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11.51 am
Mr. Henry McLeish (Fife, Central): I congratulate my hon. Friend the Member for Motherwell, South (Dr. Bray) on bringing this debate to the Floor of the House. It is an important debate in many respects, the first being the recent health scares--the most notable being the BSE scare. We need to have a debate on the safety of medicines and on the way in which the Government handle the issue.
Secondly, very sophisticated electronic news-gathering now exists, and increasingly the Government do not appear to be aware of that. Scares can develop very quickly. Thirdly, with the advances in research in science and technology we are in a much better position to identify adverse reactions to drugs, which is much to be welcomed. Fourthly--this is really the background to the debate--we need to have a wider public who are more informed and educated on health matters. It is ludicrous that in 1996 a scare can develop so quickly. One of the reasons for that is the Government's lack of trust in the public and the lack of information that the public have on which to make informed choices about their health and the health of members of their families.
Above all, there is the question of public confidence in the scientific community, and in the ability of Government to disseminate information, which is a matter that we have to take extremely seriously. It is obviously an issue of public interest, but it is also an issue for manufacturers, who use sophisticated processes to produce excellent products and have a great interest in how we deal with the safety of drugs.
As my hon. Friend the Member for Motherwell, South suggested, we owe it to our scientific community to take them seriously. Scientists do an excellent job of advising Government, but they are often dragged into a debate and treated very unsympathetically. The issue is also vital for the medical profession, especially general practitioners, who are often at the sharp end of receiving information from Government and from the Committee on Safety of Medicines. They are also at the sharp end of public reaction, as we have seen with the scare about the oral contraceptive pill. The issue is of enormous interest for all concerned.
There are, however, no easy solutions. The hon. Member for Southwark and Bermondsey (Mr. Hughes) rightly made the point that there is no quick fix for some
of the serious concerns. Nevertheless, it is incumbent on parliamentarians and on all the organisations that I have mentioned to try always to improve communications techniques so that the public have information on which to make sound choices.
I will concentrate on two areas. The first is informing the public and the professionals when there is a safety alert involving drugs and medicine. Secondly, I will refer briefly to pharmaco-vigilance and the post-market surveillance of medicines as that is clearly an important issue for those in the field who seek to monitor what is happening in relation to prescribed drugs.
Today's debate has largely, and rightly, been taken up with last October's scare about contraceptive pills. That has been well documented and I do not intend to go much further into the details. However, important lessons can be learnt from the substance of that issue. It is important to stress that Government can learn lessons. Clearly, we have become immune to the Government's indifference in recent years in relation to certain issues. However, it is vital that they take seriously criticisms that are intended to help the public and not merely to be another debating point in the Chamber.
An article in The Times on 20 April this year was headlined:
Crucially--I have made this point before, but I will make it again because it is worth repeating--the public deserve to have proper guidance and proper information. In many respects, the BSE scare highlighted a real crisis of communication from Government to people. There was no attack on the scientific community, but the initial scare was the basis of the subsequent scares, for which everyone is now paying the price. Information is important.
An article in the British Medical Journal of Saturday 28 October advising women about which pill to take was a constructive piece. However, the article said that
It is also important to consider an article in The Lancet of 27 January 1996, which states:
It is crucial that we have safety margins, but monitoring must not create medical scares. I stress that point and I hope that the Government will respond to it. I have spoken mainly about the public, but in that particular scare, GPs, who are in the front line in terms of patient in care, were given only perfunctory notice of what was happening. Again, they were reading about it in the press while information was filtering through to their surgeries as to what they could tell patients who telephoned them. That smacks of a fundamental weakness in the process.
If the Government learn nothing more from today's debate than that they must continuously give information to the professionals to pass on to the public, we shall have done the nation a favour. That said, it strikes me that the Government are often unwilling to take lessons.
Let me summarise the serious issues. First, the quantity, quality and consistency of scientific evidence must be taken seriously. Secondly, although I do not want to join in the attack on the Government in respect of the announcement regarding the contraceptive pill, it is obvious that timing is crucial. Professionals must be informed and the Government must follow up initial health alerts with positive helpful guidance. It did not happen with BSE; we nearly had another crisis on the phthalate in powdered baby milk; and then, of course, there was the oral contraceptive scare last year. There are too many scares. Ultimately, the Government must bear responsibility for improving the handling of information.
Thirdly, the Government should review the process of circulating information to doctors. Fourthly, we need to examine the process of informing the public. Fifthly, there is concern about the detailed contents of letters and advice as there have been many criticisms in the past that, to use the old adage from one of the adverts, one should never make a drama out of a crisis. Clearly, we should be cognisant of wording and keep it very simple.
My final point relates to transparency and secrecy. It is not a particular attack on the present Government, but on all Governments. We simply do not take the public into our confidence in the way that we should. There is always reluctance to provide information when we feel more comfortable hanging on to it. It is clear from the medical press and consumer groups generally that there is too much secrecy about health matters. I hope that the establishment of the European agency will provide new opportunities to make issues more transparent.
I acknowledge that companies need to have an eye on commercial confidentiality and that sophisticated processes are at work, but none of those issues should be subservient to the need for the public to know and to make informed choices on the knowledge that they have. It is a difficult balance to strike. Nevertheless, we should be making greater efforts towards it.
I have outlined the issues to which the Government should respond, which involve their attitude as well as the implementation of practical policies. They have demonstrated more than a hint of arrogance and complacency in dealing with issues involving the public. We should remember that we are elected by the public and the Government are selected from a group of elected representatives. Therefore, the public should always be the overwhelmingly important factor.
Finally, so that the Minister, who is desperate to get to his feet, can have adequate time, I turn briefly to pharmaco-vigilance and surveillance in the marketplace. The system in operation is known as the "yellow card" system. It is a basic procedure whereby adverse drug reactions are recorded and forms are submitted to the authorities monitoring drug safety. The system is working well, but the BMA has raised two issues that I should like to put to the House.
First, it is clear that there are fluctuations in the reporting of adverse drug reactions. There could be good reasons for that, but the BMA suggests that there should be further research into how the system is operating. It could be that there are fewer adverse drug reactions, which would be warmly welcomed by all concerned. Secondly, there is a possibility that the time involved in filling in forms could be a disincentive to some GPs properly to report adverse drug reactions. There may be problems that require investigation.
The second issue raised by the BMA concerns the confusing terminology used in reporting adverse drug reactions. According to the BMA:
"Britain is criticised over pill scare".
It talked about the alert which, as the hon. Member for Southwark and Bermondsey said, is likely to lead to several thousand unwanted pregnancies or abortions. We should not underestimate the importance of that. The Times article then said:
"The announcement leaves Britain isolated over its stand on so-called third-generation Pills."
We are well used to the scepticism and exaggeration that can accompany press articles, but The Times makes an important point. The article continues:
"But the European agency said that there were too many uncertainties in the three studies used by the Government to justify its alert . . . The European agency said it was calling for more research."
The article highlights the concerns about why the Government took action and when they took action. It is now important to look further at some of the lessons that can be learnt from the way in which the matter was dealt with.
"legitimate questions may be asked about the timing of the announcement, procedures for circulating information to doctors, and the detailed content of the committee's letter".
Again, that illustrates the basic problem of communication between a Government who have absorbed information given to them and the professionals and the public to whom they give information.
"The UK and German regulatory agencies have erred and their respective governments must ensure that such intemperate action does not happen again. The European Union's regulatory authority and regulatory agencies in other countries, including the US Food and Drug Administration, have waited for the opportunity to examine in detail the published, peer-reviewed . . . studies."
That is another example of the wide-ranging criticism of the Government's handling of the matter. Articles in distinguished periodicals, the British Medical Association and many consumer organisations have also criticised the Government.
"For example the British Natural Formulary uses the terms 'cautions', 'contradictions' and 'side-effects', while MIMS (the monthly index of medical specialties) uses 'special precautions','drug interactions' and 'adverse drug reactions'. There is a European Union definition of what is an adverse drug reaction."
It suggests that a standardised definition might be helpful, but acknowledges the complexity of these matters. Nevertheless, the BMA has contributed two positive ideas to the debate and I hope that the Minister will consider them.
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