Watch­dog takes new look at test al­legedly tied to birth de­fects

Cam­paign­ers find files on preg­nancy test from 1970s Bayer de­nies Pri­mo­dos caused ab­nor­mal­i­ties

The Guardian - - NATIONAL - Robert Booth

The UK drugs reg­u­la­tor is to ex­am­ine new ev­i­dence about a preg­nancy test used in the 1960s and 1970s which hun­dreds of par­ents be­lieve caused se­ri­ous de­for­mi­ties in their chil­dren, of­ten lead­ing to death.

A 7,000-page cache of files dis­cov­ered by a vic­tims’ cam­paign group in­cludes pa­pers sug­gest­ing the Bri­tish gov­ern­ment knew in 1975 that the hor­monal drug Pri­mo­dos in­creased the risk of a child be­ing born with mal­for­ma­tions. The drug was with­drawn in 1978.

Fam­i­lies have be­lieved for decades the drug might have been re­spon­si­ble for se­ri­ous birth de­fects, in­clud­ing miss­ing limbs, brain dam­age, heart de­fects and spina bi­fida, some­thing that has been de­nied by Bayer, the Ger­man phar­ma­ceu­ti­cal com­pany that owns the man­u­fac­turer, Scher­ing.

The drug con­sisted of two hor­mone-based tablets that de­tected preg­nancy by in­duc­ing men­stru­a­tion in women who were not preg­nant.

Thirty-one files about the drug were found in a state archive in Ber­lin by Marie Lyon, chair of the As­so­ci­a­tion for Chil­dren Dam­aged by Hor­mone Preg­nancy Tests, whose daugh­ter Sarah was born with­out a lower arm in 1970 af­ter Lyon had taken Pri­mo­dos.

Ac­cord­ing to Sky News, which has in­ves­ti­gated the files, one showed that in Jan­uary 1975 Dr Wil­liam In­man, then prin­ci­pal med­i­cal of­fi­cer for the UK gov­ern­ment, re­ported that women who took a hor­mone preg­nancy test “had a five-to-one risk of giv­ing birth to a child with mal­for­ma­tions”.

In­man spoke to Scher­ing but said he had con­tacted the man­u­fac­turer so that it could “take mea­sures to avoid medi­cole­gal prob­lems”.

Later files re­port­edly claimed In­man de­stroyed the pa­pers on which his as­sess­ment was based and that “he has done that to pre­vent in­di­vid­ual claims be­ing based on his ma­te­rial”. In­man died in 2005.

Sky also re­ported that doc­u­ments in the Ber­lin archives de­tail­ing com­mu­ni­ca­tions be­tween the drug firm and its lawyers state that “no tox­i­col­ogy had been car­ried out be­fore in­tro­duc­tion ei­ther in Ger­many or the UK”. A spokesper­son for Bayer said: “Bayer de­nies that Pri­mo­dos was re­spon­si­ble for caus­ing any de­for­mi­ties in chil­dren. UK lit­i­ga­tion in re­spect of Pri­mo­dos, against Scher­ing, ended in 1982 when the claimants’ le­gal team, with the ap­proval of the court, de­cided to dis­con­tinue the lit­i­ga­tion on the grounds that there was no re­al­is­tic pos­si­bil­ity of show­ing that Pri­mo­dos caused the con­gen­i­tal ab­nor­mal­i­ties al­leged.

“Since the dis­con­tin­u­a­tion of le­gal ac­tion in the UK in 1982, no new sci­en­tific knowl­edge has been pro­duced which would call into ques­tion the va­lid­ity of the pre­vi­ous as­sess­ment of there be­ing no link be­tween use of Pri­mo­dos and the oc­cur­rence of con­gen­i­tal ab­nor­mal­i­ties.”

But Lyon be­lieves the files amount to “in­dis­putable in­for­ma­tion that shows the man­u­fac­tur­ers and the health au­thor­i­ties were aware these drugs were caus­ing dam­age in ba­bies, mis­car­riages and still­births”. In a state­ment yes­ter­day, the ju­nior health min­is­ter James O’Shaughnessy said: “I wel­come this in­ves­ti­ga­tion – it’s vi­tal that we take con­cerns such as these se­ri­ously.

“That’s why we’ve asked the Medicines and Health­care Prod­ucts Reg­u­la­tory Agency to con­duct a thor­ough sci­en­tific re­view of the ev­i­dence on the is­sue.”

A 2014 re­view by the agency of 36 stud­ies on the ef­fects of Pri­mo­dos con­cluded: “The body of ev­i­dence for an as­so­ci­a­tion be­tween hor­mone preg­nancy tests and con­gen­i­tal anom­alies is mixed, with some stud­ies find­ing a strong as­so­ci­a­tion, some find­ing a weak as­so­ci­a­tion and many oth­ers find­ing no as­so­ci­a­tion.”

Pri­mo­dos was dis­con­tin­ued by the man­u­fac­turer in 1978. For the vic­tims’ fam­i­lies, the Ber­lin files have of­fered hope that a le­gal chal­lenge against the man­u­fac­turer and pos­si­bly the gov­ern­ment could start again.

A 1982 civil claim on be­half of sev­eral fam­i­lies of chil­dren born with heart de­fects had to be aban­doned.

Lyon said the As­so­ci­a­tion for Chil­dren Dam­aged by Hor­mone Preg­nancy Tests is now ex­plor­ing with lawyers the pos­si­bil­ity of a new civil ac­tion against the man­u­fac­turer and pos­si­bly the gov­ern­ment.

The ju­nior health min­is­ter James O’Shaughnessy said the gov­ern­ment had asked the UK’s drugs reg­u­la­tor to ex­am­ine the un­earthed files

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