The Petition of residents of the UK,
Declares that the Petitioners believe that children were born with serious deformities due to hormone pregnancy test drugs taken by expectant mothers between 1953 and 1975; further that the Petitioners are concerned that as the surviving victims enter their forties and fifties many of them may face a host of new problems as their bodies continue to suffer; further that no official warnings were issued about these drugs until eight years after the first reports indicated possible dangers; further that the Petitioners believe that some doctors continued to prescribe the hormone pregnancy test drugs to pregnant women after official warnings from the Committee on Safety of Medicines; and further that the Department of Health in the past has rejected requests for an inquiry into these matters.
The Petitioners therefore request that the House of Commons urges the Government to set up an Independent Public Inquiry.
And the Petitioners remain, etc.—[Presented by Yasmin Qureshi, Official Report, 17 June 2014; Vol. 582, c. 1085.]
[P001359]
Observations from the Secretary of State for Health:
The Government have great sympathy for those who believe they have been adversely affected by Primodos. In January 2014, the Under-Secretary of State for Health, the hon. Member for Central Suffolk and North Ipswich (Dr Poulter), met with the hon. Member for Bolton South East (Yasmin Qureshi) to discuss the alleged association between use of Primodos and the occurrence of congenital anomalies in the offspring.
Although some studies have found an association between hormone pregnancy tests taken during pregnancy and abnormalities in the children, it is widely recognised that investigating the effect of medicines in pregnancy is complex and subject to a number of unique challenges. The meeting therefore agreed that a thorough review of all relevant historical evidence on Primodos was needed.
The Medicines and Healthcare products Regulatory Agency (MHRA) has therefore carried out a critical assessment of key evidence on the possible effects of hormone pregnancy tests (HPTs) taken by the mother during pregnancy, on the subsequent development of the child. The report is published on the MHRA website1.
Having carefully considered the evidence, the Government’s view remains that the data are not sufficient to conclusively prove the existence of a causal association between the use of Primodos (or any HPT) and congenital abnormalities.
The Committee on Safety of Medicines (CSM) was very aware of the concerns about HPTs, including Primodos from 1967, and kept the emerging evidence under close review. The CSM also started their own study in the offspring of children from women who had already been prescribed a HPT, in an effort to confirm or refute the early findings. Although the Committee did not consider the accumulating evidence to be conclusive, in 1975 and 1977 they advised doctors not to use HPTs, given that alternative methods of testing for pregnancy were available.
Primodos had not been licensed for use as a HPT since the early 1970s; however, doctors are able to prescribe a medicine outside the terms of its licence, if they judge that it is in the best interests of their patient, and take responsibility for their prescribing decisions.
Decisions on Independent Public Inquiries have to be proportionate to the need identified, taking into account the likely benefits, time and expense. The Government do not consider that the currently available evidence has established that Primodos or other HPTs have caused congenital anomalies and so cannot justify a Public Inquiry. Nevertheless, we remain committed to reviewing any new evidence that may be forthcoming.
1 http://www.mhra.gov.uk/Safetyinformation/ Generalsafetyinformationandadvice/Product-specificinformationandadvice/Product-specificinformationandadvice-G-L/Hormonalcontraceptives/Hormonepregnancytests/index.htm.