Rapid Responses to:

EDITORIALS: Robin E Ferner and Keith Beard Regulating herbal medicines in the UK BMJ 2005; 331: 62-63 [Full text]

Rapid Responses: Submit a response to this article

Rapid Responses published:

Anything goes or everything disappears

Edzard Ernst   (8 July 2005)

Herbs as Medicine

Ned Hoke   (9 July 2005)

on herbal medicine

philip n evans   (10 July 2005)

The EU directive on Herbal Medicines

Sara A Coakley, Robin E Ferner, Keith Beard   (12 July 2005)

Today something, yesterday nothing

Giuseppe Pimpinella, Renato Bertini Malgarini - Pharmacovigilance Unit - AIFA   (13 July 2005)

Regulating herbal medicines

Ellen C G Grant   (14 July 2005)

Safe Medicines?

Nigel J Langford   (14 July 2005)

Anything goes or everything disappears 8 July 2005
Edzard Ernst, Director of Complementary Medicine Peninsula Medicine School, Univerisities of Exeter & Plymouth Send response to journal: Re: Anything goes or everything disappears	In the Editorial, Ferner and Beard (BMJ 8 July 2005) highlight the problems of judging the usefullness of herbal medicines in the absence of reliable efficacy data. The EU Directive 2004/24/EC is indeed a compromise between the present “anything goes” approach of marketing herbal remedies as food supplements without stringent regulatory control and the “everything disappears” approach. This would demand the same data for registration of herbal medicines as of synthetic drugs. For a range of reasons, herbal medicines are simply not able to meet these criteria and would therefore disappear if this approach were adopted. From the point of view of a scientist who wants to improve healthcare of tomorrow, the EU Directive has another disadvantage which, so far, has hardly been addressed: if we don’t insist on proof of efficacy for registration, the incentive for conducting clinical trials of herbal medicine will drop to zero. Thus our already woefully incomplete knowledge about which herbal medicines are efficacious for which condition will be frozen in time, and no further advance can reasonably be expected. If one believes, as I do, that herbal medicine has considerable potential, this seems counterproductive and not in the interest of (future) patients. Competing interests: None declared
Herbs as Medicine 9 July 2005
Ned Hoke, ecological medicine/private Calif, USA Send response to journal: Re: Herbs as Medicine	It is refreshing to read this article that reflects a reasonable synthesis of common thought today on these topics. These authors see conflicts that if one looks somewhat more broadly at herbalism become less certain as conflicts but almost more as misunderstandings. In the first instance much successful herbalism isn't done primarily as a tableted or capsuled "take this for that symptom" medicinal. While many industrial herbal product suppliers are offering these things to call this herbalism is not to understand what's going on. This is a poor cousin of herbalism and it's uses in the main. To therefore assume that regulation and official strategy makes whole sense with these products in mind would be a primary error if meant to effect therapeutic rationality and safety toward the public use of herbalism. Next herbalism is often part of a group of strategies for nutriative rehabilitation and so the clinical effectiveness in often a component rather than a sole primary ingredient form of intervention. If official management of herbalism is to be sought in reality then these larger pictures are necessary from which to make efficacy judgments. Lastly, as was done for acupuncture and oriental medicine by the NIH(US) in the first national consensus meeting in '97 the 'foreign science' represented in the clinical thinking was understood to be a useful and deserving of functional and clinical respect even if there was not fully developed and tested evidence using western standards. It may be necessary to realize that regulating capsule makers isn't the same thing as regulating in the public interest in the matter of herbalism. Competing interests: None declared
on herbal medicine 10 July 2005
philip n evans, medical herbalist canterbury Send response to journal: Re: on herbal medicine	There is no reference in your article to the fact that there are qualified medical herbalists in the UK, with degrees in herbal medicine from four UK Universities. As a long-standing Member of the National Institute of Medical Herbalists, which has been in continuous existence since 1864, I would like to think there would be some wisdom in your consulting our own august professional body for another version of things - from the professional practitioner`s point of view - which you might then like to publish. Otherwise it would be like asking the pharmacist all about the drug, without any practical input whatever from the GP, with the practitioner`s viewpoint and experience therefore excluded from the overview. Herbal medicine differs in that it does not treat all conditions with the same plant medicines: to us it is risible when we hear such expressions as "St John`s Wort is for treating mild to moderate depression", or "Black Cohosh is good for the menopause". There are twenty or thirty herbs we would consider for a depressed person, whom we would assess individually and prescribe for during a one-to-one consultation, and the same applies to the menopause, or to any other condition: a herbal prescription is a very subtle thing and may contain up to ten or twelve different herbs in correct combination and dosage. It is precisely this individualised approach which often makes herbal medicine successful, and completely contradistinguishes it from the over-the-counter self-medicating approach which we agree often puts people into difficulties. Many of our members now work within GP practices in the UK, and almost all of us are willing to try to `bridge the gap` where possible between the two types of medicine, so that the benefits of the practice of herbal medicine by qualified practitioners may be available to the public, which undoubtedly manifests a great demand for this type of treatment, often where drug treatment has failed or has given unacceptable side-effects. Once again therefore may I suggest you invite a contribution from the NIMH who can be contacted for a spokesperson on 01392 426022 or at our website www.nimh.org.uk Philip Evans, MNIMH Medical Herbalist Competing interests: None declared
The EU directive on Herbal Medicines 12 July 2005
Sara A Coakley, Media Relations Manager Market Towers, 1 Nine Elms Lane. London SW8 5NQ, Robin E Ferner, Keith Beard Send response to journal: Re: The EU directive on Herbal Medicines	The authors of the editorial Regulating herbal medicines in the UK (BMJ 2005; 331: 62-63) fairly point out that the strength of evidence of efficacy for individual herbal remedies varies widely. The revised regulatory arrangements for herbal medicines are designed to deal practically with this situation, whilst also maintaining consumer choice where conditions of acceptable safety can be satisfied. In future it will continue to be possible for herbal medicines, like any other medicine, to receive a standard marketing authorisation, based on demonstrating safety, quality and efficacy. In addition, a scheme to be introduced following the recent European Directive on Traditional Herbal Medicinal Products will regulate over-the-counter traditional herbal medicines suitable for use without medical supervision. Individual products will be assessed for safety and will need to satisfy rigorous quality and manufacturing standards and to be accompanied by approved patient information. The product information will make clear that the minor claims permitted are based on traditional usage. The current UK regulatory arrangements for unlicensed herbal remedies provide very limited safeguards for the public on safety, quality, and patient information. We fully share the concerns of the Editorial about the continuing evidence of adulterated and other low grade herbal remedies on the UK market, and the Agency reports such incidents via our website publication Herbal Safety News. The MHRA believes the higher standards introduced by the new regulatory regime represent an important advance for the consumer. The proposed Herbal Medicines Advisory Committee will give Ministers and the Agency independent scientific and regulatory advice on the operation of the Directive. Competing interests: None declared
Today something, yesterday nothing 13 July 2005
Giuseppe Pimpinella, Pharmaceutical Director - Former Italian Delegate - Pharmaceutical Group of the Council of the EU Italian Medicines Agency (AIFA) - Via della Sierra Nevada 60 - 00144- Rome - Italy, Renato Bertini Malgarini - Pharmacovigilance Unit - AIFA Send response to journal: Re: Today something, yesterday nothing	Ferner and Beard in their editorial (BMJ 8 July 2005) criticize Directive 2004/24/EC, finalized during the Italian Presidency of the Council of the European Union, that allows the simplified registration for herbal traditional medicinal products without requiring formal clinical trials. We would like to point out that in order to undergo this simplified procedures these products need to have been on the EU market for at least 15 years for the claimed indication, that is exclusively based upon long- standing use and has to be a minor indication. Thus, before the Directive these products were marketed as food supplements, but at the same time they could be used for medicinal use without any requirement for pharmaceutical quality, pharmacovigilance and information for the patient and without any limitation avoiding the use for serious pathologies. Furthermore, the patients could not rely on contraindications, warnings, interactions and posology, owing to the lack of package leaflet. The Directive now ensures that these medicinal products shall be used by patients in a responsible way, for specific indications and only for those. We disagree with the authors stating that the authorisation of traditional herbal medicinal products means to renounce to science and to rely on folklore, because most of the chemical drugs authorised in the fifties and in the sixties, certainly not on the basis of trials carried out in compliance with evidence based medicine, are still on the market. Nobody asked the companies to carry out new tests and trials to confirm safety and efficacy of old drugs, starting from the assumption that “they have been on the market for many years and nothing happened”. Obviously, the Directive is not perfect and will probably be modified in the future on the basis of experience, but it grants to EU citizens products with good pharmaceutical quality, acceptable safety and clearly stated indications, despite traditional, avoiding the misuse of unstudied medicines for serious pathologies. Competing interests: None declared
Regulating herbal medicines 14 July 2005
Ellen C G Grant, physician and medical gynaecologist Kingston-upon-Thames, KT2 7JU,UK Send response to journal: Re: Regulating herbal medicines	Robin E Ferner writes concentrations of compounds in unstandardised herbal products can vary several hundredfold and that "herbal" medicines may be adulterated of with active drugs such as corticosteroids and toxic substances such as heavy metals.1 Steroids are immunosuppressive and therefore herbs may suppress warning symptoms. I am concerned that women who may become pregnant, or who are having problems becoming pregnant, are being given herbal mixtures - a practise which seems to have become more fashionable. The sensible rule for safety for the fetus is the avoidance of drug or hormone “treatments” during pregnancy. The best preconception care includes assessing essential nutrient status and levels of toxic metals which act as anti-nutrients, for example, cadmium form tobacco smoking lowers zinc levels. Herbs may be inherently oestrogenic and are therefore are given to suppress premenstrual and menopausal symptoms or they may be contaminated with oestrogenic mycotoxins. I agree that historical use of herbs does not necessarily equate with safety, especially for the fetus. 1 Ferner RE. Regulating herbal medicines in the UK. BMJ 2005;331:62- 63 (9 July), doi:10.1136/bmj.331.7508.62 Competing interests: None declared
Safe Medicines? 14 July 2005
Nigel J Langford, Consultant Physician B18 7QH Send response to journal: Re: Safe Medicines?	Conventional medicine has never sat easily with alternative medical approaches, despite having similar goals and origins. The idea of splitting regulation of such products achieves little apart from a creating the false impression that if a drug is marketed by a large company and obtains a product licence it must be safe and effective. The recent safety record of newly licensed drugs appears to be otherwise as with the COX II inhibitors. Similarly obtaining a product licence does not equate to having efficacy as demonstrated in recent NICE guidelines refusing to endorse certain treatments for Alzheimer’s disease. Ideally patients want to be treated with therapies that are safe, effective and of good quality. Therapies claiming to offer treatment should at least be able to satisfy standard safety criteria. To have a second body to advise ministers directly on some substances and not others can only lead to confusion, particularly if differing criteria are being applied. Furthermore it implies that such products are of limited efficacy and safety, a situation that may be far from the truth. Products being used in the treatment of patients for a medicinal purpose require to be of a set standard. A single set body should monitor and regulate such products to ensure a consistency of approach and better pharmacovigilance. For the MHRA to orphan such products owing to potentially difficult decisions that may be required will only push conventional and alternative medicines further apart potentially placing patients at greater risk. Competing interests: None declared