The Blog

Mothers and Children Are Still Looking for Answers as to Why They Were Born With Abnormalities

Files discovered recently by campaigners, and brought to my attention, reveal that, in 1967, a Paediatrician at Queen Mary's Hospital in London, Dr. Isabel Gal, found a link between Hormone Pregnancy Tests such as Primodos, and spinal congenital malformation in newborn babies.

"I have seven spleens. My stomach is on the wrong side and I have had several operations in attempts to correct this. I was born with a number of adhesions and obstructions. I also have spinal defects and internal congenital malformations. I have had to struggle throughout my life"

These are the poignant words of my constituent, Nichola Williams, a story she painfully shared with me on a Saturday afternoon, two years ago.

When her mother suspected she was pregnant in 1971, she visited her GP and was prescribed Primodos, a Hormone Pregnancy Test.

Primodos was a hormone-packed pill, manufactured by the pharmaceutical giant Schering, now known as Schering-Bayer. Its ingredients were similar to oral contraceptives, but forty times the strength. The test worked by inducing a period if the women was not pregnant.

However, files discovered recently by campaigners, and brought to my attention, reveal that, in 1967, a Paediatrician at Queen Mary's Hospital in London, Dr. Isabel Gal, found a link between Hormone Pregnancy Tests such as Primodos, and spinal congenital malformation in newborn babies.

Triggering alarm bells, the Royal College of General Practitioners produced figures for Schering, showing higher rates of miscarriages, infant deaths, and abnormalities of babies whose mothers had taken Hormone Pregnancy Tests. The report's author, NB Dean, concluded that the "drug should be withdrawn".

In 1968, Schering's lead UK Scientist wrote to the parent company in Berlin:

"It is extremely disturbing, that the results of statistics, human studies, all point clearly to the possibility that Primodos may interfere with the pregnancy".

Similarly a letter to the Medical Research Council states: "It looks like in fact this could be another thalidomide story".

In a recent Sky News report, correspondent Jason Farrell, met with the statistician Dennis Cooke, who was contracted by Schering in the 1960s to conduct studies on its data. Comparing the increase in sales of Primodos to the number of recorded deformities in newborns, he said it showed a rather "alarming direct and strong correlation". Sifting through hundreds of documents and files from government departments, I discovered that concerns were raised by gynaecologists and paediatric research departments, clearly revealing that Primodos could affect the foetus, or even cause the child to abort.

The drug should have been immediately suspended pending full clearance by the committee. Instead, documents show hesitancy compounded by incompetence and the drug remained on the market.

As a result more than 1.5million pregnant women were placed at unnecessary risk in being prescribed these drugs. Thousands of children were damaged and still suffer today from dreadful disabilities. Many brain damaged, some with spina bifida, while others have heart and limb defects.

Instead of taking urgent action, the government did nothing. The Committee on Safety of Medicines began a belated pilot study only in 1969 and undertook no full study until 1972. This was a leisurely affair, despite the suggested link between congenital abnormalities and Hormone Pregnancy Tests and drugs eventually being found to be supported. It was not until 1975 eight years after the first reports that an official warning was published by the Committee.

In 1975, even the World Health Organisation questioned why research, on such a critical issue, published in the late 1960s, was not followed up for so many years.

The government's attitude is best illustrated in an extraordinary exchange of letters between the now highly-esteemed Dr. William Inman, at the time a Senior Medical Officer at the Committee of Safety of Medicines, who in reference to a meeting with Dr. Isabel Gal says:

"We are defenceless, in the matter of the eight-year delay".

"Isabel Gal is an intelligent, dedicated but rather sad little person...I dealt with her sympathetically, but I do not believe we have heard the last of this matter."

Given the appalling enormity of revelations, it is hard to imagine this could extend deeper, but further investigation reveals that Primodos had lost its licence for use as a pregnancy test drug in 1970 and could no longer be marketed as such, but only as a drug to treat secondary ammoreehea. Despite this, the Committee of Safety on Medicine failed to warn doctors until 1975, in a letter suggesting "it may cause congenital abnormalities" and in 1977 stating that the "Association has been confirmed".

Bayer confirmed to Sky News that the drug was not licenced as a pregnancy test after 1970, and anyone using it as such would have been doing so "off label" or, in other words, not as instructed.

This would include Nichola's mother, and thousands of others mothers who now await answers on why their doctors did not know about the change.

It is logical to assume that if a medicine has its licence changed, and if it is a significant or dramatic change in use, agencies would work together to keep health professionals updated, just as health professionals have an obligation to make sure they are up-to-date.

The authorities in Sweden, Finland, Germany, USA, Australia, Ireland and Holland issued warnings and took action on Hormone Pregnancy Tests as early as 1970, which was five years before any warning was issued in the UK, in spite of the fact that the UK's Committee on Safety of Medicine was the first medical authority to know of the hazard.

There is even evidence that some doctors continued to prescribe these drugs even after the official warnings. The reputable medical journal of the time General Practitioner estimated that, in 1976 a year after the official warnings, no fewer than 8,000 prescriptions were issued, surely revealing medical malpractice on a large scale?

Minutes of a General Medical Services Committee meeting, attended by doctors, reveal their fears on the legal consequences, but these were alleviated by the suggestion that it would be easier to destroy patient medical records, however wrong that was - a possible explanation for Nichola and many of the victims whose medical records have 'disappeared' and were given implausible reasons for their loss.

Drug company Bayer and the MHRA both say that there is insufficient data to prove a conclusive link, but this misses the point. The link, which they indicated on the packet, has not been disproved. Schering simply discontinued Primodos and never looked back, nor did the Committee on Safety of Medicine, but the victims and their parents continue to live with their defects. Mothers, unable to forget the guilt of using the drug, their children, now grown up, continue to look for answers as to why they were born with abnormalities.

Their questions about Primodos could have been avoided if the regulator and drugs company had responded more swiftly to the clear concerns and followed proper procedures to ensure the drug was not being used inappropriately after 1970. Time and time again they failed.

They say that justice delayed is justice denied. We know that too well after Thalidomide, Hillsborough and many other tragedies. But how do you wrestle with your conscience when the injustice you have perpetrated has destroyed the lives of children and left thousands of victims still enduring pain and suffering, without acknowledgement, apology and adequate compensation?

Today in a Backbench Business Committee Debate, supported by Nick de Bois, Jacob Rees-Mogg and other colleagues affected by the tragedy we take these questions to the minister to remind him that justice cannot be time-limited, it must be absolute.