Hormone Pregnancy Tests

Debate between Ed Davey and Jackie Doyle-Price

Tuesday 23rd April 2019 Westminster Hall

[Jackie Doyle-Price]

I hear what my right hon. Friend says. There has to be some element of cause, otherwise there is no scientific basis for a judgment. I will have to agree to disagree with him on that point.

[Sir Edward Davey]

I have to intervene on the Minister on that point. In many cases, drugs are looked at on the probability of risk, not on causality. Causality is a much stronger test. In science, it is very difficult to prove. If her officials are telling her that about a causal link, they are wrong. I urge her to get separate independent advice on that.

[Jackie Doyle-Price]

The drugs are no longer available because of association, due precisely to that balance of risk. The issue that we are looking at now is to what extent that was understood at the time, and to what extent there is a liability. That is what the group is ready to look at.

[Sir Edward Davey]

The Minister is being very generous with her time. I refer her to the evidence that was in the Berlin archives, which goes back to 1968 and 1969, and to the meta-analysis, which proves that on the balance of probabilities there is no doubt. That became known not this year, but years ago.

[Jackie Doyle-Price]

I am answering on behalf of the working group. That is an independent process and I will try to do my best. The right hon. Gentleman raises the issue of the meta-analysis and the suggestion that Parliament has been misled about why that was not done. The expert working group discussed the merits of doing a meta-analysis at its fifth meeting. In its view, the studies were very different, not sufficiently robust and suffered from extensive limitations. The group concluded that conducting a meta-analysis was not the most appropriate way to analyse this type of study. Instead, the group developed a set of quality criteria and presented its assessment of each study in a series of plots. To reconfirm, the data was not considered sufficiently robust for meta-analysis to be used. One of the real problems we have is that we are talking about data that, as we have mentioned, is 50 years old and not sufficiently robust.

There have been some suggestions that the expert working group has been less than transparent. In line with the Government’s commitment to publish the report of the review and all the evidence considered by the group, all documents have been available for public scrutiny since November 2017. We have been very grateful for the involvement of Marie Lyon throughout that process.

There has been some criticism of the lack of an external peer review of the expert working group report. The Government’s independent scientific advisory body on the safety of medicines, the Commission on Human Medicines, acts as the peer reviewer for all expert working groups. It reviewed the draft report on two occasions before it was published. I know that Baroness Cumberlege will be looking at whether there has been sufficient peer review of that report, and I look forward to receiving her recommendations. As with any issue, new evidence can emerge in the meantime. I reassure the House that the Government have made a commitment to review any important new evidence, and we have honoured that commitment.