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

Written by on 10/07/2020

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.

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.”

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.

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.

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.

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 again with the above sentence being struck out. There is no evidence from correspondence provided that the EWG as a group agrees to this vital change.

In one email someone comments: “It might be worth reminding them that this is their report and their conclusions.”

But there is no correspondence showing the whole group endorsed this last-minute alteration.

In a statement on Thursday, the MHRA told Sky News: “It may not be obvious because of the redactions but the expert working group chair and the Commission on Human Medicines endorsed the changes to the report.”

This still does not explain who made them, or why they apparently were not shared with the rest of the group.

Transparency is particularly important for this group of patients. It should be remembered that a Sky documentary found that in the 1970s a regulator destroyed materials relating to research which showed a link between the drug and malformations.

Documents show he had done this to protect the manufacturer from legal challenges.

The emails from the MHRA make reference to the subject being a “hot potato” and there are warnings that everyone should be on board because Sky News is planning a series of reports.

But some invited experts also criticise the report’s conclusions for not reflecting the reality of the situation.

One wrote: “My overall feeling is that there is a contradiction between the scientific conclusions, which I think are stated too negatively, and the assessment of the regulatory process which is said to have been slow and inconsistent in the face of mounting global evidence (even though today the committee says there is no evidence).”

The invited commentator added: “If the committee is saying that there is no scientific evidence, why would the evidence have been any more convincing at the time, indicating the need for immediate action, even on a precautionary basis?”

Wednesday’s Cumberlege Review also questioned the changes made between the draft and final copy of the 2017 EWG report, saying the revisions “created different impressions in the mind of the reader”.

Baroness Julia Cumberlege told Sky News: “We do recognise, listening to people, hearing what they’ve told us, that there was an association [between the drug and malformations], we believe.”

MPs have called for Bayer to make amends.

SNP MP Hannah Bardell asked Ms Dorries: “Will she commit to rigorous pressure being exerted on companies like Bayer who frankly have got away with murder?”

Ed Davey, acting leader of the Liberal Democrats, added: “I want to see criminal charges brought against the real perpetrators of this scandal – the cover up. The suppression of evidence of harm; the marketing and sale of a drug which Schering and Bayer knew was dangerous.”

Bayer continues to insist that the totality of scientific evidence does not support a causal association. The 2017 EWG report is key to its defence, but there are now questions over the transparency and independence of that report.

(c) Sky News 2020: Primodos scandal: ‘Significant’ changes were made to key report