UK Politics

Primodos scandal: ‘Significant’ changes were made to key report

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After four long decades, the families who campaigned for justice after taking the pregnancy test drug Primodos finally had their apology in parliament.

An inquiry on Wednesday ruled that many of the children born to mothers who used the drug suffered "avoidable harm".

But now a freedom of information (FOI) request has raised questions about the validity of a previous study conducted by the regulator which was less favourable to the victims.

Image: It is alleged the drug may have been responsible for life-changing deformities to limbs

Campaigners who used Primodos as a pregnancy test believe the hormone-packed pill could cause miscarriage or congenital malformations to babies in the womb, from heart defects to spinal problems or shortened limbs.

On Thursday, health minister Nadine Dorries told the Commons: "I would like to make an apology to those people on behalf of the health and care sector for the time the system took to respond."

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It came after the Cumberlege Review said there is now a "moral duty" for the manufacturer of Primodos to contribute to a fund to care for those allegedly damaged by the drug.

However, the drug's manufacturer, Schering, was taken over by Bayer in 2006, and the German pharmaceutical company disagrees with the review team.

More from Primodos

It instead relies on a report from three years ago by an expert working group (EWG) under the Medical and Healthcare Products Regulatory Agency (MHRA) – which found there was not compelling evidence of a causal link between Primodos and birth defects.

Through an FOI request, Sky News has discovered that there are questions over how the conclusions of this report were reached – and it calls into doubt the transparency and independence of the 2017 report.

On the day of publication in mid-November 2017, Sky News noticed that there were significant changes to a draft copy that we had obtained that had been due to be published in October.

In the draft copy, a graph showed the majority of historical studies found that there was an association between the drug and malformations. This had been removed from the published report.

The original report had been ambiguous about its findings and said in its final summary: "The limitations of the methodology of the time and relative scarcity of evidence means it's not possible to reach a definitive conclusion."

That line was also removed for the final copy – giving more certainty to the EWG's assertion that evidence suggested there was no causal association between Primodos and birth defects.

Last year, a visiting academic to Oxford University, assistant professor Bennett Holman, spent several weeks documenting the changes between the draft and the published report, and he shared his findings with Sky News.

Assistant Professor Bennett Holman
Image: Assistant professor Bennett Holman spent several weeks documenting the changes between the draft and the published report

He noted there had been hundreds of alterations, and some of them changed the meaning of the report.

"I would say there were about 10 to 20 significant changes. The categories they fall into are reducing the communication or not communicating the level of uncertainty the EWG has in the report and adding in alternative explanations of information that would make a causal effect [of Primodos] less likely," he said.

Commenting on this, Professor Carl Heneghan from Oxford University's Centre for Evidence-Based Medicine said: "To go from that type of language from one [draft] to two [final], I consider is not just sloppy – it gets to a point where you are in a position to say this is now misleading."

Sky News set out to discover how these changes had been decided on. After all, the draft report had been nearly finalised and was shown to lead Primodos campaigner Marie Lyon. It was due to be published in October 2017 and was only delayed after Mrs Lyon pointed out apparent contradictions in the text.

The reason for the month-long delay was always a mystery.

There was a clue to what had happened when the chair of the EWG Ailsa Gebbie had a meeting with MPs on 22 November 2017 and told them: "The report went to the Commission on Human Medicines, who had tasked us with developing the report.

"They all commented on it very fully. They heard from Mrs Lyon as well. They felt we should strengthen the wording and offer greater clarity based on the findings."

But who felt it should be strengthened, and why?

:: Listen to the podcast: Primodos, mesh and valproate scandals – what next for survivors? on Apple Podcasts, Google Podcasts, Spotify, Spreaker

Sky News submitted an FOI request to the MHRA in July 2019, but was told public interest favoured withholding the information. After appealing, it was escalated to the Department of Health. An email from the private secretary of Matt Hancock confirmed "ministers" agreed the information should not be released.

However, in March the information commissioner ruled that there was "a strong general public interest in knowing whether the conclusion of the EWG's report about hormone pregnancy tests was or was not influenced by another body".

A month later Sky News was sent documents and emails with names of people sending and receiving them redacted.

But what the documents showed was that there was a great deal of toing and froing and discussion by people who were not members of the EWG about the conclusion.

A public inquiry in investigating allegations of birth defects as a result of the drug Primodos
2017: Sky News special report

The experts on the EWG have to declare conflicts of interest and are the ones who had spent two years independently assessing the evidence, but there were now clearly other people involved in deliberations.

After several redrafts, through correspondence from unidentified people, there was an agreed conclusion which included the words "the limitations of the methodology of the time and the relative scarcity of data means it is not possible to scientifically rule out an association with certainty".

But after this is emailed to the EWG for approval, it is later redrafted agaiRead More – Source