| Previous Section | Index | Home Page |
Paul Flynn: Is the hon. Gentleman aware that Eliot Spitzer in New York took GlaxoSmithKlein to court and the company was fined? That revealed a truly shocking picture of falsified research: negative results were ignored; results showing that new drugs were not as effective as placebos had been buried and not published; and the results of trials during which people had died had been suppressed. That is a dreadful record and although I tried to congratulate the drug companies on having changed their act, the past is one of deception, errors and manipulation on a scale that most of us could not imagine.
Mr. Lansley: I understand the point that the hon. Gentleman has been making and I do not doubt his long history of work on the subject. He does an important job and I do not dispute that. We need people in this place who come at the arguments from many different angles, but his argument seems to be that the bottle is one tenth empty. We must remember that the bottle is nine tenths full; the pharmaceutical industry has made and continues to make a remarkable contribution to the public benefit by improving our health.
One of the Government's central messages is about the reduction in mortality from coronary heart disease, but they know perfectly well that that has occurred throughout the world as a consequence of the introduction of statins. That is but one example. The hon. Member for Bolton, South-East (Dr. Iddon)
8 Dec 2005 : Column 1058
rightly gave the hon. Member for Newport, West a short lecture on the range of benefits that the drug industry has brought us.
The hon. Member for Bolton, South-East was also right to point out the risks associated with both parallel trade and internet trading, which are not necessarily the same thing. Parallel trade is not illegal. It is a consequence of the fact that we do not have a single market in pharmaceuticals, nor are we likely to. I am certainly not saying that we should leap to that situation. We have to acknowledge that large price disparities, especially in parts of Europe, can have a substantial impact on trade and can dramatically undermine the intentions behind the pharmaceutical price regulation scheme. We need to be aware of that and, if necessary, adapt the PPRS in response. I shall return to the PPRS later.
Counterfeit trade is illegal and extremely harmful. Everything I hear confirms that the scale of internet trade in counterfeit drugs is rising. Whenever there are questions about the preparations for pandemic flu and the availability of Tamiflu, the counterfeiters try to trade on that public concern and satisfy the demand.
We have not talked much about the necessity for public information. There is a range of possibilities for better informing the public about the availability of drugs and about why some medicines should be prescription-only. We need to think hard about the circumstances in which they should become pharmacy medicines. That has been advantageous in the case of statins and the same may be true of antiviral drugs in the future.
We must also consider the public understanding of risk, about which we could talk for a long time. If the public become direct participants in reporting adverse drug reactions and adverse events, as they will under the yellow card scheme, they need to be much more aware of risk and the kind of adverse event that we anticipate. I am sorry that there was not more discussion during the debate of the Government's response to the yellow card scheme, which is important, although we should not get too carried away. The yellow card scheme in the UK did not disclose the problems with Vioxx, nor did the Medwatch scheme in the United States. As the Select Committee pointed out, they were largely disclosed during large-scale, long-term trials, designed to establish the efficacy of non-steroidal anti-inflammatory drugs in the treatment of other conditions. That illustrates that the longer one continues the process, the more trials one does and the more patients who are exposed to a drug, the more likely one is to establish safety data. I am not a scientist, so I cannot explain how the procedure works, but I am confidently assured that although trials that establish efficacy, safety and quality for licensing purposes are immensely expensive, there are many reasons why their scale is not necessarily sufficient to establish safety against a range of untoward events. Such trials disclose immediate safety events in controlled populations, but they do not reveal less common events that could occur in larger populations. That explains why we must think about post-licensing surveillance, which is important, as the Committee and the right hon. Member for Rother Valley rightly pointed out.
8 Dec 2005 : Column 1059
There are several factors that could help us to achieve that. The national health service could be an important international organisation in the process. It would help the pharmaceutical industry in this country if we could use effectively the connecting for health programme, the electronic patient records and everything that goes with them to create population-wide databases that would give us good information about adverse events. We have the general practice research database, but if that were to expand and migrate into the connecting for health programme, it would help us enormously. Although we have prescription-event monitoring at the moment, I understand that about 30 per cent. of GPs do not participate in it. We need something that will be effective across the board and not likely to be affected by any distortions and biases that might occur due to the self-selection of participants.
The document "Safer Medicines", which was published by the Academy of Medical Sciences only two weeks ago, makes interesting reading. I do it an injustice by picking out only one or two aspects of it, but it addresses useful matters that have not been mentioned. The document refers to conditional approval, which would occur if licensing meant not simply saying that a firm could market a drug without any further conditions, but saying that there were as yet unproven safety considerations that would have to be addressed through the subsequent use of the drug. If a company were able to extend the life of patent protection while it continued to acquire data, it would be in its commercial and economic interests to undertake much of the larger-scale work that would be necessary to acquire data from a wider population who were using a drug that was effective for their needs, rather than only those involved in clinical trials. It would thus be understood whether any contraindications associated with the drug would affect its final licensing approval. The academy did not recommend such a scheme, but as it discussed it, I thought that it would be an interesting matter to put to the Minister for further debate.
Secondly, the academy referred to the importance of using European data. Of course, the sooner one arrives at a point at which a large population is using a drug, the more likely one is to identify adverse events that might occur. The academy refers to the need for an international co-ordinating centre on drug toxicity and the ability to undertake DNA sampling. The beauty of such an approach is shown by the fact that we increasingly find that drugs might be especially effective in circumstances in which people have a genetic predisposition. For example, Herceptin is likely to be effective for the 20 per cent. of women with breast cancer who are HER2-postive. Equally, there may be genetic predispositions towards adverse drug reactions, and we must focus as much on that possibility as on the positive opportunity to find drugs by understanding people's DNA responses. If we can do so, that will provide another positive benefit.
My hon. Friend the Member for Southend, West made a good point about tuberculosis testing and the Mantoux test. If we are to have a NICE mechanism whereby the NHS undertakes evidence-based appraisals of clinical and cost-effectiveness to inform its clinical activity and priority setting, and if vaccines are available
8 Dec 2005 : Column 1060
as alternatives to drugs and chemical compounds for the treatment of prostrate cancer and other cancers, I can see no reason why those vaccines should not be subject to NICE analysis. Indeed, that would have a positive benefit, as it would be more transparent. I have voiced the persistent complaint that the joint committee on vaccination and immunisation fails to give transparent advice. Its advice is subject to delay, and all the papers submitted to it are effectively invisible, because it is only the minutes of meetings that appear on its website several months after the meetings themselves are held. My constant plea is that we should have more transparency, as vaccines will become increasingly effective treatments.
Another major issue raised in our debate is the take-up of drugs and the extent to which the NHS, through NICE, can access information about new drugs and their cost-effectiveness. My hon. Friend the Member for Windsor (Adam Afriyie) is right that there have been reductions in NICE funding, which has reduced the number of its appraisal committees from three to two at a time when their work load is increasing. For example, 29 new cancer drugs, a proportion of which will be fast-tracked, have to be submitted for appraisal. I shall not even consider the number of clinical guidelines that NICE should use, as it is important to focus on appraisals.
We have urged Ministers to make good the reduction in NICE's resources, and I hope that the Minister will confirm that the Government will do so. The aim of the review of arms-length bodies associated with the Department of Health was not to cut bureaucracy but to try to focus resources on those that would be of the most value to people working on the front line in the NHS. The Health Committee emphasised the need for NICE to gain access to all the data accompanying licence applications to the Medicines and Healthcare products Regulatory Agency. As NICE will increasingly conduct appraisals alongside the MHRA, we may need to consider incentivising the acquisition of the appropriate data for NICE purposes while ensuring that companies are aware that they must produce data for MHRA licensing approval. Very often, those things happen in series, because the data required by each body are not the same. Companies are not sure whether NICE will make an appraisal, so any work that they undertake at an early stage may be costly and abortive. As the hon. Member for Falmouth and Camborne (Julia Goldsworthy) said, they do not know whether Ministers will refer a drug to NICE, or whether there will be a delay.
We need greater independence in the process of choosing what should be referred to NICE and when. For the purposes of appraisal and issuing clinical guidelines, I accept that it is Ministers' responsibility to determine what should be referred to NICE. The structure for the appraisal of new drugs should be straightforward and independent. If they are likely to be a cost-effective response to existing NHS requirements to provide treatment, should that not be communicated to the NHS as soon as possible after independent assessment?
Herceptin was mentioned by the hon. Member for Falmouth and Camborne and others, and it raises significant issues. The hon. Member for Newport, West spoke about the speed with which drugs are taken up. As
8 Dec 2005 : Column 1061
it happens, Britain is not a country where drugs are taken up with alacrity. In October the Karolinska institute published a report, with the benefit of financial support from Roche, which I none the less think is true, showing that although Britain has the highest level of direct cancer research, we have one of the slowest rates of take-up of cancer drugs in Europe.
| Next Section | Index | Home Page |