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Is it ethical for pharmacists to sell unproven or disproven medicines?

by Edzard Ernst

Edzard Ernst, professor of complementary medicine at the University of Exeter, examines what he considers is an ethical dilemma for pharmacists

 

In 1847, Ellis Flitcroft of Bolton, former bricklayer, former policeman and “vendor of herbs from America”, was involved in an inquest on one of his patients. An indictment was obtained under the Apothecaries Act and he was sentenced to one month’s imprisonment. This was probably the first such case in England and it presented an opportunity too good to be missed.

When Flitcroft was liberated in May, he returned to the town in style on a horse drawn car, with the Temperance Band playing through the streets. Flags and banners proclaimed the “release of the persecuted Flitcroft”, and the day finished with a celebratory tea party in the Temperance Hall. Newspapers reported the event, The Lancet complained of evil quackery, quacks could make fortunes, “whilst honest surgeons trudge on as they can”.

This fascinating quote is taken from Miley and Pickstone’s account of British botanical medicine in the mid 19th century.1 Today’s pharmacists can lean back comfortably thinking: this has nothing to do with us, we have cleaned up our act long ago, and nobody can accuse us of evil quackery. But is this really the case?

Most UK pharmacies have shelves full with herbal remedies, aromatherapy oils, flower remedies and homoeopathic products. The sales figures for such items have increased steadily during the past decade. There is no question therefore that pharmacists continue to be involved in selling these products to the public and, in doing so, making a healthy profit.

Is this ethical? In order to focus the discussion on one range of products, I will concentrate on homoeopathic medicines because they seem to represent a fairly clear cut example of what one might call an unproven medicine.

The evidence

Although the current evidence for herbal medicines is mixed, some are backed up by relatively solid evidence while others are not.2 That for homoeopathic remedies is fairly straightforwardly negative. About 150 randomised controlled trials of homoeopathy are available today.

Unsurprisingly, a few of them have generated promising or even positive results. But the totality of that evidence fails to demonstrate effectiveness. A summary of all recent systematic reviews of RCTs of homoeopathy failed to show that homoeopathy was effective for any condition.3 Since then, two further systematic reviews have emerged, and their results have been equally disappointing.4,5

Homoeopaths, on the other hand, have published at least two articles that came to positive conclusions about the effectiveness of their remedies.6, 7 Unfortunately, these articles lacked rigour and have been criticised for being overly optimistic.8

One detailed critique finished with the following statement: “It is clear that the high quality studies, and especially those included in the more recent meta-analyses do not show any effect of homoeopathy above placebo.”8

Not only is there no evidence for clinical effectiveness, homoeopathy is also biologically implausible. Its two main principles —like cures like, infinitesimal dilution — fly in the face of science.9 Homoeopaths counter that we do not know the precise mode of action of many conventional medicines. This is misleading.

We are not merely ignorant of the mechanism of homoeopathy, but we know that no mechanism exists which could possibly explain how homoeopathy works and be in accordance with the laws of nature as we understand them today.9

The inescapable conclusion is, therefore, that homoeopathic medicines are not based on good evidence. Many scientists would insist that they are a classic example of a disproven treatment. For the purpose of this discussion I nevertheless want to characterise them as unproven.

The ethics

All pharmacists should know their code of ethics. But, just in case a non-pharmacist reads this, here are some relevant passages from this document. As a pharmacist:

  • You are “answerable for your acts and omissions, regardless of advice or directions from your manager or another professional”
  • You must “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”
  • You must “undertake and maintain up-to-date evidence of continuing professional development relevant to your field of practice”
  • You must “ensure you do not abuse your professional position or exploit the vulnerability or lack of knowledge of others”
  • You must “ensure that you do not mislead others or make claims that cannot be justified”

This is fairly clear language. The verb “must” is used in the original text of the code. If pharmacists must be evidence-based, up-to-date, and avoid misleading or exploiting their customers, the sale of homoeopathic medicines seems prohibited. But surely I must be wrong — I have not yet seen a UK pharmacy which does not offer these products.

To clarify the position, a second document published by the Royal Pharmaceutical Society — “Professional standards and guidelines for the sale and supply of medicines” — might be helpful. It sets out that pharmacists are expected to “be satisfied of the clinical appropriateness of medicines supplied to individual patients” and to “encourage the effective use of medicines”.

Specifically on over-the-counter medicines, it stresses that pharmacists must ensure that “when an OTC medicine is supplied, sufficient advice to ensure the safe and effective use of the medicine is provided”. Again this seems to indicate, that selling homoeopathic medicines is not an ethical thing for a pharmacist to do.

There is a separate heading for complementary medicines. Here is the entry in full: “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:

  • Assist patients in making informed decisions by providing them with necessary and relevant information
  • Ensure any stock is obtained from a reputable source
  • 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.”

This sounds different from the previous text. Most remarkably, in the last paragraph, safety and quality are mentioned but efficacy is not. Does this mean we have two standards, one for conventional and the other for complementary medicine?

Maybe not, because the pharmacist “must assist patient in making informed decisions”, and that means, as we have seen, that the pharmacist nevertheless must provide advice that is not misleading and is based on up-to-date evidence.

Even though these instructions are somewhat confusing, in essence, they do seem to tell us fairly clearly that the sale of homoeopathic medicines without relevant information is not ethical.

Comment

Pharmacists are frequently the only healthcare professionals who have the opportunity to advise patients on the use of alternative medicines. Most users self-prescribe without consulting their doctor. Many would not even inform their healthcare team that they have decided to use a remedy. This scenario puts special pressure on pharmacists to inform their clients responsibly about homoeopathic remedies and similar products.

I have used homoeopathic remedies merely as an example. I could have chosen flower remedies, aromatherapy oils or certain herbal supplements for which the evidence is equally shaky, non-existent or negative2 and which are also on offer in most pharmacies.

The sale of such goods confronts pharmacists with an ethical dilemma. On the one hand, there are consumer choice and pharmacists’ own profits. On the other hand, we have lack of evidence (or even negative evidence as in the case of homoeopathy), lack of expertise on the side of many pharmacists, and the pharmacists’ duty to supply necessary and relevant information. It is difficult to argue that the following information about homoeopathy is not necessary nor relevant:

  • The principles of homoeopathy are not biologically plausible2
  • The most reliable clinical data fail to show effectiveness beyond a placebo effect3–5
  • Most of the remedies for sale do not contain a single molecule of what it says on the package

Yet, such necessary or relevant information is not available in UK pharmacies. On the contrary, in many pharmacies, we find brochures which promote the use of homoeopathy for a range of conditions with statements that are either overtly wrong or seriously misleading.

I am sure that all of this is within the law of the country. But is it ethical? I think we should have an open, unemotional and honest debate about this question.

 

References

1. Miley U, Pickstone V. Medical botany around 1850: American medicine in industrial Britain. In: Cooter R, editor. Studies in the history of alternative medicine. Hong Kong: The Macmillan Press; 1988, pp140–54.

2. Ernst E, Pittler MH, Wider B, Boddy K. The desktop guide to complementary and alternative medicine. 2nd ed. Edinburgh: Elsevier Mosby; 2006.

3. Ernst E. A systematic review of systematic reviews of homoeopathy. British Journal of Clinical Pharmacology 2002; 54:577–82.

4. Shang A, Huwiler-Muntener K, Nartey L, Juni P, Dorig S, Sterne JA et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet 2005;366:726–32.

5. Altunc U, Pittler MH, Ernst E. Homoeopathy for childhood and adolescence ailments: systematic review of randomised clinical trials. Mayo Clinic Proceedings 2007;82:69–75.

6. Bornhöft G, Wolf U, von Ammon K, Righetti M, Maxion-Bergemann S, Baumgartner S et al. Effectiveness, safety and cost-effectiveness of homoeopathy in general practice —summarized health technology assessment. Forschende Komplementärmedizin 2006;13(Suppl 2):19–29.

7. Mathie RT. The research evidence base for homeopathy: a fresh assessment of the literature. Homeopathy 2003;92:84–91.

8. Bender DA. The evidence for homoeopathy. Health Watch Newsletter 2008;69:4–5.

9. Singh S, Ernst E. Trick or treatment? Alternative medicine on trial. London: Bantam Press; 2008.

Citation: The Pharmaceutical Journal URI: 10022926

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