§ Mr. Ashleyasked the Secretary of State for Social Services (1) what is his estimate of the number of children born malformed due to the use of the drug Primodos by their mothers in hormonal pregnancy tests;
(2) on what date his Department was first informed of the link between congenital abnormalities and hormonal pregnancy tests;
(3) on what date the suggested link between congenital abnormalities and hormonal pregnancy tests was found to be supported by the Committee on Safety of Medicines;
(4) what action his Department took when first informed of a possible link between congenital abnormalities and hormonal pregnancy tests;
(5) if he will now take steps to ban the use of the drug Primodos;
(6) what discussions he has had with the manufacturers of the drug Primodos about the payment of compensation to the families of children damaged by this drug;
(7) what responsibility his Department will accept for damage caused by the drug Primodos;
(8) if he will now hold an independent inquiry into the use of the drug Primodos.
§ Mr. MoyleA study reported in May 1967 suggested that hormonal pregnancy tests were associated with a certain type of congenital abnormality. Other investigators had not reproduced these findings, which were open to criticism on scientific grounds, but the then Committee on Safety of Drugs encouraged the publication of the results. In 1969 the Committee began a pilot scheme for a long-term study of congenital abnormalities. By 1975 its preliminary findings also suggested an association between hormonal pregnancy tests and non specific congenital abnormalities, which was confirmed this year. In 1975 pregnancy testing was removed from the permitted466W indications in the product licences, and in June of that year the Committee on Safety of Medicines warned all doctors of the hazard. The manufacturers included an appropriate warning in their product literature. The Committee has recently issued a reminder to doctors, following the publication of the further results of the study. The products have not been banned, since they are still found useful in the treatment of certain gynaecological disorders.
It has not been proved that the drug actually causes malformations: the study only shows that there is a statistically significant difference between the incidence of malformations in babies born to mothers who have taken the drug, and the incidence in babies born to mothers who have not taken it. A calculation of the possible numbers of malformations due to the drug cannot be made using the data available, which are derived from study of a selected sample. My Department has had no discussions on compensation with the manufacturers. Compensation in this instance would be a matter for the individual patient and the manufacturer or doctor; if agreement between the parties could not be reached, then it would be for the courts to decide on the facts of each particular case. I have looked carefully into this matter, and I do not consider that any further inquiry would be helpful.
§ Mr. Ashleyasked the Secretary of State for Social Services, if he will list in theOfficial Report the pregnancy tests which can he taken without the danger of foetal damage.