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I also ally myself with the congratulations and thanks that my hon. Friend paid to The Citizen for its work on the ground, to the BBC team that made the "Panorama" programmeI am mindful of its help and supportand to the Seroxat users group, which has done a great deal of work to raise the profile of some of the difficulties that our constituents have suffered as a consequence of the drug.
In addition, as my hon. Friend highlighted, there have been cases such as the one in America which resulted in the killing of the entire family of a user of Seroxat, or Paxil as it is known in the United States. That has led, among other things, to court rulings that mean that adverts for the drug are no longer shown in the US. In this country, more than 1,000 Seroxat users have taken legal action against the drug company. The World Health Organisation puts Seroxat at the top of its league table of drugs from which people have difficulty withdrawing.
I am pleased to see the significant changes to the labelling of the drug which have been implemented as a consequence of the pressure applied by my hon. Friend and others, including The Citizen, "Panorama", Mind and the Seroxat users group. That took an awful lot of work, but it is important that people are aware of the side-effects that they are likely to experience if they take the drug. It is a shame that it took so much pressure for GlaxoSmithKline to accept that the drug has addictive qualities that go beyond the scientific definition of "addiction" and come under the definition understood by the rest of us, as lay people.
I follow what my hon. Friend said with three questions for the Minister. These points have been made but need to be emphasised and re-emphasised. As my hon. Friend said, the expert working group on SSRIs has been reporting, or on the verge of reporting, for some time. It is important that we have a date for that. There have been problems with that review, and I ask the Minister to consider those that have occurred at a European level. Members who were part of that review were alleged to have had interests in the drug company and, indeed, reported to have acted on its behalf in legal matters affecting it in America.
Perhaps most important is the transparency of trial data which is required. I shall not labour the point because my hon. Friend the Member for Newport, West has already made it effectively. At the moment we are totally reliant on drug companies for information about the drugs, and the only mechanism by which it comes into the public forum is the MHRA, so we need far greater transparency.
The Parliamentary Under-Secretary of State for Health (Miss Melanie Johnson): I congratulate my hon. Friend the Member for Newport, West (Paul Flynn) on securing this debate on an issue about which I know he and others feel very strongly. I welcome the support given to him by my hon. Friend the Member for Gloucester (Mr. Dhanda). I am well aware of the early-day motion on the subject and the questions that both Members have asked of Ministers.
Before I say more, given earlier references to suicide, I would like to place on the record my heartfelt view that, whatever the circumstances, suicide is obviously a devastating event, and our thoughts go out to the families of those who have suffered as a result.
The burden of depressive illness is felt at all levels of society and from the young to the elderly. One in three families suffer as a result of a member being diagnosed with depression, and sadly the toll of lives lost remains too high, with suicide claiming, on average, one person's life every two hours.
The treatment of depression with the older tricyclic antidepressants is characterised by significant side effects and a high risk in overdose. The newer class of medicines, which are known as selective serotonin reuptake inhibitors, or SSRIs, of which Seroxat is one, have a different safety profile and, importantly, are less risky in overdose. Antidepressants, and SSRIs in particular, have undoubtedly saved many lives. However, all effective medicines are associated with side effects, and questions remain about the effects of SSRIs on some individuals. A great deal of interest has been expressed, both here and in the other place, about Seroxat and the wider class of SSRIs. This debate provides us with a welcome opportunity to update the House on recent developments, as well as to address the points raised by my hon. Friend the Member for Newport, West.
The concerns expressed by patient groups and in the media over the safety of Seroxat and other related drugs have been taken very seriously and acted on. In response to concerns about withdrawal reactions and the question of an association of Seroxat with suicidal behaviour, an expert working group of the Committee on Safety of MedicinesCSMwas convened to examine the safety of Seroxat and related antidepressants. That group, through the committee, has already delivered important new advice, but it has more to doI shall come to that in a moment.
Seroxat was not, and never had been, licensed for use in those under 18, but it was used in that age group outside its licence. New data on Seroxat use in children under 18 years were evaluated promptly as soon as they became available and was considered by the CSM. Ministers accepted the committee's advice that the benefits of Seroxat in children for the treatment of depressive illness did not outweigh the risks, and that children under 18 years of age should not use Seroxat. Therefore, in a written statement to both Houses on 10
Thus in Europe and across the world, the UK has taken action ahead of other regulators to issue clear advice on the risks and benefits of treatment with Seroxat in the under-18 age group, and has gone further still to consider the remaining five drugs in the SSRI class and one that is related. Most recently, on 10 December last year, a full review of the remaining drugs in the class was published, again in a written statement to both Houses. Importantly, responding to feedback from clinicians and others, the Government took the unprecedented step of releasing summaries of the clinical trial data on which the advice was based to ensure total transparency for health care professionals, patients and the public.
I hope that my hon. Friend the Member for Newport, West will join me in paying tribute to the rigorous approach that is being taken by the expert working group of the CSM. The group has completed the most comprehensive review yet undertaken of the safety of SSRIs in paediatric use, and is now focused on completing its task of reviewing all the data on the use of Seroxat and related drugs in adults.
All lines of evidence are being examined, including a dedicated research study that uses the general practice research database to examine the evidence further, especially the difficult question about the age at which the benefits of treatment outweigh the risks.
Miss Johnson: I believe that that refers to the yellow card scheme, with which I shall deal shortly. My hon. Friend asked when the group was expected to complete its work. It is expected to report in the summer. I am sure that that is welcome news.
At this time, CSM advice is that in adults, the benefits of treatment outweigh the risks. I am sure that both my hon. Friends agree that we need to be clear that patients who benefit from Seroxat or other SSRIs should not be frightened into stopping their medication. Indeed, my
Following paediatric advice and taking on board patients' comments, the information to patients that accompanies Seroxat was revised to reflect patient reports more closely. My hon. Friend also made that point. The MHRA has issued a question and answer leaflet to form the basis of discussions between doctors and patients. That is also available on the MHRA website.
On the resources available to support the group's work, the chairman of the MHRA has given us his personal assurance that the important work is being resourced as a priority. The team, which includes medical, professional, scientific and statistical expertise, has demonstrated considerable commitment to ensuring that the work is taken forward urgently.
It is right that the expert group adapted its work programme to reflect new information on paediatric use, first on Seroxat and then on the other drugs, to prioritise consideration of other paediatric data. I know that the group is now keen to tackle the wider issues with all due speed, but they must also be tackled thoroughly and in a way that will stand up to scrutiny.
Let us consider the alleged delay by GlaxoSmithKline in submitting data to the MHRA. The agency treats seriously any failure to comply with the law and has a statutory responsibility to enforce the requirements of both European and UK law. The obligations on marketing authorisation holders within the law are clearly set out and failure to comply with them properly is serious and potentially a criminal offence, with the penalty of fines or imprisonment.
I am sure that hon. Members understand that, in those circumstances, I cannot make any statement that would prejudice the investigation or a potential prosecution of one or more parties. I can assure hon. Members that the issues will be pursued without fear or favour, but I cannot say more in public about the facts or what proof may or may not exist to suggest that a breach of the law has occurred.
Let me deal with some of my hon. Friend's other points. I have already answered the question about the time frame for the inquiry reporting. He also asked about confidence in the MHRA and its relationship with the industry. I assure him that there are clear safeguards
There are clear powers in the medicines legislation to require the marketing authorisation holders to submit all data that bear on any risk or benefit to the producers. I can assure my hon. Friend that I do not share his concerns about the operation of the MHRA.
In regard to the prescription of unlicensed drugs to children, we are clear that the use of such drugs is a matter for the individual responsibility of those who decide to prescribe them. As my hon. Friend will appreciate, this is generally a matter for the medical practitioners deciding to issue the prescription, as it would be for any other treatment issues between doctor and patient. We are working towards producing an effective strategy to deliver medicines to children, and towards ensuring that they are licensed pending new EU legislation that will become effective in 2006. There will therefore be a change in the arrangements, but it will not involve an end to the prescription of unlicensed drugs in relation to children, for the reasons that I have already given.
The National Institute for Clinical Excellence is producing guidance on the effective management of depression, which should tackle the question of prescription and over-prescription in this area. We are currently reviewing the yellow card scheme and will be considering proposals to strengthen it. The reports from patients have been a valuable contribution to the SSRI review and, yes, the current independent review of the yellow card scheme will make proposals on patient reporting. I can therefore assure my hon. Friend that many of the issues that he has raised are either in hand or being taken forward very seriously.
It has not been possible to address every issue that might arise out of this debate, but I hope that I have made clear the Government's actions to date, and our absolute determination to establish all the factsas far as that is possibleand not to shrink from the action necessary to protect and promote public health by ensuring that Seroxat and the related antidepressants are used to maximum benefit and with minimum risk. The Government are committed to ensuring that that course of action is carried out efficiently and effectively.