56 Content. It is important to note that this imputation is not that AMI once (or twice) engaged in the conduct alleged, but that it was the practice of AMI to do so. The sting in the imputation is the suggestion that AMI directed and disciplined its employed doctors to give patients incomplete (if not, by omission, misleading) information, in order to maximise business, potentially to the detriment of the patients.
57 Confidentiality and iniquity. Assuming that such a practice were an aspect of AMI's internal business structure and arrangements, which might be the subject of Dr Almohty's contractual obligations of confidence, nonetheless the existence of any such practice - involving intentionally counselling and requiring employed medical practitioners, under threat of termination, to provide incomplete if not misleading information to patients - could hardly be the subject of an equitable obligation of confidence. Moreover, it would be so manifestly contrary to the interests of public health that there would be substantial public interest in its disclosure, such as to override any private obligation of confidence that a doctor such as Dr Almohty might have to an employer such as AMI. For that reason, the information contained in the second imputation, if true, would not have the requisite quality of confidentiality to attract protection as a confidence.
58 Notice of breach of confidence. A fortiori, it could not be concluded that Fairfax or the journalists knew, or ought to have known, that provision to them of that information involved a breach of confidence.
59 Falsity. Has AMI established, as a matter of fact, that it had no such practice?
60 In her oral evidence, Dr Almohty said that having originally not referred to the potential for penile injections, she changed her approach and came to do so, after being informed by another doctor that he had been reprimanded by an interstate medical board for failing to mention the possibility of such injections. Dr Almohty said that she explained to patients that injections were part of the programme, and that the patient may be forced to use injections if all else does not work. When asked "and did you use the word 'forced'?", she answered, "I may have used 'forced' at times". Then she said that while she probably did use the word 'force' at times, she probably said "If you don't use this, the injections which are part of the programme, you might not get a refund". Dr Almohty said that she ceased to mention to patients the possibility of penile injections after being "counselled" by Dr Vaisman and Mr Shrestha, early in 2009, not to mention injections, nor recommend a GP consultation, and directed to sit with two other doctors, in order to change her consultation style. According to Dr Almohty, Mr Shrestha said to her:
Why did you ask him 'any side-effect?'. Don't say side-effects, don't say 'go to the doctor', don't say 'get medical tests'. Sales people don't want to put phone calls to you. I can't keep hiring you.
61 Dr Almohty's own patient consultation records falsify her allegation that she ceased to refer to side-effects or penile injections. In fact, Dr Almohty regularly mentioned the possibility of injections, and the side-effects of the medications - indeed, she did so almost invariably. The records of her patient consultations demonstrate that out of the 291 documented consultations in evidence, in 276 she recorded having mentioned side-effects of the recommended treatment (or did not prescribe any treatment); in 275 she either mentioned or prescribed injections, or the patient had a condition which did not and would not require injections (such as PE), or she prescribed nothing at all; in the remaining 16 (of which four took place on 2 March 2009, and two on 17 February 2009) she mentioned side-effects. Ultimately, analysis of the 314 patient records in evidence revealed no case where penile injections were potentially relevant when Dr Almohty did not refer to that possibility. Dr Almohty's practice, as documented in her own notes, demonstrates that she was not influenced against referring to penile injections and side-effects.
62 Moreover, in her statutory declaration of 16 October 2009, Dr Almohty declared that she knew of no such practice of reprimanding doctors. As I have said, the statutory declaration is of significance, and the court can be comfortably satisfied that, insofar as she made concessions in that statutory declaration, they were correct. Indeed, the statutory declaration is not necessarily inconsistent with her oral evidence; the fundamental distinction being between something that she claims to have experienced once, and the existence of a practice of AMI of the kind described in the imputation.
63 Although in his affidavit Dr Vaisman had not refuted Dr Almohty's assertion that he warned doctors not to keep mentioning injections in consultations with patients, he did so in the witness box; and I would not infer that the earlier omission of such a refutation was any acceptance of the accuracy of the assertion. Dr Vaisman denied that he had ever personally reprimanded, or threatened with termination, a doctor for mentioning side-effects of AMI's products. He said that the training and information he gave to doctors always included reference to penile injections, which were sometimes the only appropriate treatment; he said that there was no good reason to keep information about such injections from patients. He insisted that, to his best knowledge, all doctors mentioned all treatment options, and that it was not up to him but up to the individual doctor.
64 Dr Berry gave evidence that she mentioned side-effects and injections to patients, when appropriate. Dr Goodier was not cross-examined on this issue.
65 Conclusion. I am not satisfied that Fairfax or the journalists knew, or ought to have known, that provision to them of the information contained in this imputation involved a breach of confidence. However, I am satisfied that AMI had no such practice as is referred to in this imputation, and that the imputation is therefore false. The imputation is obviously calculated to harm AMI in respect of its business.
Third Imputation - absence of scientific evidence
66 The third imputation was that for at least 18 months prior to early 2009, it was the practice of AMI customer service operators to tell patients misleading information regarding treatments, namely that patients would get the best results when using AMI products for one-two years, when there was no scientific evidence to support such a claim, and that AMI condoned that practice.
67 Content. This imputation pertains to representations said to be made by AMI clinical co-ordinators (not customer service operators), allegedly as a matter of routine - or practice - to patients or potential customers for whom certain medications were prescribed, as to certain characteristics claimed for those products, to the effect that the products would provide best results if used for one to two years. The claim, as described in the imputation, does not refer to any particular type of treatment for any particular condition. The sting in the imputation is the allegation that such a claim was misleading, in the absence of any scientific evidence to support it. Thus the imputation asserts that such a claim was misleading, not simpliciter, but because there was no scientific evidence to support it. Moreover, the imputation is not that the claim was not scientifically proved - an imputation that might have been more difficult for AMI to falsify - but the higher and wider assertion that there was no scientific evidence to support it. It is important also to recognise that the claim attributed to AMI was that patients would get "best results" with prolonged use over one to two years. In substance, this means no more than that better results were obtained with such prolonged use than with short-term use, which is not equivalent to the language into which the defendants often lapsed, of describing it as a claim of "increased effectiveness (or efficacy) of AMI products over time".
68 Confidentiality and iniquity. Whatever claims were made by AMI's clinical co-ordinators to customers or potential customers were made freely to customers or potential customers, without any obligation that customers treat them as confidential. While individual consultations between clinical co-ordinators and customers might well be the subject of obligations of confidence, it is not possible to see why a claim made generically in respect of AMI's products to customers would be confidential. And if the claims were spurious, there is nothing to suggest that knowledge of the absence of any evidence to support them was something that was imparted to or acquired by Dr Almohty in confidence.
69 Moreover, while the content of communications between AMI's doctors and patients, and between AMI clinical co-ordinators and patients, would prima facie be confidential, neither the existence of a practice of providing misleading information to patients, nor the absence (if it were so) of any scientific evidence to support AMI's claims, could be the subject of obligations of confidence: the existence of such a practice would plainly be inimical to public health, and the public interest in its disclosure would override any private obligation of confidentiality attending it. For that reason, the information contained in the third imputation, if true, would not have the requisite quality of confidentiality to attract protection as a confidence.
70 Notice of breach of confidence. It follows that I am not satisfied that Fairfax or the journalists knew, or ought to have known, that provision to them of the information contained in this imputation involved a breach of confidence.
71 Falsity. AMI's products are in general compounds, including (for the treatment of PE) clomipramine or tramadol, delivered by nasal spray, capsule or troche; and (for the treatment of ED) apomorphine, often in combination with other drugs (such as phentolamine and sildenafil (Viagra), vardenafil (Levitra) or tadalafil (Cialis)), delivered by nasal spray or troche.
72 I accept that, when medication was prescribed, clinical co-ordinators commonly recommended to customers that the products be used for a sustained period - typically 12 to 18 months - in order "to train the brain and body". Dr Berry explained:
In the case of premature ejaculation, it is necessary to retrain the mind and the body to get to the point where a patient has got past the point of anxiety about ejaculating too quickly. My intention is to recommend a treatment term which aims to get a patient to the point where he no longer needs medication to avoid early ejaculation.
73 She said that, in her experience, treatment was recommended for periods of three months, six months, twelve months or eighteen months. At least implicitly, this conveys a recommendation to use the treatment for sustained periods, because doing so will assist the mind and body to become habituated to the desired end state of minimising, if not eliminating, the impact of ED and/or PE. To my mind, the representation conveyed is rather to the effect that a better enduring result is obtained by sustained use of the medication, than that efficacy of the medication increases with sustained use.
74 Fairfax called Dr Katelaris, an experienced urological surgeon, to give evidence that there was no scientific evidence to support AMI's claims. However, while Dr Katelaris maintained that there was no scientific evidence to support the claim, it emerged that his evidence was really that there had been no "placebo-controlled double-blind randomised studies" that supported an increase in efficacy over a period of one to two years, of the drugs used by AMI (particularly, clomipramine and apomorphine), alone or in conjunction with other compounds, using the modes of administration utilised by AMI. Even when confronted with peer-reviewed articles, or a placebo-controlled double-blind study, he found some reason to discount it - that it was a decade or so old; or that there were insufficient study groups; or that the number of controls did not match the number in the test group. While I accept that each of these matters might weaken the force of the studies, it does not deprive them of all value. In substance, the effect of Dr Katelaris' evidence, in the light of his cross-examination, was not that there was no evidence supporting AMI's claim, but that the evidence for it was not, to him, persuasive or compelling. Moreover, in my view, his opinion miscued, in that while he seems to have insisted that to qualify as scientific evidence there had to be a placebo-controlled double-blind randomised study of the medications used by AMI administered by the modes of delivery utilised by AMI demonstrating increased efficacy over time, the claim in issue was not that the efficacy of the drugs was increased, but that better enduring results were obtained from the treatment, if it was undertaken on a sustained basis.
75 However, it was not for Fairfax to prove the truth of the imputation; AMI bears the burden of establishing its falsity. AMI tendered opinions of Dr Vaisman, Dr Berry and Dr Goodier, in which they drew upon their experience in practice, and articles from the medical literature, to establish that there was some scientific basis for the claim. Amongst the articles from the literature tendered by AMI are at least some that do tend to support aspects of the claim, as the following (incomplete) summary shows.
76 SM Haensel et al, "Clomipramine and Sexual Function in Men with Premature Ejaculation and Controls" (1996) 56 Journal of Urology 1310, reports that clomipramine effectively increases ejaculatory latency in men with primary PE. This provides support for the view that one of the medications utilised by AMI, clomipramine, is effective in the treatment of PE.
77 DS Strassberg et al, "Clomipramine in the Treatment of Rapid (Premature) Ejaculation" (1999) 25 Journal of Sex & Marital Therapy 89, reports a double-blind, placebo-controlled cross-over study, the results of which demonstrated the efficacy of low doses of clomipramine in the treatment of PE. It provides further support for the view that one of the medications utilised by AMI is effective in the treatment of PE.
78 DL Rowland et al, "Effective Daily Treatment With Clomipramine in Men With Premature Ejaculation When 25mg (as required) is Ineffective" (2001) 87 British Journal of Urology International 357, reports a study of four men, who had not responded to low dose on-demand clomipramine, but responded well to daily dosing, concluding that daily dosing may give better results than on demand dosing for PE in men who do not respond to on-demand dosing. This provides further support for the view that regular and sustained treatment produces better results.
79 MR Safarinejad et al, "Safety and Efficacy of Tramadol in the Treatment of Premature Ejaculation: A Double-blind, Placebo-Controlled, Fixed-Dose, Randomized Study" (2006) 26 Journal of Clinical Psychopharmacology 27, concludes that tramadol seems to be effective in the treatment of PE. This provides support for the view that another of the medications utilised by AMI, tramadol, is effective in the treatment of PE.
80 The substance of EA Salem et al, "Tramadol HCL Has Promise In On-Demand Use to Treat Premature Ejaculation" (2008) 5 The Journal of Sexual Medicine 188, is evident from the title of the article. It provides further support for the view that tramadol is effective in the treatment of PE.
81 AL Burnett, "Vasoactive Pharmacotherapy To Cure Erectile Dysfunction: Fact or Fiction?" (2005) 65 Urology 224, is a peer-reviewed article which suggests that extended use of vasoactive pharmacotherapy, including combination pharmacotherapy, can improve erectile function and examines year-long longitudinal studies on erectile health. This provides some support for the efficacy in treatment of ED of extended use of combination pharmacotherapy with vasoactive drugs - of which apomorphine is one.
82 Several other articles report that apomorphine has effect in the treatment of ED.
83 K Hatzimouratidis and DG Hatzichristou, "A Comparative Review of the Options for Treatment of Erectile Dysfunction: Which Treatment for Which Patient?" (2005) 65 Drugs 1621, a peer-reviewed article - reported that apomorphine is efficacious in improving erectile function; noted that in one study daily use rescued 86% of those who did not respond to on-demand use; observed that combination treatment with other medication such as PDE5 inhibitors seemed appealing, but that there was no clinical data available on such a combination; and also noted a study in which men responded better to daily dosing with tadalafil over a twelve week period than to on-demand use. This provides further support for the view that apomorphine - one of the drugs used by AMI - is effective in the treatment of ED; and that regular and sustained treatment produces better results than on-demand dosing.
84 P Lammers et al, "Combination Therapy for Erectile Dysfunction: A Randomised, Double Blind, Unblended Active-Controlled, Cross-Over Study of the Pharmacodynamics and Safety of Combined Oral Formulations of Apomorphine Hydrochloride, Phentolamine Mesylate and Papaverine Hydrochloride in Men With Moderate to Severe Erectile Dysfunction" (2002) 14 International Journal of Impotence Research 54, concluded that an oral combination of two vasoactive drugs with different pharmacodynamic activity - particularly apomorphine and phentolamine - may provide an alternative approach to oral treatment with the highest approved dose of sildenafil, and warranted further investigation. Significantly, their observations included:
For the mean six-point SEP score (primary efficacy variable) there was a period effect, which means that patients did increasingly better as the trial periods advanced, independent of the type of treatment.
The observed period effect across all four treatments in the study is most likely due to increased confidence with sexual performance during study participation.
85 That article provides further support for the view that apomorphine in combination with phentolamine may be effective treatment for ED, and that efficacy was enhanced over time (the "period effect"), through increasing confidence and reducing performance anxiety over time.
86 I Eardley, "Pharmacotherapy for Erectile Dysfunction" (2010) 7 The Journal of Sexual Medicine 524, reports no evidence of significant differences in efficacy, safety and tolerability between PDE5 inhibitors - such as sildenafil, vardenafil and tadalafil - and apomorphine; that apomorphine is efficacious in the treatment of erectile dysfunction in the broad population at doses of two and three milligrams taken sublingually in an on-demand fashion; and that there was intermediate level evidence for efficacy and safety of combination therapy with, inter alia, phentolamine. This provides further support for the view that apomorphine - one of the drugs used by AMI - administered sublingually - one of the modes of delivery used by AMI - was effective in the treatment of ED.
87 M Lowy and V McCann, Too Fast? Learn to Last Longer: A Guide to Premature Ejaculation, (2009) states:
Fluoxetine (Prozac), sertraline (Zoloft) and paroxetine (Aropax) are SSRI anti-depressants which are quite effective in inhibiting ejaculation and are frequently used for this purpose in Australia and the USA. They do this by raising serotonin levels in the ejaculation centre in the brain. Paroxetine is the most effective. Daily dosing is more effective than taking it as a single dose a few hours before sexual activity. It is recommended to take the medication for at least six to 12 months, however, there is no guarantee that PE will be cured after six months. Some men chose life-long treatment.
88 That provides further support for the view that long-term regular medication is typically required for PE.
89 The American Urological Association's Premature Ejaculation: Guideline on the Pharmacologic Management of Premature Ejaculation (2003), an authoritative guideline publication, advises that therapy for premature ejaculation is most likely needed on a continuing basis; that PE usually returns upon discontinuing therapy; and that clomipramine, a tricyclic antidepressant with SRI effects, has improved ejaculatory latency and other measures of PE when prescribed at particular doses. This provides further support for the view that clomipramine, one of the medications used by AMI, is effective in the treatment of PE, and that treatment for PE is usually needed on a long-term basis.
90 Other articles report the efficacy of nasal administration as a route for delivery of medication.
91 The defendants submitted that none of the studies discussed AMI's products, and that is so; but many discussed medications that were included in AMI's products. The defendants contended that scientific evidence could be provided only by a placebo-controlled double-blind randomised study of the type for which Dr Katelaris would stipulate, testing the application of AMI's products delivered via the prescribed routes for the prescribed purpose. If the imputation pertained to proof, as distinct from evidence, there would be great force in that submission. But in order to establish the falsity of the imputation, it is not necessary for AMI to establish that the claim is scientifically proved; it is sufficient to show that there is some scientific evidence to support it. Such evidence may be furnished by a range of material from which conclusions applicable to AMI's products and treatment can be drawn, as distinct from a singular study of AMI's own products. The literature tendered by AMI establishes some basis for, inter alia, each of the following: