Hormone Pregnancy Tests — House of Commons, 2017-12-14
Topic: Health
Yasmin Qureshi (Labour, Centre-left): I entirely agree with the hon. Lady on this matter The inquiry was intended to look at a possible association, not a causal link. That is very important because a different burden of proof is required for a possible association as opposed to a causal link. That was changed, and nobody can tell us who gave the authorisation to do that. The EWG was asked to look at regulatory failures. There are thousands of documents from archives in Berlin and Kew that show that there was a link between the deformities and these drugs. The Committee on Safety of Medicines looked at these documents and decided not to do anything with them. Why was that? When the report came out, the initial draft said that it was impossible to reach a definitive conclusion. However, the final document was changed to say that it could reach that conclusion. When the chair of the inquiry was asked why this happened—by Jason Farrell, by me and by other colleagues in a recent discussion—she said that the Commission on Human Medicines looked at the documents very thoroughly and told the panel that "we should strengthen the wording and put a greater clarity on it." It is unacceptable for the commission to have asked the panel to change its conclusion When I raised the report with the Prime Minister recently, one of the reasons she said that there was confidence in it was that Nick Dobrik had said that he endorsed it. However, he has said: "I was very angry when I was informed that my name was used to endorse the conclusions of this report." Is the Minister aware that the EWG refused to look at the most up-to-date study on Primodos conducted this year by Dr Neil Vergesson? It said that the study had not been peer-reviewed, yet it looked at 44 other non-peer-reviewed studies, some of which had been produced by the manufacturer itself, Schering. Dr Vergesson found that Primodos deformed fish embryos, and if given in high doses actually killed them. Dr Dean apparently carried out a study and wrote to Schering telling it what his findings were. He also informed the Royal College of General Practitioners about this. That study has also been ignored, and there is no record of it at all. We know that it exists only because a letter was found showing that he had discussed this matter and told all the parties concerned what was going on, but again nothing happened The man in charge of the Committee on Safety of Medicines—its chief scientist, Dr Inman—also conducted a study and found that there was an adverse reaction. Instead of dealing with the issue, he contacted the manufacturer and told them to "take measures to avoid medico-legal challenges." Documents from Berlin show that he later said that the documents on which he based his investigation were going to be destroyed. He made that admission at a meeting with a Schering scientist in Bermuda. A Dr Greenberg carried out a study that showed a significant twofold increase in risk of malformed babies being born to women who took this drug. Eventually, in 1977, the Committee on Safety of Medicines wrote to doctors saying that the drug should stop being given. It said that "the association is confirmed" between Primodos and deformities. It was "confirmed", unequivocally—and that was in 1977 Why does the EWG seem to have disregarded all these studies, not to have bothered to take any interest in what was happening and failed to look at the regulatory failures? It is vital that further scientific research is carried out not only to establish an association, but because the EWG report says that the component parts of Primodos are currently safe to be used. That is very worrying, because it is being used in many contraceptive pills. Studies and independent research should be carried out on this, because we might find that even though the drug is being used, it might be harmful to women, and we could prevent further problems from occurring. I am asking for an independent inquiry into the regulatory failures. We must put the families first.