Szent László Szolgálat Alapítvány Közhasznú Szervezet 5000 Szolnok, Malom u. 1. I./4. Bírósági végzés száma: 1.Kny.60.072/2009/6. Adószáma: 18843062-1-16 KIEGÉSZÍTŐ MELLÉKLET AZ ÉVES BESZÁMOLÓHOZ Kelt: Szolnok, 2013. április 17. ( Dr. Kató Ernő) Szent László Szolgálat Alapítvány Bírósági végzés száma: 1.Kny.60.072/2009/6.
Handle with Care
Adjunct Senior Research Fellow, School of Public Health, La Trobe University Some forms of complementary medicine are efficacious but many have unproven or no health benefits. Claims that cannot be substantiated by scientific research are common, In Australia, complementary medicines are equitable access and cost-effective use of necessary defined (and regulated) by the Therapeutic Experiences with some pharmacy colleagues in the products containing vitamins, minerals, herbs, home- group AusPharm Consumer Health Watch (formed in opathic medicines, traditional Chinese medicines, 2006 and now disbanded) stimulated my interest in Ayurvedic (Indian) medicines and Australian complementary medicine. Another group was formed, indigenous medicines. Complementary therapies this time with the aim of reviewing the regulation of include massage, meditation, yoga and tai chi, complementary medicine using “weight loss” products aromatherapy, reflexology, iridology and reiki.
as an example. We adopted the safer strategy of pub- Alternative medical systems developed in western lishing our report in the Medical Journal of Australia cultures include chiropractic, naturopathy and home- opathy while traditional Chinese medicine and We found that the use of complementary med- Ayurveda are examples of systems developed in non- icines by Australians was substantial and growing.
More than $2 billion is spent nationally, with up to Registration of health practitioners ensures a two-thirds of the Australian adult population using minimal level of education and training, standards of at least one product annually. The average out-of- professional behaviour and complaint mechanisms.
pocket cost to individual consumers is similar to that Chiropractors are registered in all Australian states and territories. Chinese traditional medicine practi- Despite this widespread use, the regulation of tioners are registered in Victoria but not in other these products is considerably weaker than conven- states. Naturopaths, homeopaths and other comple- tional medicines. Most complementary medicines are mentary practitioners have not achieved registration regulated as “listed” products by the TGA. This status, in part because of division in their ranks but means that they should only contain ingredients from a list the TGA regards as “relatively safe”; they My own research relates to complementary med- should be produced in accord with good manufac- icines as defined by the TGA. My background is that turing standards; and the sponsors (those who have of a conventionally trained medical graduate who submitted a marketing application to the TGA) specialised in medical microbiology and infectious should only make “low level” promotional claims for disease. I have moved from public hospital practice to academic public health where my main interest is Sponsors self-assess whether their medicines are medicinal drug policy, especially how to achieve “listable” using a web-based computer system provided by the TGA. The system checks that the mation of the complementary medicine sector”.
ingredients entered are consistent with those Others felt that our paper did not do justice to the allowed, asks the sponsor to certify that they hold Office of Complementary Medicine within the TGA. I evidence to support the indications (and claims accept that the current TGA listing process provides made), and then issues a certificate of listing after some protection to the public by ensuring that com- plementary medicines only contain relatively low-risk The TGA conducts occasional audits of these ingredients manufactured in accordance with the products but they are not routinely evaluated to determine if there is scientific evidence that substan- Herbal products comprise a complex mix of ingre- tiates the sponsor’s claims. By contrast, all conven- dients. Just as all red wine is not Grange Hermitage, tional medicines (“registered” products) are thor- different products containing the same herb are not oughly evaluated for safety, quality and efficacy necessarily chemically or therapeutically equivalent.
before they are allowed onto the market. In theory, Variability can be caused by the use of different consumers can distinguish “listed” from “registered” species or sub-species, growth conditions, methods of products by the type of number on the pack, but in cultivation, the time of year and stage of growth cycle practice most people have no idea what an AUST L harvested, extraction methods, and formulation and storage of the finished product. Even glucosamine Our study of “weight loss” complementary med- (used for arthritis) is available as several salts, in icines showed that more than 1000 of these products vastly different formulations and with varied evidence of efficacy from clinical trials. However, because the TGA does not require There is a discrepancy
clinical trial data of efficacy for “listed” products, nor evidence of therapeutic equivalence with proven between the number of
products, we can have no confidence that Australian people who believe in and
formulations of complementary medicines are effi- use complementary
cacious. In contrast, “registered” conventional med- medicine and the strength
icines must demonstrate efficacy (and safety) by well of evidence to support
conducted clinical trials or, if they are generic copies of an innovator brand, they must demonstrate that that use.
they can produce similar blood and/or tissue levels of the active ingredient to the innovator brand. Nigel Pollard and colleagues (Medical Journal of Weight loss products are clearly a lucrative Australia, 2008) argued that the lack of evidence market. A recent survey of 1000 Australian women from well-conducted clinical trials does not neces- aged between 18 and 35 by Famous magazine sarily mean that complementary medicines are clin- showed that 56% had used slimming tablets. Most ically ineffective. I agree. Traditional use has women surveyed believed that slimmer women were revealed many useful herbal products such as more successful with the opposite sex (79%) and in Artemisia annua for the treatment of malaria and St John’s wort for the management of mild to moderate Our MJA paper concluded with recommendations depression. But traditional therapies have also for regulatory reform. These included proposals that proved to be harmful; the blood letting that was per- the label of complementary medicines include a formed for centuries by the medical profession is a statement such as, “this medicine has not been classic example. When clinical trials were eventually evaluated by Australian health authorities for conducted, blood letting was shown to kill patients, efficacy”, that the advertising complaint system should be strengthened and, in the longer term, com- Although complementary medicines are regarded plementary medicines should be assessed for efficacy as “relatively low-risk” products they are not without and delisted if evidence is lacking.
adverse effects and interactions with conventional A vigorous debate ensured. A professor of comple- drugs. For example, Echinacea (of dubious use to mentary medicine from Southern Cross University shorten cold symptoms) can cause allergic reactions; believed that our recommendation to assess comple- black cohosh (of some value in relieving symptoms mentary medicines for efficacy was “ill-conceived and associated with menopause) has been associated with totalitarian in nature” and “would lead to the deci- liver failure, and St John’s wort interacts with a wide range of conventional drugs including oral contra- MAKING INFORMED DECISIONS
ceptives. Recognition of such problems can be dif- ficult because many patients don’t tell their doctors that they are taking complementary medicines and Complementary medicine is an inclusive term that
incorporates complementary medicines, complementary
As a result, adverse effects of complementary therapies and alternative medical systems. The term
medicines are almost certainly under-recognised. In complementary medicine now encompasses other
addition, ineffective complementary medicines have a names used historically such as alternative medicine,
significant adverse effect on consumers’ hip pockets natural medicine and traditional medicine. The
(or purses) and, more importantly, they can delay or approaches used by complementary medicine are often
prevent the use of more evidence-based therapy. regarded as outside the realm of conventional medicine.
There is a discrepancy between the number of Integrative medicine combines treatments from con-
people who believe in and use complementary ventional and complementary medicine for which there
medicine and the strength of evidence to support that is some high-quality evidence of safety and effec-
use. To narrow this gap the Australian government tiveness. Ask a qualified registered health practitioner
has recently announced more than $7 million of for advice in relation to complementary medicines,
research grants to study the use of complementary especially about:
medicine by consumers, to research mechanisms of • evidence of efficacy from well-conducted clinical
action, and to perform clinical trials to determine trials that tested the specific therapy or product you
are considering using for the condition you wish to
However, Australian clinical trials can only treat (or prevent); and
evaluate a handful of the 16,000 listed products cur- • possible side-effects and potential interaction with
rently available in the market. Choice magazine has your existing therapy.
proposed a pragmatic solution to this problem: an Many clinical trials are underway and the evidence
independent evaluation of complementary medicines on an opt-in, cost-recovery basis. Products shown to keeps changing. Always ask for the latest evidence.
be efficacious by well-conducted clinical trials, eth- The National Prescribing Service’s Medicine Line
ically promoted with appropriate consumer medicine provides excellent independent information about all
information, would be awarded a Trade Mark of medicines, including complementary medicines.
approval similar to the Australian National Heart Telephone 1300 888 762 for the cost of a local call.
Foundation’s “red tick”. Choice has set up a multi- Useful information may be in your local library or on
disciplinary working party to explore the practicality the Internet. However, make sure the clinical trial
of this proposal, but the concept is opposed by the evidence is critically reviewed and the source is recent.
Never buy medicines from overseas websites. More
than 60% of drugs sold by overseas online pharmacies
have been shown to be counterfeit or substandard.
In conclusion, the current Australian regulatory (Australian Internet pharmacies are regulated and
system neither controls complementary medicine reliable).
claims nor supports an evidence-based industry. This Take herbal medicines as a pill or capsules rather
is unacceptable given that Australians spend an than powdered herbs or mixtures from herbalists. The
estimated $2 billion on these medicines each year. It former are more likely to have the correct dosage and
also represents a failure of Australian health policy. less likely to be contaminated or adulterated.
The challenge for our Federal government is to Establish the cost of treatment, and shop around to
overcome industry self-interest and the perception of compare prices.
regulatory “capture” and institute the reforms Always tell your general practitioner and other
required. The challenge for the complementary health professionals what prescription, over-the-counter
medicine industry is to accept that its future must be and complementary medicines you take, as they can
based on evidence, not hype. And the challenge for interact.
both health professionals and consumers is to learn Under no circumstances abandon a prescribed con-
more about the benefits and risks of complementary ventional medicine for a complementary medicine until
medicines, to be open to new ideas but also sceptical you have discussed this decision at length with your
enough to demand evidence of efficacy, and be open general practitioner or medical specialist.
to discussing these matters with each other.
CURRICULUM VITAE PERSONAL DATA: Name : MOHAMED BADAWY HASSAN TAWFIK ABDEL-NASER Address for Correspondence: Dept. of Dermatology and Venereology, Faculty of Medicine Ain Shams University, Abbassia Square 11566, Cairo, Egypt Private : 28 Abou Hayan El Tawhidi, Madina Nasr, 7 th District Tel: (++202) 24031131/25084034/22575252/26830767 Mobile: (++2012) 2342288 Fax: (++20