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RPSGB – DC's Improbable Science

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We have often had cause to criticise Boots Alliance, the biggest retail pharmacist in the UK, because of its deeply unethical approach to junk medicine. Click here to read the shameful litany. The problem of Boots was raised recently also by Edzard Ernst at the Hay Literary Festival. He said

“The population at large trusts Boots more than any other pharmacy, but when you look behind the smokescreen, when it comes to alternative medicines, that trust is not justified.”

Ernst accused Boots of breaching ethical guidelines drawn up by the Royal Pharmaceutical Society of Great Britain, by failing to tell customers that its homeopathic medicines contain no active ingredients and are ineffective in clinical trials.

Another chain, Lloyds Pharmacy, are just as bad. Many smaller pharmacies are no more honest when it comes to selling medicines that are known to be ineffective.

Pharmacists are fond of referring to themselves as “professionals” who are regulated by a professional body, the Royal Pharmaceutical Society of Great Britain (RPSGB). It’s natural to ask where their regulatory body stands on the question of junk medicine. So I asked them, and this is what I found.

17 April, 2008

I am writing an article about the role of pharmacists in giving advice about (a) alternative medicines and (b) nutritional supplements.

I can find no clear statements about these topics on the RPSGB web site.

Please can you give me a statement on the position of the Royal Pharmaceutical Society on these two topics.

In particular, have you offered guidance to pharmacists about how to deal with the conflict of interest that arises when they can make money by selling something that they know to have no good evidence for efficacy? This question has had some publicity recently in connection with Boots’ promotion of CCoQ10 to give you “energy”, and only yesterday when the bad effects of some nutritional supplements were in the news.

Here are some extracts from the first reply that I got from the RPSGB’s Legal and Ethical Advisory Service (emphasis is mine).

28 April 2008

Pharmacists must comply with the Code of Ethics and its supporting documents. Principle 5 of the Code of Ethics requires pharmacists to develop their professional knowledge and competence whilst Principle 6 requires pharmacists to be honest and trustworthy.

The Code states:

5. DEVELOP YOUR PROFESSIONAL KNOWLEDGE AND COMPETENCE

At all stages of your professional working life you must ensure that your knowledge, skills and performance are of a high quality, up to date and relevant to your field of practice. You must:

5.1 Maintain and improve the quality of your work by keeping your knowledge and skills up to date, evidence-based and relevant to your role and responsibilities.

5.2 Apply your knowledge and skills appropriately to your professional responsibilities.

5.3 Recognise the limits of your professional competence; practise only in those areas in which you are competent to do so and refer to others where necessary.

5.4 Undertake and maintain up-to-date evidence of continuing professional development relevant to your field of practice.

6. BE HONEST AND TRUSTWORTHY

Patients, colleagues and the public at large place their trust in you as a pharmacy professional. You must behave in a way that justifies this trust and maintains the reputation of your profession. You must:
6.1 Uphold public trust and confidence in your profession by acting with honesty and integrity.

6.2 Ensure you do not abuse your professional position or exploit the vulnerability or lack of knowledge of others.

6.3 Avoid conflicts of interest and declare any personal or professional interests to those who may be affected. Do not ask for or accept gifts, inducements, hospitality or referrals that may affect, or be perceived to affect, your professional judgement.

6.4 Be accurate and impartial when teaching others and when providing or publishing information to ensure that you do not mislead others or make claims that cannot be justified.

And, on over-the counter prescribing

In addition the “Professional Standards and Guidance for the Sale and Supply of Medicines” document which supports the Code of Ethics states:

“2. SUPPLY OF OVER THE COUNTER (OTC) MEDICINES

STANDARDS

When purchasing medicines from pharmacies patients expect to be provided with high quality, relevant information in a manner they can easily understand. You must ensure that:

2.1 procedures for sales of OTC medicines enable intervention and professional advice to be given whenever this can assist the safe and effective use of medicines. Pharmacy medicines must not be accessible to the public by self-selection.

Evidence-based? Accurate and impartial? High quality information? Effective use?

These words don’t seem to accord with Boots’ mendacious advertisements for CoQ10 (which were condemned by the ASA).

Neither does it accord with the appalling advice that I got from a Boots pharmacist about Vitamin B for vitality.

Or their bad advice on childhood diarrhoea.

Or the unspeakable nonsense of the Boots (mis)-education web site.

Then we get to the nub. This is what I was told by the RPSGB about alternative medicine (the emphasis is mine).

8. COMPLEMENTARY THERAPIES AND MEDICINES

STANDARDS

You must ensure that you are competent in any area in which you offer advice on treatment or medicines. If you sell or supply homoeopathic or herbal medicines, or other complementary therapies, you must:

8.1 assist patients in making informed decisions by providing them with necessary and relevant information.

8.2 ensure any stock is obtained from a reputable source.

8.3 recommend a remedy only where you can be satisfied of its safety and quality, taking into account the Medicines and Healthcare products Regulatory Agency registration schemes for homoeopathic and herbal remedies.”

Therefore pharmacists are required to keep their knowledge and skills up to date and provide accurate and impartial information to ensure that you do not mislead others or make claims that cannot be justified.

It does seem very odd that “accurate and impartial information” about homeopathic pills does not include mentioning that they contain no trace of the ingredient on the label. and have been shown in clinical trials to be ineffective. These rather important bits of information are missing from both advertisements and from (in my experience) the advice given by pharmacists in the shop.

If you look carefully, though, the wording is a bit sneaky. Referring to over-the-counter medicines, the code refers to “safe and effective use of medicines”, but when it comes to alternative medicines, all mention of ‘effectiveness’ has mysteriously vanished.

So I wrote again to get clarification.

29 April, 2008

Thanks for that information. I’d appreciate clarification of two matters in what you sent.

(1) Apropros of complementary and alternative medicine, the code says

8.3 recommend a remedy only where you can be satisfied of its safety and quality

I notice that this paragraph mentions safety and quality but does not mention efficacy. Does this mean that it is considered ethical to recommend a medicine when there is no evidence of its efficacy? Apparently it does. This gets to the heart of my question and I’d appreciate a clear answer.

This enquiry was followed by a long silence. Despite several reminders by email and by telephone nothing happened until eventually got a phone call over a month later (May 3) from David Pruce, Director of Practice & Quality Improvement, Royal Pharmaceutical Society of Great Britain. The question may be simple, but the RPSGB evidently it hard, or more likely embarrassing, to answer.

When I asked Pruce why para 8.3 does not mention effectiveness, his reply, after some circumlocution, was as follows.

Pruce: “You must assist patients in making informed decisions by providing necessary and relevant information . . . we would apply this to any medicine, the pharmacist needs to help the patient assess the risks and benefits.”

DC: “and would that include saying it doesn’t work better than placebo?”

Pruce “if there is good evidence to show that it ???????? ????? ????????may, but it depends on what the evidence is, what the level of evidence is, and the pharmacist’s assessment of the evidence”

DC “What’s your assessment of the evidence?”

Pruce, “I don’t think my personal assessment is relevant. I wouldn’t want to be drawn on my personal assessment”. “If a pharmacist is selling homeopathic medicines they have to assist the patient in making informed decisions”

“I don’t think we specifically talk about the efficacy of any other medicine” [DC: not true, see para 2.1, above]

We would expect pharmacists to be making sure that what they are providing to a patient is safe and efficacious

DC “So why doesn’t it mention efficacious in para 8.3”

Pruce “What we are trying to do with the Code of Ethics is not go down to the nth degree of detail ” . . . “there are large areas of medicine where there is an absence of data”

DC “Yes, actually homeopathy isn’t one of them. It used to be.”

Pruce. “uh, that’s again a debatable point”

DC I don’t think it’s debatable at all, if you’ve read the literature

Pruce. “well many people would debate that point” “This [homeopathy] is a controversial area where opinions are divided on it”

DC “Not informed opinions”

Pruce “Well . . . there are also a large number of people that do believe in it. We haven’t come out with a categorical statement either way.”

I came away from this deeply unsatisfactory conversation with a strong impression that the RPSGB’s Director of Practice & Quality Improvement was either not familiar with the evidence, or had been told not to say anything about it, in the absence of any official statement about alternative medicine.

I do hope that the RPSGB does not really believe that “there are also a large number of people that do believe in it” constitutes any sort of evidence.

It is high time that the RPSGB followed its own code of ethics and required, as it does for over-the-counter sales, that accurate advice should be given about “the safe and effective use of medicines”.

“The scientist on the High Street”

The RPS publishes a series of factsheets for their “Scientist in the High Street” campaign. One of these “factsheets” concerns homeopathy, [download pdf from the RPSGB]. Perhaps we can get an answer there?

Well not much. For the most part the “factsheet” just mouths the vacuous gobbledygook of homeopaths. It does recover a bit towards the end, when it says

“The methodologically “best” trials showed no effect greater than that of placebo”.

But there is no hint that this means pharmacists should not be selling homeopathic pills to sick people..

That is perhaps not surprising, because the Science Committee of the RPSGB copped out of their responsibility by getting the factsheet written by a Glasgow veterinary homeopath, Steven Kayne. You can judge his critical attitude by a paper (Isbell & Kayne, 1997) which asks whether the idea that shaking a solution increases its potency. The paper is a masterpiece of prevarication, it quotes only homeopaths and fails to come to the obvious conclusion. And it is the same Steven Kayne who wrote in Health and Homeopathy (2001)

“Homeopathy is not very good for treating bacterial infections directly, apart from cystitis that often responds to a number of medicines, including Berberis or Cantharis”.

So there is a bacterial infection that can be cured by pills that contain no medicine? Is this dangerous nonsense what the RPSGB really believes?

More unreliable advice

While waiting for the train to Cardiff on April 16th (to give a seminar at the Welsh School of Pharmacy), I amused myself by dropping into the Boots store on Paddington station.

DC I’ve seen your advertisements for CoQ10. Can you tell me more? Will they really make me more energetic?

Boots: Yes they will, but you may have to take them for several weeks.

DC. Several weeks? Boots: yes the effect develops only slowly

Peers at the label and reads it out to me

DC I see. Can you tell me whether there have been any trials that show it works?

Boots. I don’t know. I’d have to ask. But there must be or they wouldn’t be allowed to sell it.

DC. Actually there are no trials, you know

Boots. Really? I didn’t think that was allowed. But people have told me that they feel better after taking it.

DC You are a pharmacist?

Boots. Yes

Sadly, this abysmal performance is only too typical in my experience, Try it yourself.

The malaria question

After it was revealed that pharmacists were recommending, or tolerating recommendations, of homeopathic treatment of malaria, the RPSGB did, at last. speak out. It was this episode that caused Quackometer to write his now famous piece on ‘The gentle art of homeopathic killing‘ (it shot to fame when the Society of Homeopaths tried to take legal action to ban it) Recommending pills that contain no medicine for the treatment or prevention or treatment of malaria is dangerous. If it is not criminal it ought to be [watch the Neals Yard video]. .

The RPSGB says it is investigating the role of pharmacists in the Newsnight sting (see the follow-up here). That was in July 2006, but they are stlll unwilling to say if any action will be taken. Anyone want to bet that it will be swept under the carpet?

The statement issued by the RPSGB, 5 months after the malaria sting is just about the only example that I can find of them speaking out against dangerous and fraudulent homeopathic practices. Even in this case, it is pretty mild and restricted narrowly to malaria prevention.

The RPSGB and the Quacktioner Royal

The RPSGB submitted a response to the ‘consultation’ held by the Prince’s Foundation for Integrated Health, about their Complementary Healthcare; a guide for patients.

Response by the Royal Pharmaceutical Society of Great Britain
Dr John Clements, Science Secretary

“We believe that more emphasis should be given to the need for members of the public who are purchasing products (as opposed to services) to ask for advice about the product. Pharmacists are trained as experts on medicines and the public, when making purchases in pharmacies, would expect to seek advice from pharmacists”

So plenty of puffery for the role of pharmacists. But there is not a word of criticism about the many barmy treatments that are included in the “Guide for Patients”. Not just homeopathy and herbalism, but also Craniosacral therapy, Laying on of Hands, chiropractic, Reiki, Shiatsu –every form of barminess under the sun drew no comment from the RPS.

I can’t see how a response like this is consistent with the RPS’s own code of ethics.

A recent president of the RPSGB was a homeopath

Christine Glover provides perhaps the most dramatic reason of all for thinking thst, despite all the fine words, the RPSGB cares little for evidence and truth The NHS Blogdoctor published “Letter from an angry pharmacist”.

Mrs Glover was president of the RPSGB from 1999 to 2001, vice-president in 1997-98, and a member of the RPSGB Council until May 2005. She is not just a member, but a Fellow. (Oddly, her own web site says President from 1998 – 2001.)

So it is relevant to ask how the RPSGB’s own ex-president obeys their code of ethics. Here are some examples on how Ms Glover helps to assist the safe and effective use of medicines. . Much of her own web site seems to have vanished (I wonder why) so I’ll have to quote the “Letter from an angry pharmacist”., as revealed by NHS Blogdoctor,

“What has Christine got to offer?

  • “We offer a wide range of Homeopathic remedies (over 3000 different remedies and potencies) as well as Bach flower remedies, Vitamins, Supplements, some herbal products and Essential Oils.”
  • Jetlag Tablets highly recommended in ‘Wanderlust’ travel magazine. Suitable for all ages.
  • Wind Remedy useful for wind particularly in babies. In can be supplied in powder form for very small babies. Granules or as liquid potency.
  • Udder Care 100ml £80.00 One capful in sprayer filled with water. Two jets to be squirted on inner vulva twice daily for up to 4 days until clots reduced. Discard remainder. Same dose for high cell-counting cows detected.

Udder Care? Oh! I forgot to say, “Glover’s Integrated Healthcare” does cows as well as people. Dr Crippen would not suggest to a woman with sore breasts that she sprayed something on her inner vulva. But women are women and cows are cows and Dr Crippen is not an expert on bovine anatomy and physiology. But, were he a farmer, he would need some persuasion to spend £80.00 on 100 mls of a liquid to squirt on a cow’s vulva. Sorry, inner vulva.”

Nothing shows more clearly that the RPSGB will tolerate almost any quackery than the fact that they think Glover is an appropriate person to be president. Every item on the quotation above seems to me to be in flagrant breach of the RPSGB’s Code of Ethics. Just like the Society of Homeopaths, the code seems to be there merely for show, at least in the case of advice about junk medicine..

A greater role for pharmacists?

This problem has become more important now that the government proposes to give pharmacists a greater role in prescribing. Needless to say the RPSGB is gloating about their proposed new role. Other people are much less sure it is anything but a money–saving gimmick and crypto-privatisation.

I have known pharmacists who have a detailed knowledge of the actions of drugs, and I have met many more who haven’t. The main objection, though, is that pharmacists have a direct financial interest in their prescribing. Conflicts of interest are already rife in medicine, and we can’t afford them.

Conclusion

The Royal Pharmaceutical Society is desperately evasive about a matter that is central to their very existence, giving good advice to patients about which medicines work and which don’t. Pharmacists should be in the front line in education of the public, about medicines, the ‘scientist on the High Street’. Some of them are, but their professional organisation is letting them down badly.

Until such time as the RPSGB decides to take notice of evidence, and clears up some of the things described here, it is hard to see how they can earn the respect of pharmacists, or of anyone else.

Follow-up

Stavros Isaiadis’ blog, Burning Mind, has done a good piece on “More on Quack Medicine in High Street Shops“.

The Chemist and Druggist reports that the RPSGB is worried about the marketing of placebo pills (‘obecalp’ -geddit?). It does seem very odd that the RPSGB should condemn honest placebos, but be so very tolerant about dishonest placebos. You couldn’t make it up.

A complaint to the RPSGB is rejected

Just to see what happened, I made a complaint to thr RPSGB about branches of their own Code of Ethics at Boots in Hexham and in Evesham. Both of them supported Homeopathy Awareness Week These events had been publicised in those particularly unpleasent local ‘newspapers’ that carry paid advertising disguised as editorial material. In this case it was the Evesham Journal and the Hexham Courant.

Guess what? The RPSGB replied thus

“Your complaint has been reviewed bt Mrs Jill Williams and Mr David Slater who are both Regional Lead Inspectors. Having carried out a review they have concluded that support of homeopathic awareness week does not constitute a breach of the Society’s Code of Ethics or Professional Standards.”

In case you have forgotten, the Professional Standards say

2.1 procedures for sales of OTC medicines enable intervention and professional advice to be given whenever this can assist the safe and effective use of medicines.

The RPSGB has some very quaint ideas on how to interpret their own code of ethics