§ Motion made, and Question proposed, That this House do now adjourn.—[Ms Bridget Prentice.]
9.11 pm§ Paul Flynn (Newport, West) (Lab)The Seroxat scandal is one of gigantic proportions, which affects millions of people. There has been over-prescribing and misprescribing of this antidepressant on a scale equalled only by the over-prescription of tranquillisers 40 years ago. It is likely that the legacy—[Interruption.]
§ Madam Deputy Speaker(Sylvia Heal)Order. Will Members please leave the Chamber as quickly and quietly as possible?
§ Paul FlynnThank you, Madam Deputy Speaker.
It is likely that the legacy of the misery created by what has happened with antidepressants will be at least as severe as what happened with tranquillisers.
The pharmaceutical industry has achieved miracles in disease control and elimination in the past century. It is not my intention to attack the science of that industry, but it is my intention to attack the spin, the marketing and the propaganda, all aimed at maximising profits, and the ineffective regulatory control that has failed to protect the public. GlaxoSmithKline, the manufacturer of Seroxat, has been exposed as duplicitous, profit-driven and irresponsible over the 14 years for which the drug has been available. It prizes its profits above the health of its customers.
Where there should have been scientific objectivity there has been voodoo medicine; patients who have sought care have had their trust abused. Seroxat has turned mild stress into suicidal despair, and in many cases a passing anxiety has become a lifelong addiction, leading to self-harm, suicide and even murder. Those who have long questioned the safety and efficacy of Seroxat were ridiculed and undermined by the pharmaceutical giant GlaxoSmithKline.
That company is the villain in those tragedies, but happily there are heroes— those who fought to expose the truth about the dangers, addictiveness and ineffectiveness of Seroxat. The heroes include Dr. David Healy, professor of psychiatry at the university of Wales, Bangor; the "Panorama" programme, which produced two splendid accounts about the effects of the drug; Sarah Boseley of the The Guardian; the charity Mind, one of the few charities that takes no money from the pharmaceutical industry—a significant point in this case—The Citizen,a local Gloucester newspaper which is to be congratulated on conducting a campaign with national results; and my hon. Friends the Members for Gloucester (Mr. Dhanda). for Dundee, East (Mr. Luke) and for Edinburgh, North and Leith (Mr. Lazarowicz) who have also been involved.
Seroxat is a selective serotonin reuptake inhibitor. The drug appeared only in the 1990s and took over from the tricyclic antidepressants that had been available since the 1940s. I believe that need for the drug is based on a great myth: the idea that we can go through our entire life in a state of continuous euphoria and that if we suffer a moment of discomfort, pain, boredom, grief or anxiety we should be classified as ill and in need of 111 medicine. If any of our loved ones feel similar unhappiness, we are supposed to feel guilty unless we provide them with a pill. If we are sadder today than we were yesterday, there must be something wrong with us. Humankind has progressed through many millennia without using antidepressants, yet the myth has been perpetrated and we are conditioned to believe it.
I wrote to GlaxoSmithKline more than a week ago to tell the company what I planned to say in the debate and asked for its comments. It has not had the courtesy to reply although I have received a number of letters from it over the last four years. The company has expressed the view that antidepressants should be taken by half the female population of the United Kingdom and a third of the male population; it wants to see 25 million people on antidepressant drugs. That is certainly not the number of people who suffer from the type of depression that needs medical intervention—serious, pathological, clinical depression. I do not want to minimise the effects of that dangerous illness, which can lead to self-loathing or self-destruction and certainly requires the attention of the medical profession.
We have been conditioned to believe that we need those drugs, but there are far better alternatives. For example, counselling does not involve chemical drugs; it is over-prescribed at present, but if people are looking for a way out of the hell of clinical depression, they would be well advised to study the work of Dr. Dorothy Rowe, who has written a splendid book about clinical depression, Depression: the Way Out of Your Prison". She gives vivid descriptions of people's reaction to deep depression—their feelings of hopelessness, of being locked inside a room and that no one can help them. She offers practical ways of dealing with depression through self-knowledge, meditation and exercise, which is very much in line with current Government thinking. Having spent the better part of my life ignoring exercise, I am a late convert to its joys. After discovering the great pleasure of endorphin-releasing exercise, I can go along with what is said about it.
The effect of Seroxat is not to free people from the prison of depression, but to create a new prison wall around them; that wall is all-encompassing and often encloses them in a prison of addiction. At the heart of the debate is ensuring that the Government do two things: the benefits of new medical discoveries should be enjoyed by all who need them, but the public should be guarded against the serious side-effects that such drugs can often cause.
We do not want to return to the terrible scandals of the past such as tranquillisers, thalidomide, Eraldin, Opren and others that have resulted in wasted lives. The charge against GlaxoSmithKline could not be graver: it has deliberately suppressed information on the danger of Seroxat and its lack of utility.
Two years ago, GlaxoSmithKline wrote me a letter that contains very little that is truthful apart from the date. We know that its spokesmen made preposterous claims on "Panorama", and the letter states:
The safety and efficacy profile of Seroxat has been confirmed through clinical trials involving thousands of individuals and the experience of tens of millions of patients over the 10 years the medicine has been available.112 The letter does not mention the number of reports that GlaxoSmithKline has disregarded, ignored or, as happened recently, actually suppressed.The issue is not new, but we learned about the worst case very recently. Studies have been conducted that prove that Seroxat is no more effective than a placebo, and that in many cases it is less effective. Such claims have been around for a long time, but in spite of that Seroxat was increasingly prescribed, and it overtook Prozac as the No. 1 antidepressant in the UK, with four million prescriptions a year at one time, and now that figure has greatly increased.
It is difficult to get precise figures about how many prescriptions are issued and how many people are on Seroxat, but, as with many things, we are following the United States line. We know that there are 3 million children on antidepressants in Canada and that there are 10 million children on antidepressants in the United States. Dr. Healy says
There is probably no area of medicine in which the academic literature is so at odds with raw data.After many denials, a particular report, headed "Confidential. For internal use only", has been revealed. It was prepared not a couple of weeks ago, although that is when it was published, but in October 1998. It refers to studies conducted in 1993 and 1996 of children and adolescents who were given courses of either Seroxat or a placebo. In one trial, there was no beneficial difference in the outcome between the placebo and Seroxat; in the other, the placebo produced superior results, which was not unexpected. The studies demonstrated that there is no beneficial effect in treating adolescents with Seroxat.One difference was noticed in children: suicidal behaviour was 1.5 to.3.2 times higher on Seroxat than on a placebo. It was not until 2003 that the body responsible for regulating medicine, the Medicines and Healthcare products Regulatory Agency, issued guidance to doctors that Seroxat should not be prescribed to people under 18.
However, a parliamentary answer that I have received in the last half an hour says that the Government do not intend to change the rules on prescribing unlicensed drugs to children. The Government seem to say that, if a drug works for adults, it should work for children. If so, it must also be true that, if there are increased suicidal tendencies among children, there is a similar effect on adults. Dr. David Healy reports that GlaxoSmithKline had evidence that approximately one in every 60 adults on Seroxat made a suicide attempt, while the figure for those on the placebo was one in 550 adults. That is an extraordinary difference.
David Healy gave evidence to the regulatory body, when it investigated Seroxat last year, and there is a rather bizarre story to tell about what happened. About nine months before, Dr. Healy had applied for a meeting with the regulatory body. When the meeting eventually took place, he was surprised that no one questioned the evidence that he gave to the regulatory body, although he was a long-time critic. Although some agreed minutes were supposed to be prepared, they were never sent out because many of the members of that committee had financial and other interests in GlaxoSmithKline and in other selective serotonin reuptake inhibitors. That is a deplorable situation.
I am sure that the Minister will say—it was said at the time—that the body is beyond suspicion and that those professional people will act in a disinterested way and 113 reach conclusions. That may be so. but it is unlikely that the public will trust such a body, when so many of those who judge the safety of medicines have dual interests of that kind, as well as an alternative duty as a regulatory body to ensure the success of the British pharmaceutical industry. If we are to have full trust in our regulations on such matters, we need a body that has only one commitment: the safety of the public and those who take the drugs.
GlaxoSmithKline has repeatedly failed to respond to patient reports of withdrawal difficulties and refused to publish reports that demonstrated that 85 per cent. of healthy volunteers in a controlled experiment suffered from agitation, abnormal dreams and insomnia, and there was one suicide. Let me make it clear what that shows: 85 per cent. of that control group of healthy people were not suffering from depression, even mild depression, but they experienced those problems. Time and again, we hear evidence of people whose behaviour is modified tragically by Seroxat.
Last year, the Brecon coroner, Geraint Williams, wrote to the Secretary of State for Health to ask for an inquiry into the drug after one such case. The family wished people to know about that case because they hoped that some good might come from the tragedy that had engulfed them. The case involved a retired head teacher, Colin Whitfield, who took his life after he was prescribed Seroxat. His wife said in court that that was totally out of character and that she believed that his mind had been affected by the drug. The coroner said that he was profoundly disturbed by the effect that Seroxat had had on Mr. Whitfield, and he accepted expert opinion that Seroxat could induce agitation and lead to people having suicidal thoughts.
Sadly, there are many cases of that kind. The Tobin case in America has become very well known. Again, the behaviour of a man who had taken just a few tablets changed in a way that his family said was completely uncharacteristic of him. He killed the three women in his life—the three people whom he loved the most—a wife, a mother and a granddaughter. He then killed himself. That was reported in the first "Panorama" programme on the subject.
Another case, which emerged in the second programme, involved someone in this country who suffered a similar character change after taking a few tablets of Seroxat. He tried to take the lives of his wife and daughter. and he then tried to take his own life.
It is difficult to see these cases as coincidental, because they are so similar. However, we must examine them and ask ourselves why such terrible tragedies have taken place. The clinical evidence suggests that the drug must take the blame.
The defence put up by GlaxoSmithKline is that the people involved are depressed anyway and that there is a chance that their taking the drug may lead them to self-harm. When GlaxoSmithKline examines the results of the trials, it gives the credit for beneficial results to the use of Seroxat. However, when there is a bad result, that is blamed on the depression suffered by those involved. The company cannot have it both ways.
Other side effects have been reported by the volunteers who took part in one of the trials. They reported difficulty in withdrawing from the drug and one peculiar effect of this drug and no other was electric 114 "zaps". They reported difficulty in walking, coordination problems, aggression, confusion, memory difficulties and lethargy. Yet the published account of that report never mentioned any of those things. The information was obtained because, in the court case in America, Dr. David Healy was allowed access to the files of GlaxoSmithKline, which did not include these results in its report.
That contrasts with the response received by "Panorama" following the broadcast of its first programme on Seroxat. It received 67,000 phone calls and 1,400 e-mails, almost of all of which reported problems with side effects and difficulties of withdrawal. Among the cases reported were 16 of accomplished suicide and 47 of attempted suicide. Those responses came from just the group of people who happened to be watching BBC 1 on the Sunday evening when the programme was broadcast. A follow-up survey by Panorama and Mind of 229 people using Seroxat found that 83 per cent. experienced withdrawal symptoms. The symptoms were "intolerable" for 44 per cent. and "severe" for 32 per cent. Therefore the use of the drug did not succeed for 76 per cent.
Seroxat heads the World Health Organisation's league table of drugs from which it is difficult to withdraw; it is higher than Valium. Our Department of Health agrees, and a reply that I received from one of the Minister's colleagues last year pointed out that, in her view, Seroxat makes the symptoms of depression more severe in the early stages. That point is widely recognised.
In spite of that, GlaxoSmith Kline repeatedly failed to remove the words on the side of the packet that said in unambiguous terms:
These tablets are not addictive …You cannot become addicted to Seroxat".The company changed its mind, but only in April 2003, 13 years after the problems began to emerge. In the first television programme, it was adamant that the drug was not addictive; in the second one, it blamed the patients for not understanding the warning. However, it is hard to imagine words that could be more explicit or less unambiguous. To this day, the company still gives the same advice on dependency to doctors. It argues that Seroxat does not cause dependency, but it certainly does, as the World Health Organisation and our Government agree.The patient information leaflet that GlaxoSmithKline puts out now states that 25 per cent. of those taking Seroxat will suffer a withdrawal reaction. That is an extraordinary change when compared with what it previously said. It declared the figure to be 0.2 per cent. until 2002, but it then increased the figure to 0.7 per cent. Now it has decided, after years of misleading everyone, that the true rate for addiction is about 25 per cent.
It is disappointing that the United Kingdom regulatory authority has failed to protect patients from the profiteering of GlaxoSmithKline. Even moves by the US Food and Drug Administration to warn patients about the potential problems associated with Seroxat amount to a slow reaction, and almost to a dereliction of duty. Patient complaints have been ignored by GlaxoSmithKline and by doctors, and by the regulatory body and its predecessors in this country. This is a familiar story.
115 One constituent wrote to me, saying that she reported a bad reaction to her doctor, who declined to report it under the existing yellow card scheme. That scheme, which was introduced after thalidomide, is ramshackle, does not work and is hopelessly ineffective. I remember receiving an answer from Gerry Malone, the then health Minister of a previous Government, in which he told me that the number of deaths arising from paracetamol in Britain were 46 in one year and 52 in another. I was astonished by that reply, because according to the coroner's report, there were between 500 and 600 deaths in each of those years. Mr. Malone was quoting the number of deaths reported through the yellow card system, but it understated the number; in fact, there were 12 times as many. Yet we are relying on that system to guide us on adverse reactions to drugs. It is no surprise that a system that is 40 years old is working in such an inadequate way. Only a tiny fraction of the reportable adverse effects are actually reported. It is nonsense to continue to rely on that system in this way. That is why there is a huge understating of adverse reactions, suicides and addictions. When the Minister sums up, I hope that she will say that we need to look seriously at any reliance that we place on the yellow card system.
In the television programme to which I referred, Dr. David Healy said that the evidence shows that roughly one person in 60 who uses Seroxat makes a suicide attempt. On the same programme, a GlaxoSmithKline representative gave a transparently dishonest account of its position. We are talking about a drug that is probably ineffective. There are few reports to suggest that it achieves markedly better results than placebos. As we know, it is addictive, and I should also point out—this is an important factor for the Government—that it is ruinously expensive. There has been a huge increase in the prescription of antidepressants, and few people who spend long spells in hospital can escape the well-meaning attentions of hospital staff, who regularly come round with their medicine trays and announce that one has been prescribed this pill and that pill.
A constituent of mine told me that when she was in hospital, she demanded to know what each of the types of pill that she was taking was. She was regularly told, "This is a painkiller", to which she replied, "Well, I'm not in pain, so I'm not taking it." On being told, "This is an anti-depressant", she said, "I'm not depressed either, so I'm not taking that." The excuse for prescribing such drugs is that one might well be in pain or become depressed later, so one must take them in anticipation of future pain or depression. Now that we know beyond any doubt that such pills are addictive, why on earth do we continue with this approach? Why do we still measure the efficiency of hospitals not by how much pain is relieved—admittedly, that is impossible to Measure—or how much depression is dealt with, but by how many pills are prescribed? That is an extremely ineffective method, and it is also extremely wasteful. One of the current problems is that although funding for the health service has gone up by 40 per cent., outcomes have increased by a much smaller percentage. One main reason for that is the extraordinary inflation of the drugs bill, which has increased at a far greater rate. Many of the drugs that are prescribed are probably useless or damaging.
116 Charles Medawer, the director of the medical research group Social Audit, said many years ago—before the latest announcement—that a study at the university of California's neuropsychiatric institute found that just over 50 per cent. of patients who were given Prozac, which is a similar drug, reported an improvement in their symptoms, but that an identical proportion of patients who were given a placebo drug reported the same results. That is nothing new because it has been known for a long time that SSRIs have a poor outcome for patients, so why on earth do we continue to espouse them and support their use?
Twenty-six new SSRI drugs are under development, so they will come later. We are undertaking an extraordinary experiment with human beings on a massive scale. There are rightly complaints about the drug ecstasy because it is used recreationally. It disturbs the chemistry of the brain, and no one can say what the long-term effect of that on the mental health of those who take the drug will be. The argument is precisely the same for altering the serotonin levels of the brain in the way that SSRIs do. No one can say what the long-term effects will be after 40, 50 or 60 years. The experiment is being carried out for the long-term interests of drug companies' profits.
I would like my hon. Friend the Minister to deal with several points. Although research is continuing, Charles Medawar says:
I see antidepressants as the biological equivalent of thumping a TV on the top to help improve the picture"—we know that that works, but we do not know how it works. However, in this case, we know that the drug does not work, but we still go on thumping. He said:My belief is that in 30 years, our grandchildren will look at the way we treated depression in the 20th century with the same disbelief as we look at the way we prescribed tranquillisers 30 or 40 years ago".That is the position that we are in now.When will the inquiry on selective serotonin reuptake inhibitors that ended in such confusion be re-established, and when will it report its findings? What are my hon. Friend's proposals to restore full confidence in the Medicines and Healthcare products Regulatory Agency, which is, strangely enough, entirely funded by the drug companies—only two countries in the world are in that position? The Public Accounts Committee was critical of the situation last year, and said that stakeholders would have a lack of trust because the agency is entirely funded by the companies—that is like getting Arthur Anderson to audit Enron.
What action does my hon. Friend propose to take to ensure that the pharmaceutical companies publish all results of their drug trials? We know that two trials took place that proved beyond doubt that the drugs had no utility and that Seroxat was useless. We also know that the results were not published, and the drug company made it clear why it was not publishing the results by saying:
it would be commercially unacceptable to include a statement that the efficacy had not been demonstrated, as this would undermine the profile of117 Seroxat. That is an indication—a confession—that the suppression of the truth of the report has nothing to do with health or safety; it was done only for commercial considerations.No one else is carrying out such trials on a similar scale. We give a free hand to the drug companies to carry out trials. If they do not like the results, perhaps because they are likely to reduce their profits, they suppress them and keep them secret. We must ensure that the regulatory bodies have the power to insist that the results of all trials are published. They might claim that they already have that power, and that may be the case, but the results of the trials, which finished in 1998, should be available; otherwise, there is no way of informing patients.
Will the Minister act now to at least reduce the prescription of unlicensed drugs to children? That continuing scandal has gone on for a long time. I know there are many reasons for it, but some drugs are prescribed to children which are almost certainly harmful because of a child's different metabolism. Does she have proposals to end the under-reporting of the yellow card scheme? Will she consider developing a scheme to allow testimonies from patients to be considered along with those from doctors? Underreporting is serious, but when the patient whom I mentioned tried to persuade a doctor to report her problems, the doctor refused.
Seroxat should be withdrawn from use, certainly for new prescriptions. That might cause difficulties for those who have been on it for a long time because of withdrawal symptoms. It would be cruel to take them off the drug to which they are addicted overnight, but for new patients it should be withdrawn. The evidence is there to support that. There should be an urgent review, not the relaxed leisurely review of the past two years, of Seroxat and the other SSRIs to determine their safety, the possibility of addiction and the other severe reactions that have taken place in a significant group of people, in particular those who have felt suicidal.
There has been a major failure by the regulatory authorities, especially in the light of the fact that they refused to take patients' testimonies. The new MHRA should be far more proactive in seeking adverse reaction reports and establish further ways of using direct experience of medicines in drug safety monitoring. It was shocking to discover that the MHRA and its predecessor often only looked at summaries of conclusions rather than at the conclusions themselves. All those patients who are taking drugs need better information from manufacturers and doctors on possible side effects and withdrawal effects and need advice on how to manage and support withdrawal.
There has been an immense scandal, involving many millions of people. Those patients who have gone on to Seroxat, who have sought solace and care, have been abused by the system and GlaxoSmithKline, and have been let down by us as parliamentarians and the regulatory authority.
§ Mr. Parmjit Dhanda (Gloucester) (Lab)I shall be brief, not least because my hon. Friend the Member for Newport. West (Paul Flynn) has done a thorough job, 118 and I congratulate him on his work on the drug, which he has done over many years. I am relatively new to the field, as someone who was elected in 2001, but I have become aware of the effects of Seroxat on many of my constituents. When I tabled early-day motion 238 last year, it took virtually no time to gather 100 signatures.
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" programme—I am mindful of its help and support—and 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.
As I highlighted in the early-day motion, side effects and withdrawal symptoms include muscle spasms, insomnia, anxiety, depression and, in some cases, aggression and violence.
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.
To reiterate, the WHO puts Seroxat at the top of its league table of drugs from which people have difficulty withdrawing. At the very least, it needs to be monitored 119 far more closely, and I urge the Minister to heed what my hon. Friend said and do whatever is in her power to ensure that that happens.
§ 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 Medicines—CSM—was 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 do—I 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 10 120 June last year, the Government announced new advice from the CSM advising against the use of Seroxat in children under the age of 18 for the treatment of depression. Since then, the balance of risks and benefits of Seroxat has been the subject of a referral to the European equivalent of the CSM—the Committee for Proprietary Medicinal Products, or CPMP—which is undertaking a further review of all the available evidence on Seroxat. In the United States, as hon. Members will be aware, the Food and Drug Administration has been considering the use of SSRIs in children and is considering what regulatory action is necessary.
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-8 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.
§ Paul FlynnDoes the general practice research database mean that my hon. Friend has evidence from doctors? We now know about the extraordinary underreporting by doctors, who have many things to do.
It being Ten o'clock, the motion for the Adjournment of the House lapsed, without Question put.
Motion made, and Question proposed, That this House do now adjourn.—[Ms Bridget Prentice.]
§ Paul FlynnCan my hon. Friend influence the body to accept evidence from the general public and not only from the medical profession? The Seroxat users association makes that complaint.
§ Miss JohnsonI 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 121 hon. Friend the Member for Newport, West made a similar comment. Patients who experience side effects or are worried about their treatment should discuss that with their doctor.
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 122 in MHRA staffs terms and conditions, as with those of civil servants, to prevent any influence. Furthermore, the governance of the agencies is constituted to oversee its operations appropriately.
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 facts—as far as that is possible—and 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.
§ Question put and agreed to.
§ Adjourned accordingly at eight minutes past Ten o 'clock.