Bonnie Allan, 19 January 2018 Secretary, Senate Community Affairs Legislation Committee

Dear Ms Allan,

Re: ‘Your Health Your Choice’ submission: Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017

Professor has shared with us the letter you wrote to him following your examination of the submission from “Your Health ,Your Choice” Inquiry into the Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017. There we note your explanation that:-

"The resolutions of the Senate provide that, where evidence is given to a committee which may be considered as reflecting adversely on an organisation (or a person), the committee shall provide a reasonable opportunity for that organisation to have access to that evidence and, if they wish, to respond to that evidence”. The evidence supplied would certainly be considered to reflecting adversely on ‘Friends of Science in Medicine’ (FSM) hence this response to you.

Far from being the extremist group portrayed in the submission under consideration, FSM simply emphasises that when it comes to something as important as Health and Health care, strategies should be underpinned by credible scientific evidence of clinical effectiveness and, where necessary, the scientifically sound pursuit of that evidence. Hardly a radical proposition and one supported by more than 1200 leading Australian scientists (including two Nobel Laureates and our country's Chief Scientist) clinicians and consumer organisations championing better health care. Much of our advocacy tackles misleading and fraudulent claims made for ‘alternative’ health care practices that are not pertinent to your enquiry. Our peak scientific body, the National Health and Medical Research Council has thoroughly studied the evidence base for the 17 most common alternative modalities (Iridology, Reflexology, etc) and found no evidence for any being clinically effective. Such ‘pseudoscientific’ modalities are strongly advocated by those associated with ‘Your Health, Your Choice’.

What is relevant to your committee are concerns re the misleading, often fraudulent, promotion of the health benefits of medicines and medical devices. ‘Complementary’ medicines are very popular with Australians and the industry supplying same is hugely profitable. We would emphasise that, unfortunately, we have one of the lowest levels of health literacy in the OECD that leaves Australians vulnerable to the false or exaggerated claims made by the CAM industry. While some of the complementary medicines promoted can be dangerous (particularly problematic with Chinese medicines responsible for 17% of all adverse reactions in China) most are not inherently dangerous but as there is no evidence to support the use of many such products and for many strong evidence to demonstrate actual ineffectiveness, the risk/benefit ratio emphasises risk. It is not adequately appreciated by the TGA that consumer protection should address the waste of money many cannot afford, the raising of false expectations and the delay in pursuing an accurate diagnosis and treatment. Organisations such as ‘Your Health, Your Choice’ should note that even with the current TGA regimens pre-vetting of advertisements for complementary medicines finds 70% that need adjusting for accuracy, the Complaints Resolution Panel upholds almost all of the complaints it addresses and that random auditing by TGA of claims made for TGA listed preparations finds 80-90% to be misleading. They should also be aware of the cynicism associated with successfully prosecuted cases of where manufacturers are told to refrain from making claims for a product, they simply change the name of the product and proceed with the deceptive behaviour.

It is true that FSM works closely with Professor Ken Harvey who is a valued member of our executive committee; there is a natural synergy with his work at Monash University on better protecting consumers from health fraud. The partnership has been involved in helping to expose medical scams such as the impotency treatment offered by the so called Advanced Medical Institute, those involving fraudulent weight loss treatments and the promotion of expensive ineffective hormone treatments, all of which would have been prevented from doing much harm if the regulatory frame work saw TGA doing what is necessary to protect consumers from such fraud. It is claimed that FSM does not support any research into the effectiveness or otherwise of complementary medicines. This is simply not true, as is clear from the appropriate section of our website (appended). It is true that we would not support further research into certain modalities such as Homeopathy which science has studied with world-wide agreement from learned bodies that such preparations are useless and the premise for their preparation totally unfounded.

We conclude by re-emphasising to your enquiry how important are the continuation of pre-vetting for advertisements, the maintenance of an independent complaints resolution panel (we have no confidence that internal TGA evaluations resourced or would be as independent as required), that ‘traditional use’ as an explanation for effectiveness should be accompanied by a clear statement that there is no scientific evidence to support claims made and indeed for a number of products e.g. Homeopathic products, "scientific evaluation has found no evidence for effectiveness”.

We thank you for considering this information and are at your disposal for any further request for your deliberations.

Yours Sincerely

Professor John Dwyer AO. PhD, FRACP, FRCPI, Doc Uni (Hon) ACU. Emeritus Professor of Medicine and President of FSM

ADDENDUM

Our Association, Friends of Science in Medicine (FSM) was formed at the end of 2011 to emphasise the importance of having health care in Australia based upon evidence, scientifically sound research and established scientific knowledge.

The founders of FSM were and are concerned about the increasing number of health courses and interventions on offer to Australians that fall far short of this standard, as well as the inadequacy of the measures that are supposed to protect students and consumers from such practices. This is no alarmist statement. Many supposed health treatments have no scientific evidence of their effectiveness, some have been shown to cause harm, while many could not possibly work as they are incompatible with well-established principles of physics, chemistry, physiology and pharmacology. Many are pseudoscientific; assuming the trappings of scientifically sound practices in order to gain the credibility of these without subjecting themselves to the well understood tests of scientific examination that have proved so effective in giving us medical procedures and medicines that really work.

We were particularly concerned that some of our universities were allowing pseudoscientific approaches to health education to be presented in health science courses without critical analysis of the principles behind them or of the claims of efficacy made for these procedures and treatments, including such practices as Acupuncture, Homeopathy, Energy Medicine, Kinesiology, Chiropractic “subluxation” theory, Cranial Sacral therapy and more. All of these approaches lack scientific credibility, but apparent endorsement of them by our universities can confer undeserved credibility on useless and sometimes dangerous approaches to healthcare.

While suspect university courses provided the impetus for the creation of FSM, all aspects of the penetration of pseudoscience into our healthcare system concerns us. Many, such as Iridology, Reflexology, Rolfing, Homeopathy, much of traditional Chinese and Indian medicines, etc, are an affront to our knowledge of physiology and pathology and, relying as so many of them do on mysterious, undefinable, undetectable “energy”, could never be validated by scientific investigations as, virtually by definition, they have made themselves impossible to test.

We would emphasise, however, that FSM strongly supports the need to conduct independent and disinterested scientific evaluations of those “Alternative and/or Complementary” therapies where the anecdotal evidence for benefit is strong and the underlying explanations are not incompatible with modern biological and physical sciences. Much that is of current therapeutic benefit was developed by such an approach.

As FSM we are also aware of and concerned by the discovery of cases where poor scientific methodology and the fraudulent manipulation of data have occurred within the medical/scientific establishment. Some individual researchers and some of the major pharmaceutical companies have been involved in these unacceptable practices. While FSM deplores such activities, it recognizes that there are already many and increasing checks and balances within Medicine that aim to minimise such incidents. The same cannot be said for Alternative and/or Complementary medicine, which is why FSM is concentrating its efforts in this area.

Valid scientific and medical research must adhere to well-established and widely recognized “best practice” protocols. FSM wants the evaluation of all potential health treatments to be subjected to similar standards for validation.

When we informed the scientific and clinical communities of the establishment of FSM and sought support, we were overwhelmed with encouragement from home and abroad. As of 2017 we have over 1200 leading scientists, clinicians, lawyers and consumer advocates, as supporters.

FSM has no formal links to any industry or organisation and its executive members serve in a voluntary capacity.

Speaking with a strong voice provided by our constituency we make every effort to ensure that Australians have access to interventions and medicines backed by science-based tertiary education and scientific evidence of their clinical effectiveness. FSM works towards ensuring that precious public health dollars are not wasted funding spurious treatments, many of which have actually been proven to be ineffective and thus dangerous, despite their small direct risk.

With the efforts of hundreds of like-minded and knowledgeable Friends, we strive to help the public understand the importance of a good evidence base for any treatment they are offered. We advocate for regulatory changes that better protect the public from misleading, even fraudulent, health-related claims.

Professor John Dwyer AO Founding President FSM

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