PARKE DAVIS PTY LTD v FC OF T & ANOR
Members:Davies J
Tribunal:
Federal Court
Davies J
These proceedings were commenced in the High Court of Australia and were remitted to this Court by order of Gaudron J on 17 March 1994.
The applicant, Parke Davis Pty Ltd (``Parke Davis''), which is associated with the Warner- Lambert Co (``Warner-Lambert''), seeks a declaration that a product which it manufactures, ``Listerine Antiseptic Mouthwash'' (``Listerine''), is exempt from sales tax under Item 38 in Schedule 1 to the Sales Tax (Exemptions & Classifications) Act 1935 (Cth) (``the Exemption Act''). Item 38 reads:-
``ITEM 38 Drugs and medicines (including patent and proprietary medicines) used in the prevention, cure or treatment of sickness or disease in human beings, and in the compounding or preparation of such drugs or medicines, but not including-
- (i) Drugs and preparations put up and sold for the purposes of photography;
- (ii) Toilet preparations and goods in the nature of toilet preparations, including soaps, cleansing creams, hair lotions, anti-dandruff foams, anti-dandruff shampoos, skin repair creams, skin repair lotions, tooth pastes, cosmetics, powders, pomades and perfumes;
- (iii) Dyes, naphthalene, carbonate of soda, caustic soda, sodium chloride, cloudy ammonia, alum, borax, glycerine, petroleum jelly, lead salts, zinc salts, citric acid, chromic acid, formic acid, hydrochloric acid, hydrofluoric acid, nitric acid, pyrogallic acid, stearic acid, sulphuric acid and tartaric acid;
- (iv) medicated confectionery; or
- (v) goods of the following kinds put up for sale as antiseptics, namely, sterilizing solutions, household disinfectants, combined sterilizing solutions and disinfectants, combined sterilizing solutions and antiseptics, combined disinfectants and antiseptics and combined sterilizing solutions, disinfectants and antiseptics.''
(emphasis added)
Issues in the proceedings are whether Listerine is a drug or medicine, whether it is used in the prevention, care or treatment of sickness or disease in human beings and whether it is a toilet preparation or a good in the nature of a toilet preparation. Although Listerine is marketed as an antiseptic mouthwash, the respondents have not relied upon exclusion (v). Accordingly, I have not given that exclusion any consideration. A claim that Listerine was also exempt under Item 123 of Schedule 1 to the Exemption Act was not pursued.
Listerine is listed in Martindale's Pharmacopoeia under the heading ``Listerine Antiseptic''. Its contents are shown as follows:-
``Listerine Antiseptic (Warner-Lambert, UK). Alcohol (96%) 28.4%, benzoic acid 0.12%, eucalyptol 0.09%, menthol 0.04%, methyl salicylate 0.05% and thymol 0.06%.''
I need not set out the precise formula of Listerine, which includes a number of other ingredients, and in which the percentages differ in some respects from those set out above. The formula is a trade secret. Martindale's description is sufficient for present purposes.
It appears from a paper by Professor Irwin D. Mandel entitled ``Chemotherapeutic agents for controlling plaque and gingivitis'', published in the Journal of Clinical Periodontology in 1988, that in the mid-19th century, Joseph Lister, a surgeon and researcher, became interested in surgical sepsis, which at that time resulted in many deaths. Lister introduced the use of carbolic acid, a phenol, as an antiseptic and the number of surgical deaths dropped substantially. Over the remaining years of the 19th century, attention was given to the use of antiseptics in the treatment of dental decay, particularly by W.D. Miller, who studied the use of antiseptics for this purpose. The original Listerine formulation was among the antiseptics which Miller studied for efficacy against oral bacteria. In his 1890 work on the
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Listerine has been sold without prescription in this and other countries as an antiseptic mouthwash for more than a century. In recent times, as the disease dental caries has responded well to fluoride, attention has turned to plaque and to gingivitis, which is an inflammation of the gums. A body of literature examining the chemical control of plaque and the effect of anti-plaque agents in controlling, preventing or reducing gingivitis has developed. Some of the studies have specifically examined Listerine in this context. In the light of the results, Parke Davis now markets Listerine for the control of plaque and gingivitis.
In the paper I have mentioned, Professor Mandel discussed a number of chemotherapeutic agents. Dealing with Listerine, under the heading ``Antiseptic Agents'', Professor Mandel said:-
``The totality of clinical and laboratory evidence supports the value of Listerine antiseptic as an adjunctive means of reducing plaque accumulation and toxic potential, and at the same time dampening gingival inflammation. Twice daily, a desirable combination in managing gingivitis rinsing is as effective as more frequent use (Mankodi et al. 1987). Some patients find an initial burning sensation and bitter taste. Accommodation, however, usually occurs in a few days. Occasional staining of a minimal nature has been reported, but overall side-effects are minimal and safety has been established by a hundred years of wide-scale use. As befitting such a venerable product, it has become the first over-the-counter mouthrinse to be accepted by the Council of Dental Therapeutics for its help in controlling plaque and gingivitis.''
After discussing other chemotherapeutic agents, Professor Mandel concluded:-
``Chemotherapeutic mouthwashes can be characterised as solutions that have finally found their problems. For years they have been treated with disdain or at best, tolerance, by the profession and regulatory agencies. The conventional wisdom was that their effect on the oral flora was so transitory or modest that given the rapid regeneration time of the mouth bacteria, their impact was negligible and hence they were no more than esthetic or cosmetic adjuncts.
In recent years, several changes have occurred that have resulted in a re- consideration. One, and especially seminal, has been the designation of plaque, and at least one of its consequences, gingivitis, as the target....
...
We now eagerly await the next generation of chemotherapeutic agents that have more specificity than their forebears.... In the meantime, we do have some reasonable alternatives in our first and second generation products.''
That description puts the case as the applicant would wish it to be accepted. Listerine is a very old product, developed as an antiseptic mouthwash to assist in oral hygiene. It was recognised by Miller in 1890 as a useful antiseptic and has recently been examined in several trials and found to assist in the reduction of plaque accumulation and gingival inflammation while, at the same time, being safe to use and having minimal side effects.
In about June 1987, Listerine was granted a Seal of Acceptance by the American Dental Association. In about August 1988, a Seal of Approval was granted by the Australian Dental Association. The stated objectives of the Seal of Approval program of the Australian Dental Association include:-
``1.1 To recognise oral health products of suitable quality that are marketed to the general public, and as an element of that recognition to offer to suppliers a `Seal of Approval' for use in sales promotions directed to the consumer market.
...
1.2 Through the granting of a `Seal of Approval' to offer to the general public assurances of safety and efficacy of consumer products used for oral health care.
...''
Both the American Dental Association and the Australian Dental Association established
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protocols for the grant of their Seals in respect of mouthwashes. The protocols require that the goods have therapeutic effect and that that effect be established, inter alia, by properly conducted studies.It is of assistance to the applicant's case that Listerine was registered as a ``therapeutic good'' under the Therapeutic Goods Act 1989 (Cth) and the Therapeutic Goods Regulations on 10 April 1992. The Therapeutic Goods Act requires goods for which therapeutic effects are claimed to be registered if they are to be marketed in Australia. The Act provides for an evaluation of goods in respect of which registration is sought and of the claims made in respect thereof and also for the cancellation of registration where the Secretary is not satisfied with the goods or the claims made therefor. The following are relevant provisions:-
``3.(5) For the purposes of this Act, the presentation of therapeutic goods is unacceptable if it is capable of being misleading or confusing as to the content or proper use of the goods and, without limiting the previous words in this subsection, the presentation of therapeutic goods is unacceptable:
- (a) if it states or suggests that the goods have ingredients, components or characteristics that they do not have; or
...
25.
...
the goods are to be evaluated for registration having regard to:
- (d) whether the quality, safety and efficacy of the goods for the purposes for which they are to be used have been satisfactorily established; and
- (e) whether the presentation of the goods is acceptable; and
- ...
30. (2) Subject to subsection (3), the Secretary may, by notice in writing given to a person in relation to whom therapeutic goods are included in the Register, cancel the registration or listing of the goods if:
- (a) it appears to the Secretary that the quality, safety or efficacy of the goods is unacceptable; or
- ...''
In the light of these provisions, I take the fact of registration of Listerine as a therapeutic good under the Therapeutic Goods Act and Regulations as a factor assisting the applicant's claim.
The American Dental Association, the Australian Dental Association and the Commonwealth Department of Health, which manages the Therapeutic Goods Administration, have been consulted with respect to, and have approved the labelling of, Listerine and its advertising.
The claims made for Listerine on its label, in large print, are that it is an ``antiseptic mouthwash'' and that it ``kills the germs that cause plaque, gingivitis and bad breath.'' In smaller print, the label states:-
``Listerine antiseptic mouthwash helps prevent and reduce plaque and gingivitis (red, swollen gums) and bad breath for better oral hygiene.
In addition to regular brushing alone, Listerine reduces plaque by up to 50%.''
The Seal of Approval of the Australian Dental Association, a copy of which is displayed on the label, necessarily gives support to those claims.
In Item 38, the term ``[d]rugs and medicines'' and the term ``sickness or disease'' have the meanings they hold in ordinary parlance rather than the meanings they may hold in medical circles. That a non-technical term such as ``sickness'' is used, that both patent and proprietary medicines are included and that goods such as ``tooth pastes, cosmetics, powder, pomades and perfumes'' are specifically excluded show that Item 38 has a wide ambit and is not restricted to those considerations to which scientists or medical practitioners may have regard. In the context, the term ``medicines'' includes goods which some persons would describe as ``medicaments'' rather than ``medicines''. The Macquarie Dictionary defines ``medicament'' as ``a curative or healing substance''.
Lockhart J in
Bristol-Myers Co Pty Ltd v FC of T 90 ATC 4553; (1990) 23 FCR 126 adopted this approach. At ATC 4558; FCR 132, his Honour said:-
``... Patent medicine is a term used for a medicine usually advertised to the pubic and a proprietary medicine is a term which includes any therapeutic preparation sold
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either directly to the public or solely on prescription by the medical profession: see Butterworth's Medical Dictionary (2nd ed, 1980). Again I have consulted the various dictionaries. The word `medicine' when used as a noun is according to its ordinary meaning in my opinion any substance or mixture of substances used in treating or preventing diseases or disorders. This is the meaning of the word in item 38.''
The same approach was adopted by Jenkinson J in
Nicholas Kiwi Pty Ltd v FC of T 90 ATC 4662.
A more restricted use of the word ``drug'' is that which appears in early dictionaries such as the Oxford English Dictionary in which the term refers to an ``original, simple medicinal substance'', whether used by itself or as an ingredient in a medicine. Dr M J Christie gave evidence to the same effect when he said that a ``drug'' was ``a single molecular entity with a chemotherapeutic effect by way of prevention, treatment of disease''. If this definition were adopted, Listerine would not be described as a ``drug'', for it is a mixture of such substances. However, the term is not necessarily used that way in ordinary parlance. For present purposes, there is no need to draw any distinction between ``drug'' and ``medicine''.
The Macquarie Dictionary gives the following definitions:-
``drug... 1. a chemical substance given with the intention of preventing or curing disease or otherwise enhancing the physical or mental welfare of men or animals...''
``medicine... 1. any substance or substances used in treating disease; a medicament; a remedy...''
``disease... 1. a morbid condition of the body, or of some organ or part; illness; sickness; ailment...''
The Gould Medical Dictionary gives these definitions:-
``drug... 1. Any substance other than food or water that is intended to be taken or administered (ingested, injected, applied, implanted, inhaled, etc.) for the purpose of altering, sustaining, or controlling the recipient's physical, mental, or emotional state...''
``medicine... 1. any substance used for treating disease...''
``disease... 1. The failure of the adaptive mechanisms of an organism to counteract adequately the stimuli or stresses to which it is subject, resulting in a disturbance in function or structure of any part, organ, or system of the body. A response to injury; sickness or illness...''
These meanings are, in general, those applied in ordinary parlance.
The use of the words ``sickness or disease'' show that Parliament has in mind a broad scope for Item 38. In
Federal Broom Co Pty Ltd v Semlitch (1964) 110 CLR 626, Kitto J said at 632, in relation to workers' compensation legislation:-
``In its ordinary meaning `disease' is a word of very wide import, comprehending any form of illness; and there is no reason that I can see for reading it in the present context as not extending to mental illness.''
Professor Sebastian Ciancio, Chairman of the Department of Periodontics in the School of Dental Medicine, State University of New York, described plaque and gingivitis as follows:-
``Briefly, dental plaque is a generic term used to describe the complex microbial community found on the tooth surface and embedded in a matrix of polymers of bacterial and salivary origin. It includes, significantly, live bacteria. The adhesion of bacteria to the tooth surface is a complex process, preceded by the formation on the teeth of a pellicle, initially involving a reversible phase involving Van der Waals' attractive forces and electrostatic repulsion. There follows an irreversible phase involving interactions between bacterial surface macromolecules and salivary (glyco) proteins which coat the tooth surface. Other organisms attach in a specific and ordered manner to these `pioneer' bacteria. Subsequent cell division leads to the formation of a biofilm. This microbial mass is firmly anchored to the tooth via extra- cellular bacterial polymers (of glucose) formed from sucrose. Ultimately, the microbial community becomes complex and may be calcified to produce calculus (which is also known as tartar).
While plaque is not a disease the overwhelming evidence is that its persistence leads to periodontal diseases,
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such as gingivitis, and that its prevention and/or removal is of paramount importance in the prevention of such diseases (exhibit SC 1 at page 1).... [g]ingivitis is a disease of the gums. It is a non-specific inflammatory response to dental plaque involving the gingiva. Gingivitis is the first stage of an inflammation of the gum soft tissue margins which begins at the gum margin and spreads. If untreated, it may lead to more serious periodontal disease, such as periodontitis, which is a disease of the gum tissues which connect with and support the tooth...
...
... [g]ingivitis is extremely common and most reports of the average prevalence of gingivitis, expressed as the percentage of the population with signs of the disease in at least one area of the mouth at any one point in time, range from 40% to near 100% (exhibit SC 1 at page 1). However, it is clear that gingivitis is a disease.... This is certainly my view and the view of the American Academy of Periodontology (see for example exhibit SC 1).''
Although plaque itself is not described by practitioners as a disease, because it is a naturally occurring condition of the body, it is nevertheless a complex condition in which bacteria, not external bacteria but bacteria in the oral cavity, are involved. If untreated, the condition leads to dental caries and to gingivitis. Endotoxins produced by the bacteria involved in plaque are a principal cause of gingivitis. To assist in the control of plaque and gingivitis, regular brushing of the teeth is advised and this is considered to be a necessary means of dealing with the problem. It is now common practice for dental surgeons to treat the condition in a number of ways as part of the regular maintenance of their patients' teeth.
Plaque and gingivitis are sufficiently of the nature of ``sickness or disease'', to be, for the purpose of Item 38, the proper subject of prevention or treatment by drugs or medicines.
Mr A.H. Slater QC, with whom Mr K.M. Connor of counsel appeared for the Commissioner of Taxation (``the Commissioner''), no doubt encouraged by the results in Bristol-Myers Pty Ltd v FC of T and in Nicholas Kiwi Pty Ltd v FC of T, took the approach that, if the Court finds that Listerine is a drug or medicine within the meaning of Item 38, then he would accept that it was used in the prevention, cure or treatment of sickness or disease in human beings. Mr Slater's principal submission was that Listerine is not a drug or medicine because of what he said is its lack of efficacy.
In my opinion, the best guide to whether Listerine is a drug or medicine is the use to which the product is put. Listerine is an unpleasant tasting mixture of a number of chemical substances. It is sold as an antiseptic. It is not in dispute that Item 38 would, but for paragraph (v), encompass many antiseptics. Therefore, if Listerine is used in treating, controlling or preventing disease or disorder, there seems to be no reason not to regard it as a drug or medicine.
In directing attention to the words ``[d]rugs and medicines'', rather than to the remainder of the description in Item 38, Mr Slater perhaps sought to divert attention away from the words ``used in''. Much of his attack upon the applicant's claim was upon the efficacy or the proven efficacy of Listerine. The crux of Mr Slater's submissions was as follows:-
``20. The Applicant's contention that the evidence advanced by it establishes that Listerine has the essential character of a medicine is disputed by the Respondents on three principal grounds: that the benefits alleged for Listerine are not clinically worthwhile; that the mechanisms by which those benefits are obtained are not revealed to be more than is obtained by a cleansing process; and that the studies reporting the benefits are not sufficiently reliable.''
Two of these grounds, that the benefits alleged for Listerine were not clinically worthwhile and that the studies reporting the benefits were not reliable, deal with the effectiveness of the product.
Item 38 does not specify that the product be ``clinically worthwhile''. It requires that the product be used in the prevention, cure or treatment of sickness or disease. Emphasis is placed on the manner in which the product is used, not on its proven efficacy. As to ``use'', assistance may be gained from
DFC of T v Stewart & Anor 84 ATC 4146; (1984) 154 CLR 385, where the words in question were ``for use... by'', which appeared in Item 81(1)(c) in the First Schedule to the Exemption Act. As Gibbs
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CJ pointed out at ATC 4149; CLR 390, the word ``use'' does not connote exclusive use. His Honour noted that, where it was intended that use should be exclusive, express provision was made in the First Schedule to the Exemption Act. His Honour said that the use required was a use to ``a significant degree'' and not a use that was merely ``transient or insubstantial''. The other members of the Court took a like view.In Item 38, therefore, the words ``used in'' require a use that is sufficient to give the product the character of a drug or medicine used in the prevention or treatment of sickness or disease. It does not require that that be the sole use of the product or that the product has proven efficacy. No doubt, in this context, the words ``[d]rugs and medicines'' refer to products which have a degree of recognition by professionals. ``Quack medicines'' and ``alternative medicines'', or some of them, may not be encompassed. But Listerine has, of course, professional recognition, for it has received a Seal of Approval of the Australian Dental Association.
Mr Slater laid emphasis upon the fact that Listerine is described as a ``mouthwash''. He submitted that, being a mouthwash, Listerine is used for cleansing. The Macquarie Dictionary defines mouthwash as: ``a medicated solution used for gargling and cleansing the mouth'', the OED as: ``a liquid antiseptic etc. for use in the mouth'', the Shorter Oxford as: ``a therapeutic wash for the mouth'', Gould Medical Dictionary as ``[a] solution for rinsing the teeth and mouth'' and Butterworths Medical Dictionary as: ``[a]n aqueous solution of a medicament or medicaments intended for gargling.'' I take the term ``mouthwash'' to be a neutral term referring to the manner in which the product is delivered to the part of the body to be dealt with.
The instructions for Listerine are:-
``Rinse and gargle with 20 ml undiluted for 30 seconds twice daily. Expel liquid.''
Some people consider that Listerine should be vigorously swished around in the mouth for 30 seconds. The evidence before the Court does not suggest that the use of Listerine assists the brushing of teeth. It does not appear to matter whether Listerine is used before or after the teeth are cleaned or at some other time. Presumably, however, for convenience, those persons who use Listerine regularly, do so in association with cleaning their teeth.
The evidence shows that dental surgeons advise the use of Listerine not only for the maintenance of good oral hygiene, but also at times when there is a flare up of gingivitis or when there is another problem for which the use of an antiseptic is appropriate. I assume that some persons use Listerine regularly and others use it intermittently when advised to do so or when they consider they have a condition which would benefit from treatment with an antiseptic.
Four Sydney dental surgeons gave evidence that they found Listerine to be useful and effective in preventing and curing mouth and gum infections such as gingivitis and advised their patients to use Listerine. Thus, Dr H.D. Hootman, a dental surgeon, gave this evidence:-
``It is clear to me from my experience in dental practice, and from the dental journals and literature that I have read in the course of my dental practice, that plaque is the main cause of gingival irritation and inflammation and that a reduction in plaque will help prevent gingivitis (or gum disease).
In the course of my dental practice, and based on my experience, I advise the use of Listerine Antiseptic Mouthwash (`Listerine') as follows:
- (a) I advise my patients to use Listerine as directed on the label once or twice a day to reduce plaque and hence assist in preventing gingivitis;
- (b) I prescribe Listerine for use by patients suffering from both mild and more serious gingival conditions because it is my experience that use of Listerine will cure the disease. I recently prescribed Listerine, along with a course of antibiotics, to a patient suffering from acute ulcerative gingivitis; and
- (c) I advise my patients who have had an extraction to rinse thoroughly with Listerine several times a day in order to minimise the risk of post-operative infection.
I always recommend the use of Listerine by my patients and if I have any samples of Listerine in the surgery I give them to my patients. If I do not have any samples, I recommend that my patients buy Listerine,
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or another antiseptic mouthwash such as Cepacol.''
All four dental surgeons said that they themselves used Listerine on a regular daily basis.
Dr C.H. Wall, a dental surgeon, who was for many years the Executive Director of the Australian Dental Association, gave the following evidence, inter alia:-
``In my opinion, the claims made by Parke Davis in respect of Listerine, namely that Listerine is efficacious in killing `the germs that cause plaque and gingivitis' and `helps prevent and reduce plaque and gingivitis (red, swollen gums' [sic] are correct. This opinion is supported by the material in exhibit CHW 3 and my own experience as a Dental Surgeon. The clinical studies submitted by Parke Davis and contained in CHW 3 have been accepted by both the American Dental Association... and by the ADA's [Australian Dental Association] Seal Committee as satisfying the criteria in the additional protocol. That is, they showed to the satisfaction of both bodies that Listerine was a clinically effective product.''
Dr Wall graduated from the University of Sydney in 1954. He practised as a dental surgeon both in this country and in the United Kingdom until 1968 when he took up a position which became known as Assistant Director, Dental Services in the Commonwealth Department of Health in the Northern Territory. In 1975, he was appointed Federal Secretary of the Australian Dental Association, the name of which position was subsequently changed to Executive Director. Dr Wall held that position until he retired in 1993. Dr Wall is obviously a person of wide experience and responsibility in the dental field in Australia.
Dr Wall gave evidence that he, personally, had used Listerine on and off for about 10 years and had found it to be of benefit to him in controlling plaque and gingival inflammation. He said that, during the course of his practice, he had recommended Listerine for the cure and prevention of the spread of infections in the mouth and had recommended antiseptic mouthwashes, including Listerine, to older people who were particularly susceptible to mouth infections caused by bacteria. Dr Wall gave evidence that, in the course of his practice, he recommended the use of Listerine, Cepacol (another antiseptic mouthwash), and any third antiseptic mouthwash in a cycle of one month each to patients exhibiting high levels of plaque and gingival inflammation. Dr Wall said that the elimination of mouth odour was only an incidental result of the therapeutic action of Listerine. He said that there are mouthwashes on the market which are not antiseptic and do not have any therapeutic action but which eliminate or mask mouth odours.
I consider Dr Wall to have been a reliable witness.
Dr M.J. Christie, Senior Lecturer in Pharmacology in the Department of Pharmacology in the Faculty of Medicine in the University of Sydney, devoted much of his affidavit to refuting evidence adduced on behalf of the Commissioner, but concluded:-
``In my opinion, the claims made by Parke Davis in respect of Listerine, namely that it is efficacious in killing `the germs that cause plaque and gingivitis' and `helps prevent and reduce plaque and gingivitis (red, swollen gums)' are supported by the clinical data and research published in reputable scientific journals and are correct. The material supplied to me establishes that the use of Listerine prevents and reduces plaque and prevents and reduces gingivitis by antiseptic action. In my opinion, based on the clinical data and research published in reputable scientific journals which has been supplied to me:
- (a) Listerine is a medicine; and
- (b)...''
Dr Christie also deposed:-
``The empirical evidence discloses that Listerine has an antibacterial or antiseptic action and has clinical efficacy in preventing and treating gingivitis. It does not act by a cleaning or solvent action as the Bailey trial demonstrated (a copy of the report of that trial is annexed to Dr Hellyer's report). Listerine is directed at killing germs and has that effect.''
Professor Sebastian Ciancio was a most impressive witness, being highly qualified in the field and active in researching the problems with which Listerine is concerned. Professor Ciancio was difficult to cross-examine. Mr Slater contended that he was argumentative. My own impression is that Professor Ciancio is an expert who gave his evidence clearly and fairly but was not prepared to abide looseness in
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language in questions put to him. Some signs of exasperation in the final stages of Professor Ciancio's evidence were due in part, I think, to the strain of his giving evidence at night via a video link which was not perfectly clear. I consider Professor Ciancio's affidavit evidence and his oral evidence to have been excellent.Professor Ciancio is Professor and Chairman of the Department of Periodontics in the School of Dental Medicine at the State University of New York. The School of Dental Medicine is one of the best schools in the United States and is highly rated for its research abilities. That in itself would sufficiently qualify Professor Ciancio. However, the longer the cross- examination continued, the deeper Professor Ciancio's experience and knowledge in the relevant field appeared to be. Professor Ciancio is a Past President of the American Academy of Periodontology and held office with the Academy over 14 years. He has more than 100 publications to his credit. He was a member of the Council on Dental Therapeutics from 1972 to 1976 and was Chair of the Council from 1976 to 1978. For many years thereafter, he served as a consultant to the Council on Dental Therapeutics. He is currently a member of the Council on Scientific Affairs, which is the successor to the Council on Dental Therapeutics, the Council on Dental Materials and Devices and the Council on Dental Research.
In relation to an issue, which I shall later discuss, whether the Lobene modification to the Löe & Silness gingival index has validity, Professor Ciancio gave evidence that he was not only a member of the Imrey Committee which reported thereon but since that report he has been appointed Chairman of a committee of the American Dental Association which is currently drafting revised guidelines with respect to gingival indices. Professor Ciancio said that, only a few days before giving his evidence, he had been at a conference in Washington DC at which the issue was considered and at which recommendations which the American Academy of Periodontology would submit to the American Dental Association were discussed.
Professor Ciancio is also a pharmacologist and teaches pharmacology in the School of Medicine. He is Chairman of the Dental Division of the United States Pharmacopoeia, the agency in the United States which defines the criteria for products and determines whether such products are or are not a drug. Professor Ciancio has chaired that Division for ten years and prior to that had been a member of the Division for five years.
Professor Ciancio's overall view with respect to Listerine was expressed as follows:-
``The matter of primary importance is whether the total formulation is demonstrably efficacious. My own published research and the clinical data and research published by others in reputable and refereed scientific journals confirms that Listerine is effective in preventing and reducing plaque and gingivitis, even though its precise mode or modes of action are not yet fully understood. It is clear, however, that Listerine has an antiseptic effect based on its antibacterial action which gives it clinical efficacy, regardless of the contribution to that action of the various individual ingredients.''
Professor Ciancio gave evidence that, in the course of his practice as a periodontist, he regularly recommended to those patients having difficulty with plaque and gingivitis control the use of Listerine to reduce levels of plaque and associated gingivitis.
Professor Ciancio gave this evidence as to the operation of Listerine:-
``While the mode or modes of action of Listerine are not clearly understood, it is clear that its action is antimicrobial. That is, it works by killing or inhibiting bacteria. A number of theories have been advanced by dental researchers as to Listerine's antimicrobial action. These include:
- (i) the traditional view that the mechanism of action of phenolics such as Listerine is by bacteria cell wall disruption and the inhibition of bacterial enzymes (see, for example, exhibit CHW 11 at page 4 S);
- (ii) that the use of Listerine leads to a decrease in pathogenicity of the plaque by a non-specific (bactericidal) reduction in the total number of micro-organisms per plaque volume (see, for example, the study by Lamster et al at page 20 of exhibit CHW 3); and/or
- (iii) that Listerine leads to a reduction in the total plaque endotoxin activity (see, for example, the study by Fine et al at
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pages 39 to 40 of exhibit CHW 3), possibly because Listerine can `extract' the lipopolysaccharide-derived endotoxin from gram-negative bacteria thus reducing pathogenic potential (see, for example, exhibit CHW 5 at page 261 and exhibit CHW 11 at page 4 S).''
Professor Ciancio expressed his conclusions as follows:-
``In my opinion, the claims which Parke Davis Pty Limited makes in respect of Listerine, namely that Listerine is efficacious in killing `the germs that cause plaque and gingivitis' and `helps prevent and reduce plaque and gingivitis (red, swollen gums)' are correct. Those claims are supported by the clinical data and research published in reputable and refereed scientific journals. That is, the use of Listerine reduces levels of plaque and prevents and reduces gingivitis. In the course of my practice as a periodontist I regularly recommend, to those of my patients having difficulty with plaque and gingivitis control, the use of Listerine to reduce levels of plaque and its associated gingivitis. I also lecture to my students at the State University of New York at Buffalo, and to dental professionals throughout the world in my continuing education lectures, about the benefits of chemotherapeutic agents, including specifically Listerine.
I consider that the results of the studies in relation to the efficacy of Listerine disclose reductions in the mean plaque index scores and mean gingival index scores which are both statistically significant and clinically important (such results being worth achieving in the prevention and treatment of plaque and gingivitis. In my opinion, based on the clinical data and research published in reputable and refereed scientific journals:
- (a) Listerine is a medicine;
- ...''
Professor Ciancio gave evidence that the effectiveness of Listerine which was reported in the papers and studies I shall shortly mention was, in his view, clinically worthwhile. Professor Ciancio said that that level of effectiveness had been accepted in the Imrey paper, which I shall later mention, as being a clinically worthwhile result.
The claims that Parke Davis make for Listerine were supported by a considerable number of published studies into the use of Listerine. Early papers by Kennedy & Kravets 1970, Gomer et al. 1972, Lusk et al. 1974, Fornell et al. 1975, Menaker et al. 1979 reported that the use of Listerine reduced pre- formed dental plaque and inhibited the development of plaque. The studies of Lusk et al. and Fornell et al. showed that Listerine significantly reduced the development of gingivitis as well.
There were additional later short-term trials. Axelsson & Lindhe undertook a short-term trial covering periods of three and six weeks and involving 96 volunteers, reported in the Journal of Clinical Periodontology in 1987. Their conclusion was:-
``In the listerine group, the individual mean plaque index scores, in comparison to the control data, were reduced by abut 50% after 3 and 6 weeks of trial. At 6 weeks, the individual mean gingival index score was also reduced by 50%''
In 1986, Mankodi & Lobene undertook a short-term study, the results of which were published in 1987, which sought to ascertain whether there was a correlation between Lobene's modified gingival index and three gingival bleeding indices, a subject to which I shall later turn. An incidental effect of this trial was to show that, over the three weeks of the study, the use of Listerine effected a significant reduction in gingivitis and performed significantly better than the control substance in relation to plaque. The study is of interest as, during the period, subjects were instructed to refrain from brushing or using oral hygiene measures.
The first long-term study into the efficacy of Listerine was undertaken by Lamster et al. and was published in Clinical Preventive Dentistry in 1983. The paper studied 145 subjects over a six months' period. The paper reported that the Listerine group displayed significant decreases in plaque and gingivitis scores at one, three and six months. The paper also reported:-
``By beginning our clinical trial with a population that did not receive any treatment to reduce existing gingival inflammation, we confirmed the suggestions of Fornell, Sundin, and Lindhe regarding the ability of Listerine Antiseptic to modify the development of gingival inflammation.''
ATC 4875
A further study by Gordon et al. was published in the Journal of Clinical Periodontology in 1985. This was a nine months' study. The paper reported:-
``In this study, plaque scores were significantly reduced in the experimental group at all examination times as compared to the control groups; however, % reductions were lower in this study than in those reported by Lamster et al. (1983). The lower % reduction probably reflects the lower initial plaque scores in this study due to the multiple prophylaxes received by all participants.
Unlike the study by Lamster et al. (1983), no significant difference for gingivitis was observed between groups in the first 6 months. This is probably due to the improvement in gingival health resulting from 4 prophylaxes initially, followed by continuation of usual oral hygiene. At 6 months, the control groups did show a trend toward higher gingival scores than at baseline 2, whereas the active agent group showed lower gingivitis scores that [sic] after the multiple prophylaxes. Only at 9 months, however, did this group demonstrate a statistically significant reduction in the gingival index compared to controls. This delay in demonstrating a gingivitis reduction is undoubtedly related to the lower initial gingival scores achieved by multiple prophylaxes prior to rinsing in this study (adjusted mean 1.36), as compared to the prior study (adjusted mean > 2.0).''
A paper by Fine et al., published in the Journal of Clinical Periodontology in 1985, examined the plaque samples which had been collected during the Gordon study. The authors reported a significant 52.6% reduction in plaque wet weight as compared with the water control and a 55.1% reduction as compared with the vehicle control (identical to the active rinse less the active ingredients). The paper reported significant reductions in dry weight in the Listerine group of 59% and 59.6% as compared with the water and vehicle control groups respectively. The paper also reported that the differences between the total plaque protein in the Listerine group as compared with that in the water and vehicle groups were significant and represented reductions of 59.7% and 59.2% in protein content versus the water and vehicle groups respectively. The paper stated:-
``It is clear, however, that overall or total plaque endotoxin activity was significantly reduced in the Listerine group when compared with its vehicle control. This finding suggests that, in addition to alcohol, active agents in the Listerine formulation effectively reduce total plaque pathogenic potential.''
A further long-term study by De Paola et al. was reported in the Journal of Clinical Periodontology in 1989. This was a study of a number of subjects over a period of six months. The paper reported that, after six months, Listerine produced a 34% inhibition of both plaque and gingivitis compared to a hydro- alcohol control.
Of these studies, counsel for the Commissioner particularly criticised the paper by Gordon et al. that, of the 144 subjects accepted for screening, 136 remained after the three week normalisation period, 127 completed six months of the study and only 85 subjects continued in the study for the additional three months. The reason for the drop from 127 to 85 was noted in the paper as being the fact that most of the subjects who did not participate for the additional three months of the study were dental students who had recently graduated and were not available. It is obviously desirable that those who commence in a study should go through to the conclusion. But it does not follow that the drop in numbers throws doubt upon the results obtained. In the paper, the figures taken at the end of nine months were compared with earlier figures for each of the 85 subjects who completed the study not with the figures for those who did not do so. As this study was published in the Journal of Clinical Periodontology and has subsequently been referred to without criticism, I accept it to be a reliable study.
The following is a summary of results of the studies I have mentioned:-
TABLE II : RESULTS OF SHORT-TERM STUDIES
ON SUPRAGINGIVAL PLAQUE & GINGIVITIS
+-----------------------------------------------------------------------+
| REFERENCE | MOUTHWASH | DURATION | EFFICACY |
| | | |---------------------------|
| | | | PLAQUE | GINGIVAL |
| | | | INDEX | INDEX |
|------------------+------------+-----------+-------------+-------------|
| Axelsson & | 5% hydro- | 6 W | 1.2 + 0.1 | 1.00 + 0.06 |
| Lindhe | alcohol | | - | - |
| (1987) | control | | | |
| |----------------------------------------------------|
| | Listerine | 6 W | 0.6 + 0.1 | 0.48 + 0.06 |
| | | | - | - |
|-----------------------------------------------------------------------|
| Mankodi & Lobene | 5% hydro- | 3 W | 1.69 | 1.82 |
| (1987) | alcohol | | | |
| | control | | | |
| |----------------------------------------------------|
| | Listerine | 3 W | 1.40 | 1.28 |
+-----------------------------------------------------------------------+
As can be seen, in each case Listerine performed better than the control substance or water. I shall later discuss in more detail the question whether its results were clinically worthwhile achieving.
In 1988, Professor Fine, in a status report for the American Journal of Dentistry, reported:-
``To date, two chemotherapeutic agents used for the control of supragingival plaque and gingivitis have received the Seal of Acceptance from the Council on Dental Therapeutics of the American Dental Association. One, Peridex, is a prescription mouthrinse that demonstrates potent antiplaque and antigingivitis activity but could have side effects which include tooth staining, calculus formation, possible alterations in taste, and epithelial desquamation in selected cases. The second, Listerine, is an over-the-counter mouthrinse which, although somewhat less effective in some clinical trials, appears to have minimal side effects.''
ATC 4877
In 1990, Overholser et al. reported on both Peridex and Listerine in the Journal of Clinical Periodontology of that year. This study confirmed that both Listerine and Peridex had significant anti-plaque/anti-gingivitis efficacy. The study found Peridex to be more effective in inhibiting plaque formation but found Listerine and Peridex to be comparable in inhibiting the development of gingivitis. The study also found that Peridex increased tooth stain and calculus whereas the Listerine and control groups by comparison did not form either stain or calculus.
The final paper which I should mention is a paper by Grossman et al., which was published in 1989. The paper examined Peridex and Listerine in a study completed by 481 or more subjects. The results were stated as at three and six months. The majority of the authors were members of Proctor & Gamble Co, the manufacturers of Peridex, and the paper conveys a slight air of comparative advertising. See, eg., the last sentence of the paper. Moreover, the paper did not state the standard deviation and/or a standard error of the mean. More than one witness in the present proceedings expressed the view that this detracted from the reliability of the paper. Another possible criticism is that the placebo used was the Peridex product without its active ingredients. This may not have been a neutral substance so far as Listerine was concerned.
Although the paper showed better results for Peridex, and it is not in dispute that it is the stronger product, the paper does show beneficial results from the use of Listerine at three months and six months in plaque reduction, gingivitis reduction and reduction in bleeding sites. The figures for gingivitis at six months and for reduction in bleeding sites at six months were said not to be statistically significant. This is possibly because the placebo group, with which the other figures were compared, had unexplained improvements in gingivitis reduction and in bleeding sites at six months.
It is not in dispute or not seriously in dispute that many of the researchers I have mentioned, including Professors Ciancio, Fine and Mandel, are eminent researchers in the field of periodontology. Nor has it been seriously contended that the journals in which the papers and studies appeared were not responsible, refereed journals.
Professor G. Berry gave evidence that, from an epidemiological point of view, the results obtained in the studies were statistically significant. Professor Berry gave this evidence:-
``I consider that the results of the studies are meaningful and the conclusions drawn by the researchers are supported by the data obtained in the studies. In my opinion, the results of the studies demonstrate that Listerine is effective in the reduction and prevention of plaque and gingivitis when compared with the controls to a statistically significant level. All the studies were performed double-blind.
The question remains as to whether the magnitude of the mean differences in the plaque and gingivitis index scores, disclosed in the results of the studies and which are consistently of the order of half a grade on the five or six point categorical scales of the indices, are sufficiently large to be considered by those with clinical expertise as of clinical importance. This is a matter for clinicians. However, I note that many of the studies have been reviewed by clinicians without adverse comment, and indeed favourably, in the review articles which are exhibits CHW 4, CHW 5 and CHW 11.''
I consider Professor Berry's evidence to have been sound and reliable.
The evidence adduced on behalf of the applicant, if accepted, would establish that Listerine is used in the treatment, control and prevention of plaque and gingivitis, that gingivitis is a disease and that plaque, though not a disease in the medical sense, is nevertheless a condition which needs treatment, including professional treatment by dental surgeons. Professional persons including persons as eminent as Professor Ciancio recommend its use. Listerine has been the subject of studies and papers by eminent researchers and has been consistently reported as having therapeutic efficacy. Listerine has been used as a mouthwash for over a century, in many countries, and it has the Seal of Acceptance of the American Dental Association and the Seal of Approval of the Australian Dental Association. This evidence, if accepted, would establish that Listerine is a drug or medicine used in the prevention, cure or treatment of sickness or disease.
ATC 4878
Moreover, the evidence if accepted would establish that Listerine is not a toilet preparation or a good in the nature of a toilet preparation. The Oxford English Dictionary 2nd ed. gives this definition of ``toilet'':-
``5.a. The action or process of dressing, or, more recently, of washing and grooming.''
The Macquarie Dictionary gives this meaning:-
``3. the act or process of dressing, including bathing, arranging the hair, etc.''
Listerine is generally used at the time of the cleaning of teeth, but Listerine is not used for or promoted for use in cleansing. Indeed, a paper by Dr L. Bailey, to which I shall later refer, suggests that Listerine is not of value for that purpose. Listerine is used for the treatment, control and prevention of plaque and gingivitis and on other occasions when the use of an antiseptic may be appropriate. Listerine is not promoted for use as or used as an aid to the brushing of teeth. Nor is Listerine sold for use as or used as a breath freshener or for the purpose of leaving a pleasant feel or taste in the mouth after the teeth have been cleaned. The evidence suggests that Listerine is absorbed in the plaque and in the gingiva, when swished around in the mouth, and that it also gets into the cavities between the teeth and the gingiva. It appears to operate because it is antibacterial and because it has an effect upon the endotoxins produced by the bacteria. This is not a cleansing process of the type for which toiletry is used.
On the applicant's evidence, Listerine is designed, sold and used for the treatment and prevention of bodily disorder and is not sold or used for a purpose for which toilet preparations are used.
I turn now to the evidence adduced on behalf of the Commissioner. Dr R. Hellyer is a scientist who has specialised in chemistry and who has had long experience in examining products with a view to determining and reporting upon whether they have therapeutic properties and in distinguishing between therapeutic and non-therapeutic goods.
Dr Hellyer was, from 1950 to 1965, the Chief Chemist at the Museum of Applied Arts & Sciences in the NSW Department of Technical Education. He has had considerable experience with Australian Essential Oils and natural products. He has been a member of the Committee on Essential Oils of the Standards Association of Australia. From 1966 to 1970, he was Group Leader of the Medicinal Chemistry Department in the Research Laboratories of the 3M Company and, from 1970 to 1980, he was Director of Technical Research of Richardson-Merrell Pty Ltd. Since 1982, he has been Managing Director of Engel, Hellyer & Partners Pty Ltd, which is a leading consultancy company advising companies on all regulations for pharmaceuticals, cosmetics, toiletries and nutritional foods. Since 1982, he has been the Scientific Adviser to the Cosmetic, Toiletry & Fragrance Association of Australia. Dr Hellyer is well qualified in his field, but he is not a dental surgeon and has had no experience of Listerine. Dr Hellyer expressed the view that, having regard to its ingredients, Listerine has no significant therapeutic effect.
Dr Hellyer said:-
``Products that control, reduce or kill bacteria are known as antibacterials. The general category of antibacterials includes three subcategories, one category being antiseptics, another category being disinfectants and the third category being other substances having antibacterial properties which do not satisfy the standards required to be met to be antiseptics or disinfectants.
...
An antiseptic product is a product which controls, reduces or kill [sic] micro- organisms including harmful pathogenic micro-organisms (such as P. aeruginosa, E. coli, S. aureus, etc.) on human surfaces namely skin and mucous membranes. An antiseptic product belongs to the general category of antibacterials and as such it may be called an antibacterial. A product which is an antiseptic is also a disinfectant if it is used on non-human surfaces to control, reduce or kill micro-organisms.''
At the commencement of his report, Dr Hellyer gave to the term ``[d]rugs and medicines'' a meaning which, in my opinion, is more limited than the meaning which the words carry in Item 38. Dr Hellyer commenced his report as follows:-
``In my opinion in medical and therapeutic usage the phrase `drug or medicine' denotes a substance which by a pharmacological, immunological or metabolic action has a proven efficacy in relation to the curing,
ATC 4879
treating or controlling of any diseased state in the human body. The efficacy of the substance must be substantiated by studies carried out to internationally recognised protocols and have a statistically significant effect. Products may have therapeutic claims made in relation to them, however, unless those claims can be substantiated in the manner to which I have referred they are not drugs or medicines. The difference between a drug and a medicine is that a drug is an active substance whilst the medicine, which may include a number of drugs, is the product into which the drug is formulated.''
I am satisfied that Item 38 does not require that the goods have ``proven efficacy'' in the sense in which that term is used by Dr Hellyer. Item 38 says nothing about ``studies carried out to internationally recognised protocols''. No doubt, having regard to the whole of the terminology of Item 38 and the association of its words, one can readily draw the conclusion that a degree of professional recognition of the product is required. However, the words must be given their meaning in ordinary parlance. Although Dr Hellyer subsequently retreated, to some extent, from the definition he had given, it raises a difficulty with the evidence of a witness when it is clear from the opening words that the witness is addressing an issue which is not the issue with which the Court has to deal. I am of the view that the words in the item should be given their meaning in ordinary parlance.
In his second affidavit, Dr Hellyer referred to 7th Edition of Goodman & Gilman's The Pharmacological Basis of Therapeutics 1985 in which it was said:-
``Thymol is both antiseptic and antifungal, with phenol coefficients from 27 to 44. It is used in lotions for acne vulgaris, ointments for haemorrhoids, ointments and lotions for topical analgesia, cough drops, and vaginal douches. In mouthwashes and gargles (e.g., LISTERINE) it is used in a concentration too low to be effective within any practical contact time.''
(emphasis added)
In cross-examination, Dr Hellyer conceded, however, that the 8th and 9th Editions do not contain the reference to Listerine or the last sentence of that passage.
Dr Hellyer downplayed the nature of the condition which Listerine is used to treat. Having referred to ``any diseased state in the human body'' in his definition of ``drug or medicine'', Dr Hellyer went on to say:-
``Plaque, Gingivitis and Halitosis
Plaque is made up of saliva, protein, dead bacteria and other debris in the mouth which is bound together in a matrix with calcified fragments. In my opinion, the most likely means by which the substance known as plaque adheres to the tooth surface is by a combination of Van der Waals' forces (which are forces of attraction existing between atoms), hydrogen bonds and water bonds. In my opinion, plaque is not a disease, illness or sickness.
Gingivitis is an inflammation of the gums. It results in a swelling and redness on the gingivia [sic] which is the soft mucous membrane tissue surrounding the tooth. If one has a build up of plaque on the tooth, this then can exacerbate the inflammation around the base of the tooth and lead to red and swollen gums, which then leads to the condition known as gingivitis.
Halitosis is simply bad breath which can result from poor oral hygiene, decaying teeth, upset stomach or other internal stomach problems. In my opinion, halitosis is not a disease, sickness or illness, although in certain circumstances it may be a sign of, or indirectly associated with, an illness or disease.''
(emphasis added)
On this subject, I prefer the evidence of Professor Ciancio, which I have set out above. Professor Ciancio explained that plaque includes live bacteria and that plaque is a complex microbial community. Professor Ciancio said that, while plaque is not a disease in the medical sense, its persistence leads to diseases such as gingivitis and that its prevention or removal is of importance in the prevention of such diseases.
The most important part of Dr Hellyer's evidence is his analysis of the constituent components of Listerine and of their respective concentrations. Dr Hellyer expressed the following conclusion:-
``In my opinion if Listerine removes plaque to any extent or prevents its formation, it does so by two processes, one being the solubilizing of the components of plaque by the essential oil ingredients and the ethanol, and the other being, by weakening of the Van der Waals' forces, hydrogen and water
ATC 4880
bonds that cause the plaque to adhere to the teeth so that its removal by mechanical force, such as brushing, may be enhanced. If Listerine helps to remove or prevent the formation of plaque, it does so by a cleaning and solvent action on the plaque and other debris in the mouth and not by an antimicrobial action. Further, in my opinion the antibacterial action of Listerine is so minor and insignificant that it has no direct effect on gingivitis. In my opinion, it is the removal of plaque and other debris in the mouth that could lead to any reduction in gingivitis by making the mouth cleaner. This is an indirect effect and is not what I would consider to be a therapeutic action but rather the byproduct of a cleaning or toiletry action....
In relation to the question whether Listerine is classified as a drug or medicine or a toilet preparation, it is my opinion that it is a toilet preparation in that it masks and alters the odours in the mouth and breath, freshens and cleanses the mouth and removes and reduces debris in the mouth, including plaque to a minor degree with the aid of mechanical forces. In my opinion Listerine has very little antibacterial effect and is not an antiseptic and accordingly, cannot have any therapeutic effect in relation to any infective or inflammatory disease of the mouth or gums including gingivitis.''
(emphasis added)
I do not propose to discuss Dr Hellyer's evidence in any more detail. I prefer the evidence of Professor Ciancio whose field of work is periodontology, who is actively engaged in this particular area, who has participated in studies into Listerine and who has used Listerine in the course of his practice. I accept Professor Ciancio's evidence that Listerine has a complex formulation and that the only satisfactory means to determine its therapeutic efficacy is to subject it to clinical trials. This, Dr Hellyer did not do. Dr Hellyer did, for the purposes of his evidence, have a simplistic test made on a substance containing thymol and ethanol in the percentages used in Listerine, and made tests also on Johnnie Walker Black Label Whiskey, Johnnie Walker Red Label Whiskey and Colgate Palmolive toothpaste. But those tests have no significance, particularly having regard to Dr Hellyer's reference to ``studies carried out to internationally recognised protocols''.
Dr Hellyer conceded that Listerine passed the test described as Option D used under the Therapeutic Goods Act and Regulations in respect of antiseptics and disinfectants used in hospitals. Dr Hellyer gave this evidence in cross-examination:-
``Why did not you think it was worthy of some comment that Listerine had passed the test for option D? - I have never, ever said that this product is not an antibacterial and doesn't kill bacteria, vegetated bacteria, yeast moulds, any micro-organisms. It probably even kills viruses, I'm not sure but I have never said that it doesn't. I only relate these things to the disease state in which they claim for. If they said it had been an antiseptic for handwashing in a hospital it would have passed, in an operation.''
Dr Hellyer refuted the point that phenolic compounds such as thymol are a recognised form of bactericidal substance and that at least sometimes thymol has an antiseptic effect. Dr Hellyer said he had not seen any evidence of that. Dr Hellyer had to concede, of course, that Goodman & Gilman, to which he himself had referred, recognises thymol as an antiseptic. He conceded that thymol at the concentration it has in Listerine has an antibacterial effect. He also conceded that he himself had tested an aqueous solution of thymol and ethanol at the percentages which they are used in Listerine and that this solution passed the test presently in use for the purposes of the Therapeutic Goods Act and the Regulations for antiseptics. Dr Hellyer agreed that there had been a large number of studies carried out in accordance with internationally recognised protocols which showed that Listerine had a plaque inhibiting effect and a gingivitis reducing effect.
I also have to weigh Dr Hellyer's evidence against the fact that Listerine has been on the market for over 100 years, was spoken well of by Miller in the 19th century and is spoken well of and recommended by dental surgeons at the present time. Moreover, the weight of the studies which have been done in accordance with internationally recognised protocols, comparing a group of persons using Listerine as against a group not using Listerine, favours the conclusion that Listerine has a therapeutic effect.
ATC 4881
In his evidence, Dr Hellyer relied upon a study undertaken by Dr Bailey of The School of Dental and Oral Surgery of Columbia University, New York, which was entitled ``Direct Plaque Removal by a Pre-brushing Dental Rinse''. This study compared a dental rinse which had been prepared on principles applicable to the formulation of products for cleansing biological surfaces, including anionic and non-ionic surfactants, and auxiliary cleansing agents and compared the effect of using the dental rinse before brushing against the use of a conventional mouthwash, Listerine, before brushing. The study showed that the specially prepared dental rinse removed 13 to 20% of plaque while Listerine removed only 1.3 to 2% of plaque.
Dr Bailey's study does not seem to assist Dr Hellyer's argument. Dr Bailey was not examining the therapeutic effect of Listerine. On the contrary, he intended to examine the effect of a dental rinse designed to have a surfactant action, that is an action equivalent to that of a detergent, a cleansing action. Dr Bailey sought to compare the effect of a dental rinse with a conventional therapeutic mouthwash. He chose Listerine for the comparison. This choice is illustrative of the recognition which Listerine has received in the dental profession. In his paper, Dr Bailey spoke well of it. What his study showed was that the specially prepared dental rinse had a surfactant effect whilst Listerine did not. This conclusion accords with the understood effect of Listerine. It does not matter whether Listerine is used before or after brushing or even that it be used in association with brushing. Dr Bailey's report suggests that Listerine does not work by way of a ``cleaning and solvent action''.
Dr B.A. Taylor, a periodontist who is the head of the Department of Periodontics in the United Dental Hospital at Sydney, also downplayed the nature of the condition which Listerine seeks to treat. Dr Taylor deposed that, ``[p]laque bacteria are a normal finding in both health and disease.'' She deposed:-
``There is a form of gingivitis which is the natural inflammatory response that occurs in the marginal gingiva in association with the accumulation of plaque on the tooth near the gingival margin. That form of gingivitis is extremely common, so much so that there are some researchers who consider that it is not a disease at all.''
Dr Taylor said that she herself had formed that view, but she conceded that the dental profession generally regarded gingivitis as a disease.
For the reasons I have already given, I think that the condition which Listerine seeks to treat is a relevant condition for the purposes of Item 38. I am satisfied, moreover, that gingivitis is a relevant disease, whatever the ambit of Item 38. It is not helpful, in a case such as the present, to have a witness put forward a view which is not the view taken by her profession generally.
In her fourth affidavit, Dr Taylor expressed the view that Listerine was not clinically worthwhile. In answer to a question by an over- confident counsel, Dr Taylor said that she did not advise the use of Listerine and knew of no dental surgeon who did so. She said that she thought that her view was that of the ``silent majority'' of dental surgeons. On the evidence before the Court, no conclusion can be drawn as to the proportion of dental surgeons who advise the use of Listerine and as to those who regard it as not efficacious. This matter was not investigated in any depth, presumably because of the stance taken by counsel for the Commissioner that the use of Listerine in the prevention or treatment of sickness or disease was conceded, if the Court found that Listerine was a drug or medicine. However, the evidence before the Court is sufficient to show that a significant number of dental surgeons in Australia, and elsewhere in the world, use and advise the use of Listerine. In giving her evidence on this point, Dr Taylor did not relate her view to a test such as the test of ``clinically worthwhile'' which was expressed in the Imrey paper to which Dr Taylor referred.
Dr Taylor's principal evidence was directed to the scientific literature. Dr Taylor criticised the structure of each of the studies upon which the applicant relies or criticised the conclusions drawn therein or expressed the view that the statistical differences found were not statistically significant. She did not find any of the studies to be useful.
I did not find Dr Taylor's comments on the published studies to be persuasive. It may be conceded that all of the studies were funded by Warner-Lambert. That is a factor to be taken into account, but it is not uncommon for a pharmaceutical company to fund studies into the efficacy of its own products. The evidence before the Court shows that the published
ATC 4882
papers are papers by persons who are eminent in this area and that the publications in which they were published are responsible, well- regarded publications.One of Dr Taylor's criticisms of the papers was that the three long term studies relating to gingivitis, the Lamster, Gordon and De Paola studies, used what Dr Taylor described as ``the so-called Lobene Modification of the Löe & Silness Gingival Index, rather than the original Löe & Silness Gingival Index''. Dr Taylor said the study by Overholser also used the Lobene modification. Dr Taylor said that the Lobene modification of the Löe & Silness gingival index has five grades in it, 0-4, whilst the original Löe & Silness gingival index had only four grades. One of the results of using an index with five grades is that, mathematically, the percentages arrived at are higher than those which would have been achieved using the Löe & Silness index.
The principal difference between these two indices is that the Löe & Silness index requires, at level 2.0, an indication of bleeding induced by the application of pressure or a probe. The Lobene modification has dispensed with any requirement for bleeding on pressure and, therefore, with the necessity for the application of pressure or of a probe to induce bleeding.
There is an article published in the Journal of Periodontal Research in 1994 by a Committee headed by Dr P.P. Imrey. Professor Ciancio was one of the members of the Committee. The paper reported in favour of a reporting of a bleeding test. The paper said:-
``Guidelines for measurement of gingivitis should be strengthened to elicit reporting of i) an index of gingival bleeding, coupled with ii) either a purely visually-based gingivitis index or, alternatively, a comprehensive gingivitis index which incorporates both bleeding and visual appearance. To clarify, the Löe-Silness Gingival Index (GI) would be appropriate but not mandatory for the latter; other indices might be used if justifiable.''
The paper also reported:
``By requiring only the lower standard of statistical significance, the Association risks awarding the Seal, representing a public endorsement by the American professional dental community, to products which informed members of that community would disdain to use or recommend because of insufficient benefit....
Appearance of the Seal on products whose effects are too minimal to be regarded as important by the user, or to warrant recommendation by individual dentists, is likely to erode the public's trust in the ADA Seal, and in the dental profession.''
Unfortunately for the Commissioner's case, Professor Ciancio had been one of the minority on the Imrey Committee and did not favour a bleeding test. Because of the discomfort suffered by the patient, because the degree of pressure and the manner of use of a probe were variable in practice and because the pressure was likely to dislodge plaque, he regarded a bleeding test as unsatisfactory. Professor Ciancio gave evidence that the recommendations of the Imrey Committee were no more than recommendations, that they had not been accepted by the American Dental Association, that it had been thought that the Imrey Committee had not been fully representative, that he was Chairman of a Committee which had been established to obtain further comments and that he was in the process of collating responses to the Imrey recommendations.
In the light of this evidence, it is obvious that I cannot regard the Lamster, Gordon, De Paola and Overholser studies as invalid by reason of their adopting the Lobene modification. That modification is, at the present time, an acceptable index, though the subject is one about which there is ongoing debate. The point that the mathematical percentages reported would have been lower on the Löe & Silness index is a factor to be taken into account, but it does not invalidate the studies or their results.
Dr Taylor gave evidence that, ``[t]he control group should be using a rinse with the same formulation as Listerine minus what are said to be its active ingredients.'' Dr Taylor said that the use in three papers of a hydroalcoholic vehicle was not a control, whether or not alcohol was said to be an active ingredient. Nevertheless, the substance that was used in those tests as a placebo was obviously a neutral placebo which tasted like a medicinal mouthwash. It is not suggested that the placebo had any active effect on the conditions of plaque and gingivitis. It does not seem to me that the selection of the placebo would in any way have invalidated the results achieved. If the
ATC 4883
selection of the placebo had done so, the papers would not have been accepted for publication.It is clear that Dr Taylor considers Listerine not to be clinically worthwhile. Weight must be given to that opinion and to the eminent position in Periodontology which Dr Taylor holds. However, I do not find her evidence to be persuasive. That is principally because Dr Taylor did not say that the researchers responsible for the papers and studies in question were not persons in good esteem or that the publications in which the papers and studies were published were not publications to which one should have regard or that the papers and studies had not been influential. Accordingly, her opinion merely stands as her opinion, which does not take the case for the Commissioner very far. Dr Taylor said:-
``In the scientific literature generally there are some journals which are the subject of editorial review and others which are not reviewed or refereed. The standard of what is required by way of review obviously might vary from journal to journal.''
But that was not a helpful comment, indeed it was misleading without reference being made to the actual publications.
Professor D.J. Newell, Professor of Medical Statistics at the University of Newcastle upon Tyne, gave evidence with respect to a number of the papers. Professor Newell's evidence did not attack the papers in the same way, but he did distinguish between differences which might be ``statistically significant'' and those results which showed a ``clinically important difference''. I need not mention the individual differences that there were between Professor Berry and Professor Newell. I have set out above Professor Berry's view, that the question whether the differences which the studies disclosed were of ``clinical importance'' was a matter for those with clinical expertise. In that respect, he and Professor Newell did not disagree.
Professor Newell said that the studies should have stated explicitly what was regarded by the authors as a clinically important result. I prefer Professor Berry's evidence that the absence of such a statement does not invalidate any of the studies. Professor Newell conceded that it is fairly likely that, in dental research papers in the 1980s, the criteria for a clinically important difference would not have been stated.
Professor Newell also conceded that, on his calculations of the researchers' assumptions as to a clinically significant result, it appeared that a result favourable to Listerine had been obtained. And he accepted that, in most of the studies, the researchers had expressly reported that the results were clinically significant.
Professor Newell conceded that he had been concerned with ``a scientific procedure which seeks to ascertain what the truth is with a very high degree of probability''. That, of course, is not the task of this Court.
Professor Newell criticised a number of the studies in that they commenced with subjects having a plaque index of approximately 2.0. Professor Newell said that it would appear from the Grossman study that the adoption of this level of plaque would exclude about two-thirds of the people who, on Grossman's criterion, had some gingivitis. I do not myself see any error in the studies in this respect. Professor Ciancio gave evidence that an index level of about 2.0 was the general level which he experienced in his clinics and that it was the level which he himself used when evaluating products. In this area, I think that Professor Newell's view was not based upon knowledge of the problem which was the subject of the research.
Professor Newell made calculations converting the results obtained from the use of the Loben modified gingival index to results which he considered would have been obtained had the Löe & Silness index been used. The resultant figures did not, I think, change the general picture which is conveyed by the papers. However, I prefer the view expressed by Professor Ciancio that the only proper means of comparing the two indices is to undertake a comparative study of their operation, as was done in Lobene & Mankodi et. al., ``Correlations among gingival indices: a methodology study'' published in the Journal of Periodontology in 1989. Professor Ciancio was also a co-author of that paper. The difference between the indices turns not on a mere mathematical difference, the adoption of five levels in place of four levels, but on the adoption by the Löe & Silness index of a bleeding test, which the Lobene modified index does not use.
I am not persuaded by Professor Newell's evidence that the papers and studies upon which the applicant relies are not papers and studies in which confidence can be reposed. They are
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papers and studies for which eminent researchers were responsible. There was not just one study, there were several. There are, in addition, papers commenting upon the published results. The evidence shows that the papers and studies have influenced professional opinion and have been accepted as reliable by the American Dental Association and the Australian Dental Association.On the whole of the evidence, it seems to me that Listerine is exempt under Item 38. A crucial point is whether the condition which Listerine is used to counteract, that is the build- up of plaque and the development of gingivitis, is a medical condition for the treatment of which the use of a drug or medicine would be apposite. I think there is really no disagreement that the underlying condition is one for the treatment of which the use of a drug or medicine is appropriate. The studies that have been undertaken, including Dr Bailey's paper, are illustrative of the point that the dental profession is seeking chemotherapeutic agents to assist them in overcoming the problem.
It is not in dispute that Listerine has important constituents which are recognised drugs and that Listerine itself is listed in Martindale's Pharmacopoeia where its elements are described. Nor is it really in dispute that Listerine is designed for, recommended for, sold for and used in the control and treatment of plaque and gingivitis and for the prevention of those conditions.
It is further not in dispute that Listerine has been given the Seal of Approval of the Australian Dental Association. That does not mean it is a drug or medicine, for the Seal of Approval can be given to a good such as a toothbrush or a toothpaste. However, it does indicate that there has been professional acceptance by the relevant professional body that Listerine is appropriate for the purpose for which it is marketed. The Australian Dental Association has approved Listerine for use as an antiseptic in treating plaque and gingivitis. And Listerine is registered under the Therapeutic Goods Act and Regulations in respect of that use.
In the light of all these matters, I am satisfied that Listerine is a drug or medicine used in the prevention, cure and treatment of sickness or disease in human beings.
Dr Hellyer and Dr Taylor have a view that Listerine does not have a useful therapeutic effect. They may be correct about that. But, at the present time, that is simply their opinion. It is not the opinion held by many practitioners or that of the relevant professional body, the Australian Dental Association.
If I had to determine whether the opinions of Dr Hellyer and Dr Taylor were correct, I would find, on the probabilities, that Listerine has a beneficial therapeutic effect, for I consider that its long history on the market, its support by practising dental surgeons and its recognition as an effective chemotherapeutic agent in the literature indicate that this is so. However, my preferred approach is to say that Listerine is a drug or medicine which is used in the prevention, care and treatment of plaque and gingivitis.
Dr Hellyer expressed his opinion that Listerine was a toiletry as, in his opinion, it was used in the cleansing of the mouth and teeth. For the reasons I have already given, I consider that Listerine does not operate by way of a cleansing action and that it is not used to assist brushing. The published papers throw light on the operation of Listerine. They do not suggest that Listerine operates as a cleanser. Indeed, Dr Bailey's paper shows that its function is otherwise. I am therefore satisfied that Listerine is not a toiletry or a good in the nature thereof. It is a medicament or medicine. I have earlier dealt with this point in more detail when discussing Mr Slater's submission with respect to the term ``mouthwash''.
In his evidence, Dr Wall agreed that, back in 1975, Listerine was generally regarded primarily as something that was suitable for ameliorating conditions of bad breath. This was not, I think, because it had a formula directed principally to the masking of bad breath, as do some current mouthwashes. It was because, or principally because, Listerine had a therapeutic effect and operated on the conditions which caused bad breath.
In the circumstances, I shall declare that Listerine is exempt from sales tax under Item 38 of the Sales Tax Exemptions & Classifications Act.
The respondent should pay the costs of the application. I shall reserve liberty to the parties to apply for any variation of this order as to costs. Any motion for variation and any supporting affidavit must be filed and served within 21 days. The reservation of leave will not preclude the parties from taking out a
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formal order. However, if application is made for variation of the costs order, the taxation of costs must await resolution of the motion.THE COURT DECLARES THAT:
1. Listerine Antiseptic Mouthwash is exempt from sales tax under Item 38 of Schedule 1 to the Sales Tax (Exemptions & Classifications) Act 1935 (Cth).
THE COURT ORDERS THAT:
2. The respondent pay the costs of the application.
3. Liberty to apply for any variation of the order as to costs be reserved.
4. Any motion for variation and supporting affidavit be filed and served within 21 days.
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