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Dr. Gibson: Did the Committee's study of research reach any conclusion on the merger mania in the pharmaceutical industry? When Glaxo and SmithKline merged, Sir Richard Sykes and Jan Leschly said that research would benefit from the merger because they would be working together. Is there any evidence that mergers lead to better research?
Dr. Taylor: I do not think that there was any hard evidence that that merger had produced an increase in research, but I do not think that we asked the question, so regrettably I cannot help the hon. Gentleman. The one thing I remember only too well about the Glaxo merger with SmithKline is that I had to sell my shares so that I would not have to declare an interest.
Several Members mentioned "me-too" drugs, the duplicates or near-duplicates of existing drugs, which are relatively cheap for companies to produce. We were rather down on them because of the number available. Three or four beta blockers will provide all that is needed in terms of variety, as will a small number of non-steroidal anti-inflammatory drugs. We issued a plea for a wider distribution of really effective local drug and
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therapeutics committees working over acute and primary care trusts to introduce some control to prescribing of that kind.
Clinical trials have already been mentioned briefly and several recommendations in the report refer to them. We wanted an independent register and records kept of negative trials and of drugs that were terminated due to side effects. We wanted to ensure that comparator drugs were used and that the particular comparator drug was the right one to choose. We wanted drug treatments to be compared, where possible, with non-drug treatments. It is not clear from the Government's response whether they have taken all those details into account; they seem rather to hide behind European rules.
I feel very strongly about the promotion of new drugs. Our recommendation 5, which was not answered, stated:
"The aggressive promotion of medicines shortly after launch, the sheer volume of information that is received in its many forms by prescribers and the 'promotional hospitality masquerading as education', in the absence of effective countervailing forces, all contribute to the inappropriate prescription of medicines."
I thought that that was a powerful recommendation.
I am interested to hear other hon. Members' comments on the Association of the British Pharmaceutical Industry code of conduct. I am slightly less dismissive of it than others. I agree that there may be an element of window dressing, as mentioned by the hon. Member for Newport, West, but I hope that it is at least a first attempt at self-regulation. In other inquiries, such as the one into obesity, the Health Committee has recognised that self-regulation of the food industry was probably a more practicable measure to aim for than strict regulation from outside. I will study the code of practice carefully. I am not sure whether it covers either ghost-writing or fees to experts, which are important matters.
Returning to the intensive promotion of new drugs, I would like to refer to another recommendation. To avoid confusion, it was our recommendation 33, though it appears as recommendation 6 in the Government response. Our recommendation stated:
"The intensive marketing which encourages inappropriate prescribing of drugs must be curbed. Present methods of supplying independent information, as described by Lord Warner, are inadequate."
should be "pre-vetted by the MHRA". I believe that that is going to happen. We further recommended that
"consideration be given to limiting those who can prescribe a new drug in the two years following launch. Drug and Therapeutics Committees would be well-placed to implement this."
That provides another function for such committees.
In their response, the Government agreed that there should be proper controls, but they subsequently lost the plot completely, saying:
"There is no indication that the measures currently in place are not effective. The fact that generic prescribing has risen to nearly 78 per cent. (in 2003) clearly indicates that clinicians are writing prescriptions generically and not by individual company product."
One cannot write a prescription generically for a drug that is new and under patent because it effectively does not yet exist. I was not very impressed with that aspect of the Government response.
An example of the rapid uptake of a new drug causing problems is of course Vioxx. It has been referred to by several Members today, but I will go over some of this ground again because it is so important. Vioxx was launched as an answer to all the upper gastrointestinal problems that undoubtedly occur through the use of existing anti-inflammatory drugs for various forms of arthritis. It was introduced in 1999 and withdrawn in September 2004 when work in America showed how dangerous it was from the point of view of causing heart attacks and strokes.
To express a slightly different view, we lost what was thought to be a potentially useful drug due to the unpredictable side effects brought to light by very widespread, very rapid prescribing. I have spoken to drugs firms about this and they claim that in fact, it was a good thing that Vioxx was prescribed so widely, because doing so brought the side effects to light much more quickly. I do not quite follow that argument.
During the inquiry, we visited University College London hospital to hear about its Use of Medicines Committee. We were incredibly impressed with its drug formulary, which is used not only by the hospital trust but by the nearby primary care trusts. Because members of those trusts are on the committee, it is also well accepted by the GPs in the area. Its prescribing levels of Vioxx—surprise, surprise—were lower than the nationwide average because it had careful guidelines. It took the view that this is a new drug and no one knows entirely what is going to happen, so we should be careful with it, please.
Paul Flynn: Does the hon. Gentleman believe that, given the problems with Vioxx, which is just one of the COX-2 inhibitors, there is reason to look carefully at other such inhibitors? Some 1 million prescriptions were issued for Vioxx, but 3 million prescriptions have been issued for other COX-2 inhibitors that are still being prescribed.
Dr. Taylor: I agree absolutely with the hon. Gentleman, and I shall deal with another point relating to COX-2 inhibitors in a moment.
On the explosion of new drugs, several of our report's recommendations pointed out that prescribers must share part of the blame; we cannot put it all on to the pharmaceutical companies. In this respect, local drug formularies are vital. Prescribing should possibly be limited to certain groups of doctors, and they certainly should have better education on these matters. Both the British National Formulary and the Drug and Therapeutics Bulletin are absolutely essential in that education process.
I am rather worried by a communication that I received just yesterday from the Drug and Therapeutics Bulletin, in which it pointed out that it is in discussions concerning its contract with the Department of Health to supply the bulletin free to 117,000 health professionals. At the moment, the Department of
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Health takes out a bulk subscription for doctors, nurses and other people who prescribe drugs. This little publication consists of just four pages. It can be folded, fitted into the pocket and read in the lift or on the tube, but it is incredibly important and valuable. A survey has shown that 89 per cent. of its readers find it either "very" or "quite" influential. It is in the top three of the most-read of such publications. The vast majority of respondents—86 per cent.—cited its independence as a very important factor. So I ask the Minister to examine the question of the withdrawal of that bulk subscription very carefully. The bulletin is extremely valuable to the 117,000 people who receive it.
I emphasise that the restricted prescription of new drugs is automatic when advances are made with drugs. Examples of that would include the new treatments for cancer or rheumatoid arthritis, for instance, as such drugs would be prescribed only by consultants. The recommendation mainly applies to the more popular drugs, such as those in the Vioxx group and, as usual, a balance must be struck between the pharmaceutical industry's need to get a return on its huge investment and the requirement to ensure patient safety.
I do not know whether the hon. Member for Newport, West saw last week's British Medical Journal, but it contains a most interesting report on a large group of patients who took one of the Vioxx group of drugs. The results throw into doubt suggestions that the drugs in that group are safer than the ordinary non-steroidals used for the gastrointestinal tract. The article is very interesting, and shows that we cannot win in this respect.
I was trained by wise and experienced physicians in the good old Westminster hospital, only about half a mile from here. One of them was practising when cortisone was invented and he had seen patients who were crippled with rheumatoid arthritis be cured absolutely for six weeks—the so-called cortisone honeymoon—but who had to come off the drug as soon as the side effects became evident. I was brought up to be extraordinarily careful with new drugs, because doctors do not, and cannot, know what they do. For example, thalidomide was introduced just after I qualified, and I am ashamed to say that I probably prescribed that drug for some people when I was a houseman at Westminster hospital.
The first duty of a doctor is not to cause harm. With reference to that, I came across the marvellous proverb:
Sadly, that needs to be brought up to date so that it says "like a good medicine", as I am sorry to say that some medicines are not good, contrary to initial appearances.
I also came across a quotation from Sir William Osler, as follows:
The drug industry therefore has an extraordinarily favourable market right from the beginning: people want to take medicines as they do not believe that other types of treatment work. That brings me to the need for regulation, a matter that has been covered extensively by several hon. Members already.
I am sorry that the Government have not agreed to an independent review. I am hoping against hope that the four-yearly cycle review will be independent, that it will
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cover the ground set out by the right hon. Member for Rother Valley and so go some way towards removing concerns about the independence of the MHRA.
Just yesterday, concern was expressed to me that the replacement organisation for the Committee on Safety of Medicines, which was abolished on 31 October, is not yet in place. The Minister will correct me if I am wrong, but I understand that the expert advisory groups that will take the place of the CSM in advising the MHRA have not been set up yet. During that gap, are patients more at risk? I believe that the groups will not be in place until February, and they will not be functional immediately, so for how long will there be a gap during which patients are probably vulnerable?
On post-marketing surveillance, which has also been covered quite well, let me quote recommendation 29, which was our paragraph 45:
"We recommend that the extent, cost and implications of illness resulting from the use of medicines be systematically investigated by the Department of Health in conjunction with the MHRA."
It is known, as the Government's response states, that the burden of adverse drug reactions on the NHS is high, with 6.5 per cent. of hospital admissions due to it.
Why is that still happening? Many statements in the British National Formulary, which many doctors carry, will enable the sort of side effects that lead to illness to be avoided. A classic side effect of SSRIs—selective serotonin reuptake inhibitors—particularly in the very old, is to cause a drop in the sodium level in the blood, which can be extraordinarily dangerous for the elderly. Three people in my area have suffered that side effect, which is mentioned in the British National Formulary. These are matters of education to be considered.
I look forward tremendously to electronic prescribing, which has also been mentioned, as the electronic system, when it is really working, will be able to flag up immediately side effects with other drugs or a contraindication with the age of the patient, and could make a tremendous difference.
When the Committee visited Australia, we were impressed by the production of a series of lovely little pocket books of well-organised therapeutic guidelines across many subjects in the whole of medicine. We are lagging behind on that. The only disappointment was that it did not appear that the Australian authorities had done a trial on hospital admissions due to drug-induced illness, to see whether those guidelines, which were being used widely, were making a difference.
Possibly one of the most controversial recommendations, which has been mentioned, related to the Department of Health's concern to represent the interests of patients, the NHS and the drug industry, which was described by some of our witnesses as "cross-dressing". One of the recommendations, which was responded to but in a negative way, referred to the Department of Health's role, which, because of those wide responsibilities, perhaps does not serve the public as well as it should.
I agree with everybody that we must retain a viable pharmaceutical industry. If we consider rough figures, however, 90 per cent. of the world's research is targeted at illnesses affecting only 10 per cent. of the world's population. We would love to see some guidance given to the major pharmaceutical industries to give some help to those huge numbers of the world's population who
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are not being thought of. In Australia, we came across one small firm making a microbicidal gel for the prevention of HIV/AIDS. That would be relatively cheap and a huge advance. I would love the Minister to comment on whether the Government can try to influence the industry in that way.
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