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Bayer ASM 2012

Presentation to Bayer April 2012

Good afternoon ladies and gentlemen.

My name is Valerie Williams. Some of you may remember me from the presentation I gave in Dusseldorf in 2009.

Since that time I have undertaken research and the Government UK National Archives, uncovering various documents relevant to the case which I shall make today.

I speak as a founder member of the Association for Children Damaged by Hormone Pregnancy Test Drug, PRIMODOS, which was manufactured and marketed by Schering Chemicals, now Bayer Schering.

My son Daniel was born with multiple abnormalities after I had taken Primodos as a pregnancy test in 1974. Yet when I was prescribed Primodos for a second time in 1975 for Amenorrhoea, there was then a warning attached from Schering Chemicals, stating that Primodos was not to be taken by pregnant women due to congenital defects to the unborn child.

Since then I have been campaigning to obtain justice for the victims of Primodos for 36 years, and I will not stop until Bayer accepts responsibility for the consequences of its past actions. The families of all known Primodos victims have suffered extensively.

I wish to hear from Bayer, an admission of the errors made, and an apology to all those mothers, fathers and babies who suffered then, and continue to suffer now because of abnormalities inflicted in the womb by this drug.

Our innocent victims of Primodos have suffered due to a lack of humanity and a cavalier attitude to the safety and well being of the unborn foetus. There are also concerns amongst the victims and families that there will be implications in the future, due to Primodos.

Bayer’s reputation as a responsible pharmaceutical company, with a record of producing many beneficial and lifesaving drugs, is gravely damaged by the saga of misery caused by decisions taken from the late 1950’s onwards regarding the use of synthetic oestrogens for pregnancy tests.

The Pharmaceutical Industry surely exists not just for profit but for the good of mankind. When things have gone badly wrong and so many lives have been adversely affected, responsibility must be accepted by the Industry and compensation offered to those who have been affected by Primodos.

The Primodos story is an example of what can happen when profit is given precedence over humanity.
Medicines are used for their beneficial effects but when used incorrectly or if they cause harm by death, disease or deformity, they are not medicines but POISONS.

The hormone NORETHISTERONE (as used in Primodos) is a drug with several valid uses, and is widely used today quite legitimately, for example in the contraceptive pill, even though there are some doubts of concern. However, the dose of norethisterone in Primodos was many times higher than the dosage in the pill. I am not a scientist, but surely it is the logic of a madhouse to propose its use in the early stages of a human being’s life.

We, the women who took Primodos on the advice of doctors we trusted, did not take it because we were ill, or seeking an abortion. We took the drug because we were led to believe it was a safe means of confirming that we were pregnant. At the time there were other means of testing (ie a urine test) which was totally safe to the unborn baby but our doctors did not inform us of this fact. They prescribed us with Primodos instead.

There was no need for us to take this harmful preparation. Our lives, and those of our children, were damaged for NO GOOD REASON.

Those of us affected by this dreadful drug have been traumatized by Primodos and deceit. We will continue our campaign as we face the icy currents from long ago, endured by a wave of storms to test our spirits to continue during our long haul for justice. We will fix our eyes on the horizons to carry us forward with grace, dignity and honesty as an example to those concerned that justice should be done for the victims of Primodos.

Do you not agree that the use of this drug to confirm a pregnancy was a grave error?

For many years before Primodos was marketed for use in pregnancy, the safety of this use was being questioned as early as in the late fifties by many of those in the medical professions.

In 1958, Dr J Edwards of Birmingham University stated that the use of high doses of hormones in early pregnancy was likely to cause foetal malformations, and was a type of insult to the foetus.

We know the results on the trial among 15,000 women in, The German Study, who were given Primodos did NOT include figures for spontaneous abortion, stillbirth and death in early infancy. This manipulation of results led to false representation of the facts of the matter.

In 1969, Schering Chemicals now Bayer Schering, wrote to the Committee on Safety and Medicines in the UK, saying Primodos was being withdrawn due to the high rates of abortion in a Rat Study. In the light of this, why was this drug still being prepared and prescribed as a safe pregnancy test right up until 1975?

Why did Schering Chemical ignore the advice of Dr Briggs, Medical Director of their own UK subsidiary, who urged Head Office in Germany to withdraw the drug for safety reasons??

What were your real reasons to continue manufacturing Primodos during this period when there were so many questions regarding the safety of this drug? WHY was this allowed to happen??

By 1975, Primodos was now packaged with a leaflet containing a warning that it should NOT be taken by pregnant women due to the risk of foetal abnormalities. Too little, too late for the many thousands of foetuses, already in the womb who already had been harmed by this potentially lethal drug.

Even then, no effort was made to recall packs sitting in the supply chain which did not contain the new warning information. Nor were efforts made to properly educate doctors about the new safety advice on Primodos.

In contrast to Schering Chemical, the drug company Roussel took the honourable route and withdrew their hormone pregnancy test drug, AMMENORONE FORTE an approximate equivalent to Primodos in 1969 because of adverse side effects.

Primodos was eventually banned in the UK in 1975 and again in 1978 and many others countries, but the damage was already done.

The grave consequences of Schering Chemical’s decision not to withdraw this drug as soon as alarms bells were sounded are still being felt by families today. The interests of these people were sacrificed on the altar of corporate greed.

The life sentences of pain, disability and financial penalty could have been avoided. Does corporate conscience (if there is such a thing??) not dictate that companies MUST accept responsibility for the effects of their decisions on those whom they claim to serve – members of the general public?

We, the victims of Primodos, are human beings, not merely cannon fodder for Bayer to exploit in pursuit of profit and then disregard.

The UK government also have to face the consequences of their mistakes in dealing with this matter, by not taking action quickly enough when they became aware of the potential dangers of Primodos.

A Culture of half-truths, lies and deception has surrounded this issue for over 40 years and our Governments also need to acknowledge and learn from the mistakes which they made in the past.

We now ask Bayer to accept, at long last, its responsibility for our misfortune and the damage we suffered at its hands.

I ask you the Shareholders, to reflect on the bond of love and care you have with your own children. Would you be opposing us if your lives had been affected as ours have? Think of the many parents who were denied the opportunity to see, to hear, to touch, to smell or to cuddle their children. How would you feel if you were in our place? Our babies were struck down by a toxic dose of chemicals, manufactured and marketed by Schering Chemical. Where is your humanity if you do nothing to help our cause?

BAYER, the victims of your mistakes MUST be compensated for their years of suffering.

Recently, the Member of Parliament, Yasmin Qureshi has taken up our campaign after investigating the case of her constituent, Nichola Walton.

Yasmin is an inspiring figure, who has already table an Early Day Motion in Parliament to raise the support of other MPs and call for a full, Public Independent Inquiry into this complex and tragic story. We hope that a debate in the House of Westminster will take place very soon. I shall of course attend this debate, and will speak to the press about the issues raised.

We, the victims of Primodos, challenge Bayer to reveal the full truth about Primodos, including evidence of problems which the company’s own research predicted, and which was ignored for financial reasons.

We will continue to purse this case, regardless of the financial and legal obstacles put in our way, until we receive the justice we are due. Our courage will never fail us. We will uncover the truth and expose the lies and deception which have been used to fight us. Bayer WILL be held to account, if not for us then for the sake of future generations who place their faith in drug therapy.

My last visit to this Shareholders meeting in 2009 did not result in answers to the questions I asked.
I hope that by repeating some of those questions, there will be a better and more just response than there was then.

Both our future and your futures are in your hands.