Oral Hormone Pregnancy Tests

Nick de Bois Excerpts

Thursday 23rd October 2014 Commons Chamber

[Yasmin Qureshi]

I entirely agree with my hon. Friend about the cover-up.

We have recently discovered another document in the Kew archive: a letter from the 1960s about the minutes of a meeting of the General Medical Services Committee, in which Dr Inman was involved. It says that there was worry about a request by the Committee on Safety of Medicines that doctors should be monitoring adverse reactions to medication. Doctors were a bit concerned about that in case they might be liable for negligence actions. The minutes say that doctors should stop recording adverse reactions, and, even more significantly, that those who have recorded any such evidence should have it destroyed. That fits in with the constituents, including mine, who have said that when they, as parents, have gone to their doctors to get their records, they are somehow mysteriously missing.

A British medical director of British-based Schering Chemicals, which is a subsidiary of Bayer Schering in Berlin, urged the withdrawal of the hormone pregnancy drug primodos in 1969, but his plea was rejected by the company. In the same year, the author of a survey for the Royal College of General Practitioners also recommended the withdrawal of the drug, but he, too, was turned down. Until this day, Bayer has refused to take any responsibility.

Jason Farrell, the Sky News reporter I mentioned, has met the statistician, Dennis Cooke, who was contracted by Schering in the ’60s. In a report, of which he still has copies, he compared the increase in the sales of primodos with the number of recorded deformities in newborns, which, he says,

“show a rather alarming direct and strong correlation.”

Schering stopped promoting primodos in 1970, and prescriptions fell from 120,000 in that year to 7,000 by 1977, when it was withdrawn. National statistics show that birth deformities declined during that period as well.

Another person I want to allude to is Professor Briggs. Many times, whenever it has been contacted about this, Bayer has referred to the court case of 1982. It is important to explain to the House that the damage claims brought by the victims were discontinued in the 1980s because some of the medical witnesses defected to the defendants, Schering Chemicals, so the case had to be withdrawn. Some of the victims say that the so-called experts who went over to the Schering side had an interesting story. One of those was Professor Briggs. Some years after the case collapsed, The Sunday Times published an interview with Professor Briggs by Brian Deer, a journalist, in which he accepts that he had in the past “fabricated” studies and carried out

“scientific fraud on a large scale”.

That is on the internet and can be read by anyone.

On a CD that has been kept under lock and key—there is an injunction on it—Professor Briggs is heard confessing:

“Difficulties would be encountered if doubts expressed about hormone pregnancy tests were made public. These were exactly the same hormones as the contraceptive pill and would have cast doubt on the safety of hormones which would extend doubt on the safety of the Pill. This would have a major influence on worldwide family planning which could be a real human disaster. It could cause panic among millions of women worldwide which could result in thousands of pregnancies.”

Later he claims:

“Drugs such as these would never be allowed to be on the Market today, given what we ‘now know’ and following what we know about Potential Hazards to the developing Foetus.”

Those comments were made in a documentary called “The Primodos Affair”, which has never been aired because Schering took out an injunction. Why did it do that? What did it have to hide?

There is further curious evidence regarding other witnesses. Dr Smithills approached a drug company for which he was doing research work on the drug Debendox. He suggested that he would approve the drug and that a funded research project would be an appropriate reward. Dr Inman opened a research centre soon after the case, after he left the Committee on Safety of Medicines. And guess what? Professor Briggs also opened a research centre in Australia soon after the case.

I have no hesitation in saying that those witnesses were bought off by Schering. It is amazing how all of them ended up opening research centres, which, as everybody knows, costs money.

Obviously, the situation is not this Government’s fault, but no Government have taken action over the years. Given the weight of evidence, why did the regulators not warn the doctors? According to internal correspondence from the Committee on Safety of Medicines, it admits that it has

“no defence for the 8 year delay”.

Interestingly, the authorities in Sweden, Finland, Germany, the USA, Australia, Ireland and Holland issued warnings and took action on the drug as early as 1970, five years before any warning was issued in the UK, despite the fact that the first group that knew about the problem was the Committee on Safety of Medicines.

One of the things thrown at the victims is the claim that there is no link, but there is a link: so many statistics show a correlation and so many doctors saw what happened. There seems to have been a complete failure on the part of the body appointed to monitor medication. It could have taken action but failed to do so, so the Government of the day were culpable.

Interestingly, Schering discontinued the product and stopped using it for pregnancy tests. Surely that suggests that something was wrong with the drug; otherwise, it would not have been taken off the market.

It is said that justice delayed is justice denied. We have found out in recent years about cover-ups in relation to so many tragedies, including thalidomide, Hillsborough and the sexual abuse of children in care homes and institutions. The 1960s and ’70s seem to have been an era of cover-ups, wherever we look, and victims in those cases campaigned for years and years to get an inquiry. The case under discussion has been going on for 30 to 40 years. Is it not about time for the victims—there are thousands of them—to get the justice they deserve?

[Nick de Bois (Enfield North) (Con)]

I congratulate the hon. Lady on the work she has done to secure this debate and her work with campaigners. She is drawing a contrast between this and previous cover-ups. To support her point, I should like to point out that, in this new age of transparency, we seek not a public inquiry but an independent panel, which should be well within the Government’s gift.

[Yasmin Qureshi]

I entirely agree with the hon. Gentleman. I thank him for all the support that he has given me and all the work that he has carried out in the campaign on behalf of his constituents.

I want to end by paying tribute to Marie Lyon, who has already been mentioned, and the victims association for all its work, as well as hon. Members who have given their help and assistance. I want to name-check two hon. Members who, because of their positions, are not able to speak in the debate: one is my hon. Friend the Member for Garston and Halewood (Maria Eagle), who is in the Chamber; and the other is the Minister for Government Policy and Chancellor of the Duchy of Lancaster, the right hon. Member for West Dorset (Mr Letwin), who is not here today.

--- Later in debate ---

[Nick de Bois (Enfield North) (Con)]

It is a pleasure to follow the hon. Member for Coventry North West (Mr Robinson). He may be troubled—or pleased—to know that I have spoken after him on more occasions than I have any other Member, which means that I have probably listened to more of his speeches, and he has had to listen to more of mine, than absolutely necessary.

It is a pleasure to support this debate and the case made by the hon. Member for Bolton South East (Yasmin Qureshi). I know that she has made considerable efforts in this very distressing matter. With all the cynicism about politics today, if we ever need a reminder of how active constituency MPs can play a positive role for their constituents, the evidence of this debate makes the case better than anything else I could say.

A constituent of mine, Chris Gooch, approached me some time ago about this issue and her daughter, Emma-Victoria. I echo what my hon. Friend the Member for Aberconwy (Guto Bebb) said—that the sense of responsibility that parents feel in such circumstances is magnified by the fact that they cannot as yet even be certain that the decision that they took in good faith, fully trusting the medical authorities and the drugs manufacturers and confident that regulation would protect them, has had such a dramatic effect on them and, more importantly, their offspring.

Chris Gooch made this point to me: “When I went to the GP, I did not ask for medication. I went to get confirmation of pregnancy. I knew nothing of what tests were available, but have since found out that a totally safe urine test was already available. So why was I given something that had been raising concern among professionals for many years and with no warnings given to GPs?” That sums it up. How is it possible that people can have gone with confidence to a GP they trusted, hoping for confirmation of a joyous event in their lives, and been handed two pills, without prescription, that had a legacy that will live for ever? I hope that the House will be able to make a contribution to lifting the veil of secrecy over this issue by persuading the Government to hold an inquiry.

Let us remind ourselves about that drug. One dose of primodos equates to 13 morning-after pills or 157 oral contraceptive pills. I am no medical expert, as many will testify, but it strikes me as somewhat perverse that a pill with such high levels of medication should be used as a pregnancy test. Surely that is a cause for concern.

Our motion is very simple and the hon. Member for Coventry North West has been kind enough to spell it out. We understand the constraints on government but we hope, particularly as this Government have been determined to shed transparency on so many issues that have been clouded for decades, that this relatively simple and reasonable request for an independent panel to look into the paperwork, history and documentation not in the public light will be accepted. Let me try to anticipate some of the points that might be raised in objection.

The question of causal link, which I am told scientifically may be the case, should not be a barrier to an independent panel. Many scientists and experts have raised the possibility of a large question of doubt. Let us face it: in this place we have made policy on the basis of less evidence than that which has been put forward by panels of experts who raised significant doubts about the treatment that was available and freely given to unknowing patients.

Without running through the whole list, two or three striking pieces of evidence have stuck with me. On 4 November 1966, a consultant pathologist from Sheffield said

“The test is unreliable. It may well have been dangerous”.

On 23 June 1967, the Medical Research Council said:

“It looks like it could be another thalidomide story.”

Schering’s own specialist advice in the UK raised doubts.

Our job in this House is to reflect the wishes, concerns and priorities of our constituents. I find myself at one in asking the Government’s help to navigate through these documents and this history. It becomes very complex for all but the most persistent. It is with that in mind that I pay tribute to the campaigners, because they have not been daunted by that task. They have not been daunted by the conflicting evidence. They have not been daunted by the lack of funding, or the availability and sudden loss of witnesses to legal cases in the past. They have persevered ruthlessly to try to obtain documentation, despite having the full weight of the establishment against them so frequently and so often, that I feel the time is right for us to champion transparency. Let transparency be championed across the House, albeit that we need the Executive branch of government to implement it.

[Mr Robinson]

I have been briefed fully by campaigners outside this House. Marie Lyon, whose daughter was born with a very foreshortened arm, came to see me with her husband yesterday. She has been indefatigable in her briefing of MPs and we should pay tribute to her for that.

[Nick de Bois]

Indeed we should. I echo and support those sentiments, as I am sure we all do across the Chamber. They reflect the courage and determination of every sufferer in every family. Their bravery in confronting this and in facing the future should be honoured by the setting up of the independent panel that they rightly seek.

I want briefly to press three issues: the conduct of the manufacturer; the conduct of previous Governments; and the conduct of the profession. I believe they build a compelling case for uniting behind the motion.

In 1978, when this issue was first raised, a former Labour Member, Jack Ashley, championed the cause in Parliament. It was reported in The Times that he pressed the then Health Minister to hold a public inquiry—this was after an intolerable eight-year gap between the first doubts being raised and a warning being issued by the Committee on Safety of Medicines—but unfortunately his response set the tone for the future. He said that nothing new would learned from holding an inquiry—as we now know, thanks to the diligent work of campaigners, there was lots more to be learned, and there probably still is—and that it was not worth following up because most cases would have been dealt with. I submit that this approach—expediency over justice for victims of primodos—was not necessarily the right one to take. His tone was reflected in later ministerial statements, but Jack Ashley pressed on, and I am sure he would have been proud of the hon. Member for Bolton South East for showing the same diligence.

We need to explore what the committee did between 1967 and 1975, and it is right that we now give members of the action group the opportunity to understand what happened. What government records are lurking about? It is right that we finally establish how many people were put at risk. Where was the duty of care in government, the profession and the regulatory body? In 2014, we can at least make a modest effort to make up for the then Government’s failure to consider those points.

What of the profession? In 1967, the Medical Research Council made it clear that primodos could have been another Thalidomide—so far, so good—and warnings were expressed about the high proportion of pregnancies in 1968 following use of the drug. This should have been sufficient for the profession to press for more to be done. We know that the committee was prepared to publish information letting the profession know of its concerns, and it even concluded in a letter in 1967 that if its concerns were made known, it could reduce its use by GPs, and that this would have been no bad thing. But nothing happened. In fact, the committee referred it to a GP survey for two years, until 1969, despite being fully aware of the warnings, and nothing happened until the matter was exposed by the media in 1975. This led to warnings, and subsequently the manufacturer put a warning on the box.

In 1975, the World Health Organisation asked why nothing had been done for so long. I cannot judge what was going on at the time, but I think we will be judged on how we deal with this issue in this present time, and I hope that will be sufficient to drive the Government towards the independent panel. The company was completely aware of warnings—not just from the profession and the regulatory body with which it was in communication, but from its own staff.

I freely refer Members to my declaration on the Register of Members’ Financial Interests because I worked with medical companies before coming here. I am aware of much of the excellent research and development that has come from within this sector, but let that not cloud our judgment on this issue. We must hope that it is not just our Government and our NHS who buy into transparency; it must be the role and responsibility of our pharmaceutical companies to do so wherever they may be. We are not selling a consumer good here; we are selling a product that must secure the absolute trust and absolute faith of both the profession and the users. We should never be in the position of having to say that there has been the potential for deliberate mismanagement of information from, in my opinion, right across Government, manufacturers and regulatory bodies, leading to this most distressful and distasteful situation for people who are suffering now as a result of some of that conduct.

I hope that Schering, now Bayer, will embrace the mood of this House and voluntarily come forward with as much information as possible. In this age, that would bring more benefit than harm to corporations that are understandably concerned with their image; above all else, however, such action would enable them to fulfil a moral responsibility that has clearly been lacking in this case.

I would be grateful to know that today, notwithstanding all the other issues we can argue about and the things we could do, we can take a moral and justifiable stance to help secure justice for campaigners who have been worried, troubled and wronged for far too long. I hope that the Minister will listen favourably to that request.

[Several hon. Members]

rose—