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Oral Contraceptives

Volume 264: debated on Monday 23 October 1995

The text on this page has been created from Hansard archive content, it may contain typographical errors.

3.30 pm

With permission, Madam Speaker, I wish to a make a statement about the steps taken last week to inform women of the latest evidence about the safety of some oral contraceptives.

In July this year, information was brought to the attention of the Medicines Control Agency by the World Health Organisation which appeared to show an increased risk of thrombosis associated with certain oral contraceptive pills. That information was discussed at a meeting with the World Health Organisation in Geneva on 10 and 11 July. The Medicines Control Agency immediately concluded that further evidence was necessary to test the preliminary conclusions from the work carried out by WHO.

The Medicines Control Agency was aware of another study on the same issue being carried out by Professor Spitzer, and requested accelerated analysis of his data. It also agreed with Professor Jick that he should conduct a further study using evidence from United Kingdom general practitioners.

Information from the studies conducted by Professor Jick and Professor Spitzer became available in early October. These data led the Medicines Control Agency to convene a special meeting of the Government's independent expert advisory body, the Committee on' Safety of Medicines, for 13 October. That committee advised:
"there is an urgent need to communicate the new evidence and appropriate recommendations to the professions and to the public prior to publication of the evidence."
On 16 October, Ministers accepted the advice of the committee, and asked the Medicines Control Agency to make arrangements to release the advice later in the week.

The following arrangements were therefore put in place by the MCA. First, letters were dispatched on Wednesday 18 October by first-class mail to 190,000 doctors and pharmacists. Secondly, every director of public health was contacted during working hours on Wednesday and told that he or she would receive important health information through the chief medical officer's Epinet electronic communication system overnight and asked to make arrangements to disseminate it to GPs and relevant hospital doctors immediately. That aspect of the communication arrangements reflects the method of urgent communication between the Department and doctors that we have agreed with the British Medical Association. Thirdly, faxes were sent directly to hospital drug information pharmacists.

Against that background, the Medicines Control Agency planned a public announcement on Thursday afternoon in order to allow doctors and pharmacists time to assimilate the information being provided to them. However, the first inquiries from the electronic media were received in the Department at around 9 am on Thursday. The Medicines Control Agency therefore decided to bring forward the public announcement to midday in order to ensure that a properly balanced message was made immediately available.

The key points of that message are the same today as they were last Thursday: first, that the increased risk of thrombosis from taking the seven relevant brands of pill remains roughly half the risk of thrombosis associated with pregnancy; secondly, that women who are taking one of the seven relevant brands should continue to do so until they have seen their GP or family planning doctor.

The Government have a duty to evaluate information on the safety of medicines as soon as it is available, and to ensure that doctors and their patients are in possession of the information necessary to allow them to make informed choices about their own health. That is what we have done. Such information inevitably involves extra work load for professionals, and I am most grateful to those who responded over the past weekend to the extra work load that has unavoidably been placed upon them.

I thank the Secretary of State for coming to the House and making his statement. He will be aware that I do not seek to question the judgment of the Committee on Safety of Medicines, and that I entirely accept that, as a lay person, he must accept its advice. If it advises that three new studies must be acted on, he had no option but to act.

I should like the right hon. Gentleman to deal with two points that are his responsibility: first, what happened last week; and secondly, what action he will take in the future. Is not the heart of problem the fact that over 1 million women were told that they must seek advice about a serious risk to their health, but that the doctors to whom they turned for advice were themselves in the dark?

Does the right hon. Gentleman admit that it was wholly unsatisfactory that GPs and doctors in family planning clinics were not informed in advance, and had to base advice to their women patients on what they saw on Thursday's news and read in Friday's papers? Does he agree that GPs are right to be angry that they had to rely for medical advice on page 2 of The Guardian and the BBC's "Nine O'clock News"? Would it not have been possible, in this age of information technology, to ensure that GPs got the information ahead of the press, or, at the very least, at the same time?

The press conference was planned for Thursday, but some doctors had still not received notification by the end of Friday. The notification was so slow that some doctors are calling it "snail mail". The Epinet urgent procedure, to which the Secretary of State referred in his statement, is supposed to notify doctors on the next working day after it is activated: that did not happen. Will the right hon. Gentleman agree to review its operation?

Does the right hon. Gentleman admit that the Department of Health also woefully underestimated the number of calls to the helpline, which was swamped with calls and engaged all day on Friday?

The Secretary of State has just told the House that the Government have a duty to ensure that doctors and their patients are in possession of the information necessary to allow them to make informed choices about their own health. That did not happen; last week, the Government failed in that duty. What action is the right hon. Gentleman going to take to make sure that this does not happen again?

Does the right hon. Gentleman acknowledge that, although he has been saying all weekend—and is saying again to the House today—that he is satisfied with what happened, GPs have been saying all weekend, and are saying again today, that they are not? As it is they who are the front line to whom patients who have been alerted must turn, is it not essential that GPs have confidence in the system? Will he, at the very least, undertake a review, and agree procedures that restore the trust of GPs?

Finally, I would like to join the right hon. Gentleman in thanking all the doctors, nurses and other health staff who, although completely taken by surprise, laid on extra telephone lines and clinics throughout the weekend, printed their own leaflets for their patients and generally worked their socks off. Our GPs and their patients deserve better than the complacency and incompetence that the Government have shown.

All my hon. Friends will join me in welcoming the hon. Member for Peckham (Ms Harman) to her new responsibilities. I am grateful for the fact that she does not question the advice from the Committee on Safety of Medicines. In that, at least, I entirely agree with her. We are dealing with serious information concerning the health of women. We are dealing not with the stuff of party politics but with matters that people care about, which directly affect people's lives.

The hon. Lady says that not every GP knew at the ideal moment to give advice to his or her patients. I concede that that is true, and recognise that, after any incident of this kind, we must ensure that the arrangements are reviewed to learn any lessons available to be learned.

But the hon. Lady offered me no suggestions from the Dispatch Box about how the arrangements could be further improved. She did not respond to the fact that the. arrangements planned for Thursday demonstrated that we expected to be able at least to have the morning for GPs and other doctors and pharmacists to assimilate the information made available to them. The Secretary of State for Health simply cannot carry on a cosy correspondence with 190,000 health professionals. These are issues in which the public have a legitimate interest, and it is neither possible nor desirable to carry on that correspondence in private.

The hon. Lady offered no method whereby I can ensure that professionals are briefed before their patients come to see them. She talked about electronic communication—we used it; she talked about prompt use of the mail and faxes—we used them. All those procedures were used. We shall ensure that any lessons are learned, but let us not imagine that we can deliver such information to GPs and health professionals in an orderly fashion hours before their patients come to see them. That is not the real world.

May I thank my right hon. Friend for issuing that information as soon as he received it? Had he not done so, he would, quite legitimately, have been accused of a cover-up. Does he accept that, once he knew that there had been yet another leak—goodness knows where it came from—and that the media knew about it, he had no option but to hold a press conference? We all thank him for dealing with the matter as he did.

I am grateful to my hon. Friend. Obviously, I agree with her. I am encouraged when I consider what the hon. Member for Peckham would have said at the Dispatch Box today, had the impression got around that the Government were somehow sitting on that information without making it available promptly to every professional and patient with a legitimate interest in the availability of the information. My first duty was to make it promptly available to every person who had a right to know.

Although I readily acknowledge that the Secretary of State found himself in a difficult position and did what he thought was right, will he give the House the benefit of his comment on Dr. Bogle, chairman of the British Medical Association's General Medical Services Committee, who remarked:

"I see no reason as to why the profession could not have been alerted to the potential risks of these drugs well before alarmist statements were issued to the press"?
In that context, although Dr. Bogle's comment may not be justified, will the Secretary of State undertake to consult the profession to ensure that such issues can be dealt with more professionally in future, including the need for doctors who receive information to maintain confidentiality so far as possible for whatever time is needed?

To reassure women following this episode, will the right hon. Gentleman embark on a campaign of public information about contraception and the risks associated with it, including the problems arising from different types of contraceptive and further information on the much higher risk of taking oral contraceptives and smoking at the same time?

The responsibility for reaching clinical judgments about which contraceptives satisfy the standards required by law rests on me, subject to the advice from the Committee on Safety of Medicines. I do not propose to seek to interfere in its assessment of clinical risk. It is qualified to make such assessments, and its advice is that on which any sensible Secretary of State will rest.

The hon. and learned Gentleman asked me to look again at the procedures and to learn lessons. Of course it is true that we have a continuing dialogue with the medical profession and with pharmacists. We will seek to learn any lessons that are to be learned, but the hon. and learned Gentleman cannot get away with quoting Dr. Bogle and then seeking to distance himself from Dr. Bogle's remarks.

The question for the hon. and learned Gentleman is whether he agrees with the view he attributes to Dr. Bogle. Does he think that it is possible for us to carry on a correspondence with Dr. Bogle and the medical fraternity in secret from their patients, or does he recognise that, in the real world, information on such issues is almost bound to be provided simultaneously to health professionals and their patients? That is the real world in which we live, and it would be nice to have a clear answer to that question from the hon. and learned Gentleman.

I assure my right hon. Friend that he has the full support of the Conservative party for the action he took, and for coming to the House as soon as he possibly could to make a statement. Once furnished with the information, he clearly had a duty to bring it into the public domain. Once that information had been leaked, he had no alternative either but to call a press conference.

Can my right hon. Friend assure me that he took every possible step, not only via the mail, but through electronic or other means, to communicate with all those who should have had the information? If those lines of communication were subject to delay by some means or another, can he assure me that the fault does not lie with him?

I told the House about the steps we took to draw the relevant information to the attention of health professionals and their patients. I believe that we took all the steps that were open to us to make that information efficiently and promptly available. I have given the House the only rational answer: following an incident of this nature, we will, of course, review what happened and learn any lessons that are available to be learned.

Does the Secretary of State think it might have been better if he had come here this afternoon and said sorry for the real distress he caused to many millions of women who were absolutely frightened out of their lives by a half-perceived threat? When obvious chaos and consternation has been caused, is it not a Minister's responsibility to come to the House to say that he will ensure that that does not happen in future, and to apologise to the doctors and, above all, to the women concerned?

As for the hon. Lady's proposition that millions of women were upset and rang up to seek advice, I can give the hon. Lady the relevant figures. We set up an information service to make available the information to all affected women, in fact to anyone who rang us up over the weekend.

I heard the hon. Lady try to ring up that line when she appeared on "The World Tonight" on Friday night, but it was engaged. The problem for her was that the presenter had rung up before her appearance and had got through, so that tack did not work so well. As for callers seeking information, on Saturday 1,174 calls were received, and on Sunday 1,658 calls were received. This morning, I took the precaution of asking about the tone of the women who rang, and I was told, frankly, that they were a great deal more calm and more sensible than many of the people who have commented on the subject in the past few days.

Is my right hon. Friend aware that the Family Planning Association, to which many women turn in such circumstances, said that there was very little panic, and that women were asking simple and sensible questions? It said that my right hon. Friend behaved perfectly sensibly in making the information known. As has been said several times, the panic was on the part of members of the Labour party and the press in pursuit of some story to fill their papers on a Friday afternoon.

I agree entirely. The evidence, not just the impression, is clear; most women, when given information about the health risks associated with oral contraceptives, understood the message clearly. The message was straightforward. It was that the thrombosis risk associated with pregnancy is almost exactly twice the thrombosis risk associated with the seven brands of pill.

It clearly follows, first, that a woman on a course of these pills is better advised to continue to take them, as the Committee on Safety of Medicines said. Secondly, she should continue to take them until she has have received advice from her doctor, general practitioner or family planning doctor. Those were the messages that were put out on Thursday. The evidence is that they were understood by almost every affected woman. The only people who seem to have difficulty understanding them are a few commentators, some of whom are in the Chamber now.

May I assure the Secretary of State that the women who contacted me in Halifax were not in the category that he has described? Will he accept that women were confused and frightened when Professor Spitzer came from Canada to reassure women that everything was all right, and then the Committee on Safety of Medicines said that there was a slight risk?

Would it not be in the best interests of all women if they were given a clear answer and complete reassurance about taking the pills in question? Never mind messing about with statistics and saying that it is safer if women do not get pregnant. Surely it would be better if the pills were withdrawn if there is any risk to women's health.

The thrombosis risk associated with pregnancy is a relevant consideration if we are talking about a contraceptive pill. Professor Spitzer must account for himself. My responsibility is to form my own judgment, based on the evidence available to me from the Government's independent advisory committee. The hon. Lady describes it as confusing, but the evidence is that most women do not find it confusing. There is a clear piece of advice from which I quoted. It was given to me by the Committee on Safety of Medicines. That led the Government to act, and I believe that the Government were right to act.

My right hon. Friend was right to castigate the Opposition for putting fears among people about a perceived threat. He is right that the matter is far too serious for political slandering, which the Opposition are doing. I believe that the evidence that has been made available is still in the hands of the Department of Health. Will he make the evidence available to other medical experts and to the manufacturing companies involved, which are still very much in the dark about it? They should be told, and should be able to make their own defence, if need be.

Yes. Arrangements are being made for publishing all three of the courses of evidence on which the advice was based. I remind the House that our decision of last week was based on the explicit advice of the CSM that there was an urgent need to communicate the new evidence and appropriate recommendations to the professions and the public prior to the publication of the evidence.

The reason for that was to ensure that the advice was available promptly, and that it did not filter out as a result of the publication of a scientific paper in a scientific journal. The key priority is to ensure that the conclusions from that data are acted upon by health professionals. The data themselves will follow at the appropriate time in the appropriate place.

Surely the Secretary of State is aware that general practitioners and family planning clinics, for more than 25 years, have been scrupulous in inquiring into a patient's family history. If there has been any history of thrombosis, blood clotting or varicose veins, they have advised against, and in many instances refused to prescribe, oral contraceptives. Therefore, the statement that referred to seven such drugs caused especial concern among women who believed that they were not at any risk because of their genetic make-up.

It would seem that the Department of Health was lamentable in not realising that, in placing an embargo on any sort of press release and in not involving the press, it was failing to make it clear that there was perhaps no real reason for panic among the majority of women.

I entirely agree with the last comment that the hon. Lady made: that there is no need to panic. I ask the House to consider what the reaction in the House this afternoon would have been—and, I venture to suggest, that of the hon. Lady—if there had been a report in the Sunday papers to the effect that the Government had received the advice from which I have quoted from the Committee on Safety of Medicines and had decided to ask for am embargo. I wonder how many newspapers would have observed at my request an embargo on information of that nature about the safety of women.

No, I did not, and I do not expect that any newspaper editor would have acceded to the request if it had been made.

Is this not a classic case, in which my right hon. Friend is damned if he does something and damned if he does not? On balance, would he not prefer to be damned by the men and women of straw on the Opposition Benches, whose fitness [Laughter.]—unfitness—for government becomes daily more apparent?

I think that what my hon. Friend meant was their relative fitness for government.

I entirely agree with my hon. Friend. We are faced this afternoon with the fact that some Members of the House who have read a few newspaper reports over the weekend are looking for a way of causing trouble by allowing the story to run. What we have heard from none of them is a considered view about what it is right for the Government to do in circumstances in which they have been given advice of this nature. Not one of the hon. Members on the Opposition Benches has offered a conclusion to that question.

If I may assist the Secretary of State in two regards, it seems to me that one thing that went wrong last week in the handling of what has become a panic was that the GPs, who were to be the first port of call for the women who were taking one of the seven brands of pills, were informed of the dangers in the least effective way. What I fail to understand, and I ask the Secretary of State to consider this, is why he did not use electronic mail or faxes to communicate with those GPs. [HON. MEMBERS: "He did."[He did not; he wrote to them. That was in his statement.

What further steps are being taken to ensure that all the women who take one of those seven brands of pill will be written to, so that they can have a consultation with their GP to see what appropriate action should be taken for them?

The hon. Lady asked me about the use of fax and electronic mail to communicate to GPs—and, indeed, to other hospital doctors and pharmacists; we are not just talking about GPs. Yes, we did use faxes and electronic communication to GPs, because the approved system for cascading the results of the electronic communication from directors of public health to GPs is to use faxes where GPs have faxes, which is not in every case.

Fax machines were used. Electronic communication was used. First-class mail was used. The hon. Lady has not suggested a form of communication that was not used. However, I repeat to the House that we will, of course, consider the experience of the past few days, and if there are lessons to be learned, we shall learn them.

As regards communications between doctors and their patients about the conclusions to be drawn from this evidence and the way in which women should react to the evidence that was made available last week, that is primarily a matter between the doctor and the patient. The information is now in the public domain, and the advice has been given clearly that women should consult their GP or family planning doctor before embarking on the next cycle of any one of these seven brands of pill. The advice has also been clear that, if for any reason that is not possible, the health interests of the woman are best served by starting the next cycle of the same pill.

Does my right hon. Friend agree, in the light of what he just said about communication, that the bogus waffle from Opposition Members should not be allowed to overshadow the real achievements of last week, including the ability to dispatch simultaneously 190,000 letters from the Medicines Control Agency, and should it not be congratulated and praised for that?

I agree with my hon. Friend. A number of different communication modes were used, and the fact that they were all used together and over the same extremely short period is a tribute to the commitment and professionalism of the MCA and the people who work in it.

The Secretary of State asked for practical suggestions of what could be done to make such situations easier to manage if they occurred again in future. Given the present state of medical infomatics, there is no reason in principle why all GPs should not be able to use their computers to dial into an electronic database—basically, an electronic British National Formulary—which would give them the most up-to-date information.

Having spoken to both fundholding and non-fundholding practitioners in my constituency, I know that, since fundholding started, the lion's share of money for computers in GPs' surgeries has gone to fundholders. I have raised cases of individual non-fundholders who have not been able to secure the money. When the Secretary of State considers how improvements could be made, will he take account of the proportion of fundholders and non-fundholders with whom he has been able to communicate electronically, and then give the House a guarantee that computer resources will be put into all practices—those of both fundholders and non-fundholders?

The hon. Gentleman forgets that GPs are independent contractors. It is not up to me to go into a general practice and put in a computer system; what I do—or, rather, what the national health service does—is reimburse the expenses incurred in the installation of information technology. The initiative properly rests with the independent contractor—the general practitioner. It is for him or her to decide to use information technology for what seems the most appropriate purpose.

The NHS, through the system of fees and allowances, has a clear commitment to develop information technology as an important resource available to GPs. We shall continue to do that, but it is not up to us to impose it on them.

Does my right hon. Friend agree that the hon. Member for Barking (Ms Hodge) made a ludicrous suggestion, which would lead only to hundreds of thousands of women traipsing into their GPs' surgeries and clogging up the system? It is much more sensible for my right hon. Friend to stick to his well-established method of communicating such facts to the public.

I agree with my hon. Friend. Amid all the excitement here, we need to keep in sight the key relationship between the health professional—the GP, hospital doctor or family planning doctor—and the patient. That is the channel through which advice should be given. A Secretary of State for Health should be extremely chary of intervening in that relationship, or. seeking to impose himself on it.

Responsibility for using the information that is now in the public domain rests with doctors, pharmacists and patients. The Government have ensured that that information is made available to those with a duty—in the case of professionals—and an interest—in the case of patients—in using it.

First-class post is not considered good enough for every hon. Member to receive the Whip each week; we must use special delivery. Was special delivery considered a more efficient way of sending documents to doctors?

No. As I have said, we shall review the arrangements, and if there are better ways of ensuring that information is available promptly, we shall seek to learn any lessons that can be learned. We must not, however, set ourselves the objective of conducting a private correspondence between the Department and doctors whose time scale is different from that governing the provision of information to patients. Our objective should be to ensure that such information is made available to all health professionals who need to use it in a timely and efficient manner, at roughly the same time as it is available to their patients—preferably a few hours earlier.

Can my right hon. Friend think back as far as last Thursday, when his right hon. and learned Friend the Home Secretary was at the Dispatch Box defending himself from incorrect accusations that he was interfering with an agency and exceeding his powers? Does my right hon. Friend accept that complete humbug is today coming from the Opposition Benches?

Perhaps we are missing the major point in all this, however. The electronic and printed media did a wonderful job, albeit somewhat prematurely, in ensuring that all women who were taking the seven brands of pill took action to find out whether they should continue. Indeed, the information that was printed and broadcast by the BBC and ITV was clear about the real risks. We politicians often condemn the media, but they did a good job on that occasion.

I agree with my hon. Friend. When questions about the electronic media are posed to people at this Dispatch Box, it is not every time that the person answering feels inclined to offer generous praise. All the programmes I saw and heard on Friday gave a clearer and more balanced report of the advice that was coming from the Committee on Safety of Medicines than we have heard from the Opposition Benches this afternoon.

Any woman listening to the television and radio reports on Thursday and Friday last week was clear that the advice was, first, that it was safer to use the seven brands of pill than to get pregnant; secondly, that the course should be completed; and, thirdly, that, during its completion, medical advice should be sought. That was the message that was put out last Thursday. It was carried on all the electronic media, in clear language. It is only since then that some people have been trying to stir up excitement.

Further to the last question, does my right hon. Friend agree that, if the press announcement had not been brought forward as it was, a media scare story would have been running wild, with no official, definitive version of the facts available to the general public?

My hon. Friend is right. That is precisely why the timing of the announcement was brought forward on Thursday from afternoon to morning, to ensure that the first major coverage of it by the electronic media on the lunchtime news on Thursday carried a balanced message, not a leaked half-message.

Can my right hon. Friend please be kind enough to remind the House why, in principle, any form of contraception is offered on the NHS, which was never anticipated when the health service was set up with all-party support in the 1940s? As it is not an illness to have a baby, why should the prevention of a baby be regarded as a health measure?

The answer is partly that that has grown up over the years, and partly that the delivery of the objective of every pregnancy being a wanted pregnancy is an important objective of social policy. We cannot bemoan the problems associated with single-parent families and with parents who are not interested in their children, and remove the wherewithal for family planning and planned pregnancies; so the objective of every child being a wanted child is a desirable one that is served by this policy.

Listening carefully to what the Secretary of State has had to say today, I have two quite straightforward questions. First, will he tell us exactly the proportion of GPs who had faxes and were therefore faxed on Thursday, Friday, Saturday or whenever? Secondly, given that, during those three or four days, some of the women may have been out of the country, either on holiday or on business, will he take up the suggestion of my hon. Friend the Member for Barking (Ms Hodge) that all the women who are prescribed these brands should be written to with a careful explanation of exactly what has been going on?

I do not have the answer to the first of the hon. Lady's questions, but if she puts down a written question and the information is available at acceptable cost, I will be glad to provide it. [Laughter.] The hon. Member for Dagenham (Ms Church) laughs. I put in the qualification because I do not know whether I have the information in the Department on the number of GPs with faxes.

How did the Secretary of State know which GPs to fax, then?

It was the responsibility of the local directors of public health, not of the Department of Health.

On the second question of the hon. Member for Lewisham, East (Mrs. Prentice), let us just be clear what she is saying. We are talking about 1.5 million women taking these pills. As she rightly says, it is possible that some of those 1.5 million—a few thousand, perhaps—were outside the country last weekend. Is she really suggesting that we should circulate the information to all 1.5 million of them to cover the possibility that a few thousand were out of the country?

I rest my case on the proposition that the responsibility for giving advice on the health effects of these pills rests with the clinicians who sign the prescriptions. That is their job. We have provided them with the information that allows them to do that effectively.