Irish Examiner

New Bess­bor­ough rev­e­la­tions show wider range of prod­ucts tested on chil­dren

Pre­vi­ously un­seen de­tails of a med­i­cal trial by Glaxo in 1974 at a Cork mother and baby home have gen­er­ated a whole new se­ries of ques­tions for the nuns and the com­pa­nies in­volved, writes Con­all Ó Fátharta

- Family · Medical Activism · Crime · Medicine · Parenting · Ireland · GlaxoSmithKline · Edgar Rice Burroughs · Cork · feces · United Kingdom · Kenya · Argentina · Malaysia · U.S. Supreme Court · Brian Lenihan · United Kingdom Department of Health · Saint Patrick · Dublin · Cork · County Meath · Saint Anne · Micheál Martin · University College Dublin · Department of Health and Social Care · Navan · County Westmeath · Dunboyne · Kilcullen · School of History

For al­most two decades, the pub­lic has been drip-fed rev­e­la­tions about med­i­cal test­ing by Bri­tish phar­ma­ceu­ti­cal com­pa­nies on chil­dren in care in Ire­land.

These tests in­volved the tri­alling of var­i­ous vac­cine com­bi­na­tions by pre­de­ces­sor com­pa­nies of phar­ma­ceu­ti­cal gi­ant Glax­oSmithK­line (GSK) — Glaxo Lab­o­ra­to­ries and Bur­roughs Well­come. These rev­e­la­tions gen­er­ated more ques­tions than an­swers — an­swers it is hoped the Mother and Baby Homes Com­mis­sion can pro­vide.

How­ever, it has now emerged that Glaxo Lab­o­ra­to­ries was also tri­alling other prod­ucts on chil­dren here — namely lac­tose and baby for­mu­las. This oc­curred in 1974 in the Bess­bor­ough Mother and Baby Home in Cork and had never been made pub­lic. Once again, the reve­la­tion has gen­er­ated lots of ques­tions but few an­swers.

A trial sheet ob­tained by the Irish Ex­am­iner re­veals that Glaxo Lab­o­ra­to­ries car­ried out a “clin­i­cal ac­cept­abil­ity and safety trial” of “Golden Oster­milk and Lac­tose”, while a sep­a­rate trial sheet re­veals a trial of “over­seas milk pow­ders (by 0111)”.

The “clin­i­cian re­spon­si­ble” for the tests was Eithne Con­lon — a lo­cal Cork GP who worked with the in­sti­tu­tion for many years.

The trial sheets recorded a range of re­ac­tions to the prod­ucts. These in­cluded vom­it­ing (slight, mod­er­ate, se­vere, or none), ex­ces­sive re­gur­gi­ta­tion, wind (slight, mod­er­ate, se­vere, or none), stools (lo­cae, nor­mal, or con­sti­pated) and stool colour (yel­low, grass green, olive green, yel­low green, no stools, meco­nium, chang­ing) .

Other “ab­nor­mal con­di­tions” were also noted. These in­cluded ex­ces­sive cry­ing, ir­ri­tabil­ity, nap­kin rash, thrush, and oth­ers.

The lat­ter trial sheet was con­tained in the records of Breda Bonass, who had sought in­for­ma­tion on her med­i­cal his­tory from Tusla un­der Free­dom of In­for­ma­tion. The for­mer only came to light when Ms Bonass sought fur­ther in­for­ma­tion from Tusla.

How­ever, this only con­fused mat­ters fur­ther as the trial sheet for “Golden Oster­milk and Lac­tose” was found in the an­te­na­tal records of other women — and all con­tain iden­ti­cal de­tails in­clud­ing pa­tient num­bers — some­thing which the FOI of­fi­cer told Ms Bonass was “per­plex­ing”.

“In the ma­jor­ity of cases where this record was present the record was glued to an­other copy of the same record [front to front] and de­tails about the re­spec­tive baby’s feed­ing sched­ules, types of for­mula given, re­ac­tions to feeds, etc, were hand writ­ten on this pa­per,” said the FOI of­fi­cer.

“When I pried the two sheets apart I no­ticed that these trial sheets all con­tained the ex­act same pa­tient and trial num­bers and iden­ti­fy­ing de­tails as the trial sheet lo­cated in your file.”

Ms Bonass went to the re­li­gious or­der which ran Bess­bor­ough — the Sis­ters of the Sa­cred Hearts of Je­sus and Mary — and GSK look­ing an­swers.

The nuns re­sponded via their so­lic­i­tors, telling her they no longer held the records nor had any ac­cess to them and that she should go to Tusla.

GSK’s UK data pro­tec­tion sec­tion in­formed her that the data had been “de­stroyed” as the “re­ten­tion pe­riod has al­ready ex­pired some years ago”.

The Irish Ex­am­iner con­tacted GSK in an ef­fort to get an­swers as to why this trial was car­ried out in Ire­land, how many chil­dren it in­volved and if con­sent was sought.

It re­sponded by say­ing it was “un­able to lo­cate any records re­lat­ing to a 1974 study” but that it had lo­cated records re­lat­ing to a trial from 1967.

“The as­sump­tion there­fore would be that the 1974 study’s pur­pose was to com­pare cur­rent milk pow­der with a newer for­mu­la­tion. The records con­tain no names or in­for­ma­tion about the chil­dren in­volved,” said GSK in a state­ment.

It had no doc­u­men­ta­tion to ex­plain why Ire­land was cho­sen as a lo­ca­tion, but that the 1967 trial was also car­ried out in the UK, Kenya, Ar­gentina, Malaysia, “and prob­a­bly more”.

With re­gard to the con­sent of moth­ers, GSK said that, due to the fact that it had no records, it could not con­firm who gave con­sent but that its as­sump­tion was that it would have been “those Sis­ters run­ning the homes as the le­gal guardians”. Ob­tain­ing con­sent would been left to the doc­tor con­duct­ing the trial.

The com­pany said that, to the best of its knowl­edge, no fi­nan­cial re­mu­ner­a­tion would have been pro­vided to the Or­der for al­low­ing chil­dren in its care to be used for the trial.

GSK said the iden­ti­cal sheets were prob­a­bly blank forms or tem­plates and that the in­for­ma­tion en­tered “ap­pear to be codes, pos­si­bly re­lat­ing to a spread­sheet col­lat­ing all re­sponses”.

It also con­firmed that this was the first time it was made aware of this study and that it had not been asked to dis­close it in any of­fi­cial ca­pac­ity, “as this is clearly out­side of the cur­rent Com­mis­sion’s [Into Mother and Baby Homes] vac­cines in­quiry”.

That, of course, is tech­ni­cally cor­rect. The Com­mis­sion is only tasked with ex­am­in­ing vac­cine tri­als car­ried out by GSK legacy com­pa­nies. This lat­est reve­la­tion con­firms that it wasn’t just vac­cines that were be­ing tested on chil­dren in care here.

The in­volve­ment of Bur­roughs Well­come and Glaxo Lab­o­ra­to­ries in tri­als on chil­dren in Mother and Baby Homes and other in­sti­tu­tions is worth re­peat­ing. It’s been a long tale which saw a pre­vi­ous State in­quiry —the Com­mis­sion to In­quire into Child Abuse (CICA) in 2000 — try and fail to fully in­ves­ti­gate the mat­ter.

Be­fore that in­quiry was halted fol­low­ing a Supreme Court rul­ing in 2002, GSK had con­firmed just three vac­cine tri­als in the 1960s and 1970s in­volv­ing more than 250 chil­dren.

In 2011, in a re­sponse to an RTÉ in­ves­ti­ga­tion, it ac­knowl­edged a fourth trial but stated that this was the only other clin­i­cal trial spon­sored by Well­come us­ing chil­dren in in­sti­tu­tions in Ire­land.

How­ever, in 2014, doc­u­ments un­cov­ered by Michael Dwyer of UCC’s School of His­tory re­vealed a fifth trial of a measles vac­cine on 34 chil­dren took place in 1965. It was car­ried out by Irene Hil­lary and Pa­trick Meenan of UCD’s mi­cro­bi­ol­ogy depart­ment and AJ Beale of Glaxo Lab­o­ra­to­ries. The UCD aca­demics (both now de­ceased) were also in­volved in the first two vac­cine tri­als also.

Ear­lier that year, Dr Dwyer also dis­cov­ered ev­i­dence that Well­come had car­ried out vac­cine tri­als on more than 2,000 Irish chil­dren in 24 res­i­den­tial in­sti­tu­tions be­tween 1930 and 1935.

De­spite this, the In­ter-De­part­men­tal Group on Mother and Baby Homes pub­lished in 2014 only re­ferred to three vac­cine tri­als. It also failed to men­tion a 1965 trial of a 5-in-1 vac­cine car­ried out on Philip De­laney at Bess­bor­ough Mother and Baby Home in Cork.

Ques­tions around the in­volve­ment of Bri­tish phar­ma­ceu­ti­cal com­pa­nies in vac­cine tri­als in Ire­land have been pop­ping up in the me­dia for al­most three decades now.

They first hit the head­lines in the 1990s, but it wasn’t un­til 1997 that then health min­is­ter Brian Leni­han gave an un­der­tak­ing that the mat­ter would be ex­am­ined.

This re­sulted in the Kiely Re­port in 2000, by Jim Kiely, chief med­i­cal of­fi­cer of the Depart­ment of Health, which con­firmed three tri­als had been con­ducted on be­half of the phar­ma­ceu­ti­cal com­pany the Well­come Foun­da­tion. The i nsti­tu­tions in­volved were Well­come Lab­o­ra­to­ries in Bri­tain, the Depart­ment of Med­i­cal Mi­cro­bi­ol­ogy in UCD, and the Eastern Health Board.

The first trial took place be­tween De­cem­ber 1960 and Novem­ber 1961 in four Mother and Baby Homes — St Pa­trick’s on the

Na­van Road in Dublin (14 chil­dren), Bess­bor­ough in Cork (25 chil­dren), Castle­pol­lard in West­meath (six chil­dren), and Dun­boyne (nine chil­dren). Four chil­dren from Sta­mullen baby home in Meath were also used for this trial.

The pur­pose of the trial was to look at the re­sponse the chil­dren would have to a 4-in-1 vac­cine — diph­the­ria, whoop­ing cough, tetanus, and po­lio.

The sec­ond trial in­volved 69 chil­dren from St Anne’s In­dus­trial School in Boot­er­stown in Dublin be­ing ad­min­is­tered an in­tranasal rubella vac­cine. A fur­ther 53 chil­dren from the wider com­mu­nity in Kil­cullen in West­meath were also used in this trial.

The first two tri­als were car­ried out by Prof Hil­lary and Prof Meenan from the depart­ment of Mi­cro­bi­ol­ogy in UCD, as well as other doc­tors. The third trial in­volved 53 chil­dren in a num­ber of res­i­den­tial in­sti­tu­tions in Dublin in­clud­ing St Pa­trick’s Home, Madonna House, Bird’s Nest, and Bo­heenaburna. A to­tal of 65 chil­dren liv­ing at home in Dublin also re­ceived the vac­cine.

The aim of the third trial was to com­pare com­mer­cially avail­able batches of the 3-in-1 vac­cine — Tri­vax and Tri­vax D — with that of equiv­a­lent vac­cines pre­pared for the trial. There is no pub­lished pa­per or re­port of this trial, but the Eastern Health Board was aware it was be­ing con­ducted.

Dr Kiely’s re­port in 2000 con­cluded that, given the con­di­tions which the vac­cines sought to counter, the de­ci­sion to con­duct the tri­als was “ac­cept­able and rea­son­able”. How­ever, Dr Kiely said there was a lack of doc­u­men­ta­tion avail­able to clar­ify whether con­sent was ei­ther ob­tained or sought from the par­ents of the chil­dren or the man­agers of the in­sti­tu­tions.

How­ever, an en­try in the 1962 Bri­tish Med­i­cal Jour­nal con­cern­ing the first trial seems to con­firm that parental con­sent was not sought.

“We are in­debted to the med­i­cal of­fi­cers in charge of the chil­dren’s homes for per­mis­sion to carry out this in­ves­ti­ga­tion on in­fants un­der their care,” it wrote.

Re­spond­ing to the Kiely Re­port in 2000, Prof Hil­lary said it was her “in­vari­able prac­tice at the time to ob­tain con­sent of the com­pe­tent au­thor­ity”, be it the mother, the man­ager, or the med­i­cal of­fi­cer.

How­ever, no record of writ­ten con­sent has been ac­knowl­edged. The re­li­gious or­ders who ran the homes in­volved in the tri­als have also de­nied that they au­tho­rised any clin­i­cal tri­als.

Of the vic­tims of the vac­cine tri­als who have lo­cated their nat­u­ral moth­ers, all moth­ers have said they were not asked for their per­mis­sion.

In 2000, then min­is­ter for chil­dren Micheál Martin ad­mit­ted the Kiely re­port was “in­com­plete” and raised “as many ques­tions as it an­swered”.

How­ever, de­spite this, Mr Martin re­as­sured the Dáil that the tri­als ap­peared to have had no med­i­cally neg­a­tive con­se­quences for any of the chil­dren in­volved.

In an ef­fort to deal with the mat­ter, the Gov­ern­ment de­cided to ex­tend the terms of ref­er­ence of CICA.

This was done de­spite ob­jec­tions that the tri­als could not ad­e­quately be dealt with by an in­quiry look­ing pri­mar­ily into phys­i­cal and sex­ual abuse.

The ‘Vac­cines Mod­ule’ of CICA be­gan in­ves­ti­gat­ing in early 2002.

It ob­tained doc­u­men­ta­tion from GSK — the suc­ces­sor of Well­come — and iden­ti­fied the names and ad­dresses of some of those in­volved in the tri­als.

It also sought records from a range of re­li­gious or­ders who were car­ing for the chil­dren used in the tri­als.

In Novem­ber of last year, the Irish Ex­am­iner re­vealed that the files of vac­cine trial vic­tims from Bess­bor­ough in­volved in the 1960/61 4-in-1 vac­cine were altered just weeks af­ter the CICA sought dis­cov­ery of records from the Sis­ters of the Sa­cred Hearts of Je­sus and Mary. The doc­u­ment list­ing the changes opens with: “8.8.02 Checked the 20 files.” This is im­me­di­ately fol­lowed by: “9.8.02 Made the changes.”

The changes made to files Nos 5, 8, 11, 12, and 15-20 are then de­tailed.

The changes in­clude:

The al­ter­ation of dis­charge dates of moth­ers (by a pe­riod of one year and two years):

The chang­ing of dis­charge dates of chil­dren;

The chang­ing of ad­mis­sion dates of moth­ers;

The al­ter­ation of the age of a mother (by two years);

The al­ter­ation of dates of adop­tion; The chang­ing of bap­tism dates and lo­ca­tion of bap­tism;

The in­ser­tion of cer­tain named lo­ca­tions and in­for­ma­tion into ad­mis­sion books.

In a se­ries of state­ments, the or­der said it wished to “cat­e­gor­i­cally state that no doc­u­ments were altered”.

“In your re­cent cor­re­spon­dence, you are sug­gest­ing that some­thing il­le­gal or in­ap­pro­pri­ate had oc­curred in re­gard to the doc­u­ments to which you re­fer. This is en­tirely un­true; and we will con­tinue to deal di­rectly with the of­fi­cial com­mis­sion on all such mat­ters,” said a state­ment.

This doc­u­ment list­ing the changes was dis­cov­ered in the Bess­bor­ough ar­chive handed over to the HSE by the nuns in 2011. It wasn’t dis­cov­ered un­til 2016 — some 13 years af­ter CICA’s in­ves­ti­ga­tion into the vac­cine tri­als was sus­pended.

This oc­curred af­ter the probe was hit with a Supreme Court rul­ing which up­held Prof Meenan’s chal­lenge against a High Court or­der di­rect­ing him to give ev­i­dence be­fore the in­quiry.

The court also crit­i­cised the de­ci­sion to ask the com­mis­sion to ex­am­ine the vac­cine tri­als in the first place, stat­ing they had “only the most ten­u­ous con­nec­tion, if any, with the ap­palling so­cial evil of the sex­ual and phys­i­cal abuse of chil­dren in in­sti­tu­tions, which was the specific area into which the com­mis­sion was es­tab­lished to in­quire”.

Mr Jus­tice Hardi­man stated that Prof Meenan’s in­volve­ment in vac­cine tri­als re­lated only to one trial in 1960/61 and that the is­sue of the “rep­u­ta­tional dam­age” as­so­ci­ated with be­ing in­volved with a com­mis­sion pri­mar­ily look­ing at sex­ual abuse had to be con­sid­ered.

Fol­low­ing this, Prof Hil­lary chal­lenged the Gov­ern­ment’s or­der di­rect­ing an in­ves­ti­ga­tion into the vac­cine tri­als and when the the Gov­ern­ment de­clined to ap­peal this de­ci­sion, the work of the Vac­cines Mod­ule ceased in Novem­ber 2003.

How­ever, at the time, many peo­ple be­lieved there were far more than three tri­als car­ried out by Well­come here.

The Third In­terim Re­port from CICA in De­cem­ber 2003 con­firmed as much when it stated that the doc­u­men­ta­tion it re­ceived from GSK “dis­closed a con­sid­er­able amount of in­for­ma­tion in re­la­tion to other vac­cine tri­als con­ducted in the State”.

When RTÉ’s Prime Time asked the phar­ma­ceu­ti­cal gi­ant about this state­ment in 2011, it con­firmed a fourth trial had taken place in 1965. This trial in­volved giv­ing dif­fer­ing doses of the measles vac­cine to 12 ba­bies aged be­tween nine and 19 months in the Sean Ross Abbey mother-and-baby home in Tip­per­ary.

GSK stated that this fourth trial was the only other clin­i­cal trial spon­sored by Bur­roughs Well­come us­ing chil­dren in in­sti­tu­tions in Ire­land.

Then, in 2014, the Irish Ex­am­iner re­vealed a fifth trial also oc­curred dur­ing this pe­riod.

An ar­ti­cle in The Lancet med­i­cal jour­nal in Au­gust 1965, dis­cov­ered by Dr Dwyer con­firms that Glaxo Lab­o­ra­to­ries Ltd car­ried out an­other measles vac­cine trial on 34 chil­dren aged be­tween eight months and just over two years.

The trial was car­ried out by Prof Hil­lary and Prof Meenan and AJ Beale of Glaxo Lab­o­ra­to­ries. It is also the first trial which con­firms Glaxo Lab­o­ra­to­ries in­volve­ment in a vac­cine trial.

The re­port does not men­tion an in­sti­tu­tion. How­ever, it makes ref­er­ence to the fact that the re­ac­tion to the vac­cine were monitored by “the adults look­ing af­ter the chil­dren”.

It also says ex­am­i­na­tions were done on the chil­dren from day six to 14 at the same time — 6pm — in­di­cat­ing the chil­dren were in a group set­ting.

How­ever, in re­sponse, GSK dis­agreed that these ref­er­ences amounted to ev­i­dence that the trial was car­ried out on chil­dren in care.

The phar­ma­ceu­ti­cal gi­ant pointed out that, in other pa­pers by the same in­ves­ti­ga­tor, it was stated ex­plic­itly that the study was car­ried out on chil­dren in care. GSK said if it had any ev­i­dence that this trial was car­ried out on chil­dren in care, it would have handed it over to the CICA at the time.

So, three years on, we now know that it wasn’t just vac­cines that were be­ing tested on chil­dren in Ire­land’s Mother and Baby Homes.

Now, we know that clin­i­cal ac­cept­abil­ity and safety tri­als of lac­tose, Golden Oster­milk and “over­seas baby pow­ders” were be­ing tri­alled in at least one Mother and Baby Home.

Can and will the com­mis­sion ex­am­ine this lat­est de­vel­op­ment? Why was a Bri­tish com­pany test­ing such prod­ucts in Ire­land?

Were re­li­gious or­ders ben­e­fit­ing fi­nan­cially by al­low­ing chil­dren in their care to be in­volved in such tri­als? Was the con­sent of moth­ers ob­tained, or was it even sought?

The Mother and Baby Homes com­mis­sion did not re­spond to a re­quest for com­ment.

 ?? Pic­ture: Jim Cough­lan ?? The Lit­tle Angels Plot in Bess­bor­ough, Black­rock, Cork, one of the fa­cil­i­ties where phar­ma­ceu­ti­cal com­pa­nies tested var­i­ous vac­cines and other prod­ucts on the ba­bies res­i­dent there.
Pic­ture: Jim Cough­lan The Lit­tle Angels Plot in Bess­bor­ough, Black­rock, Cork, one of the fa­cil­i­ties where phar­ma­ceu­ti­cal com­pa­nies tested var­i­ous vac­cines and other prod­ucts on the ba­bies res­i­dent there.
 ?? Pic­ture: Larry Cum­mins ?? A plaque on wall of a grave­yard in Bess­bor­ough which bears the fol­low­ing in­scrip­tion: ‘In re­mem­brance of all ba­bies who died be­fore or shortly af­ter birth. I gath­ered you in all your fresh­ness be­fore a sin­gle breeze had dam­aged your pu­rity.’
Pic­ture: Larry Cum­mins A plaque on wall of a grave­yard in Bess­bor­ough which bears the fol­low­ing in­scrip­tion: ‘In re­mem­brance of all ba­bies who died be­fore or shortly af­ter birth. I gath­ered you in all your fresh­ness be­fore a sin­gle breeze had dam­aged your pu­rity.’
 ??  ?? The Bess­bor­ough premises in Black­rock in Cork is still owned by the Sis­ters of the Sa­cred Hearts of Je­sus and Mary.
The Bess­bor­ough premises in Black­rock in Cork is still owned by the Sis­ters of the Sa­cred Hearts of Je­sus and Mary.
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