Live at the Houses of Parliament

Thank you to Yasmin Quereshi for inviting me here today. And for those who know Marie Lyon, thank you, Marie, for telling me to be here today.

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In the 1960s and 70s, thousands of women were given the oral hormone pregnancy test Primodos and have been living with the consequences of their decisions ever since.

My expertise lies in determining the effectiveness of interventions based on the best available evidence. A systematic review is the highest level of evidence for determining an intervention's effects. It ensures you don't cherry-pick studies that suit your desired answer and uses all the available evidence to inform decisions.

In 2018, we published the first version of our systematic review.

The Primodos Scandal - Part 1 Carl Heneghan and Tom Jefferson · June 21, 2023 Read full story

We found 26 studies, including over 70,000 women, of whom 4,209 were exposed to HPTs.

Exposure to oral HPTs was associated with:

• A 40% increased risk of all congenital malformations:

• A near doubling of congenital heart malformations:

• More than doubling of musculoskeletal malformations

• And a near-tripling of nervous system malformations

HPTs also increased the specific VACTERL syndrome (Vertebral defects, Anal atresia, Cardiovascular anomalies, Tracheoesophageal fistula, Esophageal atresia, Renal anomalies, and Limb defects) by more than sevenfold.

However, was this finding new? No.

In 1975, the Committee on Safety of Medicines concluded that a warning should be added to the Data Sheets, stating that HPTs should not be taken during pregnancy. Two years later, regulators wrote to doctors, stating, "The association is confirmed.”

A doubling of risk is important, as it provides sufficient legal certainty to establish causation. In the US and UK law courts, a doubling of risk is accepted as a minimum threshold for establishing causation—the “but for test”.

So, what did the MHRA do to facilitate understanding of the evidence?

They tried to shut down the debate:

The MHRA emailed me in February 2019, stating that the discussions and participation in their review—of our review—could not be disclosed. On 5 February, I wrote, ‘I do not sign confidentiality agreements and cannot agree not to disclose my participation.' Six days later, they backtracked, ' As a visiting expert, you will not be required to sign a confidentiality agreement.’

Refusing to sign NDAs means I can continue to speak about their approach and be here today.

They also tried to obfuscate:

The MHRA refused to release the raw data from their own review. On 28 February 2019, Lord Alton of Liverpool in the House of Lords requested the data from the EWG report: ‘I welcome that. However, the raw data that Professor Heneghan needs to complete his review has not been made available, ' he said.

When we got the raw data, what did we find?

The data presented in the EWG report matched the results of our meta-analysis. They were nearly identical to the findings of Heneghan et al.'s review. Moreover, they showed low heterogeneity, meaning pooling the results was statistically appropriate. The MHRA’s reasons for not pooling the data in the EWG report were scientifically illiterate—they do not reflect an evidence-based approach.

The MHRA’s problems stem from its lack of independence. The notion that it can form an independent expert working group is an oxymoron for an organisation that receives more than 80% of its funding from industry.

Dame June Raine, the MHRA’s Chief Executive Officer, is to step down from transforming the MHRA from a regulator or watchdog to, in her own words, an “enabler.”

Consequently, the MHRA cannot keep patients safe. Importantly, it cannot accept the truth and does everything to defend the status quo. Hence, it fails to learn vital lessons as it tries to defend the indefensible.

In this House, the following was stated:

“I understand that it has not been promoted for pregnancy testing since 1969. Following evidence of a statistical association between its use and an increased incidence of congenital abnormality, the safety of the drug was discussed with the manufacturers.”

The year was 1979 - the speaker was Raymond Moyle, Labour Minister of Health.

The Primodos Scandal - Part 4 Carl Heneghan · June 28, 2023 Read full story

As we have heard, the drug continued to be used beyond 1969: women continued to be harmed until 1978, when it was removed from the market.

Baroness Cumberlege's IMMDS review, which examined the evidence for HPTs, mesh, and Valproate, stated that ‘her recommendations would improve the lives of people who have been harmed and make the system safer in the future.’

The independent expert working group review needed was the systematic review that our team conducted. Our centre's policy is to never accept industry funding as a means of remaining impartial.

Combining evidence from animal studies with statements made over the years, many of which have been made in this house, and the systematic review evidence leads to only one conclusion: oral HPTs in pregnancy increase the risk of congenital malformations, matching the findings from the EWG.

The people are losing faith in the institutions that govern them; it's time to put that right; it’s time to make the system safer - I consider that starts with Parliament's review of the MHRA’s independence and the acceptance that hormone pregnancy tests caused significant harm to the offspring of women - it’s time to apologise and provide redress to all those harmed by tests they never wanted nor needed.

The Primodos Scandal - Part 5 Carl Heneghan · June 30, 2023 Read full story

Many thanks for listening.