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Bayer Shareholder Meeting

STATEMENT VALERIE WILLIAMS

GOOD MORNING. I AM THE FORMER CHAIRPERSON OF A BRITISH ORGANIZATION FORCHILDREN DAMAGED BY THE HORMONE PREGNANCY TESTING DRUG ‘PRIMODOS’. WHICH THE INJURIES TO THESE CHILDREN CONSISTED OF, HEART DEFECTS, SPINA BIFIDA, HYDROCEPHALUS, KIDNEY DAMAGE,GENETAL ABNORMALITIES, LIMB DEFORMITIES, HAIR LIP AND CLEFT PALATE, TO NAME BUT A FEW.

I AM ALSO A MOTHER OF A SON WHO SUFFERED MULTIPLE ABNORMALITIES TO HIS HEART AND GENTALIA, DUE TO THE FACT THAT I WAS PRESCRIBED BY ‘PRIMODOS’ BY MY DOCTOR IN SEPTEMBER 1974. EVEN THOUGH THERE WAS A SIMPLE SAFER URINE TEST, TO DETERMINE MY PREGNANCY AT THAT TIME.

‘I WOULD LIKE TO ASK YOU AT BAYER’S, WHO TOOK OVER SCHERING CHEMICALS TWO YEARS AGO, WHY DID SCHERING WITHDRAW THEIR OFFER OF A SETTLEMENT ON BEHALF OF MY SON, DANIEL WILLIAMS, IN THE JANUARY OF 1978. THIS WAS FOUR WEEKS BEFORE I LAUNCHED THE ASSOCIATION IN THE FEBRUARY. STATING CONDITIONS THAT, IF WE AS DANIEL’S PARENTS ACCEPTED THIS OFFER, WE WOULD NOT BE ABLE TO DISCLOSE ANY INFORMATION OF THE SETTLEMENT TO ANY THIRD PARTIES.’

‘SURELY, BY OFFERING TO SETTLE ON BEHALF OF MY SON, THIS HAS TO INDICATE THAT YOUR PRODUCT ‘PRIMODOS’ WAS RESPONSIBLE FOR THE HORRIFIC INJURIES THAT DANIEL SUFFERED FROM.

FOR ME IT WAS HEART RENDERING TO WATCH MY SON SUFFER SO DREADFULLY. BY THE TIME HE WAS SIX YEARS OLD, HE COULD NO LONGER COPE, MENTALLY, PHYSICALLY, OR EMOTIONALLY, DUE TO THE NUMEROUS SURGICAL PROCEDURES HE HAD TO ENDURE.

I ASK YOU THEN AT BAYER’S, WHEN PRIMODS WAS FIRST LAUNCHED IN 1958, AS THE REVOLUTIONARY TEST TO DETERMINE A PREGNANCY, IT ACTUALLY SAID, ‘THAT IF A WOMEN WAS PREGNANT, IN NO WAY WOULD THE FOETUS BE AFFECTED BY THIS DIAGNOSTIC PROCEDURE’. WHY THEN DID MANY THOUSANDS OF WOMEN WHO TOOK ‘PRIMODOS’ BETWEEN THE FIFTH AND TENTH WEEK IN PREGANCY, WENT ON TO DEVELOP BABIES WHO SUFFERED FROM BIRTH DEFECTS?

I BELIEVE WE ARE A MORAL SOCIETY, “BUT WHERE ARE THE MORALS OF A DRUG COMPANY, WHO DENIED THE SAFETY OF OUR BABIES.

CAN THE BOARD OF DIRECTOR’S AT BAYERS, TELL ME: WHY WHEN I TOOK ‘PRIMODOS’ AGAIN IN 1976 FOR AMENNORRHOEA, JUST ONE YEAR AFTER MY SON WAS BORN, YOU NOW ATTACHED A WARNING SAYING THAT IT WAS NOT TO BE TAKEN IN PREGNANCY AS IT COULD CAUSE HEART DEFECTS.

‘PRIMODOS CONTAINED THE SAME HORMONES AS THE ORAL CONTRACEPTIVE PILL, ONLY IN A MUCH HIGHER CONCENTRATION. ‘WHY WAS IT CONSIDERED THEN TO BE SAFE TO BE USED ON THE UNBORN FOETUS IN THE FIFTIES UNTIL IT WAS BANNED IN 1978, IN EUROPE, AUSTRALIA, AMERICA, AND JAPAN’? YET TODAY, THE ORAL CONTRACEPTIVE PILL, IS USED BY MILLIONS OF YOUNG WOMEN TO PREVENT A BABY, AND IN 2009, YOU ARE STILL MARKETING ‘PRIMODOS’ IN AFRICA, FOR WOMEN TO SELF ABORT A FOETUS?’.

‘I ASK YOU THE BOARD OF DIRECTORS: WHAT INVESTIGATIONS WERE CARRIED OUT ON PRIMODOS PRIOR TO YOUR MARKETING OF THIS DRUG, FOR THE SAFETY OF THE UNBORN FOETUS, AND WHAT PROOF DO YOU HAVE TO BACK UP YOUR STATEMENTS THAT ‘PRIMODOS’ WAS SAFE?.

‘WHY DID SCHERING’S NOT SEIZE THE SAME PRECAUTIONARY MEASURES LIKE THE FRENCH MANUFACTURER, ROUSELL’S, HRT DRUG, AMENORONE, WHO TOOK ACTION AND STOPPED PRODUCING IT IN 1969?

‘I ALSO ASK YOU, ‘HOW WOULD YOU FEEL IF YOU, OR YOUR OWN CHILD HAD BEEN BORN WITH THESE MULTIPLE DEFECTS AS A RESULT OF THIS HORMONE DRUG, THAT WE AS PARENTS STILL BEAR THE BURDEN, AS WE WATCHED THEM SUFFER AS CHILDREN FROM THIS HORRIFIC DRUG, WHICH IMPAIRED FOR MANY OF THEM, THE INNOCENSE OF CHILDHOOD, WITH SCARRING WELL INTO ADULTHOOD?

‘WHY COULD YOU NOT LISTEN TO THE CONTINUING EVIDENCE THAT WAS ACCUMULATING’ AND BY 1969, A SURVEY BY THE, ROYAL COLLEGE OF GENERAL PRACTITIONERS IN THE UK, WHO WERE SHOWING A HIGHER INCIDENCE OF MISCARRIAGES AND ABORTIONS AMONG WOMEN WHO HAD TAKEN THE HORMONE PREGNANCY TESTING DRUG, ‘PRIMODOS’. DR DEAN WHO LED THE SURVEY, RECOMMENDED THAT ‘PRIMODOS BE WITHDRAWN FROM THE MARKET IMMEDIATELY.

‘WHY WAS IT SO DIFFICULT FOR YOU TO EVEN LISTEN TO YOUR OWN MEDICAL ADVISORS FROM YOUR OWN SUBSIDIARY COMPANY IN THE UK, WHO WROTE SAYING THAT THE QUESTION OF THE SAFETY OF ‘PRIMODOS’ HAD TO BE RESOLVED. THEY ALSO EXPRESSED THEIR CONCERNS BY SAYING, ‘WE MUST REACH A DECISION REGARDING OUR OWN PRODUCTS, AND ITS POSSIBLE RELATIONSHIP TO FOETAL ADNORMALITIES. AS MANUFACTURES IT IS OUR MORAL DUTY TO DO ALL POSSIBLE TO ENSURE THE SAFETY OF THE PREPARATIONS WE MARKET.’

‘WHY DID YOU NOT INFORM THE BRITISH GOVERNMENT WHEN YOU DECIDED TO STOP PROMOTING ‘PRIMODOS’ IN THE UK IN JULY 1970, CONSEQUENTLY, DOCTORS WENT ON PRESCRIBING ‘PRIMODOS’ AS A HORMONE PREGNANCY TESTING DRUG UNTIL THE FIRST WARNING WAS ISSUED IN 1975.

I ASK YOU THE BOARD OF DIRECTORS, ‘WHY WAS NOT THE OPINIONS OF THE MANY SCIENTISTS AROUND THE WORLD WHO WERE VOICING THEIR CONCERNS, AND HAD NOTICED THE CORRELATION OF ABNORMALITIES AND THE USE OF THE HORMONE DRUG?’

AS A RESULT OF THE INCREASED PUBLICITY, AND A PETITION FROM TWO HUNDRED MEMBERS OF OUR PARLIAMENT, THE ASSOCIATION FOR CHILDREN WAS ESTABLISHED IN 1978. THERE WERE NOW SIMILAIR ORGANIZATIONS IN OTHER COUNTRIES WHERE ‘PRIMODOS’ WAS MARKETED ,INCLUDING HERE IN GERMANY, WHERE ‘PRIMODOS’ WAS SOLD UNDER THE NAME OF DUOGYNON.

‘WOULD YOU PLEASE ANSWER ‘WHY WAS DR GAL’S SURVEY ON A HUNDRED BABIES WITH CONGENTIAL MALFORMATIONS, AND A CONTROL GROUP, HAD FOUND OUT THAT OUT OF THE TWO HUNDRED MOTHERS, TWENTY THREE HAD BEEN PRESCRIBED ‘PRIMODOS’. NINETEEN MOTHERS HAD GIVEN BIRTH TO MALFORMED BABIES, AND FOUR HAD HEALTHY BIRTHS. DR GAL WENT ON TO SAY THAT THE POTENTIAL RISKS OF THE PREGNANCY TEST DRUG, OUTWEIGHED ANY POSSIBLE BENEFITS, AND SAW THEIR USE AS BEING UNECESSARY.

EVEN DR CLAUS NEWMAN, A LEADING CONSULTANT PAEDIATRICIAN PHYSICIAN, AND A LEADING EXPERT ON THALIDOMIDE CHILDEN, IS QUOTED AS, SAYING, ‘THE ISSUE OF PRIMODOS AND ITS POTENTIAL ROLE AS A CAUSE OF CONGENTIAL MALFORMATION BECAME WHAT HE BELIEVES WAS ALMOST INVISABLE IN THE GLARE THAT RESULTED FROM THE THALIDOMIDE DISASTER. HE CONTINUES TO QUOTE ON THE SIMARALITIES BETWEEN THE TWO DRUGS, AND THAT LIMB DEFORMITIES CONSTITUTED ONLY A PART OF THE EFECT WHEN TAKING A DRUG ON A DEVELOPING EMBRYO. HE WENT ON TO SAY, THERE IS A POSSIBLILITY THAT THE NUMBERS OF GROWING FOETUSES THAT WERE AFFECTED BY THE HPT DRUG, WAS EVEN GREATER THAN THOSE WHO WERE AFFECTED BY THALIDOMIDE.

‘ARE YOU ALSO AWARE THAT THE SAME SYNTHETIC OESTROGENS USED IN THE ORAL CONTRACEPTIVE PILL, AND THE HORMONE REPLACEMENT THERAPY DRUG, ARE NOT ONLY A THREAT TO WOMEN’S HEALTH, BUT HAVE BEEN, AND STILL IS OF A GREATER RISK TO MAN AND THE ENVIRONMENT?

CAN YOU TELL ME IF YOU THINK THAT TAKING THESE POISONOUS DRUGS, JUSTIFIES THE COUNTLESS ABORTIONS THAT TOOK PLACE, OR THE MANY, MANY THOUSANDS OF BABIES WHO DIED SOON AFTER BIRTH BECAUSE OF ABNORMALITIES CAUSED BY THESE HPT DRUGS. OR TO THE THOUSANDS OF BABIES WHO WERE BORN WITH MULTIPLE ABNORMALITIES, AND WHO STILL BEAR THIS BURDEN OF SUFFERANCE, AS YOUNG MEN AND WOMEN WHO ARE WELL INTO THEIR ADULTHOOD LIFE TODAY.

ON YOUR HOMEPAGES AT BAYER SCHERING, YOU SAY YOU DEVELOP DRUGS OF HIGH MEDICAL VALUES SO AS TO CONTINUOUSLY IMPROVE THE QUALITY OF LIFE: HOW CAN YOU BE SO SHORTSIGHTED, INSTEAD, I CHALLENGE YOU PUBLICLY TO ANNOUNCE, THAT SOME OF YOUR PRODUCTS ARE NOT FIT FOR HUMAN CONSUMPTION?

TO YOU THE SHAREHOLDERS, ‘I IMPLORE YOU TO FIND A PLACE WITHIN YOURS HEARTS, BY DELVING DEEP WITHIN YOUR CONSCIENCE, AND TO USE YOUR AUTHORITY AS SHAREHOLDERS, TO UNBOLT THE PERMANENT SHUT EYES AT BAYER’S BY ENFORCING THE FACTS ON TO THEM, THAT, ‘PRIMODOS; WAS UNSAFE TO USE ON THE UNBORN FOETUS.

I WOULD LIKE TO ASK YOU TO CONSIDER WHAT I HAVE PRESENTED TO YOU, AND WHATEVER YOU DECIDE UPON, HOPEFULLY, THIS WILL BE THE ANSWER THAT I, AND MANY THOUSANDS OF PARENTS WORLDWIDE HAVE BEEN WAITING FOR.

IT HAS BEEN A PRIVILEDGE TO BE HERE, AND I THANK YOU FOR LISTENING TO ME.

THANK YOU.