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11.18 am

Mr. Simon Hughes (Southwark and Bermondsey): I am grateful to the hon. Member for Motherwell, South (Dr. Bray) for introducing the debate, but I take a fundamentally different view of the lessons to be learnt and I shall set out why. For the record, I must say that, last October--the time that is most relevant to the debate--I was not doing my current job on health for my party, and I was therefore not directly involved at the time.

I was appointed to my current job later in the autumn and, by doing by my own research and investigation, I have come to the conclusion that several severe questions have yet to be answered by Ministers and that they have not yet come clean. Something appears to be rotten in the state of the advisory system on the safety of drugs. I am not a conspiracy theorist, but I remain to be persuaded that politics and medical advice were not intermixed in this instance, with the serious result that the health of a considerable number of women was adversely affected--in one case, potentially, fatally.

About 1.5 million women were using third generation oral contraceptives during the second half of last year and, as the hon. Member for Motherwell, South said, a preponderance of them were young. They were much more likely to be prescribed what are called third generation oral contraceptives, the clearest definition of which, as I understand it, is those that contain one of two chemicals--desogestrel or gestodene. They are the type of products affected.

I want, first, to put on record what I understand to be the sequence of events surrounding the Government's announcement on birth control pills, and a letter sent to general practitioners, last October, which had the same sort of effect as their subsequent announcement on bovine spongiform encephalopathy--namely, that they caused people to change their habits. It is clear that, as a result of the announcement in October, a considerable number of women stopped taking a particular pill, or any pill. The result was that many women had either abortions or unwanted pregnancies.

No later than July last year, interim results of a World Health Organisation study into second and third generation oral contraceptives were issued. The results were sent to the Medicines Control Agency, the body with responsibility for regulation in Britain. On 19 September, the MCA requested a meeting with Professor Spitzer, one of the three academics referred to by the hon. Member for Motherwell, South. Spitzer is the author of the transnational report. The meeting took place on 9 and 10 October, and those who attended were given tables from the expedited analysis of the study. On 10 October, Professor Spitzer met the MCA and the Committee on Safety of Medicines sub-group, which specifically comprises the people who make the decisions and recommendations.

The very next day--11 October--the MCA called a special meeting of the Committee on Safety of Medicines for 13 October. On the same day, it referred the matter to

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the European Committee for Proprietary Medicinal Products, the CPMP. Papers were sent on 11 October to CSM members who, on the same day, received the final manuscript from one of the other academics referred to by the hon. Member for Motherwell, North, Professor Jick.

CSM members received the papers--about 150 pages each--on 12 October. On the same day, the MCA met the producer companies, Organon, Schering and Wyeth. On 13 October, with only two days' notice, the CSM met. I hope that the Minister will tell us what it decided and specifically what it recommended, because it would be very helpful if its decision and recommendations were put in the public domain.

On 16 October, the hon. Member for Bolton, West (Mr. Sackville), who was then an Under-Secretary of State for Health, approved the sending of what has come to be known as the "Dear Doctor" letter, to be issued on 18 October. On 17 October, the European Committee met to consider the safety of oral contraceptives and that meeting went on until 18 October. On the afternoon of 18 October, the "Dear Doctor" letter was sent to about 27,000 GPs across the country. I shall deal later with whether it actually reached all those whom it was intended to reach.

On 19 October, there was a press conference to announce what was going on and that the letter had been issued. A press release was also issued. The press release is material because it gave doctors advice on what to say to patients but it also specifically made it clear that some women should be advised to change their contraceptive. In the press release, the chairman of the CSM stated:


The salient part of the press release is that advice should be given to change from an otherwise commonly used third generation oral contraceptive.

The very same afternoon--the public and the House can draw their own conclusions about this--and a matter of four hours after the press conference, there was a debate in the House on the Learmont report, during which the Home Secretary, more than ever before or since in his career at the Home Office, had his back to the wall. The Government were in considerable difficulty. On Friday--the following day--the Department of Health issued a press release refuting the claim that its analysis of the three independent studies was not the final one.

Mr. John Marshall (Hendon, South): The hon. Gentleman is obviously trying to create the conspiracy view of history, but on that particular day the Home Secretary gave the shadow Home Secretary such a beating and won such a parliamentary victory that the Government would have wanted it to make the headlines.

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Mr. Hughes: I accept that, but nobody was to know in advance that the Home Secretary would come out on top, not least the Home Secretary.

Mr. Marshall: The Home Secretary wins against the shadow Home Secretary in every debate. The shadow Home Secretary is an embarrassment even to members of his own Front Bench.

Mr. Hughes: I am not going to respond to that. I have my own views on those particular battles, but this is a debate on another matter which appears to have become intertwined with the Government's agenda of defending themselves against a serious report on the conduct of the Prison Service.

On Monday 23 October, the Secretary of State for Health made a statement to the House. In that statement, he did not reveal, although he knew it, that the "Dear Doctor" letter was going to be supplemented by a further letter intended to limit the damage caused by the first. The second letter was being prepared, and was sent on 26 October. It clarified and, in a sense, sought to allay the alarm caused by the first letter that had been sent only a few days earlier. Both letters came, in effect, from the Committee on Safety of Medicines.

To complete the series of events, in November, the hon. Member for Bolton, West was moved to the Home Office but, most materially, in April this year, the CPMP recommended that no action needed to be taken. On 1 May, however, the CSM sent a letter, which also is not yet in the public domain, to the manufacturers stating that it, the CSM, had advised the licensing authorities that regulatory action should now be taken. I understand that manufacturers are now considering appealing against that.

Dr. Bray: At this point in the hon. Gentleman's account of events, might it be relevant for him to say that, although the European committee did not recommend action, the German committee took action in amending the licence and, furthermore, since then I understand from a pharmaceutical company that the CSM has written to it proposing a change in the licence?

Mr. Hughes: I accept the hon. Gentleman's first point, although I am not in a position formally to agree it. On his second point, I said that my understanding was that the CSM had written on 1 May, and that and it is against its position that there will be some regulation that the producers are now considering appealing.

I contend--it is a belief that is also widely held in relevant professions--that there was great haste in rushing the issue through the CSM, in literally two days, and then on into the public domain, that that great haste was unjustified and that it cannot be adequately explained either by the scientific evidence or by the supposedly increased risk faced by women.

That view is supported by eminent people. For example, the Government's chief medical officer in Scotland, writing in the January 1996 edition of his official publication, "Health Bulletin", said:


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He refers to it as "an error of judgment". He goes on to say:


    "The Health Departments owe general practitioners an apology"

for what he then called


    "the fiasco over oral contraceptives."

That is the view of the Government's chief medical officer in Scotland, and I should be grateful to know whether the Minister agrees with it, and if not, why not.

Secondly, the chairman of the family planning faculty of the Royal College of Obstetricians and Gynaecologists, David Bromham, who I understand was present at the CSM meeting on 13 October as an outside adviser, has said:


I shall come back to him in a minute.

Why was there such urgency to get the CSM advice on supposedly new information relating to third generation oral contraceptives on 11 October? Again, to pick up a point made by the hon. Member for Motherwell, South, the issue was not considered by the sub-committee on pharmaco-vigilance, on the ground of the urgency of the matter, on any date before 13 October, even though it is the normal practice for safety issues to go to that committee for prior consideration.

The Minister, in an answer to me on 19 December, said that it is normal practice for urgent safety issues to be considered without prior consideration when there are time constraints, but here there were no necessary time constraints. The evidence had been around at least for weeks, if not for months. I say that for this reason. The regulatory bodies had information and did nothing about it from May last year until October. It is clear that the sub-committee met on 5 September and 3 October. We know that oral contraceptives were placed high on the agenda of the European working party in August last year. Therefore, it was already known that there was a problem.

The question is, why was the matter not on the agenda of either of the two meetings of the relevant sub-committee of the CSM in the UK, which had the principal responsibility for considering these issues, when it could have considered the matter on either of those dates last summer. A full committee meeting was called, at two days' notice, in October, the sub-committee was by-passed, and members were given 24 hours to read all the papers.

Next, I have a set of questions about the regulatory action. Why, if there was such an urgent need for people to know about the increased dangers, was no regulatory action taken from last October until 1 May this year? If the pills were dangerous, why was it perfectly permissible for them to go on being prescribed? The MCA specifically asked the CSM to consider at its meeting the regulatory implications and whether there should be withdrawal or warnings. Nothing happened for more than six months.

To make it clear, the word "warning" is, I am advised, a synonym of the technical term "variation"--a variation that applies to the regulations which govern the use of pills such as these.

The CSM was specifically asked about regulatory action in October. What we have not heard, and what the Minister has so far refused to reveal in any parliamentary answers, is whether the CSM recommended any regulatory action. I ask the Minister to make sure that he tells the House that in his answer today.

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With regard to the regulatory issues, as far as I can judge, and as far as I have been able to research and am advised, it is unprecedented to make an announcement, as the Government did and always planned to do, and then not to take regulatory action within a short period thereafter.

There was always going to be a public statement. It would have created as much of a scare as did the one issued at midday by the Department of Health. We know that because the Secretary of State said, in his statement to the House on 23 October, that the MCA planned a public announcement on Thursday afternoon. The Minister has twice refused to answer parliamentary questions from me asking him on which other occasions, if any, such a warning letter has been issued without follow-up action.

For fear that the Minister might interpret that as an unqualified criticism, I should say that I am grateful to him and to his officials, although they may not love me for it, for the many answers to my many questions that I have received. I do not want anyone to assume that a large amount of information has not been revealed. However, some of the key questions have not been answered and I do not want the Minister to believe that he is yet off the hook, because I do not think that he should be. I hope that he will answer today the questions that I pose today. If he does not, I give him warning that they will certainly be pursued. Has there been any warning letter in the past to doctors without regulatory action linked to it?

The only reason that I have been given for our not having the answer so far is that it would be disproportionately costly. That is a normal let-out of the Government, but compared with the consequences of this action, it could be argued that the costs would be worth paying. Perhaps the answer would be unhelpful to the Government.

Can the Minister be clear in his answer whether the pharmaceutical companies have a right of appeal? Were the regulatory authorities right to behave as they did? My advice is that, although they were given early advice that they were acting within their power to take the action, or inaction, that they took, they were subsequently told that they were not. We need to be told.

The fact that such issues have not been addressed and that answers have not been given is ground for suspicion about what the Government were playing at through those crucial days in mid-October last year. What was the outcome? Nothing happened in October, but on 1 May this year, more than six months later, the committee sent a letter to companies stating that it had advised the licensing authority that regulatory action should now be taken.

The only thing that had happened, apart from, if the hon. Member for Motherwell, South is right, the change in the German regulatory body's view, was that the European body, meeting on 16 and 18 April, decided that there was no decisive evidence of any increased risk from oral contraceptives, and had declined to recommend any regulatory action. Indeed, the chairman of the European body, Professor Alexandre, said last month that it would be "absurd" to take any regulatory action against any of the pills, given the uncertainty of the data.

If the Government did not take any action until May--they have now, apparently, taken action--because they were waiting for pan-European advice or action, why have

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they now proceeded to propose regulations through their agency, the CSM, against the recommendation of the European body?

In any event, the Minister for Health at the time said:


In his statement, the Secretary of State for Health said:


    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."--[Official Report, 23 October 1995; Vol. 264, c. 704.]

I assume, therefore, that that means that the Secretary of State takes responsibility for the regulatory action that the regulatory authorities have the power to take. The conclusion to be drawn must be either that the oral contraceptives concerned did not satisfy the standards required by law, in which case regulatory action should have been taken, normally on the same day, or they satisfied the standards, which we must assume was the case given that nothing happened for six months. If that was the case, why on earth did we have such an alarmist announcement in October?


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