Part of the debate – in the House of Commons am 12:23 am ar 22 Gorffennaf 1991.
At least we have gained one admission right at the beginning of the debate.
Since Roussel Uclaf applied for a licence to market the drug in September, stories have been leaked to the press that the Department of Health was "fast tracking"—that is the term that was used—its progress to ensure that it would reach the marketplace with such speed that one would hardly notice its arrival.
On Thursday, my hon. Friend the Member for Hexham (Mr. Amos) tabled a question asking the Minister how many drugs had received product licences in the United Kingdom in the last year, and how long each took to receive its licence. The answer is interesting: it showed that new drugs took 19 months, and that established drugs also took 19 months, unless referred to a committee established under the Medicines Act, in which case the period was 23 months. That is surprising, because the process took only 10 months in the case of RU486.
By the most remarkable of coincidences, the company just happened to have organised, for the second half of July and the beginning of August, a series of seminars to take place all over the country, to promote the use of the drug. As a former Minister in the Department of Health, I know that seminars take a great deal of organisation, requiring considerable advance planning. However, the company was able to send out letters to every gynaecologist in Britain, on the very day that the licence was issued, inviting them to seminars, the first of which was to take place within days of the letter being posted.
Neither the Secretary of State nor the Minister saw fit to inform the House. They both know that there is a joint committee of both Houses of Parliament that holds a watching brief in pro-life matters. They know, especially from the debates last year, that there is considerable interest in the subject on both sides of the House. But all this was done in secret. No sooner was the licence granted than the company moved. The seminars had been organised, and everything was ready to go ahead.
Such is the scenario that a fair-minded person would wonder whether the company could assume in advance that a licence would be issued. We insist on having a clear answer on whether the company was told this in advance. If we do not have the answer tonight, we must have it from the Secretary of State. If the answer is no, my right hon. Friend the Secretary of State will have to draw up new rules to ensure that there is no repetition of such indecent haste in introducing a drug that it known to be dangerous, and is banned in other countries such as the United States and Germany. We are being used as a guinea pig for the vaster markets in countries which have a policy of restricting population growth.
What is more, as the Secretary of State knows, the drug has long aroused deep suspicion in the minds of parliamentarians and leading medical authorities. We were finally informed that the licence had been issued only because of the persistent questioning of my hon. Friend the Member for Lancashire, West. By the time that the question was answered, the licence had been issued. Such indecent haste demands an explanation, especially when one looks at the data sheet to examine the admissions that both the company and the licensing authority deigned to make.
As I have said, the Medicines Act was passed to ensure that never again would we experience another tragedy such as that caused by thalidomide, yet this drug was licensed behind closed doors, in record time, when, as we learn from the company's data sheet, it could result in the child being handicapped in the case of a failed abortion.
The data sheet says that, in such cases, the woman should be informed of the dangers, and it stresses that it is essential that the termination is carried out by another method. The manufacturers do not explain just how dreadful these abnormalities might be. My hon. Friend the Member for Lancashire, West has said that rabbits treated with RU486 developed sirenomelia—in plain English. mermaid syndrome—where the child's legs are fused together, quite apart from other gross deformities of the organs.
Let us be clear about this grave matter. Let us weigh carefully what the Department of Health has done. It may be said that the Department proceeded to license the drug in a fit of absent-mindedness, but I do not believe that for a moment.
We know that, in France, at least one baby exposed to RU486 was aborted at 19 weeks because its legs were fused. Its mother had changed her mind about having an abortion, but then the child developed such horrendous abnormalities that she clearly felt compelled to end the pregnancy. I use the phrase "at least one baby" advisedly. The case was cloaked in such secrecy that, when the story leaked out from the hospital, it took months for any real details to filter through. We have no idea whether information about similar cases has been successfully suppressed or not.
We need to know exactly what independent investigations, if any, were carried out by the Department of Health before it granted the licence. Both the manufacturers and the licensing authority have left unsaid things that most people would consider they ought to have said in explaining the possible handicaps that children who survived exposure to the drug might develop. They have also failed to make any reference to other abnormalities that could be just as dangerous, or even more so, since they could be passed down from generation to generation.
I should explain that I have been advised on such matters for some years by a committee whose membership includes some of the most distinguished medical figures not only in this country but in the world. RU486 is not dissimilar to another drug—DES, or diethylstilboelstrol —which was originally produced with the laudable aim of preventing miscarriage. In this country, it was given to some 10,000 pregnant women between 1940 and 1970.
Apart from the fact that it was not effective in preventing spontaneous abortion, the drug was finally withdrawn from the market when it was discovered that teenage girls who had been exposed to it in utero had developed cancer of the vagina. It was also discovered that 25 per cent. of males and 40 per cent. of females who had been exposed to it had developed abnormalities of the reproductive tract, none of which had been apparent at birth.
As if that were not tragic enough, it has been discovered in the past few years that the third generation may also have been affected. People who had been exposed to the drug in utero, but were apparently normal, have now produced children with urinogenital tract deformities, or children who have developed cancer in their teens or twenties. As a distinguished embryologist told me recently, the chemical time bomb ticks on; we can have no idea whether a fourth generation will be affected, or how.
Having considered the children who may be affected by RU486, let me now turn to women who, in their dilemma, may now be subjected to it. Admittedly, the manufacturers warn that women taking the drug could have heart attacks. At least one unfortunate patient has died in France from a heart attack, and at least two more have suffered severe cardiac trauma. The manufacturers have persistently stated that the drug should never be used in cases of ectopic pregnancy; that is also one of the contra-indications of the licence.
When a woman is being considered for an abortion by RU486, it should be mandatory for her to be given a scan to confirm an intra-uterine pregnancy; otherwise, her life will be in danger. As a number of our medical advisers—including gynaecologists—have pointed out, a woman suffering from pain and bleeding after taking the drug might well believe that the symptoms were related to her abortion, rather than being the early signs of a rupturing ectopic pregnancy, which could be fatal.
In this connection, it is of supreme importance to note that ectopic pregnancies have increased. I hope that the Under-Secretary of State will confirm that they have increased and are a significant cause of maternal deaths, yet nowhere in the Department of Health circulars on the subject of RU486 is scanning considered to be mandatory. We consider that to be absolutely scandalous. I hope therefore that we shall hear that there are plans to rectify that omission quickly. I require a precise answer to that.
I have been an opponent of abortion for a quarter of a century, but this is the first time that I have ever called for the withdrawal of a drug or for the banning of a technique to terminate a pregnancy. I do so now for one reason only. Far from being a simple, easy, new method of abortion, this drug, introduced by ministerial decree, is potentially very hazardous, and there has been almost no independent research on it.
I call upon the Secretary of State for Health to withdraw the licence and to order a proper scientific and wholly independent investigation that is not financed by the manufacturers. I should have preferred to say that to my right hon. Friend the Secretary of State for Health. I expected him to be here, since this is the most important subject that we have debated today. It relates not only to the health of women but to our children's futures. The Department is represented by the Under-Secretary of State. I hope that he has been fully briefed on the subject, for he will have to answer a great many questions. I hope too that he will pass on the message that I should have preferred to see my right hon. Friend on the Treasury Bench.
It will take great courage by my right hon. Friend to withdraw the licence, but for him to admit the possible dangers and to do what, in the circumstances, is right will enhance, not weaken, his reputation.