Oral Hormone Pregnancy Tests

Paul Burstow Excerpts

Thursday 23rd October 2014 Commons Chamber

[Paul Burstow (Sutton and Cheam) (LD)]

I congratulate the hon. Member for Bolton South East (Yasmin Qureshi) on securing this Back-Bench business debate, which is a great example of such debates being used purposefully to pursue a passionate commitment of a Back Bencher. I also congratulate all the hon. Members who have applied for this debate and participated in it on the basis of constituency experience. What has emerged palpably is a deep sense of injustice, and Nichola’s story, mentioned by the hon. Lady, is telling in that sense. These families’ lives have been marred by a sense of not knowing, of grief and, in some cases, of guilt, as was mentioned by the hon. Member for Aberconwy (Guto Bebb). Clearly, there is a strong belief that oral hormone pregnancy tests—primodos and others—taken between 1953 and 1975 did lead to children born with serious deformities.

It has been interesting to hear the evidence that has been gradually ferreted out of the system. It has been reluctantly given but persistently chased by those who believe that a deep injustice has been done. Some of the material that has come to light from the national archive as the relevant periods of time have elapsed demonstrates that. The hon. Member for Enfield North (Nick de Bois) and others have cited it, but it is worth saying that the director of the Medical Research Council—that is who this person was, so we are not talking about a small, insignificant organisation—said in June 1967:

“It looks as if this could be another thalidomide story”.

That should have rung alarm bells at the time, and it raises questions as to why if the bells did ring, they did not get heard and why the necessary steps were not taken for a considerable time after that.

It is interesting to look at this April’s report by the Medicines and Healthcare Products Regulatory Agency. Although it acknowledges that a number of the studies do identify concerns about an association between hormone pregnancy tests and abnormalities in children, it goes on to dismiss them, and that is a cause for concern. I was struck by the fact that the Committee on Safety of Medicines in the 1970s—the independent body that advised at the time—did advise on the safety of these drugs, albeit slower than many others when it did so. It advised that pregnant women should not be using these drugs. We have heard compellingly about how other countries acted sooner, presumably on the basis of the same evidence, and it behoves us to try to understand why we did not act sooner. We know from freedom of information requests that the MHRA did write to doctors in the 1970s—in 1975—warning GPs of its concerns about the congenital defects.

The MHRA made it clear that primodos was not licensed as a pregnancy drug from the early 1970s, so it was being prescribed off licence. If we look at the current codes of conduct within the General Medical Council about prescribing off-licence drugs, it is very clear what needs to be done. Extra obligations are placed on those prescribing, and I cannot believe that those obligations did not and should not have applied in the 1970s. That alone warrants this panel having a chance to ask questions. Thousands of prescriptions were still issued right through to 1977 despite the warnings and those extra obligations on doctors when they prescribed off-licence drugs.

In April, the review of the 36 studies that have been undertaken concluded, rather disappointingly, that the evidence was inconsistent and not sufficient to reach a conclusion. I cannot help feeling that there is something missing from the MHRA’s work. Indeed it says itself that something was missing. All it could rely on was the available published evidence. My question today is: what about the unpublished evidence—the evidence that sits in the vaults of the companies that manufactured the drug? I hope that, as an act of good faith, those companies that protest their innocence in all of this are now prepared to put into the public domain and fully disclose all of their information about trials, so that that can be taken into account as well.

The motion that has been tabled today is perfectly reasonable—some might say almost too reasonable—in what it is asking for. It is not an unreasonable request of the Government to have a panel to examine the evidence and to look at what is in the national archives, the MHRA files and the Department. I hope that Bayer, the pharmaceutical company that owns Schering, which manufactured the drug, co-operates as well. This is about learning lessons, ensuring that these things cannot possibly happen again and shining a light on to a very dark period in our medical history and understanding that even things that happened a long time ago continue to have real consequences in people’s lives today. Although I fear that action will not bring closure, we should at least take it because it might, and I hope that the Government will listen to the representations that have been made today, because the case for a review is compelling.