a'tnut a lack qf txtrkla,sh, "Wil study of , how the
medlcnl devices tnuustn
hers")fis^noofthreep,voplewhn wenlintr ,,rt;rrruv;hnrnnphol,irntnil.A'nt In the rohcs w'ILt thl'
wrrld'n ntuo
, , - , , .r , r , .r , , , n , , i 1- , , ... , 1 Kth'lnl', ,t r^4.n!a!,, n 1" . t; . .,
.1,. Amerlcan wcman
.
COyiPAv}' S:lf0::I1G B:LNS: Do they Is Kept Off the
~~~ar~ie}
actually help workers quit'.
5t(,rc'k Chairm,^.n Roy Vagelos says the !Uther NatIOI)S :~~.)~1rOV'E;Cl it.
numbe!' of employees who smoke fell 25~~r ! '
during the first IS months of a companyw'ide I ,jt,t, U.S. DOIT1uI2CIS Proof
b!n; more than 2 third of the employees who ;
mok s^:okingcessation classes stayed off SlII1ple Pad Isn tF.1SE:V
ciQarottes fcr two vears. State Farm r eports
similar ress,lts. "?'ve had employees come
up and say to me that this is the only way 1 IN tIIC Y e3f }3 1ttlE 1'~t ith ~L~ ~+
they ever could have quit smoking," says
personnel director Ron Prewitt.
But Country Companies Insurance,
Bloomington, Ill., which boasted a 25Sr suc-
cess rate when it launched antismoking
Ftelds and Fa
ctones

0
t"ith th!','1.IJ c;:1 irr pIlliuUt frotn I
.....o + on;: .. ~,
. nl~;.,s::wt;
'. 4!<ttl.ti tniC.rCbt ::1 :Olni[ti .
tint'i 1'ri?^r
'lA:-
Itr tb i ey ':tlr,
.: alliit'1': I'i',) (I al'; ilf i,r ;{n
T?:r acrurd.. trir,.,,,,.
* * *
t health and education programs
of these chiidren are loeked out ofi
ng to a congressional study that said !
; the natiun's lnfants and toddlers,I
n:. (Art!clt' ntt PaCe I)i)
"utertc Is increaslnF dramatically
~
p op _ w o wan
t.:t. } nt , s t n r. ' cantss
ge, s ra,g,a
o;
nn,v i; t;,:;e ted to t,(' prc an i fice is ;!uatcd in the lCt:itr tiousr,'s West ~ There i;
r,nthing in the countr} Ii}:e this, i
r! u` tlu: monat ti'inl,i not one rctirement heme" for gays and
But therr are questions about what I lesbians says Mr. Laini`., who n!ans to
' hralns >''cnr m; L-cd te G<' mcre ; ls, Wilitams has dc,ne regarding the vex 'I ir,ciudc; a
permaner.tcare hon(e for resl
:~'e thut;,rr;'viousiy itrl~u;;ht, wt,n thr': 1",ir cnntrcvers} over Pres!dent and ,trs, dents
unable to cook and handle daily
~'f bcair, ceia and connectinns Clin;on's incest;nent in fhe Whitewater ~ chxa. What about
heterosexual appii
I
h.^ , c~ d b '^'i n' lepme r Co real-estate vetuure. ^,~If i t' rt ^ in `h t
t
e un h; be si ;,+. ... .. :t: :': - ` il:ams s own 0, i ment ilOme. ' i
immigrants. Gov. Chile. .aid the I
^,son beds for hun(!reds of thousands of ;
for providing schxiing, health carc I
Iio:ldc sued to collect 51.5 billion from
i
;^eral govern:nent to compensate the ;
t-v; s the first of its kind.
^r.;earche in ?: edetp?da sr_id the}' '
u~,~ ann experimental vaccine to reduce the ,
-^ence of malignan: me'.a.^o^ta ie z I
group of patients wtt(t ti.e skr.^. i
r. iArticie on Page B6) i
* * * I
te^,ar Ir, Ci^cinnati on radi^-
'
>:neri:nents ronducted cturit: ; the 1960s.
.rcerpati_^te r;ost' pxrand black.
* * *
cus. par.ei hca-d tesamony trom pa (
..,..., ' elati~'e= A deicr'11ee
s`-, ,. be coTaensa:efl. Th= oer.
~^ -ere p_. :y fttn ded by the Fe-a.~, or.
Ye: ., iT~ t 1c KO:-._Ll kr Is i/sir.,j l:e- i
to a survey, with nearly <: qua. ier of ;
i:'~7s sr.}^:ng at least one of their wori;ers'
ceea attacked or killed or, the job since'
:. According to the study, though, only;
of emplovers offer some of their em- I
lres any formal training in coping with i
~r::,;iacc violence. (Arttc:e on Page Bl) i
t:: a!ne and Russia itavo escaIated the:r ;
;
te over the former Soviet Unio;t's Black
eet. In the late;t of a seriec of ;nci-
e w, ::k.rainian scrvicemen seized control,'
t fac; ity in Odessa harbor we: the ;
^d. (Artlcc on Page A12) ~
* ~ u
hz_rd-?;ne p:;me mL^,ister qult i
-2s succee~ed by the r.atior:'s ece:p-!
^ttnister, 'xho . a moderate.
after wec e' army ciashe. ,''.'.h i
.. ;uadantcnta:!sts.
.... .. ^F:i To F?rSt','S3ESTv . _-:'LS oF FAG^ a?
.
'.CiF'iCY DT~.IL7
;T>-estern `,' aste's
:OI:P.dcr 1'ii,rog a
re;o, Ti;tiind ed
o:.:tsde- . it , goai of
cu,Costw:
. .:. . i:alnr.
> s: pe<-fc:r:a;;ce. 3_.
.w C:`i TI£r jTi:3t~': f.iiel'lert.~',~
a0_'0:.~
leave r ai; o` U.S., Cl
MeT?f~~i 1 :C~~eG: Morgan
_: ?aunc'.:cs a mak°c : e-,
CHE:YIICAL wOFC¢'ARE: Nearly two of
;
three workers world-wide are ezr~sed to
chemicals at work, the Internationai Lstxor i
Organization reports. The United Nations ;
arm says many problems involve agricul ~
tural pesticides and chemical production. i
"The problem is quite chronic in developing
countries," says Isaac Obadia, iL0's health
Her boss, having been viewed as an t come in, I cannot by law keep them out," he hir. «r(ght s
struggle, m the eyes o
some
nsl:iration for v:omen, is increasingly por says. "f3ut they must know that it's going to ; , ts
mnre than jttst the tate of a
tra}ed in the press as an uptight lawyer be made up of gay and lesb:Zr peoltle." smailtown
entreprcne;;r's tangle with far
who is at the crnter of many of the I away bureaucrats; it ls more, too, than a
mr. I aing satrs he is pleasar,tty sur I study of how the medicaMevices Industry
adn;inistration's problerns. Ms. ;villiams i prised about a lack of backlash. "LI'e
herself is one of three people who went into i hat en't pctten env homn hohic rnnih Not j in the
U.S. copes with the world's most
stringent regulatory system. To some ad-
Depuly ~'~ hite ?Iouse Counsel Vincent Fos- an,t I
ter's c:iice the night he committed suicide. vocates of his simple device, it Is a mani
Sl:c has been the target of conspiracy i THE FEDERs GOVEP`f iEh r kicks ~ fes[atlon of the way the
nation's lftigatlon
theories concerning what might have hap- off a massive effort to spur early retire driven aversion
to Nsk can stifle =nnova-
ened to Mr. F'o_t^r's files on the Clintons' ~ tion In the medical marketplace. "V, e as a
P ` ments, USs officiais hope to lure as many as
invesiments i: Whaewater, ahich :ater ~ 1!b,00L workers to bail eut, as par t of the society refuse
to take risks and wan! wer rsmoved and handed over to the fheyear goal of reducing the federal
work j Pmarantees 'hat our lives are f cing to be
Clin`ens' p°rsonal lawyer. force by 2(2.CO0. Buyout o,fers begin at, perfect," says Mar} .almore,
a C;ticago
~ .
p~sT10ecitth°or~? 3s ~Viiiiamsewent into re ,' sevea agencies, irciuding the Agriculture jpDr~l P
Imore acknowledges that the
} and State depar ments. ,,G ,t
Foster's o:`ftce, not out ci grief, as she says, FDA has a legal duty to ensure L°: the .
o to look fo suicide rote, as ott.erP-7:;te ~ I;OhEY GnTS 'E1', but management ' isn't falsely
promoted as a diap^osu; too;
uc se aides have saic, but to retrieve any + i but suggests that the agency Iself may be
keeps 'em, recent s:udles show. Sear c1; fira ;
ooct:tnenis that might hurt the first lady. I Challenger, Gray & Christmas found in aI~ught up in
what s't e sPes as a nptionai
Th2 t is onr~ of the issues Speciai Counse': ' survey that;ob cardidates are wooed to new f
Dbsession with safety. "The FDA ts cer.
Robert Fistie is investigating. He also is I firms mostly by big salaries. But a separate cerned
that in our liLg ors sxiet;: , a
prr,b!ng wtiether there w ere improper com ' urvey by Wilson Learning Corp. says that i womau wih
say: 'I used i;. and Irt
tacts between R nite House and Treasur. ~ what keeps e^ ployees happy is sirong lead 4 anvway,' "
Dr. Palmere sc} s
c`fic ais over the fa.iied ?,Iadison Guaranty ! ership skilis amDng top m^nage ner,t. ; The agency
says tha: safe ., t;;
cavings t: Loan run by the Cl+^tons' «'hite- : tion, isis main concern. An: t: r.rrr.: ;.
"wate- Partner. :is. GVilliams was present
at c:ebroary meeting with Deputy Trea-
s.: ti' Secreta*' Roger Altmar..
SS': tpath r Cards
Her involvement in the controversy has
bee:nn painful and ironic for a woman who
came to the White House as an idealistic,
new-generation Democrat hoping to re-
store faith in government Instead of acco- I and safety expert. Training and be tter infor- ~
iades `or her influential position at the ! mation are crucial solutions, he says.
',`;hite House, Ms. Williams receives sym- II
pathy cards from family friends. Some ;
send flowers.
I r'
TRADING PLACES: Chemical compa nles switcP: emp:oyees to learn new tric,'s.
Dow Chemical Co. sent emplo^ee John I
Latham on a tao-year stint to show Nalco I
~
na« I's r;r;nvcntor, h^vc br , f::.
ttin^ } t ars to get c'I nr the produ: t
41h'1t bean as r t'D: request for mrve
nforn;aUOn has de; :;erntrd imo a long.
debi!uattng strvggl :ttnd altcgattons that
the w'n,thts viol::ted federal law. So frus'
tratec: did th^ l~'riithtv become r:hout the
bureaucratic maze ttm: six years ago they
stnrtc:a selling the pad to U.S. hospitais
without h'DA clearance That trlgr~cred a
court battle that they Iost in 1P9'3, rVow they
aru back to trying to win FDA blessing f lr
the pad.
Stifling Innovation?
But if the dispute isn't resolved soon,
Grant Wright says, he wilt close his Deca
tur, ill., company, which costs about S4,t>0G
a month to operate and has atrendy btur,ed
through $356,000 in Iega1 fees. "I'm 33, wtth
a wife and three kids," he says. "I've got to
do something with my life."
lin:ai!:n;:y loyal to the first lady. Ms. i
~r azrs deciires to talk publicly aGout the
;
,ifewafe: controversy, or a ut "any
t"ing that has to do with tny work." But ,
however Whitewater turns out fcr her, she '
says it is nothing compared with other I
struggles she already has endured in her ~
lifi and carE^r.
"You have to lonk at everything ;
Serso- F w
Chemical Co. a few i'tings about environ ! defends its refusal to!urn:-rr :-,r S.,sor
mental and safety ope:ations. In exchange, I Pad "Their intentv,c : vt ^ wrtr,,
Dow gets Nalco employee Steven Curtis to Susan Alper , director o' :~ F.
share his expertise in sales and marketing j of Detidce Evaluation, se}
with Dow's Advanced Clea: ing Systems i ^
"Buttheissu_ort...2n.
bllsiness. that we don't a:bw V -,rR
c
is a!mo,: unheard of in the i that
Such a swa
s
i:i
;
p
pc
r.
es sgn
czn
in,se T!rn to Pace t 5. Cel<imv: i
i cor,orate world. Dow North America.':ice ,endantberefit."
PC i ICS POi ^Y: Leach, Clintons'
cri:ic, :aces skeptics in ie a, AZQ.
It '~.TIi: Nonp. 'f t hospitals stress
ch^rity ~,ork to save tax breaks, Di.
IRir.R*:::TIO:;P.i: Tourists' deaths
sour Taipeii`ieijiny ties, ii.3.
i?E .L't'! & OLi?.00`r ; Whitewater
George Mitchell and the Court, A1S.
0_jL~Or : _-rthu7 Scttlesinger agrees
:fh r3idwater on V+nitewater, A1E.
LlISUFM & AP.'S5: Beethoven, P4ozart
2.^.c S ra ~ns y on CD RO' i, Pu5.
,c;v"r; ha!f of thc d;srnuntcr; r:tr for <.ny
, r i' in c'it t pt `n:: fre,l,te::t'rhe'r mileti
S,It:: !Ir, Jtc i,uc;t~rr+ pruc,`as, shc a~c: _ . .
hr,s tucnmc' tl;o
ii G:1YIiZ:PlRI:I;ti.ticronw'Pi?latethc'irmrn
r.^s; w'.'l " ul r'urf r"tLronur,t cu:nnronlt,r
of $lafi ttuu la" N,llsf ~. I
i 'Chc Pnl:ns of Dfnnaso,r, n la e,rru
VJin" - th:' ftrst is on tt'r drmvint; boards outside ~
Isc~v s doromin nt thr ;`,trasoLt, Fla. Bill Ltin;;, who is building the I
.:r. Ilnusc - has I~ro;~c'rtr, is still searrhinn for thc right site, '~
eversecn; instntus- ~ hut r.xpr'cts tu find it su;m. I'Ic already has ~
~'
hi
Jas
cnnscious
ng received more than 300 inquiries nfter ads ia i
tcn, lt is extrrmely ev n,thlir;tthns Such as 10 Percent and the ~
stj;nffi°a:;i that bis. Idlur:te tuut "Ttte I'irst Alternative Ret!re i
President John Duren says the erehange j Indeed, many cens' n' .. ; r.,~
resuitec f om the firms' mutual respec;. I hea;th-care specialtss Er, uA F 1 , s
"They buy thino frorr us, we buy things l riEror in screening de:nces, :.c scrn, co^t.
from thAm, and we like the way they do
business," Mr. Duren says. "We are eoing
to borrow from each other's strengths,"
adds Nalco President Ted'foore',.
Trte suap also saoes the co7,.panies a
hit oJ money. Without the sucp, Mr.
Moortey says, Nalco u'ould hatr: had to
hire someone tcfth e;ttrirortrrcentel and
sqtety espertise.
plain that it doesn't act tur.e:u:,y ca:,,:6a.
The FDA, meanwhile, faces a huge backlog
of applications for new medial devtces,
which has stretched the averate revtew
time to 196 days. The agency says it is
working hard to whittle the backlog e!
mo;'e than 5,OS-0 applicat:ans.
Breast cancer took an esumatnd 46,0N
lives in the U.S. last year and vras th.
secondbi;gest cancer killer of women,
TIiE CIIECiiOPF: Only ,oO,p~J women i Early detectlon is essential in de;eating it,
n the U.S. earn more than S75,aJO a year, ; and frequent self-exa.mination is essentian
.fo. . But many women don't find
about one-eighth ef the numbe: of inen to that er
~ making that much, notes Women's Bureau this easy, and that is where the pad comes
11 Director Karen Nussbaum in Working ~ in. Is lower sSeet clings to the skin vrh;le
Ne'her magazine. . . . About a quarter of all ~ the top sheet "floats" on a thin layer of
~ unfair labor practice complaints filed with i liquid silicon, eliminating fric~+o n+on so a
i the ''LRB relate to the L'.S. Postai Se^vice I finger can explore the cortours or an ob,.wt
postal board Chairman William Gould IV ; as small as a grain of salt.
esi:nates. _ ~ "The thing Lhat amazes me " says t;,c
G. S,u.v.T-^ ~ Picrsc Trn to Pay_ .45, Cn?vyn,;
{

11
4
G.,/+?i: T'til: `t'"ALl, ti'CIiF'F';1' J!)ufnAL'1'UESUAY, APRIL 12, 19N'i
A
11
C", wft.,i~7 c,fT.-st: A. T,on.g FDA-Companv Fight Keeps
S ~~f~p~e t'~~3c~ ~o Breast Selr-E~.amindt~on Of~ Market
('nrtRtttti 'd 1`v"t F}rs1 Prri)O
younl;c^ dL.',Vriilht, "is that thc rc;u;!rrh
sprndirt;; on hreast cancerl keeps going
np ;tnd 1 can't get this simple $7 product
!,snid, Inventive f'nxlucts wott!d have to ! tions.
conduct exhaustive clinical testr on ! MeanwhiL', members of the medical
women comparing the number of brear'. ~ community continue to supr)ort the Sensor
cancer cases detected through self-e:;am,' Pad. Dr. Withers, the surgeon at Maui
nation with and withaut th,, Senso:' Pad. Clinic, savs the pad has twice enabled him
anto the hands of women who want It."
I{!s father, Earl, ,m°r tlmut;ht thc 5en i Such testy, Mr. 1Vri^ht says, would require t, feel
otherwise undetectable lutnps. He
sor 1'ad wnuLl hc a bi!: succcss. Nir. ;t hugc samptc a minimum of R2,OO0 ~ scoffs nt thc idc a that
using It might give
Wrrgla. G:+, !s an eslubitshrd invenlor I women to produce statistically meaning I women n false
sense of security, one of the
whuse pnaiucts range from a blood-serum I ful results. An FDA spokeswoman disputes i FD.A's main
concerns. "There is no ques
fi!ter used in laborttones to nunaeraso! ! that figure. "We want to be as reasonable I tion that the
Sensor Pad increases my
foaming pumps used by hosp!tal surgeons. ',ts we can," she savs. "The number wiil be 1 tactiic
ability," he says. "It makes it 100`:'~
~tr. Wright in 1956 set uf) Inventivc 1'rod- ~ mucn less than that" ~ easter."
ucts as a suhsidiary of his t;ar! G`:right Co. j Mr. Wright says he has already done ~ Gale
Katterhagen, medical director of
sole;y to make and r,tzrkc, ti:e 5ensor !'ad. two trials with simulated breast models, the cancer
center at St. Joseph Medical
fie put his son in charl,e. ~ which he claims yield more accurate re- Center in Burbanlc, Calif.,
says tests he
Gaining approval to se!l it in other ' suits. In thc first, women examined the conducted for
Inventive Products several
countries wasn't a prubiem. Inventive ~ artificial breasts for lumps using both the i y(iars ago
indicated that women who used
Tn)ducts applied fur n;arketinti authoriza. t~~
,.d and their bare hands. In the second, 1 the pad were 22 f more likely to perfornt
tion in Camid,: in 1P8;~ and got i: +vithir. 30 I 1 they used both those methods and aisc a m.nnthly
breas: exams. "This device is
days, Grant 4ti'r;ght says. I:e a!so says thc ' third method - soap and water on their i harmless,"
Dr. Katterhagen says.
pad has been approved in Japan. Singa- hands. The tests showed that the pad Women who use the pad
swear by it.
^
K
T
il
d
d
D
re
orea
ha
an
ecatur
an
most Westhanced sensitivity and resulted in in Ms Richardson a 43year-old
,, en- !..
European countries, although Inventive creased lump detection, Mr. Wright says I resident, doubts
that she would have found
Products hasn't actively promoted it ~ The FDA rejected his trials as insuffi I two small lumps
without the pad. She bad a
abroad. "We've had no problems any- I cient. The prospect ef starting over with I double mastectomy.
"It probably saved my
v herc irn the werid," he sa)'s. the ]engthy, expen -~ lite" she says, adding that she gave one to
B>xept at
home. When the P:rights ' sive tcsL the FDA her 19 yea.* old daughter.
scu;-ht ItDA clear<tnce :^- the devic: in
I demanded pushed Mr:n' C-orman, a 55y'earold writer in
9ES, ':e ager.cy's the Wrights to '','ashington. is certain the pad saved her
initial res, or.se :;as > cha';ge their ~ ~ breast. "I found my cancer before it was
i
S
i
h
"
~
'
'
posa
ve.
h
L tt;e
e says.
.e on a mammogram, s
v i detectab
` coarse. Because r_
governmentwar.ted t '~_. ~
e;' ne;e: conc Her surgeon, Katherine Ailey, say, the
mor e information. ered the pad ±o be a device may have saved Ms. Gorman's li,e.
"Evcr> n medical dc+':c Considering the lethality of breast cancer,
Suhmllfed inform: _ . c";ned by Dr. Alley says, "it is just ridiculous" tn
[ on, they a_},co fcr ia ;, thct decidAd keep the pad off the market,
ma e," the son re- 19SS to market tne Potential demar u appaars to be huge.
ca i!s. Afte; se. erai n p y uct dtrect' to ~; Ps When a Pitsburgh hosptta; oftered on tazl
mon:hs, .hc a.eencl hospitals. The X:: k' &
_..:.b I Ty' in 1990 to send out free samples, it was
:
`
`
denied anprnvaa for .'
.~;:', ,-
~' . {.ri hs sav they- r., ,r I flooded with .6000 calls and letters
t,'1e pad - h!; indi and their attorney- - f For aL' t`,at, tt e FDA's Dr. Alpert
c-:c:3 :;~ conc`-~rn` fi~'red the FDA either would recc rtize is ' be'.ieves that Inventive Products
ts large'y
mtr,ht be met by - - '-- lack of jurisdiction or take Inventive Prod
exter,sive labeling (%rrznt 1i'n91'' i ucts to court and force the issue.
chtin6'"s Over 15 months, the Wrights sold 250,-
The F~A the !abe!mg to state ~ 000 pads to some 2G~ hospitals. But in April
that the Sensc, Pad ce::id be sold by ~ 19S9, federal agents raided the company's
prescription only. And it wanted all refer- i Decatur plant and a number of hospitals
ences to breast cancer de!eted. The label ' and confiscated the pads.
was to include the chcnical composition of The action came one day after Earl
the device. It a:so was to describe the ~Wright was narrted a finalist in the Intel!ec-
lp-i.n,ch-diameter pad's "s:aceptibility to I tual Property Owners Foundation's inven-
heat, <oap, "or;r:a!ie. alcohol and t tor-of-thevear contest for his "touch
othcr :nechaaica; xgents." i enhancing decice.
\L'r:hht s:;;s ;tC !; , ne0:;ielt' tiet
ie ' ccn.plying with the renuests. But I Grant Wright challenged the FDA's
about threP months later, he says, the FDA ( claim to jurisdiction over the oad. But ir,
^ably notified h;m that it wouidn't 1°90 a U.S. district court in Dam~ille, Ill.,
nezp'' ~ tuled for the FDA. Mr. Wright appealed,
reconsider approving the product. Instead, and two veats later an apoellate court in
he was to!d. Inventh'e Products would have Chicagc upheld the ruling. At that point,
to go through a :crious "p-emarket imentive Products told the FDA it had
approv;;!" process :`or n-.: medicai de ceased marketing the pad.
rTtus process is meant tc keen ne'', ! But Mr. Wright didn't give up. In March
mostly r echno!o~ instruments o:`f ~ 1992 he filed an ethics complaint with the
g~-' ! FDA's inte,grity office against some
the maricet until they can be adequately I agency officials after learning that they
tested for safetv. Few people wnttid d!s- of had met with a minority shareholder o, the
ag ee tha! :he 713' should cet convincing I company without his knowledge. After he
evidence that invasive devices are safe. filed the complaint, he says, the FDA
~.cre than ?00 people died in the 19SOs i turnedh^stile.AtameetinginWa,shington
when their 5;0: k-Shilec ;ear: valves :`rac i Qa ~;
in August 1.~2 to discuss req rements ior
':red. for instar.ce. But J:r. {'lrtght ar,:.ies premarket appreva:, he says, an FDA
.. the : ensr Pad rnses no d,rect r~S}: to 1 ta.aT.er - flanked bl: 10 other agency o:`fi-
users. cials and a Justice Department la ,~er-
The,-FDA' tesponds Shat,.the +?idfreet I "told us we'd never get our product to
tisk -- l~ncettxtskum ~abtHd ~o
+= p market."
!^de~ec!~d-.s pN.entia!!v !e'haL An agency spokeswoman says it is
Thc a,en^y's Dr. Alpert says the fact i
doubtful such a remar'rk was made. "We
that a device is simple doesn't necessar.ly I
havP gqne out of our way te show the
m-r it ; r 4u; c: r, thing depends on tiL'r i;';ts how in get thcir product marketed.
n~!*~it r. ' SI:, dis^;isses cndo!se curh a rnt;itn!'e; dc csn'; mri!c scnsr," she
;. h. I
responsible for the delays it has encotln-
tered. "There are iots of difterenttnds of
trials they could do to show this Is effec-
tive," she says. "It doesn't have to be
years and years."
The elder Mr. Wright has managed to
commercialize the Sensor Pad's antifric-
tion technology for a much smaller mar-
ket. He has built the Slipp, a nylon and
plastic sheet used in hospitals to transfer
patients from a gurney to a bed About 500
have beer. sold.
! But his son spends much of his time in
his nearly empty headquarters explaining
I to doctors why he can't send them samples
( of the Sensor Pad. Last year, he laid off his
own brother, reducing his work force to
irimself and his secretary from a peak of 28
six years ago. "We're at the point of
surrender," he says.
I
Northwest Illinois
Pact With FirstRc
To Alerge !?,iv
lt1~ n~n' , J.,1'nneLSfc(f
Northwest utm,ris Bancorp
hYntHock Bancorp Inc., both c
agrced definitively tomerge into
traded company to be called Tc.+c
corp Inc.
The agreetnent, which tho ;
called a"merger of equals," w;
bank holding company with
nearly $900 million. Both o
shareholders are to get shares i
Bancorp equivalent the number
they held before the merger. TI
market value of stoek in both cor
$93 million. In Nasdaq Stock M:
ing, Northwest Illinois's shares
25 cents at 519.25, while FirstRoc
closed unchar,ged at 51.8.
Northwest IllincoFs, based ir:
has assets of S417 million and e
million, or 51.65 a share, last y
Rock, Rockford, has assets of
lion and earned 54.2 million ir
year ended June 30. FirstRock v
in October 1992.
Dan Heine, president and cl
tive officer of Northwest Illino~s
as chairman and chief execuh+'
the new holding company, w'h:
Inp assia, president and ch:e' c
FirstRock, wili te pres:dcnt
operating off!cer.
mh^ m^_r; ^-, subject to m~
shareu^,i,r
in the fourth quarter.
Separately, Northwest Illir
signed a definitive agreemer.t
TriState Bank & Trust Co. of `
que, Ill. Terms wemn't dise:~sP
tlas asses nf S44 t^itt;nl 9h' Lc r
expected to be comptutg in A,;
I First Union Unit's:'1cqu:
JACKSONVILL.E, Fla. - F
National Bank of Florida ac
insnred deposits and some cas
Jacksonville Federal Savings
from the Resolution Trust Corp.
000.
The purchase includes r:
insured deposits and S30 mil:
asses, First Union said.
First Union National Bank
r^irst Union Corp.
Fitst Union National Bank
sonville Federal Savings will c,
tions "within a few months,
seven branches are converte
Union National Bank branches

i
C
;?
::;
~ I'.:., s".cr ir.vrnt! r Prnd ! mucn ;ess t;tan that,"
nrt~ Wi ;:,i;i;suhi:n' of lus Ii;u' 1'i r:ul:t ('n. I `4r. Wright su}s he has a!ready done
s,!cl b,'''t.^ a.r.? marl:c! thc Svnsr.r 1'ud. i two trials with stmu!ated breast tnndels,
lIc ,v; h;ti yun in chi;rke. ! which h^ claims yield more accurate re
Ctata,-i^ appr, vnl tn .cli it in other ' sults. Irt thc fitst, women examtned the
tnnntr!t~ %casn't tt prnhlrmn. Inve;,tive artificial breasts for lumps using both the
t'IVducts ap! licd for marketln,q au;huriz;t pt;d and their bare hands. In the second,
:ion in Canada in Ll~a anr+ ,m' it v: ithin 3n I the} uscd both those methods and also a
dnys, Gr,:nt Wri;,ht says. ite alsu says thr I third mrthud - soap and water on their
pard has been approved in ,)aptin, Sngit-' hands. The tests showed that the pad
pore, Korea. Thniland and most West , enhnnced sensitivity and resulted in in-
r.uropean countries, although Inventive creased lump detection, Mr, Wright says,
Pnxlucts t,;tsn't txtively promoted it ~ The FDA rejected his trials as Insuffi
abrn d. "It'e'vc had no prolllerns nny cieni. The prospect of starting over with j
doublemastectomy. "Itprobablysavedmy
where in the wtirid," h, ,ays. I the lengthy, expen life," she says adding that she gave one to
i?xccpl nt hante. When tite 41'rights I sive tests the FDA
sought FDA c!earnnce for the device in ; demanded pushed
tV95, thc a{;ency's ! the Wrigitts to
initial res;xmse wis % y I change their
~'stttvc. Stili, ti!e
course. Because
guvernment wanir.l .`. :~. the" never amsid
tnore informntiun. ered the pad to be a
"Evcry ti:nr' medical dcv!c, a.'
}''}g
subrntttrcd tnfurtna If .;Z,, aeCnc,i by ' ,
Cion, they nsked for ~' 1, '!aw, they decided in
more," the son re- ', 19SS to market the
G.ils, After several product directly to
months, the agenc;; r,
hospitals. The
denied approval for :_:'~ Wrights say they-
the pad - but indi t'to ~;. ~1:; ~ j and their attorney-
Earl L:';ipkt
~ ~
cated its concerns ~ figured the FDA either wotild recognize its
might be met by
~ lack of jurisdiction or take Inventive Prod-
e;ter.sive labeling Gran! Wri~hf ucts to court and force the issue.
changes. Over 15 months, the Wrighis sold 250,=
Thc: FDA wanted the labe!ing to ,siate ~ 000 pads to some 200 hospitals. But ir April
that the Scnsc Pad could be sold by 19S9, federal agents raided the comoany's
prescription on!}. And it wanted all refer- I Decatur plant and a number of hospitals
ences to breast car:cer deleted. The label ~ and confiscated the pads.
was to include the chemical composit+.on of The action came one day after Ear!
the device. It also was to describe the Wright was na^ted a finalist in the Intellec
10inch-diameter pad's "susceptibility to i tuai Property Owners Foundation's ir.ven
heat, sun!i:ht, soap. Irormatin, alcohol and tor-ofthe-year contest for his "touch-
c:her mechanical agents." ~ enhancing device."
%Sr. ','Iri!,'ht says he imr:.ediately set i Grant challenged ci m, !;; im, th the requests. Gut
«'r ght chenged the FDA's
about three months !ater, he sa s, the FD : j cia:m to jt risdlction over the pad. But in
y 1590. a U.S. district court in Danvilie, IP,
inexpl!cabl~: notified him that i; wouidn't I
ed,
ru;ed 'or the FDA. "fr. Wr.gh: appea: court in
reconsider approvzn~ the product. Lstead, j
,i^ was told, irventiv^ Pro,jucts would have ' and nvc ; ears later an appella.e
to t^rou ~ laborlous " remarket ~ Cricagc upheld the ruiin;. At that point,
gc~ q~' a p snven';ve Products told the FDA it had
appro:;±! process for ner medtca: de- i
vices.
.
g
g
p.
This process is meant `,~ kee,, ^eu' ! 1992
h
fi:
d
thi
m
laint with the
an e
p
,
e
e
s co
mestlc hih-techno!og<' instruments off i FDA's integrity office against some
.he market until the} can be adequately i agency officiais after learning that they
lested for safety. Few people would dis had met with a minority shareholder of the
agree that the FDA stteuld get convincing + company without his knowledge. After he
evidence that invas:ve devices are safe. I filed the com laint, he sa sthe FDA
More tha.n 201 people died in the 19SOs ~ turned hostile. At a meetin in Washington
when their Rjor::-Shii?y i~eart va(ves frac- in Augus' 1992 to discuss requirements for
tured. for instance. But Vrri~ht argues I premarke; approval, he says. an FDA
that the Sensor Pad ,roses no direct risk to ~ lawer - flanked by 10 other agency offi
users. cials and a Justice De artment lav ei-
risk - The that FDA a responds cancerous L a; lump the indirect told us we'd never get our product
to
wouid go
undetected-is petentially lethal- An market." agency spokeswoman says it is
The agency's Dr. Alpert says the fact doubtful such a remark was made. "We
that a devi ce is simple doesn't necessarily have gon2 out of our way to show the
mean it i> benign: everthing depends on `~; rights how to get their product marketed.
its "intended use." She dismisses endorse- Such a comment doesn't make sense," she
ments from doctors and patients - which, ~ says.
she says, man;: device ma}:ers trot out-as Mr. 4~'right promptly fired off lettera of
anecdotal evtdence ti~at is insuf[icient te complaint about the meeting to the FDA
make z scientific case. "Re~rting dosn't t and to Rep. John Dingell of Michigan, who
do it-data does," she says. is, tutow^t for flailing the FDA for its
In 1992, only 12 medical devices were missteps. More letters flew back and forth.
given FDA premarket approvai, including ~~A integrity officer wrote that the
heart pacemakers, lenses that are im- ~t, was acting in good faith. Mr. Wright
planted into the eye after cataract surgery responded by demanding an investigation
and devices for smashing kidney stones 0: of the FDA lauyer who attended the Au
the simple, noninvas:ve pad. "I've never , gust meeting. A couple of days later, his
seen a product like this held off the mar I
ket," sa;:s John Isaacs, a s:; necologist in ' Washing on lawyer sent a seven-page let
nvanston, Iil.. who is the author of a I ter to a Dingell staffer, accusing the FDA
teatboci: or, breast disease. of "hounding" Inventive Products.
But the FDA sa}'s th.^ Sensor Pad needs ~ Four months later, the Wrights re-
to be scrutinized because it isn't "substan- ' ceived notice from an FDA compliance
tially equi~ralent" to a product already on I officer that the agency was investigating
the mar ket, a legal r equirement for quick I them for possible violations of federal law
approval of simple devices. The ~i'rights for selling the pad in 1990-91. hir, Grant
a,ue that tite pad is substantially equiva- ~ says he has received no word about the
!cnt to soap and water, a mixture the ' investigat!on since an FDA administrative
medica! commun!h P,as leng recom hearing in Chicago last June. But, he says,
rm; n:' In reauco fr!rtlrrn at hren;! srifee , he has gotten the messaRe: "If you
c
k
ti
th
d
mar
e
rg
.
cease
e pa
~ But Mr
ht didn't
ive u
In'darch
Wri
t l,'....,. 1 :,rl It:cre;:-5 I;II . . ..
I .. ..
.
' :i tii"lr:' . ~ rl . .i ... `rl , . -
casicr." I shareholders are to get
Gaie Kattcrtwgen, medicrtl director of ~ Bancorp equivalent the nur,''
the cttncer center at St. toseph Medical I they held before the meTz-.
Centrr in Burbank, C:alif., says tests he ! market value of stock in txit:; c.
conductrrd for Inventive Products several f Sn;t million In Nasdaq Sti ck t.t
yoars a!;n indicated that women who used Ing, Northwest Illinois's shar^
the pad wete 2L"%, more likely to perform ,2, cents at 119.225, while F!rstRr
monthly breast exams. "This device is closed unchanged at $18.
harmless," Dr. Katterhagcn says. Northwest Illinois, based i
Wotnen who use the pad swear by it. has assets of S417 million and
hts. Richardson, a 43-year-old Decatur million, or Si65 a share, last }
resident, doubts that she would have found Rock, Rockford, has assets o
twosmalllumpswithoutthepad.Shebada lion and earned 54.2 million i,
tter 19-year-old daughter.
Mary Gorman, a 55yearold writer In
is certain the pad saved her
W
shin
tnn
,
a
g
breast. "I found my cancer before it was
detectable on a mammogram," she says.
Her surgeon, Katherine Alley, says the
device may have saved IN`,s. Gorman's i,;e
Considering the lethality of breast cancer,
f>r. Alley says, "it Is just ridicu!ous" t,
keep the pad off the market.
Potential demarid appaars to be huge,
When a Pittsburgh hospital offered on local
TV in 1990 to send out free samples, it was
flooded with 36,000 calls and letters.
For all that, the FDA's Dr. Alpert
believes that Inventive Products is largely
responsible for the delays it has encotln-
tered. "There are lots of different 11tinds of
trials they could do to show this is effec-
tive." she says. "It doesn't have to be
years and years."
The elder Mr. Wright has managed to
commercialize the Sensor Pad's antifric-
t;on technology for a much smaller mar-
ket. He has built the Slipp, a nylon and
plastic sheet used in hospitals to transfer
patients from a gurney to a bed. About 500
have beer. sold.
But his son spends much of his time in
his nearly empty headquarters explaining
to doctors why he can't send them samples
of the Sensor Pad. Last year, he laid off his
own brother, reducin, his work force to
iiimsel,` and his secretary from a peak of 28
year ended June 30. FtrstRock I,
in October 1992.
Dan Iteine, president and c
tive officer of Northwest Illinois
as chairmnn and chief executi
the new holding company, whi
Ingrassia, president and chief .
FirstRock, will ~e presider'
operatin offier.
'rna mer;^,, subject to te!:
shsrcuob,. . , rn,,zis, is 'n ' '
in the fourth quarter.
Separately, Northwest IltiT
signed a definitive agreemen
TriState Bank & Trust Co. of
que, Iil. Terms weren't disc'.os'
has assets of S4Y millinn. Tha i,
expected to be cumptrAp? in A
First Union Unit's Acqu
JACKSONVILLF., Fla. -
National Bank of Florida a
insured deposits and some ca
Jackscnvllle Federal Sav',ngs
from the Resolution Trust Cor;
000.
The purchase includes 97
insured deposits and s.30 mit
assets, First Union said.
First Union National Banl
First Union Corp.
First Union National Ban
sonvil!e Federal Savings u^il
tions "within a few month,~
six years ago. "Vre're at the point of ' seven branches are convert
surrender," he says. I Union National Bank branche
00
~
~
