THURSDAY 16 DECEMBER 2004

MS MARGOT JAMES, MR MIKE PALING, MR RICHARD HORTON, MS JENNY HOPE AND MS LOIS ROGERS

  Q640  Dr Taylor: It is a lot more than you have to pay for The Lancet.

  Ms Rogers: Yes I know, but you are belonging to the BMA and you are supporting the editors of the BMA principally rather than the journal, I think, which is a fairly enormous operation employing a large number of people with regional offices.

  Q641  Mrs Calton: Can we move on to contact with patient groups and professionals? Ms James, the Shire Health Policy Unit is involved in—and I quote—"health policy intelligence gathering and lobbying". Could you explain what this lobbying involves? Is this an important part of the work of medical communications companies?

  Ms James: Lobbying is a very small part of our business. The example that first leaps to mind is a campaign that we undertook in the late 1990s on behalf of a drug called Taxol which was a new treatment at the time—or relatively new—for cancer. It was not funded by the majority of health authorities at the time so we brought our expertise at a local level to deploy a serious of meetings around the country in the areas where we knew women were being denied the treatment of Taxol and we would get together a local oncologist, some interested general practitioners and a member of a patient group (I cannot recall which one it was, it was probably BACKUP but I could not be sure about that now). We would then have a meeting and invite the local press to attend a press briefing at the end of it. We would write up the outcome of the meeting and use that in a series of one-to-one meetings with key decision makers with the then local health authorities. That campaign was combined with a lobbying campaign here in Parliament as well. There was a lot of activity trying to make MPs aware of the benefits of better treatment for breast cancer and how this was being denied at the time. That is a typical example of a quite all-embracing lobbying campaign. For the most part our relations with patient groups I would not describe that as lobbying; I would describe that as a meeting of minds about a particular condition, what the patients' needs are. The patient groups are obviously expert and I think they will help companies put across very appropriate and very balanced messages about a particular disease. We will help them with a lot of research and communication skills and so forth. The moment that relationship gets out of kilter it is a disaster; you cannot try to influence the patient groups to think a certain way about a condition. Any patient group worth its salt—and I am talking about quite small ones as well, not just the big ones—will not wear that.

  Q642  Mrs Calton: Could we just explore this a little further? I am aware as an MP that I frequently have people coming to my surgery who are my constituents who are, nevertheless, asking questions about specific drugs or whatever. As part of your lobbying package, if you like, of all of the different things, would you encourage members of patient groups to go and see their MP to raise this issue; to raise a particular issue about a particular drug that you were working on?

  Ms James: Very rarely. I would not say that it did not happen, but it is certainly not commonplace. I suppose our motivation really is to inform patients such that if they have questions in mind they visit their doctor rather than their MP. There are conditions, I suppose, when it is funding related that I could imagine companies would do that, but I do not myself have personal experience of it.

  Q643  Mrs Calton: Could I go back to the original question which I asked about the health policy intelligence gathering. The Shire Health Policy Unit states that it is involved in health policy intelligence gathering. Could you tell us a bit more about that?

  Ms James: Yes, it is straightforward monitoring of public health policies so, for instance, when the national service frameworks came out we would make sure that we were very much in touch with the advisors to the Government on those implementation task forces. Where vaccine policies are concerned we would make sure that we are in touch with advisors so that we know where Government priority is going to be and that way we can advise our clients. If any of our clients have an interest in helping the Government reach its targets then we would bring that kind of information to our client's attention and work with them to see how best to capitalise on the opportunities.

  Q644  Mrs Calton: How would you go about gathering the health policy intelligence? How does that work?

  Ms James: An awful lot of it, to be honest, is available on the internet. The Department has a good website that issues names. A number of these doctors are known to us anyway. We would make contact with them; we would discuss the way things were going, what sort of priorities were going to come out. It is not in any sense to manipulate the agenda, it is more to find out what is going on so that if our clients, for instance on the elderly side, have anything that would be really beneficial in helping the Government attain those targets then obviously there will be a pay off for the company as well. It is a case of getting intelligence and using it appropriately.

  Q645  Mrs Calton: Mr Paling, would you say it is fair to say that the core of your business involves promoting clients' brands by stimulating demand through authoritative third parties such as patient organisations or leading healthcare professionals?

  Mr Paling: We do not work with patient organisations and have never done except with one exception which was on some disease awareness work which I mentioned in my submission for erectile dysfunction. The bulk of the work we do—which is paid-for advertising or sales promotion—is very clearly branded and it is a branded message that we have developed as part of the process of deciding how to present and offer the product to the doctor which would primarily be a general practitioner in most instances.

  Q646  Mrs Calton: So you would not say that you are involved in stimulating demand.

  Mr Paling: Advertising and promotion is there to do a number of things. It is there to raise awareness first of all of a drug, particularly if it is a new drug or raise awareness of an issue that might be a new indication or a new piece of information for instance. In that sense we are part of the process of taking the information on the products we work on to the doctor. That could result in him changing his practice from one treatment to another. If it were a treatment that he was not particularly aware of it could start him using that treatment in isolation. The way that all advertising works—the advertising to doctors and the advertising to the general public—has many similarities. The difference is in tone and approach..

  Q647  Mrs Calton: What about yourself, Ms James? Would you say that you stimulate demand via the vehicles of patient organisations or leading healthcare professionals?

  Ms James: I think what we want to achieve is improved management of the conditions that our client has an interest in. I think, whether it is a happy coincidence or what—I do not know—that 90% of our clients I would say have products which are really going to improve opportunities for patients. We seek to inform opinion leaders and get their views as well. Sometimes clients are over-ambitious with their products and the intelligence we gather from opinion leaders reveals something of a gap between the clients' aspirations and what the opinion leaders feel is an appropriate goal and at that point we will go back to the client and say, "Look, doctors are thinking that this treatment has a place, but it is not perhaps the sort of place in the sun that you were hoping for". A dialogue will take place and very often the brief will change and will moderate. What it is about really is getting more awareness of the potential of treatments and informing patient groups. Patient groups will have their own views because they will have members perhaps who have been on clinical trials and will be reporting anecdotally. They will see the peer review evidence as well. They will have their own views. Similarly they will inform us. It is not really as crude as to say "stimulating demand". I think it is partly because the drug development process is so slow. You might hear news of a product that is a major breakthrough and that kind of news will stimulate demand and quite right too. However, it is the exception, not the rule.

  Q648  Mrs Calton: Would you say your work involves any form of relationship that the public might conceive as improper?

  Ms James: No, I really do not. I think in any commercial relationship in the healthcare business there is always a potential for something improper, but I think that the checks and balances work in such a way as to preclude that from being a possibility.

  Q649  Mrs Calton: Do you believe that drug promotion through disease awareness campaigns is a good thing? Are there any aspects of this type of campaign that concern you or that you think might have negative effects? Could I start with you, Ms James, and then move on to others?

  Ms James: I think for the most part they are a very good thing, yes. I think without them patients would be in the dark on so many conditions. I have the benefit of quite a lot of hindsight now and I can remember the introduction of statins for the treatment of cholesterol in this country. They were introduced in 1989 and for the first five years of their life the BMJ led a vociferous campaign to undermine them, claiming that cholesterol was not a risk factor for heart disease at all and that drug companies were manipulating and stimulating demand for something that people did not need. Looking back it was quite scandalous. This is not the only example; I do not have time to give you all the examples. A lot of people did die unnecessarily from that mis-information but many more would have done. I think we really do need the pharmaceutical industry appropriately regulated to bring out some of these things with a kind of "not invented here" syndrome that attacks them at every turn. It is the same thing in schizophrenia, in cancer. These public awareness campaigns are a vital source of good public health. They do need to be properly regulated and I accept sometimes the case you outlined from Australia sounds most unfortunate and I am sure they do exist, but in a very small minority of cases.

  Q650  Mrs Calton: Does anyone else want to add to that or put a different point of view?

  Mr Paling: I do not think anybody would disagree that we need to increase the level of public awareness on general health issues in this country. It is the view of the public—it is certainly the view of the Government—and I think that is very important. Like Margot, I think the industry can have a large part to play in that partly because to do it would cost money and that perhaps is part of the reason more has not been done before. I think if it is harnessed in the right way there are rules and checks and regulations and they should be adhered to. I think it is very important that we are able to communicate with the public. I would rather—particularly in a condition where somebody has diabetes or whatever—that 10 patients went to the doctor who did not need treatment than one missed it who did and subsequently could be in a far more serious situation because they had not received treatment. Having said that, with our limited experience I think it is quite surprising how hard it is through disease awareness to actually get patients to go to doctors. Maybe that is a British thing; maybe it is the condition that we worked in (which was basically middle aged or older men who do not like going to the doctors) but it is not simple to do that. It is a hard task; it takes a lot of time and money.

  Q651  Mrs Calton: Dr Horton?

  Dr Horton: I think if you are looking at disease awareness campaigns amongst doctors, let us be real: this is about selling drugs. We had a paper submitted to us about a disease awareness issue. It was submitted to one of The Lancet's speciality journals, Lancet Neurology and in the process of peer review of that paper the company was trying to negotiate a reprint sale and the e-mail from one of the communications companies that the pharmaceutical sponsor had hired read: "As I am sure you can appreciate the more reviewing that is done on the papers" (that is the papers that were submitted to The Lancet) "the less value the ultimate publication will have to Sheering as the information on Sheering's products becomes more and more dilute." So let us have a reality check on the purpose of disease awareness campaigns. This is about sales; it is not about disease awareness.

  Ms Hope: I recognise that disease awareness campaigns will at least indirectly benefit drug companies. I probably think on balance they are worth while because of the information gap in this country between the way that people get information about drugs from newspapers and doctors and the fact that it is very hard in the middle when you are diagnosed with something to actually get more information easily. It is a fine line with disease awareness campaigns because you cannot advertise prescription medicines directly to the public in this country and this is a way, if you like, of—in quotes—getting round it. You could argue the same with celebrity endorsements that are carried out of a disease whereby somebody who has got a disease talk about it because they want to raise awareness which is all well and good, but they may well be being paid to raise that awareness so I take that into account when I am actually looking at something that is being offered like that, but I think on balance people would like to read about a famous person who has a disease.

  Ms Rogers: I would say it is highly arguable whether they have any benefit at all. It is an almost daily irritant. A PR person rings me to tell me about a disease awareness campaign and I think where disease awareness campaigns end and disease mongering begin is a very indistinct line and I think that in general if people are ill they know they are ill and they go to the doctor. Disease awareness is basically selling more drugs to people who do not necessarily have anything wrong with them.

  Mr Paling: I think there are many illnesses where a patient certainly would not know they were ill unless something was pointed out and therefore they went to the doctor. At the end of the day the doctor is in a position to decide, surely, if a patient needs treatment. If it is not a sick person the doctor is not going to give out a drug anyway.

  Q652  Dr Taylor: We have heard a great deal about the length of time it takes for a drug to be developed. At what stage does a company like yours get involved with the process, with the planning of publicity?

  Mr Paling: Over the years that I have been involved with the pharmaceutical industry I think it is fair to say that that time period has shortened quite dramatically. Twenty-years ago it probably would have been a year or 18 months and all sorts of development was being done relating to the product. Right now I would say it is more likely to be five or six months.

  Q653  Dr Taylor: Five or six months from what stage?

  Mr Paling: Five or six months from the point where an advertising agency would be appointed by a pharmaceutical company to a point where a product might be launched.

  Q654  Dr Taylor: So five or six months before the launch.

  Mr Paling: Yes, that would be more normal time now; six months probably.

  Q655  Dr Taylor: I think we are all extremely keen to make this report fair. Something that Ms James said implied that reading through the transcripts before it has been heavily loaded against the industry. This is because we have not really had much evidence from the industry yet. Mr Paling, right at the end of your written evidence you say you have been proud to work with the pharmaceutical industry and in your opinion it does behave ethically in its dealings with the medical profession. Yet we have these tremendous criticisms coming. Would any of you like to summarise the criticisms that we have heard in a very few words?

  Mr Paling: I think part of the reason I feel like that about the pharmaceutical industry—and I have been in or around it now for 35 years—is the incredible difference that the industry has brought about because of its medications. I do not think anybody would deny that and I know that this Committee does not deny it in literature and information I saw at the beginning of this inquiry. I think what is unfortunate is that starting from that base the industry does not have the best possible reputation it could have of any industry in the country. I do not think by any means the reputation is dire and there is a piece of research that MORI brought out last year which showed the reputation of the industry was much better than most people who have been in front of you in the last few months would feel. I think there needs to be a more open attitude. I think there has to be more transparency in certain areas and the way that we present ourselves to the doctor I feel is ethical and open. I feel that in the areas we work in—and I am sure Margot would say the same thing—everybody is tightly governed by a code; that code is part of how we behave as well, we are part of that process. Everybody knows the code; everybody is trained to the code and I think it is rigorously applied and is stringent and strong.

  Q656  Dr Taylor: Could I ask each of you for one sentence of the main criticism? Is that fair?

  Ms Rogers: I would respond to that by saying that I think the Government could help to improve the reputation of the industry by assisting the likes of us—Jenny and myself—with information when we ask for it. It recently took me 10 days to get information on adverse drug reactions on a particular group of products; that is 10 days of daily telephone calls. This is on a database and they obviously are withholding it from the press. That is not the first time it has happened. If you ask about adverse reactions to drugs it is sort of deeply confidential, sensitive information and the impression that you are automatically given is that somehow the Department of Health is assisting the manufacturers in withholding information. It is not conducive to us thinking that everything is all right in the pharmaceutical industry.

  Ms Hope: I would completely agree with that and say that the whole point of going to the Department of Health is because we are concerned about drug safety not because we are going there to get a puff or a drug. We still find it hard to get information.

  Dr Horton: In one sentence it is hard, but I would say that the practice of medicine and the delivery of healthcare have become overly dependent upon the pharmaceutical industry to the point where the integrity and validity of medicine and science is being compromised and risks being compromised further.

  Ms James: Are you asking me to summarise any criticisms?

  Dr Taylor: If you have one, your main one in one sentence. If you do not have one and are full of support, great.

  Q657  Chairman: Can I ask a final question which might help you? In a sense Richard Horton referred to his views on this some time ago where when we try to strike a balance between the commercial imperatives and the public health good it is a tricky area and this is at the heart of this inquiry which I am sure you all understand. Richard Horton was talking about some kind lightweight oversight with legal statutory tests. I do know whether you have any thoughts on this as to what might be that key conclusion as to where this tension could be resolved and some of the issues we have picked up today addressed in a way in which the public can have some confidence.

  Ms James: I think that the tension between the public good and the commercial interests have to be resolved in the regulatory process. From what I have read there is a need for a greater transparency of the regulatory process. There have been various recommendations to you of a way of tightening up the process of clinical trial publication so that absolutely every trial embarked upon has the potential for publication. Most are published and a lot of the time they are not published because they are not deemed of interest for quite genuine reasons. Where there is any scope for a trial that does not give the desired outcome to be suppressed that shocked me; it had not been in my consciousness before. If there is any potential in the system for that to occur then that should be regulated out.

  Mr Paling: I would agree with that entirely. That was the point I was making about transparency before. I think through this process I have also learned a few things and that is one that I was not aware of. I think that is important and I think there are firm moves within a number of companies—we heard that from Sir Richard Sykes—that that should happen; I am sure that will happen and I think that is a very good thing.

  Ms Hope: We need to know how decisions are arrived at as to whether a drug gets licensed or not and why and what the evidence was upon which that was based.

  Q658  Chairman: Transparency is crucial.

  Ms Hope: Yes, exactly. Then you can market these things because we know that they do work.

  Ms Rogers: I would concur with almost everything that everybody else has said. I think that the regulatory process needs to be far more transparent.

  Chairman: Can I place on the record the Committee's thanks to all of you for an excellent session and for your written evidence which has been most useful. We are very grateful to you for coming along today to take part in this inquiry. Before we conclude, can I just say that after this meeting we are loosing the most important member of our Committee, Anna Browning, who is our Committee Secretary. I would like to place on record the Committee's thanks to you for your work over many years. You are a very key figure in our Committee's work and we appreciate everything that you have done. We wish you well in your retirement because you retire at Christmas. We thank you for all your work. Can I also wish everyone the compliments of the season; this is the last meeting before Christmas. Thank you very much everyone.