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Health: Hormone Pregnancy Tests

Volume 768: debated on Thursday 21 January 2016


Asked by

To ask Her Majesty’s Government what is the timeframe for the inquiry into the safety of hormone pregnancy tests, and when they expect the report to be published.

My Lords, an expert working group of the Commission on Human Medicines has been convened to review all available evidence on whether use of hormone pregnancy tests may have been associated with adverse outcomes in pregnancy. The group met twice in 2015 and a number of further meetings will be held in 2016. A report of the group’s findings will be published once the review is complete, which is expected before the end of the year.

My Lords, the terms of reference of the inquiry still do not include past regulatory failures and the campaigners fear a veil of secrecy and an inability to get to the truth. What can the Minister say today to alleviate people’s fears? Will he agree to meet a delegation of campaigners and interested Peers to discuss how we can shine a light on what happened to learn the lessons of the past so that they are there for the future?

My Lords, this issue goes back to the 1950s, so trawling back over that period may not be that helpful. What is helpful is that we learn lessons from the past so that the existing regulatory system can learn from those errors. I am, however, very happy to meet the noble Lord and others who are interested to discuss this further, if they wish to do so.

My Lords, given that many of the survivors of Primodos, the drug in question here, were not told that they were taking part in a clinical trial, will the noble Lord assure us that today nobody would take part in a clinical trial without their knowledge?

My Lords, I understand that to be the case but I will double-check and, if it is not, I will of course write to the noble Baroness.

My Lords, is it absolutely clear that there will be full disclosure of all public documents and the regulators’ documents for this review?

I understand that all the relevant documents are being made available to the expert working group. The chair of the association looking after the children who have been damaged by these pregnancies is an observer on that committee.

My Lords, with deference to my noble friend’s Question, is it not a fact that 40 years on—it is actually more than 40 years because the last letter in the British Medical Journal was in 1977 on things that had happened previously—it is now really impossible to decide the precise nature of what happened after the dosage of Primodos? While an inquiry might be helpful to some people, it is very unlikely that we will uncover anything that will be really useful in the future. Is not the message to pregnant women that they are not advised to take any kind of drug during pregnancy?

My Lords, the noble Lord is clearly an expert in this field. If the advice is that pregnant women should not take any kind of drug during pregnancy, that must be the right advice. I agree with him that many of these documents go right back to the early 1950s and many are in German rather than English. The quantity of documentation is enormous. That is one reason why this review has taken so long. However, the people on the expert working group are very distinguished clinicians and are doing the best they can in very difficult circumstances.

My Lords, will the Minister confirm the reply he gave that no one will be asked to take any of these experimental things without being aware of doing so, because pregnancy is a time of great anxiety, particularly in view of the accidents that have happened in the past?

My Lords, there has been great fuss about the Prime Minister’s wish to ensure that all women, particularly Muslim women, learn English. What steps can the Government take to make sure that all pregnant women receive directly the medical advice that they need during pregnancy?

Much advice is available on NHS Choices and elsewhere. Clearly, GPs have a primary responsibility in giving initial advice to women, of whatever nationality, when they become pregnant.