Independent Medicines and Medical Devices Safety Review

Allan Dorans Excerpts

Thursday 8th July 2021 Commons Chamber

[Allan Dorans (Ayr, Carrick and Cumnock) (SNP)]

I wish to speak about the devastating effect that the drug Primodos had on countless families, including my constituent, Nan McGradie, and her daughter, Michelle.

The hormone pregnancy test drug Primodos was taken by women in the 1960s and 1970s to test for pregnancy. There was considerable evidence that women who took the drug prescribed by their general practitioner and were pregnant at that time gave birth to babies with serious birth defects including deformities, disabilities, missing limbs, cleft palates, brain damage and damage to internal organs, and in some cases miscarried or had stillbirths. The surviving victims of Primodos are now in their 40s and 50s and many face a host of new problems as their bodies continue to suffer. Many have died prematurely.

Despite the serious concerns raised by paediatrician Dr Isabel Gal in 1967 indicating the possible dangers of Primodos, no official warnings were issued about these drugs until eight years later. The Committee on Safety of Medicines and the Committee on Safety of Drugs were the Government drug vigilance authorities at that time. Those committees were set up specifically to ensure that nothing like the previous thalidomide tragedy could ever happen again. There is strong and compelling evidence of systematic regulatory failures demonstrating that the committees tasked with safeguarding the health of pregnant women failed in their duty of care.

I want to briefly highlight the case of my constituent Nan McGradie and her daughter Michelle. In 1975, Mrs McGradie was a recently married, healthy young woman. Feeling sick and suspecting she may be pregnant she went to her doctor for a pregnancy test expecting, as was normal at the time, to have a urine test. Instead her doctor prescribed her two Primodos tablets. It was subsequently confirmed that Mrs McGradie was about seven or eight weeks pregnant at that time—incidentally, around the time that a foetus in a womb develops a diaphragm. At the time, in 1975, Primodos had already been banned for use as a pregnancy test for five years in Norway and Sweden.

Mrs McGradie had a totally uneventful pregnancy during which she neither smoked nor drank, and on 20 August 1975 her daughter Michelle was born. It was discovered immediately that Michelle had been born with a hole in her diaphragm, which had allowed her bowel and spleen and part of her liver and kidneys to be forced into her chest cavity, crushing her lung. Michelle was not expected to live, but through the skills of our national health service she survived and is now aged 45.

Throughout her life Michelle has endured numerous operations and surgeries and long, long periods of hospitalisation and has suffered severe health issues including breathing difficulties, a weakened immune system, numerous bowel obstructions and inflammatory bowel infections, and has been unable to conceive children. The effects of these debilitating physical, psychological and medical extremely challenging health conditions suffered by Michelle and her parents for the last 45 years just cannot be adequately described in words.

Michelle was born in 1975, and at that time Mrs McGradie was unaware that Primodos, the drug she had been given to test for pregnancy, had been associated with birth defects for at least eight years, but some two and a half years later, in 1978, she read an article in the press which reported on a number of cases linking birth defects to the drug, including internal organ damage similar to that suffered by her daughter. Since that time, Mrs McGradie has, along with many other women, been fighting the injustice that no one has been held responsible for the damage caused to so many lives through the prescribing of Primodos.

I pay tribute to the right hon. Member for Maidenhead (Mrs May) for her leadership and thank her for initiating the independent medicines and medical devices safety review overseen by Baroness Cumberlege, and I thank Baroness Cumberlege and her team for their hard work. The review was instructed to consider the regulation of the hormone pregnancy test, Primodos, and the other medical products debated today. One of the report’s conclusions is that Primodos should have been withdrawn from the market in 1967 after the first substantial, and very significant, report by Dr Gal. However, the Government refuse to accept responsibility for the effects of Primodos without appropriate causal association, yet they admitted later in a Sky TV interview and to the independent medicines and medical devices safety review team that they did find a possible association.

There was a moral duty on the Government representatives on the Committee on Safety of Medicines to protect patients at that time, but they failed in their duty of care by suppressing evidence of harm caused by the drug. The Government continue to deny and suppress the evidence even today, while supporting the flawed conclusions of the 2017 expert working group report. The damage to individual lives and families caused by Primodos, fuelled by successive Governments’ lack of action and failure to prevent this, is immeasurable. This could be a far greater tragedy even than thalidomide.

I welcome the £40 million provided by the Chancellor in the last Budget for the ongoing care of families affected by thalidomide, but there can be no justifiable reason to deny the victims of Primodos the closure, support and justice they so clearly deserve. The Government now have an opportunity to right a tragic historical wrong, and I urge them to implement the independent medicines and medical devices safety review’s recommendations in full and without further delay.

Finally, on behalf of the Primodos children and their families, I pay tribute to Mrs Marie Lyon, the chair of the Association for Children Damaged by Hormone Pregnancy Tests, for her tireless campaigning for over 40 years, and to the hon. Member for Bolton South East (Yasmin Qureshi), as chair of the all-party parliamentary group on oral hormone pregnancy tests, for her exceptional support for the campaign.