TGA RESTRICTED REPRESENTATIONS
APRIL 2018: "OFF LABEL CONDITIONS RESTRICTIONS" (NON-MEDICARE)
Australian Therapeutic Goods Act (TGA)
* Restricted representation is a reference, expressly or by implication, to 'forms of diseases, conditions, ailments or defects'.
** To use restricted references (clinical conditions) in advertising (web, facebook, social media etc) for therapeutic goods without committing an offence, it is necessary to have written TGA approval prior to those claims and services being made available to the public.
https://www.tga.gov.au/form/application-approval-use-restricted-representation-advertising (how to apply for approval)
https://www.tga.gov.au/restricted-representations (general information about restricted representations)
** Requires a completed and published Clinical Trial specific to the 'physical condition' using the 'unapproved therapeutic goods and service' before public use.
Clinical Trial Notification (CTN) scheme
"Completed" clinical trials are required for "unapproved therapeutic devices" and use before public approval.
- meaning if the service is considered as "off-label" then a "completed clinical trial is required for each specified condition before Public Use".
The TGA will make determination as to whether the "unapproved" therapeutic device/goods or service require Trial Notification or Trial Exemption.
An 'unapproved' therapeutic good requires Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) for "each unapproved condition" under the National Health and Medical Research Council (NHMRC).
The Australian clinical trial sponsor must notify the TGA of the intent to sponsor a clinical trial involving an 'unapproved' therapeutic good. This must take place before starting to use the goods.
The TGA does not evaluate any data relating to the clinical trial at the time of submission.
The Human Research Ethics Committee (HREC) reviews the scientific validity of the trial design, the balance of risk versus harm of the therapeutic good, the ethical acceptability of the trial process, and approves the trial protocol. The HREC is also responsible for monitoring the conduct of the trial.
The institution or organisation at which the trial will be conducted, is referred to as the Approving Authority which gives the final approval for the conduct of the trial at the site, having due regard to advice from the HREC.
The Approving Authority is typically a hospital with all administrations and control subject to hospital and HREC governance.
"It is the responsibility of the sponsor to ensure that all relevant approvals are in place before supplying the 'unapproved' therapeutic goods in the clinical trial."
The complex framework required to get a "non-pharmaceutical goods or service' to meet NHMRC trial approval for each specific "unapproved condition" is 'extra-ordinary'.
- This author has been through this process on multiple occasions - refer below.
The NHMRC requires 'large cohort numbers' to be in the clinical trial requiring significant (non-drug) funding models available to get up a prospective trial. In short - it is virtually impossible unless you are conducting a pharmaceutical trial with the prospect of taking the (incentified) product to market ie Viagra.
* Double jeopardy is a procedural defence that prevents an accused person from being tried again on the same (or similar) charges and on the same facts, following a valid acquittal or conviction.
Health Practitioner Regulation National Law Act 2009
A complaint was brought against Dr Malcolm R. Hooper in 2009 by the Chiropractic Board of Australia (CBA).
In 2010, the newly established Australian Practitioner Registration Agency (AHPRA) exercised its powers under the Health Practitioner Regulation National Law Act 2009.
The complaint was escalated to a full substantive hearing before the Victorian Civil Court - Victorian Civil Administrative Tribunal (VCAT).
- The case ran for a total of 66-sitting days with the substantive hearing sitting for 36 days.
- The case was described by Beth Wilson, former Health Services Commissioner as the "longest practitioner case in (Australian) history". "A real David and Goliath struggle".
- The applicant (and media) stated Dr Hooper had no evidence to support the use of HBOT for "off label therapies" and "unapproved conditions" or the use of a "glorified treadmill like device".
"Unapproved Therapies" challenged under AHPRA.
Hyperbaric Oxygen Therapy for the 71-conditions listed on the HyperMED website (2006-2010).
The disputed 71-conditions were directly sourced from the internationally respected Textbook in Hyperbaric Medicine by K. K. Jain. 'Summary of International Conditions Treated Using Hyperbaric Oxygen Therapy' (P76).
Lokomat - Robotic Gait Assisted Walking for a range of neurodegenerative disorders including Cerebral Palsy.
** The combination of Hyperbaric Oxygen Therapy and LOKOMAT (Robotic Gait Assisted Walking) being a "pioneering world first" (2006).
In contrast, this was not the view by the Applicant (CBA and AHPRA) or senior counsel, Professor of Law Dr Ian Freckelton, who stated in his opening remarks referring to the matter as a “test case for junk science with a cohort of others sitting behind it”.
Prior to taking on the controversial AHPRA case, Dr Freckelton's bias is evident in the Panel Session: Science and Law; a Clash of Cultures NJCA/ANU Expert Evidence Conference 12 Feb 2011 (page 4);
"There is another area here too, in which we see junk [inaudible] science litigated in our courts, and it deserves just to be identified briefly. It is not so much in your classic criminal and civil litigation. It is in fair trading- and trade practices-type cases, which are becoming more and more common.
I am prosecuting a chiropractor in a couple of weeks time for using hyperbaric oxygen therapy without any legitimate scientific justification.
You might have seen in the paper of this week that there has been an ongoing action against some people for using very dubious asthma tests. What we are seeing, in a number of ways in our legal system, is enforcement of principles of orthodox scientific methodology as mechanisms for excluding certain kinds of behaviours within the general community. In those cases, what happens is that well respected doctors and scientists talking about empirical bases and methodologies for particular kinds of procedures and techniques come in saying, ‘this is how things ought to be done’, with the onus shifting to those who have been doing them in a different way, against whom the actions are being brought.
That is an area of discourse which is opening up and is very controversial and becoming an important part of regulation of both doctors and dentists, health professionals generally, and some out-and-out charlatans".
"The onus is shifting to those who have been doing them in a different way, against whom the actions are being brought"
- in a democracy, the accused is innocent until proven guilty.
Pietro Longhi: The Charlatan, 1757
A charlatan (also called swindler) is a person practicing quackery or some similar confidence trick or deception in order to obtain money, fame or other advantages via some form of pretense or deception. Synonyms for "charlatan" include "shyster", "quack", or "faker". "Quack" is a reference to "quackery" or the practice of dubious medicine or a person who does not have actual medical training who purports to provide medical services.
Dr Freckelton described the contested "unapproved treatments" (without any legitimate scientific justification) as "novel and unique therapies not supported by the greater percentage of medical doctors or medical organisations in Australia".
The case ran for an exhausting 66-sitting days. I spent in excess of $1M and no doubt the applicant costs if not greater.
The Applicant's evidence included Dr Michael Bennett and Dr Ian Miller both members of the UHMS (Undersea & Hyperbaric Medical Society).
The UHMS “experts” in the VCAT referred to the text by Jain, Harch and others as “misguided enthusiasts”.
Specifically before the VCAT, the UHMS "expert evidence" was that the “Jain Text was not highly regarded in Australia”.
The UHMS expert (Dr Michael Bennet) provided his evidence to the VCAT referring to the newly established Cochrane Collaboration Reviews.
Dr Bennett was engaged by the Cochrane Collaboration Reviews to under take review of 19-conditions using Hyperbaric Oxygen Therapy.
All conditions reviewed by Dr Bennett failed to provide "high level evidence" with only "weak supporting evidence" or "little to no evidence" to support the use of HBOT for any of the reviewed conditions. Dr Bennett effectively dismissed Hyperbaric Oxygen Therapy as an effective treatment for virtually any condition.
However in contrast to Dr Bennett and the Cochrane Collaboration Reviews, governments around the world including the Australian Medicare Scheme continue to fund Hyperbaric Oxygen Therapy for "emergency" conditions. Internationally, there is a growing list of "non-emergency" conditions including over 70-listed conditions in China, Russia etc.
In the USA, numerous states are funding HBOT for returned war veterans suffering the effects of Traumatic Brain Injury (TBI), Post Traumatic Stress Disorders (PTSD), Shock Blast and Concussions. The United States Department of Defense (DOD) has reported a reduction in "suicide ideation" after Hyperbaric Oxygen Therapy.
Dr Bennett and others in Australia, do not support the expanded and growing list of approved conditions.
Reference Combat Stress Part 1 HBOT: Brain Healing Hidden in Plain Sight (March 2018) and Part 2 HBOT: Brain Healing Hidden in Plain Sight (May 2018)
Of the 70+ conditions challenged in VCAT, the UHMS 'expert evidence' was not favourable to the Applicant's case.
Subsequently, during the final hearing the Applicant dropped over 40 of the 70-conditions contested.
Dr Freckelton on behalf of the Applicant further failed to get up a requested "prohibition order" to restrict the use of Hyperbaric Oxygen Therapy for a further 21-conditions. I gave an undertaking not to treat 10-conditions which was accepted by the VCAT in the Final Orders.
Of the 71-conditions challenged under AHPRA, 61-conditions were ruled in the Respondent's (Hooper) favour.
The VCAT Final Orders ruled that Dr Malcolm Hooper was of “good character”, “unyielding in his belief”, “relied on his text, his Holy Grail".
The VCAT Final Orders ruled there were to be “no restrictions” to the “conditions” I have been treating or the “pressures” I have been using for the past 20+ years.
However my chiropractic registration was ‘cancelled’ for 2 years even although the VCAT knew I had not been a traditional chiropractor for over 25 years.
The entire matter of LOKOMAT (Robotic Gait Assisted Walking) was dropped.
LOKOMAT Robotic Gait Assisted Walking now being funded by state government and controlled within the ‘hospital’ system.
National Health and Medical Research Council
Dr Malcolm Hooper (2006-2012) submitted multiple submissions to the NHMRC, Victorian NeuroTrauma Initiative (VNI), Workcover, Transport Accident Commission and Federal
I was repeatedly informed by the NHMRC and VNI that Clinical Trials had to be conducted under an approved institution (hospital) with all aspects of the trial subject to the Human Research Ethics Committee (HREC), and the hospital governance including funding allocation to the trial..
- No submissions by Dr Hooper were approved for Clinical Trials.
Case Studies A5 Booklet - Victorian WorkCover Authority (1997) Hyperbaric Oxygen Funding Application (selected case studies only - this is a large file to down load)
The VCAT "contested" matter was a full and exhaustive review conducted by the AHPRA with the full weight of the VGSO (Victorian Government Solicitor's Office) exercising its powers under the Health Practitioner Regulation National Law Act 2009. The VCAT contested decision was the summation of considerable evidence by the Applicant and myself over the 66-sitting days.
Further the VCAT decision assists to diminish the economic burden on the Public System, for those individuals that can afford to attend privately with no claim for services under Medicare, TAC, Worksafe or Private Insurance.
The VCAT decision clearly identifies that the determined services are not “public goods”.
The challenge of constraining health expenditure:
The problem for policymakers is that because there is so much uncertainty in health, in many cases it is difficult if not impossible to define what constitutes necessary and unnecessary care. Treatments once thought to be unnecessary can, over time, become widely regarded as necessary, so definitions are not static. As a result, much of the decision-making on what constitutes necessary health care is left to health professionals. Health professionals, however, cannot always be certain about the causes of ill health in an individual, and therefore they cannot be sure if a treatment will be effective. Governments sometimes get directly involved in decisions about what constitutes necessary care but it can lead to controversy. The most recent example of this was the controversy over the Government’s decision to defer listing some new drugs on the Pharmaceutical Benefits Scheme, even though they had been recommended by the independent Pharmaceutical Benefits Advisory Committee.