House of Commons Hansard Debates for 12 Jun 1996 (pt 7)

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:

"I have written to all doctors and pharmacists to provide them with detailed advice . . . We realise that our advice will place a burden on doctors and pharmacists . . . Doctors should discuss the CSM's advice with patients taking the pills listed in order to determine whether a change in brand is necessary. In general, women taking a pill containing gestodene or desogestrel should be advised to change to another brand, unless they are intolerant of other oral contraceptives."

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:

"Last October's decision to publicise the CSM's warning to all doctors . . . was taken too hurriedly."

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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:

"one is forced to wonder whether the haste in disseminating the CSM letter was justified."

I shall come back to him in a minute.