Oral Hormone Pregnancy Tests

Roberta Blackman-Woods Excerpts

Thursday 23rd October 2014 Commons Chamber

[Roberta Blackman-Woods (City of Durham) (Lab)]

I congratulate my hon. Friend the Member for Bolton South East (Yasmin Qureshi) on securing this important debate and thank the Backbench Business Committee for granting it. I would like to thank, too, my hon. Friends for setting up the all-party group, which has been so helpful in supporting campaigners on this issue.

In common with my hon. Friend the Member for Coventry North West (Mr Robinson) and the hon. Member for Enfield North (Nick de Bois), I have come to this issue via my constituents, and I shall talk in greater detail about the experience of Mr and Mrs Chapman in a few moments. When they came to see me at a surgery a few months ago, I approached the issue, as have most hon. Members, with a certain degree of incredulity that a situation such as that experienced by that family could have gone on for so long without any action being taken, particularly without any serious examination of why so many babies were born with serious deformities between 1953 and 1975 or of the relation between those deformities and the hormone pregnancy drug that so many of the women had taken.

We know that the most common abnormalities identified include neural tube defects, cleft lip and palate, limb reduction defects, general cardiovascular defects as well as many more. It is believed that 1.5 million women took primodos and the effect of the drug much depended on the stage of pregnancy, but in addition to many women having children with defects, it is thought that in many more women the drug caused miscarriage.

In a written parliamentary answer in the previous Parliament, the number of those affected in the longer term by primodos was assessed at about 3,500. Most campaigners think that that figure is too low and that the real figure is much higher. We know that the drug company simply discontinued primodos and never looked back, but the victims, their parents and their wider families continue to live not only with the birth defects, but with uncertainty over what has caused them. Mothers are unable to forget the guilt for using the drug. Their children, now grown up, continue to look for answers as to why they were born with abnormalities. It is up to us in the House today to try to ensure that those people get the answers they have been seeking for many decades.

We know from sales statistics that many thousands of women used primodos as a pregnancy test between 1970 and 1977 even though it was not licensed for use in that way. We know that there was a huge delay in putting information into the public domain about the possible dangers of using the drug; indeed, information did not appear in the public realm until eight years after the first reports indicated possible dangers. That seems to be an extraordinary delay and, again, one for which no real explanation has been given.

Similarly, and despite the weight of evidence, regulators did not warn doctors and patients about the possible dangers of using the drug until much later than in other countries. Authorities in Sweden, Finland, Germany, USA, Australia, Ireland and Holland issued warnings on the drug as early as 1970 to 1975. That was many years before any warning was issued in the UK, despite the fact that the Committee on Safety of Medicines was the first medical authority to know of the hazard, as other Members have said. We know that some doctors continued to prescribe the drug to pregnant women even after official warnings from the Committee on Safety of Medicines had been given. We need some answers as to why doctors kept on prescribing the drug even when it was known that there were some dangerous consequences of using it.

We also need to ask why the medical community and indeed the committee that was licensing medicine did not take on board much earlier information, especially in the academic medical community, about the potential harm that could be caused by taking the drug. As early as 1967, as Dr Isabel Gal discovered, there were warnings that primodos potentially caused spinal congenital malformations in newborns. The Medical Research Council picked up on that the next year and said that it could be another thalidomide story. Yet no real action was taken to remove the drug until 1978. Some explanation for that delay would be very helpful.

We know that the drug companies and the MHRA are now saying that it is very difficult, given the passage of time, to do anything about this dreadful situation. We have to reject that notion very strongly. There are data available. They may not be in the public domain at the moment, but those data need to be examined and that is the purpose of the motion. The issue needs to be examined very carefully to provide some answers and to see whether a causal link can be confirmed. If not, other answers must be given to the people who have for many years considered primodos to have been the cause of the birth defects they experienced.

I will try to stick to the 10-minute ruling on speech length, so finally I will talk about the case of Mr and Mrs Chapman. I have their full permission to talk about their situation. It is truly heart-wrenching. Their daughter, Margaret, was prescribed primodos—two tablets were the instructions—simply to confirm a pregnancy. It was not her first pregnancy. She was surprised that she was being given medication to assess whether she was pregnant, and queried it, but the doctor said there would be no side effects, so she trusted the doctor and took the tablets. After her baby was born in March 1975, she noticed that her baby was blue, called the midwife and the baby was rushed to Newcastle general hospital. The baby was diagnosed as having a deformed heart and they were told she would probably not live very long. She was given emergency surgery in a specialist heart unit and, despite dedicated nursing at home by her mother and wider family, lived only for 18 months. That dreadful situation has stayed with that family for many years. It is heart-wrenching, and they desperately want some answers.

My hon. Friend the Member for Coventry North West said that these families desperately need closure. I agree, and I hope we make a decision today to set up an independent panel, and to have all the relevant documentation put in the public domain. These families have been extraordinarily patient—we must pay tribute to how they have kept campaigning year after year, despite not really being listened to—and I hope today we listen to them and start the process that will perhaps give them some answers.