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Dr. Bray: Does the hon. Gentleman consider that he is advancing the cause of safety of medicines if he asks for watertight, cast-iron judgments on whether a product is safe? To insist on a reply to such a question would force Ministers and the system into a quite impossible position. The Minister must ensure that agencies spell out the facts and that a judgment is given, but we must recognise that it is a judgment. Now that all the material has been published, is the hon. Gentleman saying that the general view of the medical profession is that they should prescribe third generation drugs in preference to second generation drugs in the ordinary case?
Mr. Hughes: The hon. Gentleman asks a perfectly proper and profound central question. I share his view. On this issue, I have been supportive of the Government, such as when the Secretary of State for Health made a statement about bovine spongiform encephalopathy. It is not my case that the Government should always reach conclusions on the basis of scientific evidence, and I hope that the hon. Gentleman accepts that. My case is that the letter and the press release that went out in this instance made it clear that the advice that should be given to general practitioners, and which it was suggested they should give to their patients, was that women on the third generation pill should change their prescription. That was the balance of view that was taken. I do not argue that the Government should substitute their view for that professional one.
The hon. Member for Motherwell, South is a scientist, and I am not, but I have done enough science to understand the issue. My case is that we should give people the evidence and the facts and that, from it, different conclusions can be drawn. I hope that the hon. Gentleman will accept that it is not the burden of my case that the Government should always have a definitive view, and I would not wish to push this or any other Government into that position. It is important that we do not spoon feed, or pretend to spoon feed, the public when evidence is often contradictory and difficult to draw conclusions from.
I shall move on to my final remarks, as I know that the hon. Member for Fife, Central (Mr. McLeish) wishes to speak from the Labour Front Bench, and I am keen to give the Minister plenty of time to answer the questions that remain to be answered. I have given the Minister notice of three specific questions.
First, the Secretary of State stated on 23 October 1995 that the concerns relating to oral contraceptives arising from the World Health Organisation study were brought to the attention of the Medicines Control Agency in July. Will the Minister confirm that that is not correct and that the MCA had the information in May, not July, as the evidence shows that it had a further two months' notice, which the Government have so far not admitted?
Secondly, in his statement, the Secretary of State indicated that adequate information had been made available to doctors to allow them to make informed decisions. That point was made by the hon. Member for Motherwell, South. When the Secretary of State made that assertion, the MCA was working with the Family Planning Association to sponsor a letter to correct some of the deficiencies of the 18 October "Dear Doctor" letter. The chief medical officer in Scotland made it clear that the "Dear Doctor" letter did not get through to all doctors, and he has severe concerns about the fax system, however good it might be in theory. The MCA spent in excess of £90,000 to sponsor the second letter, which was, in effect, a correction of the first. One of the Minister's written answers describes the second letter as having been issued because of a clear need to provide health professionals with additional advice and guidance on the practical management issues arising from the advice issued by the CSM. I hope that the Minister will issue a correction to the statement of 23 October, and confirm that the Government accepted that the information issued on18 October was inadequate and flawed and that they knew that by the time the Secretary of State came to the House on 23 October.
Thirdly, in a written answer on 19 December 1995, the Minister stated that the final report of the WHO study had been received by the MCA on 6 October. A further question, on 30 April, elicited the information that the final WHO report was dated 13 October. Any document received on 6 October cannot therefore have been the final report, which must mean that the answer given to the House on 19 December was inaccurate.
We are told, in "Questions of Procedure for Ministers":
Finally--this is a scientific point--why was an announcement made when there was no new evidence of increased risk? I have taken the advice that is available to all of us, and it has always been known that there is a small risk of blood clots--thromboembolism--from all oral contraceptives. It has generally been supposed that the risk was to about 30 cases per 100,000 women each year. All that the new evidence revealed was that the risk continues with third generation oral contraceptives, while for those containing second generation drugs it is lower than was previously supposed. The news was, therefore,
good news. It was that there is no greater risk and, therefore, there was no need for any alarming announcement.
Dr. Bray:
There were new data--I am sure that the hon. Gentleman accepts that--on second and third generation drugs. The new data showed that the risks from second generation drugs were lower than was thought and that the risks from third generation drugs were twice those of the second generation ones. The absolute level of risk depends on the denominator. A notorious problem in testing is that it is very difficult to know with what a comparison is being made, but in this case it is quite clear: it was between second generation and third generation drugs. I think that there is no dispute about the evidence.
Mr. Hughes:
I am happy to tell the House that, on those facts, there is no dispute between the hon. Gentleman and me, but I draw the same conclusion as I drew before: what went out was a warning. I think that he will accept that it was stated in the letter that GPs should advise women on third generation pills to change their prescription--but there was no evidence of greater risk. It was greater than with second generation drugs, but there was no evidence of greater risk than was known before. I shall conclude with what the professionals say about that.
The family planning faculty of the Royal College of Obstetricians and Gynaecologists advised GPs this January that it is safe for them to continue to prescribe third generation oral contraceptives. The chairman, who was present at the meeting of 13 October, said:
A separate survey by a family doctor in Oxfordshire found that 12 per cent. of users at her practice had stopped taking the pill on the day of the warning. A family planning expert, Dr. Horrocks, at Frenchay hospital in Bristol, said that at least 56 women were known to have had a termination in the past three months because fear had prompted them to stop taking the pill. She said:
"Ministers must not knowingly mislead Parliament and the public and should correct any inadvertent errors at the earliest opportunity."
I hope that the Minister will correct today what I am still perfectly happy at the moment to accept were inadvertent errors.
"The surprise is that the older Pills carry a lower risk than previously supposed. As this emerges as the true situation, one is forced to wonder whether the haste in disseminating the CSM letter was justified."
On 23 October, the Secretary of State said:
"the evidence is that . . . women do not find it"--
the advice--
"confusing."--[Official Report, 23 October 1995; Vol. 264, c. 706.]
I do not think that that is true. A survey of 1,300 third generation pill users carried out in November by Exeter university found that half had had their confidence shaken and that teenagers were particularly confused about the level of increased risk.
"This is probably an underestimate. In February, we could barely cope with the numbers coming in. Instead of having 70 waiting at one time, there were 170. The waiting list was much longer. Sometimes it was difficult getting women seen before 12 weeks."
There was widespread confusion and there was panic. Some doctors advised women to stop taking the pill immediately, even if they were in mid cycle. Others advised an immediate change to second generation pills and it has been professionally argued--I say this carefully because I do not want to be alarmist--that there has been one death of a woman who suffered a massive blood clot as a direct result of being switched from a third-generation pill to another.
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