ARTICLE
‘A leas ou pi ui a ies will see he wo ld’: Pi ui a y gland
expo om communis Bulga ia
Daniela Kole a
Ins i u e o E hnology and Folklo e S udies wi h E hnog aphic Museum, Bulga ian Academy o Sciences, So ia, Bulga ia
Email: [email p o ec ed]
Abs ac
The a icle ocuses on he expo o cada e ic pi ui a y glands om communis Bulga ia in he 1980s, used o he
p oduc ion o human g ow h ho mone. The case is explo ed in he b oade con ex o p ac ices and ansna ional
ne wo ks o he supply o pi ui a ies. Special a en ion is paid o he changes esul ing om he u n o he
p oduc ion o ecombinan g ow h ho mone in he mid-1980s, which pu an end o he in e na ional ‘ma ke ’o
pi ui a y glands. In he las sec ions, di e en pe spec i es a e explo ed o make sense o he case unde sc u iny:
hose o bioe hics and biolaw, on he one hand, and o bioeconomy in a globalising wo ld, on he o he .
Keywo ds: Pi ui a y; G ow h ho mone; Bulga ia; Biolaw; Bioe hics; Bioeconomy
This a icle ocuses on a speci ic case o ansna ional linkage and exchange, o a ype ha has so a
la gely emained unde he ada o medical his o y esea ch, al hough i has occasionally a ac ed
public a en ion. Assuming ha he I on Cu ain was in many espec s a ‘nylon cu ain’, ha is,
pe meable, I am ying o unde s and wha used o ‘ low’ h ough i and in which di ec ion. The case
unde s udy e e s o a c ucial momen in he de elopmen o bio echnology gea ed o he ea men o
pi ui a y dwa ism – he sho s a u e and slow g ow h in child en due o he de iciency o g ow h
ho mone. I am in e es ed in he p ac ices and ne wo ks o he supply o pi ui a y glands ex ac ed om
human cada e s o he p oduc ion o he ho mone, and he changes esul ing om he u n o
ecombinan g ow h ho mone in he mid-1980s. This u n b ough an ab up end o he in e na ional
‘ma ke ’in pi ui a y glands and hence o he ques ionable p ac ice o hei ha es ing and expo by some
So ie bloc coun ies, which s a ed in he 1970s and lou ished h oughou he 1980s.
I shall i s desc ibe his p ac ice in wo o hese coun ies: Hunga y and Bulga ia. While he
Hunga ian case is only b ie ly ske ched, I ha e s udied he Bulga ian one in some dep h, based on he
a chi es o he Medical Academy in So ia and o he Na ional Tele ision, as well as on se e al in e iews
wi h con empo a ies: medical pe sonnel om he ins i u ion expo ing he pi ui a ies, and he jou nal-
is s who in 1991 epo ed he p ac ice in na ional media. Then, I shall zoom ou o he b oade
in e na ional con ex o he p oduc ion and dis ibu ion o g ow h ho mone and he sha ing o ela ed
knowledge. Finally, di e en pe spec i es owa ds he case a hand will be discussed: o bioe hics and
biolaw on he one hand, and o bioeconomy on he o he . I belie e ha hei jux aposi ion leads o a
deepe unde s anding no only o his pa icula p ac ice, bu o some speci ici ies o he scien i ic
in e na ionalism o he la e yea s o he communis egimes in Eu ope.
T a elling pi ui a y glands
In 1987, a public scandal b oke ou in Hunga y, ollowing an appeal o he Sup eme Cou : a enowned
p o esso a he Uni e si y o Szeged, head o i s Endoc inology Depa men , was accused o an unusual
© The Au ho (s), 2025. Published by Camb idge Uni e si y P ess. This is an Open Access a icle, dis ibu ed unde he e ms o he C ea i e
Commons A ibu ion licence (h p://c ea i ecommons.o g/licenses/by/4.0), which pe mi s un es ic ed e-use, dis ibu ion and ep oduc ion,
p o ided he o iginal a icle is p ope ly ci ed.
Medical His o y (2025), 1–14
doi:10.1017/mdh.2025.10029
h ps://doi.o g/10.1017/mdh.2025.10029 Published online by Camb idge Uni e si y P ess
ba e .
1
He was ound o ha e acqui ed consumables o his esea ch om he I alian pha maceu ical
company Se ono
2
in exchange o pi ui a y glands (hypophyses) ex ac ed om cada e s du ing
au opsies in Hunga ian hospi als. This wei d coope a ion had las ed o abou en yea s, esul ing in
he expo o se e al housand pi ui a y glands in he luggage o passenge s c ossing he Hunga ian
bo de . In 1986, he cus oms o ice s ound he p ecious goods, and he ensuing in es iga ion esul ed in
cha ges agains he p o esso . Wha he Hunga ian cou had o decide, howe e , was no whe he his
was a misapp op ia ion o human cada e issues wi hou he knowledge o he ela i es o he
oppo uni y o op ing ou , bu whe he his ac i i y had led o p i a e inancial gains, causing loss o
p o i s o he s a e. As i u ned ou , awkwa dly, he s a e-owned Human Vaccine Subs ance P oduc ion
Company had engaged in he same ype o ansac ions wi h a ew Wes e n Eu opean companies,
including Se ono. Bo h he p o esso and he s a e company a gued ha hei only aim was o p o ide
esou ces o medical esea ch and o imp o e he quali y o heal hca e in Hunga y. The public, howe e ,
was less in e es ed in wha he pi ui a ies had paid o ; he scandal b ough a en ion o he ac ha
Hunga ian ci izens had been o gan dono s o yea s wi hou knowing i . Wi h his ‘ u bulen his o ical
e ospec ’, Judi Sando opens he a icle on pa ien s’ igh s in he con ex o o gan and issue dona ion.
3
I shall con ex ualise he case om a di e en pe spec i e, as an example o a ‘bioeconomy’o so s aking
place ac oss he I on Cu ain.
A couple o yea s la e , a simila scandal bu s ou in Bulga ia: on 25 July 1991, he na ional ele ision
ai ed a epo on he pa ho-ana omy depa men o a So ia hospi al, ollowed by an in e iew e ealing
he p ac ice o he ex ac ion o o gans om he bodies o pa ien s who died in hospi als.
4
The iewe s
saw he epana ion ools wi h which he o gans we e ex ac ed and he acili ies o hei p ese a ion.
The ex ac o explained he p ocedu e and ci ed he p ices o he o gans: i e le s o du a ma e , en le s
o ibia, e c. A ew days la e , he weekly humou and sa i e magazine S a shel [Ho ne ] published on i s
on page a b ie bu caus ic ex s a ing: ‘We knew ha ou minds belonged o he s a e, bu hones ly, we
didn’ ancy ha ou bodies belonged o i as well, and in such a li e al sense’. Re e ing o he TV
b oadcas , he au ho pi ched in o he expo o ‘Bulga ian mea ’:‘We may no be able o a el ab oad,
bu a leas ou pi ui a ies will see he wo ld’, he concluded sa cas ically.
5
The accompanying ca oon
showed a cow, a pig, a man and a woman lying up o hea en wi h angels’wings a ached o hei
shoulde s. The pig explained o bewilde ed God: ‘Thei o al was sold in Malee ’s slaugh e house’. The
‘slaugh e house’in he case o hypophyses was he Resea ch Ins i u e o Endoc inology, Ge on ology
and Ge ia ics (RIEGG), pa o he Medical Academy (MA), and A anas Malee was he MA p esiden
and b o he -in-law o Todo Zhi ko , head o he communis pa y and he s a e ill 10 No embe 1989.
Based on RIEGG a chi es and o he a chi al ma e ial, I ha e acked down he beginning and he
de elopmen o his p ac ice in he 1980s. My in e iews wi h he TV epo e and he S a shel au ho , as
well as wi h wo o me RIEGG esea che s, one o whom was in ol ed in he collec ion and p ese a ion
o he hypophyses, added no only ac ual de ails bu also a sense o he p o essional e hos and he
pe sonal pe spec i es o pa icipan s and wi nesses.
The idea o expo pi ui a y glands was launched by Ema Bozadjie a (1920–96), p o esso o
endoc inology, who go he PhD deg ee in he So ie Union in 1968 and was p omo ed o he posi ion
o Di ec o o RIEGG in 1976. As a pa icipan in he communis esis ance du ing he Second Wo ld
Wa and a membe o he Bulga ian communis pa y, awa ded wi h he p es igious Geo gi-Dimi o
o de , Bozadjie a was e y well-connec ed in bo h p o essional and pa y ci cles. He o me subo din-
a es desc ibed he as an excellen physician, e y knowledgeable, ully de o ed o he wo k, and an
ou s anding manage : ene ge ic, en e p ising and in luen ial, albei quick- empe ed and nagging. He
esea ch ocused on he pa hologies o he hypo halamic-pi ui a y and ad enal sys ems, in pa icula
1
I am g a e ul o P o . Judi Sando o sha ing he de ails o his case.
2
Founded in 1906 in Rome; la e eloca ed o Swi ze land.
3
Judi Sando , ‘Righ o heal h and he human o gan: Righ as a consequence?’,P a ni Zapisi, 5, 2 (2014), 384–412.
4
O z uk [Echo] commen a y s udio, BNT a chi e, 25 July 1991.
5
Rumen Belche , ‘Spi spokoino, hipo izo moya!’,S a shel, 2373, 2 Augus 1991, 1.
2 Daniela Kole a
h ps://doi.o g/10.1017/mdh.2025.10029 Published online by Camb idge Uni e si y P ess
pi ui a y umou s and endoc ine hype ension.
6
Resea ch on hese opics was de eloped a RIEGG
al eady in he ea ly 1970s, which was e lec ed in i s s uc u e: one o i s depa men s was he
Diencephalic-pi ui a y one.
7
Bozadjie a’s guiding mo i a ion was epo ed o ha e been he need o
esou ces o se up RIEGG labo a o ies: ‘An ins i u e wi hou labs is a illage hospi al,’she used o say,
acco ding o he in e iewees. They singled ou he g ea es success as head o RIEGG, whe e she
es ablished en new labo a o ies and s a ed hem wi h op specialis s. One o hem was he Labo a o y
o Pep ide Ho mones, which is o in e es he e.
In a epo o he Chai man o he Commi ee o Science and Technical P og ess da ed 27 June 1980,
Bozadjie a p esen ed a esea ch heme o which she sough unding: ‘Isola ion o soma o opic and
gonado opic ho mones om human pi ui a y glands om cada e s and de elopmen o a p oduc ion
echnology and dosage o ms o hei adminis e ing’. She explained ha he soma o opic/g ow h
ho mone (GH) was a complex polypep ide compound, which was no ye syn hesised chemically, e en
hough i s composi ion was known.
8
The e o e, he ea men o pi ui a y insu iciency in child en ( he
so-called hypopi ui a y dwa ism) depended on he ex ac ion o GH om he pi ui a y glands o human
cada e s, he ho mone being species-speci ic. Bozadjie a de ended he p oposal, poin ing ou ha in he
So ie Union, GH was p oduced and child en we e ea ed as o 1959–60. The GDR also p oduced i s
own GH bu ‘ e used’i s expo o Bulga ia. This was why by he ime he epo was w i en, no
ea men had been p o ided o Bulga ian child en su e ing om pi ui a y dwa ism.
9
The e is no clue
in he epo as o he numbe o hose child en, and hence he social signi icance o he issue. A 1982
su ey iden i ied a o al o 209 such child en and adolescen s egis e ed in he paedia ic wa ds o he
egional hospi als and a equency o one ou o 19,000 child en.
10
RIEGG ocused p ima ily on such widesp ead and hence socially signi ican diseases as diabe es,
hype ension, goi e, and a he oscle osis. Ha ing meag e chances o ga ne suppo based on he social
impo ance o he p oblem, Bozadjie a adop ed a di e en ac ic. She e e ed o he si ua ion in Wes e n
coun ies, whe e he e was a ch onic sho age o GH.
11
Hence, he inancial a gumen ollowed:
Bozadjie a es ima ed ha on a e age, 15–20 housand au opsies we e ca ied ou in Bulga ia pe yea ,
which would accoun o 15,000 pi ui a ies. The GH ex ac ed om hem would be mo e han enough o
Bulga ian needs, and a subs an ial sha e o i could be expo ed. The a e age p ice o a pi ui a y a he
in e na ional ma ke being USD 8, Bozadjie a es ima ed ha he annual e enue om he expo would
each 200–300 housand cu ency le s pe yea .
12
In addi ion o he ex ac ion o pi ui a y glands and
clinical esea ch o be pe o med a RIEGG, he p oposal en isaged labo a o y esea ch, including
expe imen s on animals and, las bu no leas , ma ke -o ien ed p oduc ion.
6
Ema Bozadjie a, Endok inni hipe onii (So ia: Medicina i izkul u a, 1979); idem, Geo gi Papazo , Ho moni i mine alen obmen
(So ia: Medicina i izkul u a, 1984); idem, Lyubomi Ka agyozo , Tumo i na hipo iza a (So ia: Medicina i izkul u a, 1987).
7
Repo on he ul ilmen o he plan o esea ch o he Ins i u e o Endoc inology, Ge on ology and Ge ia ics o 1972.
So ia S a e A chi e, holding 2265 (RIEGG), in en o y 3, a chi al uni 10, shee 6.
8
The biochemical s uc u e o he g ow h ho mone was i s iden i ied in he ea ly 1970s by C. H. Li and J. S. Dixon: C. H. Li
and J. S. Dixon. ‘Human pi ui a y g ow h ho mone. 32. The p ima y s uc u e o he ho mone’,A chi es o Biochemis y and
Biophysics, 146, 1 (1971), 233–6.
9
Repo by P o . E. Bozadjie a, di ec o o RIEGG, o he Chai man o he Commi ee o Science and Technical P og ess,
com ade Nacho Papazo ex. No. 694 / 27 June 1980, So ia S a e A chi e, holding 2265 (RIEGG), in en o y 3, a chi al uni
31, shee 14.
10
Lilia Pene a, Hiposoma o opizam de ska a i yunosheska a yz as . Unpublished D . Sci. disse a ion, So ia: MA,
Resea ch Ins i u e o Paedia y, 1984, 88–9.
11
RIEGG managemen o en used compa isons wi h o he coun ies o push o mo e unding, a p ac ice ha was ob iously
no excep ional (c . Paula A. Michaels, ‘So ie medical in e na ionalism amid des aliniza ion, 1953-1958’,The So ie and Pos -
So ie Re iew, 50 (2023), 40–63, 58).
12
So ia S a e A chi e, h. 2265 (RIEGG), in . 3, a.u. 31, shee 15. The ‘cu ency le ’was an accoun ing cu ency uni used o
he ecalcula ion o e enues and expendi u es om o eign cu encies in o Bulga ian le s and ice e sa. I s ela ion o Wes e n
cu encies was a bi a ily de ined each yea and kep un ealis ically low, and was highly di e en ia ed by ype o indus y and
ype o cu ency. In he 1980s, he US dolla equi alen was close o double, i.e. 1 USD = 1.5–2 cu ency le s. I am indeb ed o
P o . K assen S anche o hese cla i ica ions.
‘A leas ou pi ui a ies will see he wo ld’3
h ps://doi.o g/10.1017/mdh.2025.10029 Published online by Camb idge Uni e si y P ess
Bozadjie a was ei he unawa e o p e e ed no o men ion ha some child en ac ually did ecei e
ea men a he Endoc inology clinic o he Resea ch Ins i u e o Paedia ics as pa o a esea ch p ojec
led by D Lilia Pene a (1929–2020). I s a ed in 1970 wi h eigh child en and de eloped o include a o al
o 43 child en and adolescen s by 1984. They we e ea ed wi h cada e ic GH p oduced in Bucha es ,
Romania, and in D esden, GDR (So opin H), la e also wi h Se ono’s G o m, ecei ed in exchange o
pi ui a ies ex ac ed om cada e s in MA clinics.
13
While hese de ails we e missing om he epo , he
small-scale in o mal exchange o pi ui a ies mus ha e p o ided a powe ul incen i e o i s au ho : one
o my in e iewees emembe ed Pene a’s name and hose o wo o he doc o s who collec ed pi ui a ies
in ace one and handed hem o a lady who pe iodically came om I aly (p esumably om Se ono). He
did no know o Pene a’s esea ch; a he , he belie ed ha he pi ui a ies we e simply sold, and e en
men ioned he p ice o USD 2–2.5 pe uni –a p ac ice closely esembling he one in Hunga y. A abou
he same ime, a ep esen a i e o he Swedish pha maceu ical company Kabi
14
con ac ed RIEGG
managemen and p oposed a highe p ice, especially i he pi ui a ies we e ozen. So, he chance was
he e o expand he en e p ise and channel he e enue.
Bozadjie a and he eam did no miss hei chance: he epo s in he subsequen yea s ocus mos ly
on he expo o pi ui a ies and less on he esea ch ca ied ou a RIEGG. Only in 1987 did he RIEGG
managemen epo ha GH was ob ained and pu i ied, and es ed on animals. A adioimmunoassay was
de eloped and p epa ed in comme cial o m. Ha d cu ency
15
was secu ed o depy ogena ion il e s,
which would allow he se ial p oduc ion o GH.
16
The e is no e idence in he a chi e ha he Paedia ic
Endoc inology clinic bene i ed om hese achie emen s, and i hey had any consequences o ea ing
he Bulga ian child en su e ing om hypopi ui a y dwa ism.
The bounda ies be ween labo a o y science and in e na ional ade p o ed a he po ous. As can be
seen om Bozadjie a’s u he epo s, he supe io s seemed o be mo e in e es ed in he expo han in
he esea ch. He epo o he Di ec o o he Impo -Expo depa men o he Medical Academy
(MAIMEX), da ed 28 Janua y 1981, e eals he commi men o de eloping a la ge-scale ha es ing o
pi ui a y glands: ollowing he ins uc ions gi en by Kabi, she inspec ed a ew egional hospi als o
o ganise he ex ac ion and he p ese a ion o pi ui a ies. Thei ex ac ion did no c ea e any p oblems,
as, like in Hunga y, pe o ming an au opsy was equi ed in each case o a pa ien dying in a hospi al.
17
The e was no legal obliga ion o seek consen om he ela i es o he deceased, o e en o in o m hem.
18
The e o e, Bozadjie a ocused on p ac icali ies: she asked o a dedica ed o de o he MA P esiden ,
A anas Malee , ‘ o egula e he collec ion’na ionwide,
19
and o hi y eeze s o secu e he ha es ing o
10–15 housand pi ui a y glands pe yea ac oss he whole coun y.
The s a o he collec ion campaign was p omising: he pa ne ship wi h Kabi wo ked smoo hly, wi h
hei ep esen a i e coming mon hly o pick up he pi ui a ies and pay. RIEGG s a ou ed he coun y
o collec hem om he hospi als. A he nex s age, wo esea che s isi ed Kabi labo a o ies in Sweden
o ge acquain ed wi h GH p oduc ion. In a le e o Malee om 23 June 1982, Bozadjie a announced
ha 3000 pi ui a ies had al eady been collec ed o he i s hal o he yea and u ged him o o de hei
ha es ing all o e he coun y. The p ice was al eady USD 16.5 pe uni , bu she easoned ha i would
be economically mo e p o i able no o expo he unp ocessed glands bu a he a semi- inished p oduc
13
Pene a, op. ci . (no e 10), 83, 193; idem, R. Sla o a, Zh. Zhele , ‘Lechenie s cho eshki as ezhen ho mon na de sa s
hipopi ui a izym’,Pedia ia, 15, 2 (1976), 98–106, 99; idem, Zabolia ania na hipo iza a III. Lechenie na hipo iza nia nanizym,
Pedia ia, 21, 6 (1982), 547–53.
14
Founded in 1931 in Malmö. Nowadays pa o P ize .
15
‘Ha d cu ency’was he e m used o e e o Wes e n cu encies, ypically US dolla s and FRG ma ks. I was essen ial o
he impo o p e e ed, some imes unique, equipmen and consumables.
16
In o ma ion on he ul ilmen o he Bio echnology P og amme o MA by RIEGG in 1987. Holding 2265 (RIEGG), in .
3, a.u. 33, shee 69.
17
Public Heal h Ac , Da zha en Ves nik [S a e Gaze e] No 88, 1973, a icle 37. Acco ding o he ex ac o in e iewed in
O z uk s udio, he ‘big sho s’, i.e. high- anking pa y and s a e o icials, we e exemp om au opsy.
18
Ibid., a icle 34(2).
19
So ia S a e A chi e, holding 2265 (RIEGG), in . 3, a.u. 13, shee 2.
4 Daniela Kole a
h ps://doi.o g/10.1017/mdh.2025.10029 Published online by Camb idge Uni e si y P ess
ob ained om hem.
20
I was he e o e necessa y o equip a labo a o y.
21
This eques mus ha e been
aken in o accoun : he annual epo o 1983 boas s ha he plan o ‘ha d cu ency’was me , which was
a chance o RIEGG o in es he e enue in he pu chase o unique equipmen . The collec ion o
pi ui a ies was ‘ hy hmic’due o he young colleagues’‘ esponsible and conscien ious’pa icipa ion.
22
The labo a o y was ins alled by Kabi. I was a simple and p ac ical s uc u e assembled o con aine s wi h
ou ooms equipped wi h ai condi ioning o main ain low empe a u es. The quali y o he p oduc was
hus gua an eed, and he e enue inc eased.
The exchange o pi ui a y glands o ha d cu ency in he si ua ion o g owing na ional deb and
ch onic sho ages was o g ea impo ance o MA. Fo 1985, he e enue om pi ui a ies was 702,000
cu ency le s, c. 30% o he o al ha d-cu ency e enue om MA’s p oduc ion and in e na ional
ac i i ies;
23
o 1987, he sha e was 26%.
24
The g ea e pa o he ea nings, as in he Hunga ian case, was
in es ed in equipmen and consumables o esea ch. Unde he condi ions o an o e -cen alised and
ine planning sys em, his was no a all simple. In a se ies o epo s o he P esiden o MA, he RIEGG
Di ec o asked o pe mission o spend pa o he o eign cu ency e enue o addi ional equipmen
and consumables, which had no been included in he plan bu we e u gen ly needed. By he ea ly
au umn o 1982, Bozadjie a epo s, he expo o pi ui a ies had yielded 76,249 cu ency le s; 45,313
we e al eady alloca ed o he pu chase o equipmen and consumables, ‘ he es we e p o i ’ ha was
placed a he disposal o MA managemen . Bozadjie a asked o pe mission o spend pa o i on
addi ional equipmen . Since u he ha d cu ency income was expec ed ill he end o he yea , hese
expenses would no impai he p o i , she p omised.
25
I could no ind ou i his eques was app o ed o how long i ook o he equipmen o be bough
and ins alled. As seen om o he cases, he p ocedu e was slow and cumbe some. Fi s , he equipmen
had o be included in he plan o he nex yea (ideally –in he i e-yea plan), based on a p o en need,
i.e. ha i was indispensable o he implemen a ion o planned and app o ed esea ch asks; some imes
his also necessi a ed p oo ha equi alen equipmen was no p oduced in any o he So ie -bloc
coun ies. Nex , e en i p esen in he plan, he pu chase depended on he a ailabili y o unds, which
we e always in sho supply, hus gene a ing ough compe i ion among heads o depa men s/ins i u es
wi hin he MA.
26
The success o en depended on he winne s’connec ions and posi ions in complex,
la gely in o mal, p o essional-poli ical ne wo ks.
27
In his si ua ion, he capaci y o RIEGG o ga ne
o eign cu ency boos ed i s p es ige among he o he ins i u es and depa men s as a dono o he
cu ency budge o he MA.
Howe e , he si ua ion wo sened d ama ically in he second hal o he 1980s. In 1988, he new
RIEGG Di ec o D agomi Koe ough o a budge o only 3000 cu ency le s o he Labo a o y o
Pep ide Ho mones in addi ion o he 7000 alloca ed o RIEGG as a whole.
28
He explained ha he sum
was u gen ly needed o he impo o ma e ials and subs ances ins umen al o he p oduc ion o he
adioimmunoassays planned o 1988. I he s anda d supply p ocedu e we e o be ollowed, hese
essen ial ma e ials would a i e only in 1989, jeopa dising he achie emen o he plan. The eason was
20
Ibid., a.u. 7, shee 40–41.
21
Ibid., a.u. 50, shee 1.
22
Ibid., a.u. 26, shee 8, 10.
23
‘Repo on he ul illmen o he cu ency plan o MA o 1985’, So ia S a e A chi e, holding 3863 (MAIMEX), in .
4, a.u. 16, shee 21.
24
‘Repo on he e enues in non-socialis cu ency on MA’s bank accoun in 1987’,ibid., shee 46.
25
So ia S a e A chi e, h. 2265 (RIEGG), in . 3, a.u. 7, shee 48.
26
Repea ed complain s can be ound in he epo s and he minu es o RIEGG assemblies ha he sys em o planning and
supply o labo a o y consumables was ‘ a he ine and does no mee ou needs’(So ia S a e A chi e, h. 2265 (RIEGG), in .
1, a.u. 9, shee 28a) and ha ‘we plan esea ch asks o he nex yea necessi a ing ele an equipmen , which is also included in
he plan, bu we ecei e i in 3-4 yea s’(So ia S a e A chi e, h. 2265 (RIEGG), in . 3, a.u. 4, shee 7).
27
On he impo ance o pe sonal connec ions, see Daniela Kole a, Igna Pe o , ‘Socialis ge on ology? O ge on ology du ing
socialism? The Bulga ian case’,His o y o he Human Sciences, 36, 3–4 (2023), 178–201, h ps://doi.o g/10.1177/09526951231178434.
28
So ia S a e A chi e, h. 2265 (RIEGG), in . 3, a.u. 7, shee 4-5.
‘A leas ou pi ui a ies will see he wo ld’5
h ps://doi.o g/10.1017/mdh.2025.10029 Published online by Camb idge Uni e si y P ess
no ha Koe lacked his p edecesso ’s au ho i y (which he did, in ac ); no was i only he deepening
economic c isis in he las yea s o he communis egime. A look a he epo s shows he ac ual
si ua ion: while RIEGG inc eased he plan o he expo o pi ui a ies o 850,000 cu ency le s
( o honou he 13
h
Cong ess o he Bulga ian Communis Pa y in 1986), only 44.89% o his amoun
was achie ed.
29
The nega i e endency con inued, down o a 10% execu ion o a plan al eady educed o
400,000 cu ency le s in 1989.
30
To explain his collapse, a b oade in e na ional pe spec i e is needed.
Helping child en o g ow
The medicalisa ion o soma ic eali ies, including sho s a u e (especially o boys), s a ed a he ea ly
in he wen ie h cen u y. As in an mo ali y declined, paedia icians’ ocus shi ed owa ds issues o
‘no mal’physical and psychological de elopmen .
31
GH he apy a ac ed he a en ion o esea che s
and he media by he 1930s.
32
Because o he ho mone’s species-speci ici y, i had o be isola ed om he
pi ui a y glands o human cada e s and pu i ied o he apeu ic use. This only became possible in he
1950s. The p epa a ions ollowed wo me hods, known as he Raben and Wilhelmi me hods, whe eby
‘[a]ce one-d ied powde ed pi ui a y issue was subjec ed o epea ed o ganic sol en ex ac ions (Raben)
o alkali and acid p ecipi a ions (Wilhelmi)’.
33
A e 1975, he la e me hod was modi ied using ozen
glands and a mo e gen le ex ac ion p ocedu e.
34
In he USA, whe e GH he apy was i mly es ablished
by he ea ly 1960s, he supply o pi ui a ies depended on people’s decision o dona e hei o gans pos
mo em, especially a e he adop ion o he Uni o m Ana omical Gi Ac (UAGA) in 1968.
35
The
Na ional Pi ui a y Agency (a ede al body es ablished in 1963 o s anda dise he collec ion, p oduc ion
and dis ibu ion o human GH)
36
and he Human G ow h Founda ion (an o ganisa ion o pa en s o
small-s a u e child en) ene ge ically campaigned o he dona ion o pi ui a y glands. S ill, he la e we e
in ch onic sho supply. Ini ially, he he apy equi ed 1 mg o GH pe day, which was ex ac ed om one
gland; so 365 pi ui a ies we e needed pe pa ien pe yea . Abou 10,000 o hem we e a ailable in o al.
37
Tha is, he annual yield o pi ui a ies in Bulga ia, wi h i s popula ion o sligh ly o e eigh million, was
compa able o o exceeding ha o he USA.
In he 1970s, ex ac ion and pu i ica ion we e amelio a ed and ‘only’50 o 200 ex ac s we e needed o
p o ide one child wi h one yea o ea men .
38
S ill, he he apy was ha dly a ailable o all hose who
wan ed i . Doc o s had o single ou hose child en who we e in he g ea es ‘need’ o ea men , which
led o a ‘ a ioning men ali y’and a ec ed he e y de ini ion o he condi ion as agains he ‘no mal’
29
So ia S a e A chi e, h. 3863 (MAIMEX), in . 4, a.u. 16, shee 34.
30
Ibid., shee 50.
31
On he medicalisa ion o social s igmas in ela ion o he de elopmen o he GH indus y, see Aimee Lynn Medei os,
Heigh ened Expec a ions: The His o y o he Human G ow h Ho mone Indus y in Ame ica. UCSF Elec onic Theses and
Disse a ions (2012), h ps://eschola ship.o g/uc/i em/5n8021 j.
32
D Ha ey Cushing coined he e m in 1909, and he g ow h-p omo ing e ec s o GH we e p o en in a g oundb eaking
s udy by H. M. E ans and his eam in 1921 (Ma in O.Sa age, Abdullah Alhe bish, ‘G ow h ho mone he apy o paedia ic
g ow h diso de s: The pas , p esen and u u e’,D . Sulaiman Al Habib Medical Jou nal, 2, 1 (2020), 4–9, h ps://doi.
o g/10.2991/dsahmj.k.200227.001.
33
C.J.Ellis, H. Ka i i, R.O. Welle , ‘A u he B i ish case o g ow h ho mone induced C eu z eld -Jakob disease’,Jou nal o
Neu ology, Neu osu ge y, and Psychia y, 55 (1992), 1200–2, 1201.
34
Ibid., 1201. Fo de ails see R. Lumley Jones, G. Benke , P.P. Salacinski, T.J. Lloyd and P.J. Low y, ‘La ge-scale p epa a ion o
highly pu i ied py ogen- ee human g ow h ho mone o clinical use’,Jou nal o Endoc inology, 82 (1979), 77–86.
35
h p://www.uni o mlaws.o g/sha ed/docs/ana omical_gi /uaga%201968_scan.pd , accessed 28 Ap il 2025.
36
Renamed as Na ional Ho mone and Pi ui a y P og am, NHPP. I epea edly issued appeals o pa hologis s o engage in he
collec ion o pi ui a ies, and o ci izens o dona e pos humously hei pi ui a ies in o de o help dwa ed child en. Simila
go e nmen -sponso ed agencies we e es ablished in o he coun ies, such as he UK, Canada, F ance, Aus alia, and Is ael.
37
Robe M. Blizza d, ‘His o y o g ow h ho mone he apy’,Indian Jou nal o Pedia ics, 79, 1 (2012), 87–91, 88, h ps://doi.
o g/10.1007/s12098-011-0609-4.
38
Medei os, op. ci . (no e 31), 151.
6 Daniela Kole a
h ps://doi.o g/10.1017/mdh.2025.10029 Published online by Camb idge Uni e si y P ess
s a e.
39
Pa ien s we e ec ui ed as pa icipan s in esea ch p ojec s, as was he case a he Resea ch
Ins i u e o Paedia ics in So ia. Ne e heless, hei ea men was o en in e up ed because o a GH
sho age.
40
Only in he mid-1970s, wi h he in oduc ion o comme cial pi ui a y GH, did he supply
inc ease. I s main p oduce s we e Se ono and Kabi. The ea men wi h hese medica ions cos be ween
USD 9,000 and USD 20,000 pe yea .
41
The high cos , de e mined by he low supply, was ye ano he
p oblem bo h public heal h agencies and pa ien s’ amilies aced.
Since he supply o pi ui a y GH p oduc s was es ic ed due o he limi ed numbe o human
hypophyses, bo h scien is s and pha maceu ical companies u ned o gene ic enginee ing echniques in
o de o p oduce syn he ic GH. In pa icula , Kabi, which domina ed he global GH ma ke , joined o ces
in 1978 wi h Cali o nia-based labo a o y Genen ech (GENe ic ENginee ing TECHnology)
42
o ob ain
gene ically modi ied bac e ia capable o p oducing human g ow h ho mone. Kabi unded he en u e
and supplied human pi ui a y ma e ial. I migh be ha some o he hypophyses ex ac ed in Bulga ian
hospi als and sold o Kabi we e alloca ed o his esea ch. The ho mone was syn hesised in 1979 and
submi ed o he US Food and D ug Adminis a ion (FDA) o app o al.
43
The syn he ic GH was
expec ed o compe e wi h he pi ui a y GH, which was conside ed mo e ‘na u al’, and whose addi ional
ad an age was ha i was o en dis ibu ed by go e nmen agencies ee o cha ge.
The echnology was new, and he app o al necessi a ed ex ensi e ials o e a ela i ely long pe iod o
ime. Howe e , he FDA ials ended ab up ly, and he app o al was u gen ly g an ed in Oc obe 1985, in
he mids o a c isis igge ed by an ala ming disco e y: a link was p o en o exis be ween cada e GH
ea men and cases o a a e and a al b ain disease, C eu z eld -Jakob disease (CJD). The ic ims we e
young adul s om se e al coun ies, including he USA, he UK, and F ance. The p oblem was e y
se ious, bea ing in mind ha o nea ly hi y yea s, mo e han 27,000 child en wo ldwide had al eady
been ea ed wi h cada e ic GH.
44
The public ou c y was signi ican , due o bo h he young age o he
ic ims and he long incuba ion pe iod, which led o he pe cep ion o he disease as a cons an hidden
h ea o he pa ien s and a po en ial isk o hei amilies and he wide public.
45
Fu he mo e, he
39
Mau een D. McKel ey, E olu iona y Inno a ions: The Businesso Bio echnology. (Ox o d: Ox o dUni e si y P ess, 2000), 231.
40
E an G abe , Edwa d O. Rei e and Alan D. Rogol, ‘Human g ow h and g ow h ho mone: F om An iqui y o he
ecombinan age o he u u e’,F on ie s in Endoc inology, 12 (2021), 1–19, 6, h ps://doi.o g/10.3389/ endo.2021.709936.
This was also he case in So ia, as Pene a epea edly explained. The i egula supply and he high p ice o he GH led he o
expe imen wi h in e mi en ea men a e he i s yea . Pene a, op. ci . (no e 10), 337; op. ci . (no e 13), 551; Pene a e al.,
op. ci . (no e 13), 99.
41
Medei os, op. ci . (no e 31), 184.
42
Genen ech, in collabo a ion wi h Eli Lilly, de eloped ecombinan human insulin, he i s bio ech he apy app o ed by he
FDA in 1982 (P iya Venkas en, Michael A. Pe e s, ‘Biocapi alism and he poli ics o li e’,Geopoli ics, His o y, and In e na ional
Rela ions, 2 (2010), 100–22, 107).
43
Medei os, op. ci . (no e 31), 186–8.
44
Un il 2021, mo e han 250 indi iduals who had ecei ed cada e ic GH ea men we e diagnosed wi h CJD wo ldwide
(G abe e al., op. ci . (no e 40), 6). Some s udies es ablished a possible gene ic p edisposi ion o ia ogenic CJD (John Collinge,
Ma k S. Palme , Aidan J. D yden, ‘Gene ic p edisposi ion o ia ogenic C eu z eld -Jakob disease’,The Lance , 337, (1991),
1441–2), o he s poin ed ou ha mos CJD pa ien s ecei ed ea men be o e 1977, he yea when he me hod o ex ac ion was
signi ican ly imp o ed (Joseph Y. Ab ams, Law ence L. Schonbe ge , E mias D. Belay, Ryan A. Maddox, Ellen W. Leschek,
James L. Mills, Diane K. Wysowski, Judi h E. F adkin, ‘Lowe isk o C eu z eld -Jakob disease in pi ui a y g ow h ho mone
ecipien s ini ia ing ea men a e 1977’,Jou nal o Clinical Endoc inology & Me abolism, 96, 10 (2011), 1666–9). S ill, a much-
discussed F ench s udy e ealed ha he new me hod did no ully exclude con amina ion (T. Bille e de Villemeu , J.P. Deslys,
A. P adel, C. Soub ié, A. Alpé o i ch, M. Ta dieu, J.L. Chaussain, J.J. Hauw, D. Do mon , M. Rube g, Y. Agid, ‘C eu z eld -
Jakob disease om con amina ed g ow h ho mone ex ac s in F ance’,Neu ology, 47, 3 (1996), 690–5, h ps://doi.o g/10.1212/
wnl.47.3.690). Recen s udies ha e sugges ed a connec ion be ween cada e GH ea men and Alzheime ’s disease (G.Bane jee,
S.F.Fa me , H.Hya e, Z. Jaunmuk ane, S. Mead, N.S. Ryan, J.M. Sco , D.J. We ing, P. Rudge & J. Collinge. ‘Ia ogenic
Alzheime ’s disease in ecipien s o cada e ic pi ui a y-de i ed g ow h ho mone’,Na u e Medicine, 30 (2024), 394–402, h ps://
doi.o g/10.1038/s41591-023-02729-2).
45
Fo he UK see Tim Kelsey, ‘Doc o blocked g ow h ho mone in 1970s: P essu e g ows o compensa e pa ien s a isk o
incu able b ain disease’,Independen , 19 Augus 1993, h ps://www.independen .co.uk/news/uk/doc o -blocked-g ow h-ho
mone-in-1970s-p essu e-g ows- o-compensa e-pa ien s-a - isk-o -incu able-b ain-disease- im-kelsey- epo s-1462154.h ml.
On he social cons uc ion o GH as dange ous in ano he con ex see Be na Lopez, ‘C ea ing ea : The social cons uc ion o
‘A leas ou pi ui a ies will see he wo ld’7
h ps://doi.o g/10.1017/mdh.2025.10029 Published online by Camb idge Uni e si y P ess
ia ogenic na u e o he CJD made i look like ‘ iendly i e’, which unde mined public us in
biomedicine.
46
Unde he p essu e o he con olling agencies, he pha maceu ical companies had o
wi hd aw hei cada e -based p oduc s om he ma ke . Howe e , wi h housands o child en’s
ea men in e up ed, he FDA and he con olling bodies in o he coun ies we e hemsel es unde
p essu e o p o ide an al e na i e. As a esul , he syn he ic ( ecombinan ) GH ( GH) was speedily
app o ed, and he expec ed bias agains i s ‘a i iciali y’did no ma e ialise. By he la e 1980s, he
ea men wi h cada e ic GH was discon inued, i s in he USA and he UK in 1985, hen in he es o
he wo ld as well. I s eplacemen , he GH, is conside ed o ha e ‘an en iable ack eco d o sa e y’.
47
S ill, lessons lea ned om he CJD c isis led o acu e awa eness o po en ial ad e se e ec s. The e o e,
many coun ies es ablished egis ies o pa ien s ea ed wi h GH o moni o po en ial side e ec s.
48
These de elopmen s explain he p oblems RIEGG was acing in mee ing i s expo plans in he second
hal o he 1980s. E en a e he planned e enue om he expo o pi ui a ies was dec eased, he ailu e
o mee i was spec acula , due o he apidly sh inking demand. This mean less o eign cu ency, less
labo a o y consumables and eagen s and consequen ly, ailu e o pe o m planned esea ch asks. The
plan was gea ed o he majo poli ical e en in communis Bulga ia, he 13
h
cong ess o he Bulga ian
communis pa y, and did no e en ake no ice o , le alone analyse, he ac ual si ua ion o he he apy
based on pi ui a y GH. In 1991, in he wake o he public scandal, he RIEGG Di ec o in o med his
supe io s ha legal ad ice had been sough and a change o he law was needed in o de o con inue he
expo o pi ui a ies. Howe e , he e was no mo e demand o hem.
Legal and e hical dilemmas o cada e ic dona ion
The hypophyses case can be iewed om di e en pe spec i es. The b oade s o y is one o a
bio echnological b eak h ough: a be e and sa e p oduc was in en ed, allowing many mo e pa ien s
o ecei e e ec i e ea men .
49
As o 1993, Bulga ia s a ed o impo GH, and Bulga ian child en
su e ing om hypopi ui a y dwa ism ecei ed ea men wi h good esul s. In he subsequen yea s,
pa ien s wi h o he condi ions ela ed o GH de iciency became eligible o such ea men .
50
The
a ailabili y o app op ia e d ugs played back on o he de ini ion o he no m and pa hology in ela ion o
he le els o ho mone sec e ion and hence he c i e ia o eligibili y o ea men .
51
The cu -o GH le el
sepa a ing no mali y om GH de iciency ell om 10 o 7μg/L.
52
The ques ion was now whe e o d aw
he line be ween he no m and pa hology, he apy and cosme ic enhancemen . The kind o knowledge
needed o implemen such di e en ia ions wen beyond labo a o ies in o he legal and mo al sphe e.
human G ow h Ho mone as a dange ous doping d ug’,In e na ional Re iew o he Sociology o Spo , 48, 2 (2012), 220–37,
h ps://doi.o g/10.1177/1012690211432209.
46
Paul B own, Michael A. P eece, Robe G. Will, ‘”F iendly i e”in medicine: ho mones, homog a s, and C eu z eld -Jakob
disease’,The Lance , 340 (1992), 24–7.
47
Ron G. Rosen eld, Pinchas Cohen, Leslie L. Robison, Ba y B. Be cu, Pe e Clay on, And ew R. Ho man, Sally Rado ick,
Paul Saegne , Ma in O. Sa age and Jan M. Wi , ‘Long- e m su eillance o g ow h ho mone he apy’,Jou nal o Clinical
Endoc inology & Me abolism, 97, 1 (2012), 68–72, 68.
48
Fo de ails, see ibid. and Ande s Tidblad, ‘The his o y, physiology and ea men sa e y o g ow h ho mone’,Ac a
Paedia ica, (2021), 215–24, h ps://doi.o g/10.1111/apa.15948.
49
Fo an o e iew o he de elopmen o he GH he apy o e he pas 100 yea s, see Michael B. Ranke and Jan M. Wi ,
‘G ow h ho mone –pas , p esen and u u e’,Na u e Re iews/ Endoc inology, 14 (2018), 285–300, h ps://doi.o g/10.1038/
n endo.2018.22.
50
E. S e ano a, ‘Lechenie s as ezhen ho mon de ska yz as ’,P ak icheska pedia ia, 16, 11 (2014), 4–6. The lis o
app o ed indica ions o GH he apy g ew subs an ially om he 1990s onwa ds. See Vageesh S. Ayya , ‘His o y o g ow h
ho mone he apy”,Indian Jou nal o Endoc inology and Me abolism, 15, Supplemen 3 (2011), 162–5, 163–4; G abe e al.,
op. ci . (no e 40), 6–12.
51
McKel ey, op. ci . (no e 39), 232.
52
Ma in O. Sa age, ‘The changing ace o paedia ic human g ow h ho mone he apy’,Endoc ines, 3 (2022), 419–27,
420, h ps://doi.o g/10.3390/endoc ines3030033.
8 Daniela Kole a
h ps://doi.o g/10.1017/mdh.2025.10029 Published online by Camb idge Uni e si y P ess
The hypophyses case, howe e , poses ano he ype o e hical issue. I can be iewed in he con ex o
decades-long legal and e hical discussions on he u ili a ian ea men o he dono s. In he si ua ion o
sho and unp edic able supply o o gans and issues o ansplan a ion, some legal schola s ha e a gued
o ‘o gan consc ip ion’, i.e. a uni e sal and manda o y pos -mo em d a o o gans and issues, seeing
he law as a media o be ween he medical needs o he li ing and deep- oo ed sen imen s owa ds he
dead, and insis ing on i s ole o ‘implemen common will and wisdom whe e olun a y incen i e is
lacking’.
53
Such a posi ion iews he human body as a kind o na u al esou ce ‘on ex ended loan om he
biomass’ o which i e u ns a e dea h.
54
I s p oponen s a gue o he ‘au oma ic’a ailabili y o cada e
o gans,
55
p io i ising (no wi hou good eason) he needs o he li ing o e he in e es s o he dead. O he s,
howe e , ha e emphasised he in eg i y o he human body. They ha e poin ed o he speci ic on ological
s a us o he co pse, asking i he human body u ns in o an objec a e dea h, and, i so, who has owne ship
igh s on ha objec .
56
S ill o he s ha e a gued ha a co pse ‘can be said o ha e limi ed human igh s,
“passi e” igh s, o be su e, bu igh s none heless’since, be o e he bu ial i ual, which deli e s i o he wo ld
o he dead, ‘ he co pse emains o some deg ee a membe o he li ing human communi y’.
57
I s ‘ igh s o
bodily in eg i y, digni y, and espec ’a e ‘a einsc ip ion o obliga ions and expec a ions ha cons i u e social
li e’.
58
The e o e, he dead body does ha e speci ic igh s and ‘an e hical s a us abo e ha o p ope y’.
59
In
any case, as many o hese schola s ag ee, ‘economic conside a ions canno o e ule e hical ones’.
60
Coming back o he hypophyses case in Hunga y and Bulga ia, a conclusion ha he o ali a ian
communis s a es disposed o he bodies o hei ci izens as i hey we e ye ano he s a e p ope y would
be a has y and pe haps a supe icial one. Indeed, he p ac ice o o gan and issue ha es ing o pu chase
by pha maceu ical companies, based on he assump ion o aci consen , was no limi ed o communis
and so-called ‘Thi d Wo ld’coun ies. A e he scandals in Hunga y and Bulga ia, ano he one bu s ou
in I eland in 1998, when i became known ha in he 1970s, pha maceu ical companies had paid
pa hologis s o ex ac pi ui a y glands and o he o gans om cada e s, especially hose o child en,
wi hou in o ming hei pa en s. The p ice hey we e paid o a pi ui a y gland in 1978 was £1.50, and
in 1985 i g ew o £3.50. The amilies o he deceased child en es ablished he ‘Pa en s o Jus ice’g oup
o in es iga e he issue, which hey de ined as ‘ he wo s kind o he ’. Al hough a he ime he e had
been no explici egula ion equi ing in o med consen , he p ac ice was c i icised on e hical g ounds as a
iola ion o he public’s us in biomedicine and condemned as ‘da k age medicine’.
61
The deba e on public us in medicine and i s ins i u ions and p ocedu es was also simme ing in he
USA, al hough he e, he supply o pi ui a ies was conside ed o ha e been be e egula ed. No so long
ago, he o me di ec o o he Na ional Pi ui a y Agency (NPA) admi ed ha he ex ac ion and
collec ion o pi ui a ies had been ‘a ale o in igue and sec ecy’.
62
The ex ac o s we e paid $2 o he
collec ion, s o age and shipmen o a pi ui a y gland o he NPA. Howe e , he compe i ion o
pi ui a ies was so s ong ha a black ma ke de eloped. As i u ned ou , NPA was no always success ul
in i s egula ing and s anda dising ole, which led o ‘ques ionable occu ences in conjunc ion wi h he
NPA’s collec ion’.
63
53
Theodo e Sil e , ‘The case o a pos -mo em o gan d a and a p oposed model O gan D a Ac ’,Bos on Uni e si y Law
Re iew, 68, 4 (1988), 681–728, 697.
54
H.E. Emson, ‘I is immo al o equi e consen o cada e o gan dona ion’,Jou nal o Medical E hics, 29 (2003), 125–7, 126.
55
John Ha is, ‘O gan p ocu emen : dead in e es s, li ing needs’,Jou nal o Medical E hics, 29 (2003), 130–4, 130.
56
S oyan S a u, Vesh nop a no deis ie na sma a. [Implica ions o dea h o p ope y law] (So ia: Cibi, 2008).
57
John Su on Baglow, ‘The igh s o he co pse’,Mo ali y: P omo ing he in e disciplina y s udy o dea h and dying, 12, 3
(2007), 223–39, 224.
58
Ibid., 235.
59
Thomas H. Champney, ‘The business o bodies: E hical pe spec i es on o -p o i body dona ion companies’,Clinical
Ana omy, 29 (2015), 25–9, 28.
60
Sando , op. ci . (no e 3), 399.
61
Sabine Louë , ‘Da k Age medicine’,Na u e (12 Oc . 2004), h ps://doi.o g/10.1038/news041011-4.
62
Blizza d, op. ci . (no e 37), 88.
63
Ibid., 89.
‘A leas ou pi ui a ies will see he wo ld’9
h ps://doi.o g/10.1017/mdh.2025.10029 Published online by Camb idge Uni e si y P ess
