Examination of Witnesses (Questions 1-111)|
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 Bootswelcome to
you, Paul, and thank you very much for coming; Tracey Brown, the
Managing Director for Sense About Sciencewelcome to you,
Tracey; Dr Ben Goldacre, a journalist from The Guardianwelcome
to you, Ben, this morning; Professor Jayne Lawrence, the Chief
Scientific Adviser for the Royal Pharmaceutical Society of Great
Britainwelcome 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
Q11 Chairman: So why do they not
Mr Wilson: They do believe us.
Q12 Chairman: He has just said they
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
Mr Wilson: Yes.
Q16 Chairman: Even though there is
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
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 trial3,700
patients involvedand 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
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
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
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
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
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
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
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
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 trialslarge ones,
small oneswhich are well-designed. That is what they do.
Do you acceptand I will ask you this for the third timethat
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
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
Q38 Dr Harris: I would just like
to ask Paul Bennett if he has any qualms at all about making money,
as you doit is your right to do thatout 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 nothingthat is
finebut 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
Dr Harris: How would it be helpful? There
has been a series of systematic reviews which demonstrate in homeopathyI
am not talking about the herbal stuff that is aroundthat
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
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
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
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
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 comparisonabout £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
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,
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
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 fourit
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
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
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 onthe fees that they charge
for processing themand 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
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
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
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
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
Q65 Mr Boswell: Do you want to comment
on that, Paul, from the point of view of a large pharmaceutical
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
Q67 Mr Boswell: Did you want to say
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
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 televisionI
saw this programmesaid, yes, if you want to avoid malaria,
you have a malaria-sized hole in your aura, take this homeopathic
remedyno advice on bed mosquito nets or proper malarial
prophylaxisand 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.
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 caseand I think these were Boots pharmacieshe
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
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 understandfor 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, benzodiazepinesthere
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 smallmy 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 researchand there is a lot of good researchin
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-effectivenot 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
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 medicinesor 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
Q87 Ian Stewart: That is not what
I asked; I asked if you could categorically say that it does not
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
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
Q90 Dr Iddon: Yes.
Professor Lawrence: I have not
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 granulesa 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
Ms Brown: From unregulated homeopaths?
Q94 Ian Stewart: Yes.
Ms Brown: Meaning they are not
professionally registered homeopaths?
Ian Stewart: I will say it againin
an effort to get balance into these questionsis 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
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 followsand perhaps the others will take this
into considerationis: 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 earlierthis is a worse
situation for the patient than if it was a regulated and licensed
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 malariaI 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
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
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
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 momentthat
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
Mr Wilson: Can I answer your second
Q108 Chairman: I will let you have
the last word, Dr Harris.
Mr Wilson: On regulation, obviously
I work for the manufacturersI represent the manufacturers
here todaybut 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
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
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
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
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