Evidence Check 2: Homeopathy - Science and Technology Committee Contents


Examination of Witnesses (Questions 1-111)

MR PAUL BENNETT, MS TRACEY BROWN, MR BEN GOLDACRE, PROFESSOR JAYNE LAWRENCE AND MR ROBERT WILSON

25 NOVEMBER 2009

  Q1 Chairman: Good morning everyone. This is a one-off evidence check session on homeopathy. It is part of a series of evidence checks we are doing as the Science and Technology Committee looking across government at whether there is evidence to support Government policy or, indeed, what evidence there is to actually scrutinise the effectiveness of Government policy. In a public call for topics homeopathy was one of the issues that was raised, and we are very happy to have this session. We welcome for our first panel Paul Bennett, Professional Standards Director and Superintendent Pharmacist Boots—welcome to you, Paul, and thank you very much for coming; Tracey Brown, the Managing Director for Sense About Science—welcome to you, Tracey; Dr Ben Goldacre, a journalist from The Guardian—welcome to you, Ben, this morning; Professor Jayne Lawrence, the Chief Scientific Adviser for the Royal Pharmaceutical Society of Great Britain—welcome to you; and, last but by no means least, Robert Wilson, the Chairman of the British Association of Homeopathic Manufacturers (BAHM)—welcome and thank you very much indeed for coming. I wonder if I could start with you, Paul, this morning. You actually manufacture and sell homeopathic remedies. Do they work beyond the placebo effect, very briefly?

  Mr Bennett: First, I need to correct you actually, I am afraid. We do not manufacture products.

  Q2  Chairman: You sell them though?

  Mr Bennett: We do sell them.

  Q3  Chairman: So you sell them?

  Mr Bennett: We do indeed sell them and there is certainly a consumer demand for those products.

  Q4  Chairman: I did not ask you that question. I said do they work beyond the placebo effect?

  Mr Bennett: I have no evidence before me to suggest that they are efficacious, and we look very much for the evidence to support that, and so I am unable to give you a yes or no answer to that question.

  Q5  Chairman: You sell them but you do not believe they are efficacious?

  Mr Bennett: It is about consumer choice for us. A large number of our consumers actually do believe they are efficacious, but they are licensed medicinal products and, therefore, we believe it is right to make them available.

  Q6  Chairman: But as a company you do not believe that they necessarily are?

  Mr Bennett: We do not disbelieve either. It is an evidence issue.

  Q7  Chairman: Robert, what is your position? You do manufacture.

  Mr Wilson: We do manufacture, yes, and I represent 95 per cent of the manufacturers in the UK. Definitely we believe there is a strong case for the efficaciousness of homeopathic medicines. This is an industry that has been growing strongly. It has been around for 200 years and I think it is worth saying that in France it is a 400 million euro business and in Germany it is the same.

  Q8  Chairman: So is prostitution. It does not mean to say it is right, does it? My question to you, Robert, is does it work outside the placebo effect?

  Mr Wilson: It definitely does work outside the placebo effect.

  Q9  Chairman: It definitely does. You have cast-iron evidence to support that?

  Mr Wilson: We have many trials that show a strong efficaciousness for homeopathic medicines.

  Q10  Chairman: Why do you not supply that to Boots then?

  Mr Wilson: We do supply that to Boots.

  Q11  Chairman: So why do they not believe you?

  Mr Wilson: They do believe us.

  Q12  Chairman: He has just said they do not.

  Mr Wilson: No.

  Q13  Chairman: He said he neither believes you or he does not believe you.

  Mr Wilson: He has not asked us specifically about the efficaciousness of homeopathic medicines. Boots are a very important retailer; they sell a great deal of these products. You have also got to ask the question, if these products did not work beyond the placebo effect, why do people keep buying them? Leaving that aside, there is a trial out which was literally published in the last—

  Q14  Chairman: That was not a serious point, was it? Was that a serious point you were making?

  Mr Wilson: Yes, I believe, certainly, that people continue to buy products because they work for them.

  Q15  Chairman: Because they work for them?

  Mr Wilson: Yes.

  Q16  Chairman: Even though there is no evidence.

  Mr Wilson: There is a lot of evidence.

  Q17  Chairman: Will you give me just one product where you say there is clear evidence that one of the things that you manufacture as a homeopathic remedy actually works?

  Mr Wilson: Arnica, which is for bruising, and is extremely useful in post-operative care. There was a major trial done on arnica and, indeed, there is one that has just been published, the Witt Trial, which was done by the Charité Hospital in Berlin. It was a large trial—3,700 patients involved—and that has shown clearly that there is a strong benefit in homeopathic use to these patients with long-term chronic conditions. One of the subjects of that trial was arnica.

  Q18  Chairman: Professor Lawrence, from the Royal Pharmaceutical Society, do you believe that homeopathic remedies work beyond the placebo effect?

  Professor Lawrence: No, we do not believe there is any scientific or clinical evidence, using standard clinical trials, that there is—

  Q19  Chairman: Even for arnica?

  Professor Lawrence: I have not seen this latest trial, but certainly up until recently we reviewed all the evidence and we believe there is not any clinical or scientific evidence supporting their use.

  Q20  Ian Stewart: Does that mean they do not work at all? Are you very definite that they do not work at all?

  Professor Lawrence: Some patients, a lot of patients in fact, claim to have benefited, if they are asked afterwards, from the therapies.

  Q21  Ian Stewart: That is a different issue.

  Professor Lawrence: There is no evidence that we can see that supports—

  Q22  Ian Stewart: It is only that there is no evidence. You are not saying that that does not mean that they work in some cases?

  Professor Lawrence: There is no scientific basis for their being effective. There is no reason why they would be effective scientifically.

  Q23  Chairman: Dr Goldacre, what is your view? Is there any effect beyond the placebo effect?

  Dr Goldacre: No. The placebo effect is undoubtedly very powerful, and that is one reason why they are very attractive to people, but if you look at all of the trials in the whole, collectively, what you see when you look at the best quality trials is that homeopathy pills work no better than placebo pills. You can select individual trials and say: we have got this individual trial, or even ten individual trials, which show that it works, but if you cherry-pick your literature and pick out only the positive results and ignore the unfavourable results, you can make any treatment work, including ones that are known to be ineffective or even dangerous. That is just bad scholarship.

  Q24  Chairman: Do you believe that they are harmful though?

  Dr Goldacre: I do not think they are physically harmful, in the same way that they are not physically beneficial. I think that they can have other harms. For example, I think pharmacists selling homeopathic sugar pills on the high street to patients and to the public is very harmful to the public reputation of pharmacists. The RPSGB describes pharmacists on the high street as being the "scientist in the high street", and I think it is sad that the public are now having to realise that, in fact, what should be a trustworthy resource for information on healthcare is, in fact, somebody who is, as a business person, selling them sugar pills.

  Q25  Ian Stewart: Can we be clear as to what you have said there. It is harmful to pharmacists; you are not saying it is harmful to patients.

  Dr Goldacre: That was one example of non-physical harm. I think they are culturally harmful. I think it is harmful, for example, to tell people that a sugar pill is an effective treatment when it is not; I think you undermine the credibility of the doctor, the healthcare worker, the pharmacist; I think you undermine the credibility of the MHRA. When you drive people into the hands of alternative therapists who may not be adequately medically trained by giving them credibility through MHRA approval, as it is perceived, then you drive people into the hands of people who may not be able to spot serious diagnoses. I think there are a number of harms that come, but none of them, you are absolutely correct to say, are direct physical harms. I do not believe that sugar pills are physically harmful; nor are they beneficial to people physically.

  Q26  Chairman: I want to try and move on. Beyond the placebo effect, no justification?

  Ms Brown: No, I am of a similar mind to Ben and Jayne Lawrence.

  Q27  Chairman: But they are not harmful?

  Ms Brown: Actually, I think there is the issue that even minor conditions can sometimes betray a more serious condition. For example, constipation. It sounds harmless to be taking sugar pills for constipation, but actually sometimes that is a symptom of a more serious condition and diagnosis is necessary. So there is the possibility of delayed diagnosis or people believing that they are seeking effective treatment when they are not. There is also a broader harm to the public, I think. If you think about the rows that have happened around things like the prescription of Alzheimer's drugs on the NHS, on the one hand, you are expecting people to look at the evidence to understand why certain drugs are available for people with a condition and certain are not and, on the other, you throw the evidence up in the air and say that if people want it they should have it. We just lose, as a society, the dividing line, the ability to talk to people about the evidence behind their medicines, and I think that is a serious public health issue.

  Q28  Chairman: So we should sell nothing unless it has got clear evidence to support the claims of what it does?

  Ms Brown: I think the point at issue is that we should flatter nothing with official endorsement. If people want to make potions and lotions and sell them to one another, I do not have a very strong view about that, but when that has official endorsement, for example a medicines licence, then I think we have a problem, because that does give people the message that some judgment has been made about its use and the treatment of that condition.

  Q29  Chairman: So you think that homeopathic products should be licensed before they can be sold?

  Ms Brown: There was always previously what is called the Simplified Scheme, which is about manufacturing safety, quality and cleanliness, and I think there is no problem with reviewing that kind of quality over medicine, but any suggestion that they should have indications that they are effective in the treatment of certain conditions, I think that becomes a problem, and that is the situation we are in at the moment.

  Q30  Dr Harris: Can I first declare an interest that I have worked with Sense About Science on a number of issues and I have personally argued a lot with Ben Goldacre over the years. I want to ask Mr Wilson, while we are on declarations of interests, you and your members make money out of selling this and, obviously, if they can have medical indications on them they might sell better and then you might make more money. Is that accurate?

  Mr Wilson: I represent the manufacturers. There is one thing I would like to say on the scientific evidence, if I may. I think it is important to say that a number of the trials that are put forward about discrediting homeopathy are with very, very small sample groups.

  Q31  Dr Harris: I was going to come on to that. I just wanted to give you the chance to put your interest on the record.

  Mr Wilson: Yes, I represent the manufacturers.

  Q32  Dr Harris: Let me ask you a question then, and I will ask you about evidence. You heard Dr Goldacre say that the best way of looking at the evidence is to look at all the evidence, positive and negative, look at, for example, systematic reviews or meta-analyses as the best way of looking at published data, so that you are looking at the best trials, selecting the best trials and discarding those that are flawed and then using that. Do you accept that as the best way of doing it, or do you think that picking a trial that other people may not have seen that has just been published is a better way?

  Mr Wilson: No; absolutely. I think the important thing is the homeopathic industry is extremely pro research and pro trials. What we say is there have to be good trials. In The Lancet article there was the Langer experiment where they compared 100 trials. In each of those trials the median number of people involved was 65. Now 65 people in any trial is not statistically relevant. If you look at a number of the experts in trials, they will always say size is the only thing that matters. When you talk about a trial, the second question you should ask is how big was the sample? Any sample of fewer than 500 is not going to be statistically relevant.

  Q33  Dr Harris: Hang on a second, because this was not my question. Firstly, I think we can all agree, but I will stand to be corrected, that whether the sample size is statistically significant depends on the frequency of the outcome you are measuring. So for rare outcomes you would clearly need to power up the sample, but that was not my question. My question to you, which I would urge you to answer, is do you accept the assertion that has been made that the best way to consider the evidence is to look at systematic reviews, including meta-analyses which combine sample sizes from a number of studies in a scientifically valid way, and judge the outcome, the conclusions of those systematic reviews which discard the flawed trials? It does not matter how many patients you have in a flawed trial if it its flawed. Do you accept that that is better than, to quote Dr Goldacre, cherry-picking from either side of the argument individual trials? That is a straightforward question.

  Mr Wilson: The danger of meta-analysis is that all it does is compare a number of trials. If those trials are not good, it is still comparing bad trials. So if you have got a series of small groups of, say, 20 patients in a trial, and then you compare that with a series of others, you are still getting a skewed result.

  Q34  Dr Harris: You are repeating yourself. I am asking a different question. Systematic reviews discard flawed trials, they do not count them at all, and they aggregate the results of a number of trials—large ones, small ones—which are well-designed. That is what they do. Do you accept—and I will ask you this for the third time—that that is a better way of judging the whole of the evidence than cherry-picking, on either side of the argument, individual trials?

  Mr Wilson: I think the key question is—

  Q35  Dr Harris: Yes or no. You are not asking me a question.

  Mr Wilson: You have used the phrase "well-designed" a number of times. It does not matter how well designed a trial is if it is only 20 patients.

  Q36  Dr Harris: I am talking about systematic reviews. Are you saying some systematic reviews are good and some are bad? I am not making progress there, so I will change my question. When you were asked about the evidence, you did not suggest, as far as I can recall, homeopathic provings as being good evidence. Do you think, compared to cherry-picked trials or systematic reviews, homeopathic provings represent good evidence of effectiveness?

  Mr Wilson: No, a homeopathic proving is a technical term for when homeopathic medicines are assessed. It is not a way of doing a trial, proving.

  Q37  Dr Harris: But it is the provings that are relied on by the MHRA. That is a condition, under the new scheme, the new National Rules, for the MHRA allowing indications to be given, claims to be given for the alleviation of minor illnesses. That is right, is it not?

  Mr Wilson: The proving is part of the bibliographical traditional evidence for a homeopathic remedy.

  Q38  Dr Harris: I would just like to ask Paul Bennett if he has any qualms at all about making money, as you do—it is your right to do that—out of selling products which you do not believe are effective but which have, on the basis of homeopathic provings (which even the homeopaths do not think is the best evidence of effectiveness) a stamp from the MHRA saying you are allowed to say this is effective, or can be effective, in constipation. Do you have any qualms about that?

  Mr Bennett: I think actually at the root of this is that these are regulated products which are safe, and it is actually really important that we are able to support the very large number of our consumers who believe they are efficacious through their own experience and through recommendations from others. I think to deny somebody access to a product of that nature where they strongly believe it is efficacious would be wrong for us to do.

  Q39  Dr Harris: If someone believed that paracetamol was efficacious in preventing heart disease and the paracetamol said on it "this can be used to prevent heart disease" you would not be happy and I am sure Jayne Lawrence would not be happy with that. So what is it about homeopathy which does not give you qualms when they make claims which you say you do not believe stand up? No-one is saying you should not sell them and you should not sell them as certified as safe and well-manufactured and the box says what is in it, which is nothing—that is fine—but do you not have qualms about selling things that have assertions on about clinical effectiveness that do not have evidence behind them and evidence that you do not believe?

  Mr Bennett: Again, our key requirement here is for greater clinical evidence. If that were available to us as retailers and to the consumer, I think that would be extremely helpful.

  Dr Harris: How would it be helpful? There has been a series of systematic reviews which demonstrate in homeopathy—I am not talking about the herbal stuff that is around—that there is no effectiveness beyond placebo. Yet you are not selling them as placebos, you are selling some of these products with indications. Do you not feel that if you were a manufacturer of something that had gone through clinical trials to treat these minor ailments—

  Chairman: I think he has got the point.

  Dr Harris: There has been all this evidence.

  Q40  Chairman: He has got the point. I am sure he will give us an answer.

  Mr Bennett: The point is that the products that we retail clearly have a label on them which states "a homeopathic medicinal product without approved therapeutic indications", because we cannot draw upon any further information to give that therapeutic assurance.

  Q41  Dr Harris: Some of them now will have under the National Rules this claim?

  Mr Bennett: They will under the National Rules.

  Q42  Dr Harris: Indeed, some of them have from the old PLR.

  Mr Bennett: But the products that we have available which are manufactured by Nelsons on behalf of Boots would be of that type, the type that does not have a therapeutic indication.

  Chairman: I am going to call a halt there and bring in Brian Iddon.

  Q43  Dr Iddon: I have a problem with the interpretation of EC Directive 2001/83 through the National Rules Scheme. I turn to you first, Paul. When you are selling vitamins and minerals on your shelves you are not allowed (and neither are other manufacturers or wholesalers or retailers) to advertise any medicinal value for those products unless there is clear scientific and clinical evidence for the medicinal claims, but the way that the MHRA in this country have interpreted that EC Directive through the National Rules Scheme allows you to sell homeopathic products with medicinal claims without the evidence. Surely that is a serious contradiction in this country?

  Mr Bennett: I am happy to respond. I am concerned I am going to sound a little bit like a broken record in my response. I actually think that question would be a good one for the MHRA, who, I believe, are attending this Committee at another session.

  Q44  Dr Iddon: We will put it to them.

  Mr Bennett: I am sure you will. From a community pharmacy retail point of view, we rely very heavily on the regulatory process to indicate to us which products are approved and safe for sale. If the regulatory process is inadequate, then I would suggest that is something that does need to be taken up with the MHRA. We would respond accordingly to that, but at the moment we are operating within the regulatory framework that exists.

  Q45  Dr Iddon: I turn to Robert Wilson at the other end of the table and put a similar question to you, Robert. Has not the National Rules Scheme been written deliberately to allow the interpretation of this EC Directive so that the homeopathic industry can expand?

  Mr Wilson: The National Rules Scheme is the implementation of an EU Directive; so it comes from Europe. The homeopathic market in Europe is £1.5 billion. One in four prescriptions in France is homeopathic, so this is a sizeable European business. In this country the market is very small by comparison—about £30 million. So these are rules that have come from Brussels that is used to homeopathy as part of their mainstream healthcare offering. All the MHRA has done is implement a series of Directives that have been pushed from Europe and the National Rules Scheme is embodying clause 16.2 of that Directive which allows indications for minor complaints. By minor complaints we mean things that are not going to require the intervention of a doctor or medical practitioner. All that the UK MHRA is doing is implementing an EU Directive. There are a number of examples of EU Directives in herbal medicine, in traditional use medicine, where a system of medicine has been around for hundreds of years that they will allow bibliographical evidence to uphold a medical claim in a self-limiting or minor symptomatic area.

  Q46  Dr Iddon: I will put to the rest of the panel now another question. Why should the MHRA have an interest in supporting the homeopathic industry when so many people believe there is no clinical evidence for the efficacy of the products?

  Ms Brown: That sits really uneasily with the mission of the MHRA, which is to tell the public what works. I think it is very difficult to see how they identified a public health interest in putting forward these National Rules. Can I just clarify that it is a National Rules Scheme, that the EC Directive makes provision for national agencies to introduce their own national rules. Under the EC Directive it would have been perfectly acceptable to require homeopathic products to go through the same licensing procedures as other products if they wanted to make medicinal claims, so it was not the only option. It was not simply reading off from the European Directive straight into UK law.

  Q47  Dr Iddon: Perhaps, for the record, you would give us the other options that MHRA gave to Government when they chose to go forward with the National Rules Scheme?

  Ms Brown: The other options were to do nothing, and the problem that was identified prior to the 1968 Medicines Act was that there were a number of homeopathic products which were granted a product licence of right, and they continued to be sold on that basis, and then other products coming onto the market had had to use the Simplified Scheme, which had been introduced particularly after 1971 and the European Community requirements. The only reason for not doing nothing (and this is the description given by a MHRA to Government) was that sections of the homeopathic industry were unhappy with what they saw as not a level playing field, where the PLRs could make claims and the new products could not make claims. Another version of doing nothing would have been option two, which is to revoke the PLRs and require the medicine simply to go through the Simplified Scheme. That would mean that they would not be able to make medicinal claims. Again, that would have been perfectly acceptable.

  Q48  Dr Iddon: Without the evidence?

  Ms Brown: Without the evidence. They could either go through the full application for a licence, in which case they would have to bring the same quality of information about efficacy as any other medicine, or they could register under the Simplified Scheme, which was simply, as we have talked about, manufacturing safety.

  Q49  Dr Iddon: That would have levelled the playing field between the various homeopathic products?

  Ms Brown: It would have done, but, clearly, the manufacturers of those products which were being sold with medicinal claims would not have been very happy at having to lose the ability to make those medicinal claims on their products. So that section, in effect, would have lost out of the homeopathic industry.

  Q50  Dr Iddon: But the other section of the industry, who sell vitamins and minerals, will be put under that pressure. It seems a contradiction that the homeopathic industry is not put under the same pressure.

  Ms Brown: Yes, it certainly does. Options three and four are not that dissimilar. Option three was to introduce National Rules and option four similarly; there are just some differences between the requirements. I find it very difficult to make sense of these options, because from a public health point of view none of these options has a rationale in terms of public health, they all have a rationale in terms of the industry, and, in fact, that becomes much clearer when you look at the rationale that was given to government. The only rationale for government intervention given by the MHRA was "although the development of National Rules by Member States under Directive 2001/83 is optional"—just to make that point clear—"failing to introduce a scheme would inhibit the expansion of the homeopathic industry by the prevention of the development of new products with indications". So that is why they preferred option four—it allowed indications and levelled the playing field for the industry; there was no other justification.

  Q51  Dr Iddon: Robert, it just seems to me, and possibly other members of the Committee, that the National Rules Scheme was produced by the MHRA to allow your industry to expand. What is the evidence since the National Rules Scheme was introduced? Have your product lists grown and have you expanded?

  Mr Wilson: Again, I think this is something that needs to be made clear. Currently under the National Rules Scheme there is one licence that has gone through that process since 2006. We submitted a dossier for arnica in 2007 and it was granted to us in March 2009, so you are talking about one product in the whole of the UK homeopathic industry. The National Rules Scheme is implemented by the UK but there are clear understandings from Europe that indications on products for homeopathic use which have been around since the start of the various Medical Acts in all the countries need to be regularised, and this was a way of bringing products that had been on the market for over 30 years into a standard way that could come across Europe. The homeopathic industry has been in quite serious decline because there has been a huge amount of negative PR about homeopathy built on a lot of spurious trials and the homeopathic voice has not been allowed to be heard. If I could make one point, in 2005 the NHS prescriptions for homeopathics was 500,000; in 2007 it was 320,000.

  Q52  Chairman: I want to come on to that separately; so please do not take us down that road. Ben Goldacre, in terms of responding to Brian Iddon's point, if, in fact, in France a significant amount of "homeopathic medicines" are being prescribed, the French do not seem to be dying in droves as a result of it. Why on earth should we bother? Why do we not just say perhaps they have got something that is going which we should have?

  Dr Goldacre: I agree. I do not think it is the most important issue in the world. I do not think people taking homeopathic pills is very important, but I think the MHRA endorsing them is extremely problematic. In answer to Dr Iddon's question why they would be interested, the MHRA is the regulator of the pharmaceutical industry but it gets, as I understand it, 90 per cent of its income from the pharmaceutical industry and much of that income comes in the form of product licence applications, and so on—the fees that they charge for processing them—and when they say that they are passing a new regulation to enable the expansion of the homeopathic industry, I think, unfortunately, that sends out a clear message that this is a £1.5 billion European industry that is able to influence the activities of an industry regulator, and that is problematic.

  Chairman: That is very cynical.

  Q53  Graham Stringer: Is the definition of homeopathy in France exactly the same as it is in this country?

  Dr Goldacre: Yes, it is sugar pills that have been treated ceremonially, if you like, but I do not believe that Robert Wilson, who is a manufacturer of homeopathic pills, could tell the difference between one of his arnica pills and one of his arsenic pills; they are simply sugar pills.

  Q54  Ian Stewart: Is that the formal definition in the UK and in France? The question you were asked was: is the definition the same? You gave what appeared to me to be a personal definition. That was not the question you were asked.

  Dr Goldacre: I would imagine that there would be a huge number of different definitions in France and in England.

  Q55  Ian Stewart: That is a very different answer than you gave to Graham Stringer before.

  Dr Goldacre: There is no substantively different understanding of the meaning of the word "homeopathic" between France and England.

  Q56  Chairman: Professor Lawrence, in terms of the Pharmaceutical Society, I presume there is an equivalent of the Royal Pharmaceutical Society in France?

  Professor Lawrence: Yes, there is.

  Q57  Chairman: Why are they not jumping up and down, or are you just so much better?

  Professor Lawrence: I am sorry?

  Q58  Chairman: Is yours so much more a professional organisation in the UK? Are they a little bit backward in France?

  Professor Lawrence: No, the organisations are actually quite different. Although they are national societies, I think the Pharmaceutical Society is rather unique in being, up until recently, or presently, both the regulator and a professional body. So there is a difference between the societies across Europe.

  Chairman: Can I move on then to Tim Boswell.

  Q59  Mr Boswell: Some questions about the role of pharmacists in this, and I am talking about pharmacists as pharmacists rather than as retailers. Could I invite the panel to go straight down the line and give me a one word or one sentence answer to this question, starting with Paul and proceeding: should pharmacists sell homeopathic products?

  Mr Bennett: Yes.

  Ms Brown: No.

  Dr Goldacre: Yes, but they should not say they are effective.

  Professor Lawrence: Yes, but they should not say they are effective.

  Mr Wilson: Yes.

  Q60  Mr Boswell: Following on from that, perhaps I could ask Professor Lawrence to lead and others to feel they can join in. Questions about the role of pharmacists specifically. Can you explain to us how pharmacists assist patients in making informed decisions, as they would do in relation to other medicines, by providing them with the necessary relevant information about homeopathy?

  Professor Lawrence: I think the first thing to realise is that the homeopathic preparations sold in pharmacies are over-the-counter products. So it is possible for a patient to just walk up, take a product off the shelf and buy it. We would contest it is better for the patient for pharmacists to be present when that happens, because they are able, if appropriate, to offer advice to that patient, and there are two things that are important. It is important that patients should realise there is not any evidence for the particular preparations and, also, it gives the pharmacist an opportunity to ensure that the patient is not actually taking something unnecessarily. Somebody mentioned before about taking inappropriate medicine. If they come into a pharmacy, they can have a consultation and the pharmacist can check it is not inappropriate.

  Q61  Mr Boswell: So if you present with a particular condition, say, as it has been mentioned, constipation, for the sake of argument, there is no sort of implied either financial or other pressure which the pharmacist would feel to steer them towards a homeopathic product?

  Professor Lawrence: No.

  Q62  Mr Boswell: Or to make claims for the efficacy of that product which would not otherwise be scientifically justified?

  Professor Lawrence: No, that would go against the pharmacists' Code of Ethics.

  Q63  Mr Boswell: Would anyone else like to comment on that specific line of questioning? If there is not, could I ask this. Often the difficulty arises in delivery, however well the Royal Society has set out its stall, and you have, as you have rightly said, drawn up ethical guidelines. How can you ensure as a Royal Society that pharmacists selling homeopathic remedies are adhering to those guidelines? Can you discipline people? Is there any evidence of disciplining where people have gone outside the rules?

  Professor Lawrence: There are two ways a pharmacist might be disciplined. One of them is through the Society's inspectorate which visits the shops on an occasional basis, and one of their roles is to check that the pharmacists are adhering to ethical guidelines. So it might be picked up there and, if it is, it might just initially be a warning, but if that is not complied with, it would go to—

  Q64  Mr Boswell: There have actually been cases where there has been a warning in relation to homeopathic products that you are aware of?

  Professor Lawrence: Not from the inspectorate, but the other way is from complaints from perhaps a member of the public, and they would be investigated, and there has been a case recently where it did go to a fitness to practise case.

  Q65  Mr Boswell: Do you want to comment on that, Paul, from the point of view of a large pharmaceutical retailer?

  Mr Bennett: Talking in general terms, clearly pharmacists are trained healthcare professionals, they are members of the Royal Pharmaceutical Society, which is a regulated profession, and clearly aspire to very high professional standards. Internally within our own business we would supplement that with standard operating procedures and provide training material and facilitate the development of professional capability of our individual pharmacists. It is really very important that pharmacists adhere to the professional code at all times and, if I can, I would just like to quote from some guidance from the Royal Pharmaceutical Society which I think is succinct but very relevant to this point. That guidance states: "Pharmacists providing homeopathic therapies have a professional responsibility only to offer advice if they have undertaken suitable training or have specialised knowledge," and further (and my last point): "Pharmacists should consider whether any symptoms described by the patient and for which they are taking a homeopathic preparation could be associated with a serious or life-threatening underlying condition. If in doubt, refer the patient to a general practitioner."

  Q66  Mr Boswell: I have two questions arising from that, if I may. The first one is: do you have operational experience if a particular employee of yours who is a pharmacist is "pushing" homeopathic remedies or might be inclined to disregard some of the small print of the code? Do you actually have cases where you have had to discipline or retrain people where this has happened that you are aware of?

  Mr Bennett: Not at all. Our pharmacists take their responsibility very, very seriously. I have not, as Superintendent Pharmacist within Boots UK, encountered that circumstance at all.

  Q67  Mr Boswell: Did you want to say something, Tracey?

  Ms Brown: I did want to say that, whilst Boots' experience may be that (and it is an on-going situation that I cannot give you details of), there is a situation that has arisen where we discovered one large high street pharmacist was selling homeopathic anti-malarial prophylaxis prevention.

  Q68  Mr Boswell: Without scientific evidence.

  Ms Brown: Certainly so, and that, in fact, in one case was making appointments for a homeopathic travel clinic providing anti-malarial prophylaxis. That is something that the RPSGB is looking into.

  Q69  Dr Harris: Is looking into! I am amazed, because this was July 2006. Pharmacists, on television—I saw this programme—said, yes, if you want to avoid malaria, you have a malaria-sized hole in your aura, take this homeopathic remedy—no advice on bed mosquito nets or proper malarial prophylaxis—and Dr Brown has just said that you are still looking at that. I would have thought that is an emergency, is it not? I think there were ten pharmacists doing that.

  Professor Lawrence: I really cannot comment on the disciplinary procedure, unfortunately.

  Q70  Mr Boswell: But it is on-going. Just to confirm, it is not resolved or you are not aware of it.

  Professor Lawrence: I cannot comment.

  Q71  Dr Harris: Wait a minute. Forget those cases. Can you give me the assurance that the people you regulate on behalf of the public are not selling homeopathic anti-malarial prophylaxis in the absence of conventional evidence-based prophylaxis and advice on bed nets?

  Professor Lawrence: Obviously I cannot assure you that every pharmacy is not, but I can assure you that the pharmaceutical society has made it very clear to its members that it is completely inappropriate to use homeopathy for the treatment of malaria.

  Q72  Dr Harris: They should be struck off if they do.

  Professor Lawrence: Yes.[3]

  Q73 Mr Boswell: That is helpful. To come back to Paul Bennett, presumably, statistically within a large organisation some of your pharmacists will themselves be interested in homeopathic remedies for self-medication, as it were. Is there any evidence at all, that you are aware of, of the individual who might be pushing a homeopathic solution because they are, as it were, committed to it?

  Mr Bennett: I would have no evidence to support that assertion at all.

  Q74  Chairman: Yes, Ben?

  Dr Goldacre: I just want to say very briefly that I think very widespread anecdotal evidence is that if you ask a pharmacist, including in Boots, for advice and you say that you are interested in homeopathic pills then you will get advice that is certainly not in keeping with the evidence. I know that Professor David Colquhoun recently went into six pharmacies and said: "I've got a five-year old who has had three days of diarrhoea and I would like an alternative treatment", and in all but one case—and I think these were Boots pharmacies—he was told about a homeopathic pill.

  Q75  Mr Boswell: Can I just be clear because I may have misheard you. You are suggesting that the potential patient or customer has self-declared an interest in homeopathic medicine before this is prescribed? You are not saying that if I walk in, not having made any commitment and just say: "I have a problem; my child is ill" that it will be "pushed" to you? I just want to be clear of the difference.

  Dr Goldacre: They have expressed an interest but they are not getting accurate and impartial information.

  Q76  Mr Boswell: Can I just round up and ask Robert Wilson a couple of questions. You chair the BAHM. How do you ensure that member companies comply with the MHRA regulations on labelling and marketing?

  Mr Wilson: All of our members have what are called GMP licences, which are good manufacturing licences. They are inspected by the MHRA on a two-year basis; so every two years.

  Q77  Mr Boswell: This is primarily about safety?

  Mr Wilson: Safety and making sure that all the labelling is in line. All our members are licensed and the products they sell are all licensed, and there is a very rigorous set of disciplines that you have to go through to make sure of that and there is also a checking mechanism with the MHRA regularly. All our labels are approved by them; all our leaflets are approved by them. So everything that goes out from many of our members would have been—

  Q78  Mr Boswell: Is there much evidence of complaint or failure to comply with that, or not?

  Mr Wilson: None whatsoever.

  Q79  Mr Boswell: Final question: it is slightly more numinous but I think it might be appropriate to clear it now. In making the case for homeopathic remedies, which you made, and we have had a discussion about evidence, which is our primary concern today, are you at all attracted by the argument (I have to admit I have used it myself in relation to organic farming, where you get the same kinds of arguments about what is or is not evidence) or do you ever use the argument that it is quite important for the scientific community to have that body of practice in place, irrespective of the evidence, in order, perhaps, that some evidence might emerge at a later stage? In other words, when you are looking at the case for homeopathy is this not just a matter of the particular products at the particular time but, also, as it were, having a body of custom and practice which is at least in existence separately from conventional medicine and can be assessed against it from time to time?

  Mr Wilson: I think it is very important that homeopathic community makes the case that we are very much pro-research, but, as I said earlier, it has to be good research. Also, this discussion about placebo, I think, is a very interesting one because there are a great deal of things within orthodox medicine that people do not understand—for instance, anaesthetics; they do not know why anaesthetics work but it does not mean that they do not work. The same with electro-shock therapy, or ECT; the schizophrenia treatments, benzodiazepines—there are lots and lots of areas of conventional medicine where they do not understand the mechanism but that does not mean you do not use them.

  Q80  Dr Harris: Would you agree that where you do not understand the mechanism, or the proposed mechanism does not make scientific sense, there is a higher onus to show effectiveness than in medicines where there is good evidence and there is a very clear knowledge? So, if anything, the evidence base on homeopathy should be stronger because of the implausible scientific basis for it.

  Mr Wilson: I would agree entirely on that, but I come back to the question of who will pay for this? One important point to make is that we do not have patents at the end of our process; we have generic medicines. Anyone can make an Arnica pill, and we are very small—my business in homeopathies is £5 million in this country; we are not talking about huge multinationals here. Who is going to pay for this research? Some of the good research—and there is a lot of good research—in Germany has been funded, interestingly, by some of the healthcare insurance companies, and this Witt Trial that I made reference to has shown, and it was funded by the healthcare companies because they wanted to see was it worth their while funding homeopathies through private health insurance, and the answers came back that, actually, it was cost-effective—not just on cost, it was effective for the patient.

  Q81  Chairman: I just wanted to pin you down. Ainsworth is one of your members, is it not?

  Mr Wilson: It is, yes.

  Q82  Chairman: It sells a Swine Flu Formula—"Swine Pneumonia 36C" online. Is it still doing it?

  Mr Wilson: I understand that we had words with them about removing that. However, I am not sure.

  Dr Harris: Kind words?

  Q83  Chairman: Even though that was clearly quite a dangerous product to be selling, given the pandemic which is sweeping the world, you are still happy to sell that through one of your members?

  Mr Wilson: No, absolutely not.

  Q84  Ian Stewart: Can I start at this end and work through and just ask: can any of you say categorically that homeopathy does not work in any circumstances to reduce illness, ailments or adverse conditions?

  Mr Bennett: Again, it is back to the evidence point. So I could not categorically say it does not work, and I know that there is a strong belief in a number of people that it is efficacious.

  Q85  Ian Stewart: So, for you, there is no evidence to show that it works but there is no evidence to show that it does not work. Is that right?

  Mr Bennett: Correct.

  Ms Brown: I think that misunderstands what the placebo effect is. The placebo effect is very powerful and people do heal, and this accounts for the effects of a lot of medicines—or a certain part of their effects. I think that you would expect to see people benefit from taking a placebo.

  Q86  Ian Stewart: Let me help you. I did understand the placebo effect. Other than the placebo effect, can you answer my question?

  Ms Brown: I have not seen any evidence to suggest there is any systematic benefit beyond the placebo benefit.

  Q87  Ian Stewart: That is not what I asked; I asked if you could categorically say that it does not work?

  Ms Brown: Yes. Insofar as I can categorically say anything in this life, I would say yes.

  Dr Goldacre: There have now been around 200 trials of homeopathy against placebo sugar pills and, taken collectively, they show that there is no evidence that homeopathy pills are any better than a placebo. So I would say, on the basis of that, that they do not and, also, that it is not worth doing any more placebo controlled trials because you would be throwing good money after bad and you would have to have a huge number of very strongly positive trials to outweigh all of the negative ones.

  Professor Lawrence: I agree there is no evidence on controlled trials. However, patients do feel benefit, and I think that may come from the fact that when they go to a homeopathy practitioner, often, they have a consultation and there are others things associated with treatment other than pills, in some cases.

  Q88  Ian Stewart: Does that mean, Jayne, that you cannot categorically say it does not work?

  Professor Lawrence: In randomised controlled trials I categorically say it does not work.

  Q89  Dr Iddon: How do you interpret the arnica trials that Robert Wilson was mentioning? Have you looked at those?

  Professor Lawrence: The arnica trial?

  Q90  Dr Iddon: Yes.

  Professor Lawrence: I have not seen that.

  Q91  Dr Iddon: Bruising is a physically observable effect and he is claiming that arnica reduces bruising quicker in a random controlled trial with people in who do not have any application of medicine.

  Professor Lawrence: I have not seen the data so I really cannot comment on the trial. However, as Ben said before, you will always get some positive and negative trials, and you have to take overall the results.

  Q92  Ian Stewart: Paul, can I start with you again—

  Mr Wilson: Can I just come in? Actually, there was a trial by Mollinger et al in April this year which showed that "patients given homeopathic remedies showed responses characteristic of those expected from the remedy, while those given natural placebos did not. This points to a genuine homeopathic effect rather than a mere placebo response." I am very happy to submit any of the things I have mentioned to the Committee afterwards. Just one other thing on a more personal level: teething granules—a teething product we give for babies, which is one of our bestsellers and is recommended highly by pharmacists because it is effective. Babies do not manifest the placebo effect and mothers continue to buy this product enormously because they see it working and working incredibly quickly.

  Q93  Ian Stewart: Can I start again at your end, please, Paul? Is there any evidence that patients are being put at risk from unregulated homeopaths?

  Mr Bennett: Absolutely no evidence that I am aware of, and if there was we would probably act on that.

  Ms Brown: From unregulated homeopaths?

  Q94  Ian Stewart: Yes.

  Ms Brown: Meaning they are not professionally registered homeopaths?

  Ian Stewart: I will say it again—in an effort to get balance into these questions—is there any evidence that patients are being put at risk from unregulated homeopaths? I will bring in some other questions.

  Dr Harris: The question is in the context of a proposal to regulate them—

  Q95  Chairman: I am sorry, Dr Harris; a colleague is asking his questions, and I want him to ask them.

  Ms Brown: If you are referring to the professional registration as regulation then I have not seen any evidence to suggest a significant difference between regulated and unregulated. They are currently unregulated. The difference I have seen, referring back to the anti-malarial prophylaxis issue, was that at the time we tested, having found that various pharmacies were willing to provide anti-malarial prophylaxis and homeopathies with consultations, we tested also whether a similar thing would happen if you consulted GPs who also practised homeopathy, or people who were medically trained, and the answer was no; we did not find (I cannot categorically say) anybody with a medical training who was willing to prescribe homeopathic anti-malarial prophylaxis.

  Q96  Ian Stewart: Maybe for Ben's benefit and the others, I have spent the last four years working with the British Acupuncture Council and the Traditional Chinese Medicine Association, on the basis of developing the regulation that has just been implemented by the Government. So I am very much in favour of appropriate regulation and safeguards. The question that then follows—and perhaps the others will take this into consideration—is: how do you determine between a good homeopath and a bad homeopath, in the current circumstances?

  Ms Brown: Anybody offering medical advice, I believe, needs to have medical training. I think that the best way of ensuring that patient care is at its optimal is to ensure that they have medical training.

  Dr Goldacre: It is not entirely clear to me what is being asked.

  Q97  Ian Stewart: The question is that whenever a patient goes to a pharmacy or any other outlet and is offered homeopathic remedies, whether that is being done on the basis as explained by Paul earlier—this is a worse situation for the patient than if it was a regulated and licensed situation?

  Dr Goldacre: It depends how well they are regulated, but Professor Ernst has shown that the Society of Homeopaths are not adequately regulating their own members at present and that they make claims which breach their own regulations. The evidence of the Sense About Science and Newsnight stint, if you like, where they went to ten homeopaths and found that nine out of ten were happy to give advice on malaria—I do not imagine that a problem like that will go away just because of regulation; I think there is a deeply ingrained systemic problem with people who believe that sugar pills are medically effective. I think you can tweak at the edges but, fundamentally, when you are talking about people who believe that sugar pills have medical effects without evidence then you are starting from a position that is actually quite difficult to reason with.

  Q98  Ian Stewart: In our briefing, Ben, we had it explained that homeopathy claims that water has a memory. In the statement that we received against homeopathy it said that if that was true it would turn the science upside down. Do you agree with that?

  Dr Goldacre: Physics is not really anything that interests me; I do not know if it would turn the world upside down, but the bottom line is it does not matter about the mechanism by which homeopathy is claimed to work or does not work; it does not work.

  Q99  Ian Stewart: Are you sure it is not just the level of knowledge and understanding we have at this point in time? I remember the story about Niels Bohr going to Max Planck and saying: "Nobody accepts my theories and work" and Max Planck saying to him: "You'll need to wait till they die before you are accepted". Is this not the same case here; that the evidence just is not there yet?

  Dr Goldacre: No. I think 200 trials which, taken collectively, showed that homeopathy pills worked no better than a placebo is very good evidence against homeopathy.

  Q100  Ian Stewart: Do you accept Robert Wilson's critique of those trials?

  Dr Goldacre: No. What Robert Wilson has done is exaggerate what homeopaths—

  Q101  Ian Stewart: I am sorry, do you accept his answer that those trials were done in an insignificant sample?

  Dr Goldacre: No, and the criticisms that he made did not hold up. For example, it is the smaller, poorer quality trials which he criticises which are more likely to give a result that favours homeopathy, and it is when you remove those smaller and less effective trials that homeopathy is shown to be no more effective than placebo. What Mr Wilson has done on several occasions today is pull out individual trials. It is a basic, central tenet of evidence-based medicine that you cannot pull out individual trials which go against the grain of what the totality of the evidence shows. You would not accept that for any medical treatment.

  Q102  Ian Stewart: Jayne, would you like to comment?

  Professor Lawrence: There were several questions there. Which one do you want me to answer?

  Ian Stewart: You choose.

  Q103  Chairman: The most interesting!

  Professor Lawrence: First of all, I think the Pharmaceutical Society would recommend some regulation of homeopaths, because while we are sure a lot of homeopaths are responsible there are a number of them that do make irresponsible claims, and I think it is very important that that is actually stopped.

  Q104  Ian Stewart: Is it fair to say that that is the same in any discipline?

  Professor Lawrence: Yes. With respect to the science issue, I think it probably would be revolutionary if homeopathy was proved to be right, because it does go against a lot of fundamental understanding of science as it stands at the moment.

  Q105  Ian Stewart: Is that what subatomic particle physics did for Newtonian physics?

  Professor Lawrence: I do not know. There is the question of dark matter at the moment—that may turn science on its head as well.

  Q106  Ian Stewart: Robert, do you want to conclude?

  Mr Wilson: Just on your science question, I think you have hit the nail on the head; that we just have not yet understood these highly dilute substances. Two points: it is interesting that since the mapping of the human genome we are now talking about bespoke remedy, or medicines, for cancer treatment; not a blanket cancer treatment. Hahnemann talked about treating the person not the disease 200 years ago. Secondly, with highly diluted substances, again, we are now pushing at the boundaries of this. Some of the drugs used in psychosis and in mental conditions are using extremely high dilutions. So I believe that we will find the answers to why homeopathy works because, clearly, in our view, it does work and there is a lot of evidence. I am not just cherry-picking because the other side, equally, cherry-picks. I would say, again, that as far as the homeopathic industry is concerned we would welcome research.

  Q107  Dr Harris: What are your scientific qualifications?

  Mr Wilson: Can I answer your second question?

  Q108  Chairman: I will let you have the last word, Dr Harris.

  Mr Wilson: On regulation, obviously I work for the manufacturers—I represent the manufacturers here today—but we would strongly support regulation. If you look at, for instance, the osteopaths, who have set up a very strong regulatory body of their own, I think it is a shining example that has benefited the osteopaths, because all of their members are regulated by the same authority, and the patients know that they have got the protection of that body behind them. So I think the osteopaths are an example of a very successful complementary system that is working well with regulation at its centre.

  Chairman: At least we have found one point of agreement, that better regulation would help. You have, literally, 30 seconds.

  Q109  Dr Harris: You opined, Mr Wilson, on the dilution of anti-psychotics and other treatments for mental health. I was just wondering what your scientific qualifications were. I know you are an expert in marketing and manufacturing of homeopathic medicines, but I was wondering what your scientific qualifications were that made you confident to opine on the science and the pharmacology of anti-psychotics.

  Mr Wilson: What interests me are arguments within conventional medicine that resonate with some of the principles of homeopathy. One of the great stumbling blocks that homeopathy has today is its dilution. That is the central question—

  Q110  Dr Harris: I was just asking whether you have any qualifications.

  Mr Wilson: I have none other than an interest and having spent 25 years in this field.

  Q111  Dr Harris: Finally, you said that you regretted that in recent years the volume of sales had reduced because of what you described as "attacks" on homeopathy from the science community. Would you say that, if the scientific community think they have the data, that is probably a good thing? Is it not? You could say that that is an effect of memory of data versus memory of water; that people are making data-based decisions.

  Mr Wilson: Yes, I think my view is that we need to have more research into homeopathy; research that can stand up to some of the criticisms that have been placed at it.

  Dr Harris: We should continue to do research until it shows it works?

  Chairman: On that note we will call this session to a halt because I think that is something else we can agree on, that more research would help. Saved by the bell. Can I thank our panel very, very much indeed. It is a difficult area but you have done brilliantly this morning, and we thank you very much indeed.





3   Note by witness: this is a matter for the fitness to practice panel and may result in a striking off the register if the case was proven. Back


 
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