Dáil Éireann díospóireacht -
Thursday, 5 Apr 2001

Vol. 534 No. 2

Adjournment Debate. - Diethylstilbestrol Use.

Mr. Allen

I am delighted to get the opportunity to ask the Minister what investigations took place in his Department into a situation whereby hundreds of women whose mothers took the drug diethylstilbestrol to prevent miscarriages have suffered serious health problems and the reason the drug continued to be administered in Ireland several years after the drug had been withdrawn for use in the United States by the Food and Drug Administration there.

The drug, DES, prescribed to prevent miscarriage, was administered to women in Ireland between 1955 and 1975. Hundreds of Irish women whose mothers were given the drug which guaranteed a healthy pregnancy have developed serious health problems, such as miscarriages, irregular bleeding or infertility. Already more than 100 women have the symptoms but doctors believe this is only a small fraction of the real number of victims as many suffer symptoms but do not realise the cause of those symptoms.

The use of the drug was discontinued by the Food and Drug Administration in the United States in 1971 after mounting evidence proved it was linked to a rare form of gynaecological cancer. More than 10,000 pregnant women in the UK and as many as five million US women are known to have received the drug. In an article in yesterday's Irish Examiner written by Carl O'Brien, we read of horrific cases regarding the effect the drug had on the personal health of the women who took it. Despite all of this, Irish women affected by the drug are not able to get compensation from drug companies because medical records have been destroyed or lost. This excuse of missing records has been heard before in previous medical scandals but the big question here is, where have the records gone? Why was this drug administered here four years after it was ordered to be discontinued by the American FDA following evidence linking it to cancer?

I ask the Minister to set up an inquiry to establish how the records have gone missing – we have seen this before with the three in one and the polio vaccine where records are unavailable or have gone missing – what companies were selling the drug in Ireland in the years mentioned and the role of the Irish Medicines Board. I do not understand how the drug was allowed to be used in this country years after it had been withdrawn in the US.

At this stage, it may be difficult for the women affected by the drug to get compensation for their wrecked health but, in the interests of justice, the drug companies should live up to their responsibility towards the hundreds of Irish women whose health has been irreparably damaged by their products. The drug companies must compensate Irish women for the permanent damage to their health. There is a grave responsibility on the Minister and the Department of Health and Children to help these women get justice by getting to the truth of this horrific medical scandal.

Mr. O'Dea

I apologise for the absence of the Minister for Health and Children but I assure Deputy Allen that I will communicate his views to him.

DES is a synthetic non-steroidal hormone which was developed in 1938 by Sir Charles Dodds, Professor of Biochemistry at the University of London. It was used in pregnancy to prevent miscarriages and premature births, particularly in pregnancies complicated by diabetes or toxaemia. In 1971, the development of a rare form of vaginal cancer in the young daughters – that is, those in their teens or early 20s – of women who had received DES when pregnant was first noted.

There is no information available on the level of prescribing in Ireland in the 1940s, 1950s or 1960s. The following were licensed by the National Drugs Advisory Board in 1979: Boestrol tablets for the treatment of malignancy and atrophine vaginitis and Tampovagan Pessary for the treatment of atrophine vaginitis and the management of post-menopausal disorders but this product was withdrawn in 1992 for commercial reasons. Both products were contra-indicated in the case of pregnancy, suspected pregnancy or in patients who may become pregnant.

Concern in this country in relation to DES mainly centred on the lack of awareness among the medical profession as to the benign nature of DES related vaginal adenosis and the danger of unnecessary surgical intervention. The view, therefore, at the time was that the most appropriate way to deal with this matter was to ensure that all the information available was channelled through the medical profession with assistance from the Department of Health, as required. A leaflet on DES was prepared in 1991 by the Institute of Obstetricians and Gynaecologists of the Royal College of Physicians of Ireland, in consultation with the health promotion unit of the Department and distributed to the medical profession.

The Council for the Status of Women met with the Minister of State at the Department of Health in 1990 to discuss the matter. Essentially, the council wished to make contact with the daughters of women who took DES during pregnancy in the 1940s, 1950s and 1960s, to alert them to the possibility of their having contracted vaginal adenosis and to advise them of the relevant treatment for this condition. A special unit was set up in the National Maternity Hospital, Holles Street, Dublin 2, in 1990 to assess and deal with the matter. The Department of Health and Children has been advised by the unit that approximately one-third of the women, 120, who have been seen at the unit are deemed to have been exposed to the drug. The majority of these were treated with the drug in the 1960s, with only a couple receiving it after 1972. The remainder who attended the unit were anxious to have their anxieties that they may have been exposed to the drug allayed.

In 1992, the Minister for Health, on the invitation of DES ACTION IRELAND, launched the European DES Awareness Week. From information to hand, it appears that all information was channelled through the appropriate medical personnel with a view to ensuring that those women affected by DES would receive appropriate and speedy medical care.