Independent Medicines and Medical Devices Safety Review

David Jones Excerpts

Thursday 8th July 2021 Commons Chamber

[Mr David Jones (Clwyd West) (Con)]

May I, too, commend the Backbench Business Committee for securing this important debate?

My constituent Mrs Jennifer Meakin was pregnant with her third child, Daniel, when she was prescribed Primodos as a pregnancy test. Daniel was born on 14 September 1974, with severe birth defects. He had an occipital swelling containing brain cells and fluid, which had leaked out when the neural tube was developing, and he was categorised as spina bifida. Daniel has undergone five major brain operations. By any standard, he is severely disabled. Equally, by any standard, the challenges experienced by the Meakin family since his birth over 47 years ago have been enormous.

Hormone pregnancy tests first came on to the market in the early 1960s, and approximately 1 million prescriptions were dispensed. As early as 1967, warnings were made available to the Committee on Safety of Drugs that such tests were unreliable, might cause neural tube defects of the sort that afflicted Daniel, and could precipitate an early abortion. However, a 1967 CSD press release reported:

“The consensus of expert opinion is that there is no scientific evidence to support the view that the hormones used in pregnancy tests can cause congenital malformations.”

The IMMDS report comments on that very forthrightly, stating:

“Given the concerns raised, the non-essential nature of HPTs and the provision of risk-free alternative tests…the CSD…should have recommended the withdrawal of the indication for use as a pregnancy test in 1967.”

However, it was not until June 1975 that a general warning was issued by the Committee on Safety of Medicines, the statutory successor to the CSD, about the possible association between hormone pregnancy tests and an increased incidence of congenital abnormalities, with an explicit recommendation that doctors should not prescribe hormonal preparations for pregnancy tests. That was some eight years after concerns about the tests were first raised and eight years after the date when, according to the report, the CSD should have recommended that Primodos should not be used as a pregnancy test—and sadly, of course, it was after Mrs Meakin was prescribed the drug for that purpose.

The report makes two specific recommendations in relation to Primodos, which I strongly endorse: first, the establishment of specialist centres for all families adversely affected by medicines taken in pregnancy, to provide integrated medical and social care in one place; and secondly, an ex gratia scheme, to provide discretionary payments. Families who have been afflicted by this scandal for half a century need all the support that they can get. It is a tribute to their persistence and indefatigability that they have pursued their campaign for so long. The report rightly observes that, although causal association has not yet been established, families such as the Meakins have suffered stress, anxiety, psychological harm and the general toll of fighting for recognition. They have, in short, put up with almost unbearable adversity.

The Government did the right thing recently when they confirmed a commitment to lifetime support for the thalidomide victims. I say to my hon. Friend the Minister that the Government would, similarly, be doing the right thing now if they were to establish a support scheme for the families affected by Primodos. I strongly urge them to do so.