Researchers have recently discovered how zinc helps rid the body of Streptococcus pneumoniae, a bacteria that can cause meningitis, pneumonia and bacteraemia. Streptococcus pneumoniae can be fatal, with medicos urging vaccination against pneumococcal diseases. Now we know why zinc may help the body fight these nasties. Basically put, Streptococcus pneumoniae uses the trace metal manganese to defend itself against the body’s immunity, binding the manganese with a spring-hammer mechanism. When zinc is given, the smaller molecule zinc is bound instead, and being a smaller molecule, causes the Streptococcus pneumoniae spring mechanism to unwind too far and lock shut. This starves the bacteria of manganese, allowing the body to clear the infection more easily. Kudos to Australian researchers at the University of Queensland and University of Adelaide for their discovery! It’s great to identify the actual reasons why Natural supplements work, allowing Naturopaths to prescribe very specifically and accurately.
Michel Lotito ate metal, lots of it. In his lifetime he consumed;
- 1 Cessna Aircraft
- 18 Bicycles
- 15 Shopping Trolleys
- 7 Televisions
- 6 Chandeliers
- 2 Beds
- A pair of skis
- A coffin
- and 400 metres of steel chain
While iron deficiency may not have been a problem for Monsieur Lotito, I suspect his death in 2007 from “natural causes” at age 57 may have actually been from heavy metal poisoning.
For some it’s too late, but you can have a hair mineral analysis to check for heavy metals and levels of other necessary minerals. This test provides an accurate look at tissue levels of compounds that can make you well or sick, allowing me to prescribe the most exact supplements to help you achieve health. Check out the details on my tab “Hair Analysis” and, oh, here’s a video about Monsieur Lotito
TGA Proposed Reforms Update
The Australian Traditional Medicine Society (ATMS) hosted a meeting in Sydney on 25th August 2013 addressing “Practitioner Only Product” (POP) advertising reforms proposed by the Therapeutic Goods Administration (TGA). Attending this meeting was Prof. John Skerritt, National Manager of the TGA, Wendy Morrow, CEO of the Complementary Healthcare Council, a number of POP suppliers and practitioners. Submissions for the “Response to the Consultation, Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public” closed on the 19th July and Prof. Skerritt mentioned “that there were more objections being made in this single call to action than any other that the TGA have seen before” (more than 1,200 compared to a typical less than 50). Prof. Skerritt advised that amongst the mountain of submissions received there were a number of other options suggested that the TGA will consider. One of the most significant suggestions offered was that until Naturopaths, Western Herbalists, Nutritionists and other natural practitioners were regulated under a registered body, there would be a requirement that ‘Schedule 1’ be amended and updated to recognise unregistered practitioners.
Importantly, Wendy Morrow highlighted to Prof. Skerritt that there is not a single practising naturopath or herbalist on any board or association that is recognised as a consulting body to the TGA, who can adequately assist the TGA in making suitable suggestions or decisions about the future of our profession.
Ultimately, the suggestion was made by Prof. Skerritt that further lobbying to political ministers was needed after the election result on the 7th September to help qualified complementary health practitioners to become registered. This would help define complementary healthcare providers and assist in upholding a professional reputation of safety.
David’s comment – this is good news, and exactly what our profession needs; to be travelling in the direction of professional registration & recognition. The TGA proposal and public response may have provided the needed impetus for this to finally happen.
RE Consultation: Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public – 31 May 2013
FROM; David Howell B.Nat.Dip.H.Sc(nurs) Naturopath, Herbalist Toowoomba Q 4350
To the TGA
The following comments relate to the above mentioned document sections as follows;
“The Problem – part 7 – “Advertising Directed to Health Professionals” Page 28
“Proposal 6 – Advertising Directed to Health Professionals” Pages 42-45
I strongly oppose the TGA Proposal 6 Option 2 (Pages 43-5) for the following reasons;
REMOVAL OF ADVERTISING
1) As a Naturopath and Herbalist in clinical practice, my interests would be significantly affected by this option. Advertising of Therapeutic Goods provides a concise gathering of scientific data that enables rapid appropriation of the main ingredients, uses and contraindications of a specific product. Within a busy clinical practice, such rapid analysis assists me in considering the relevance of a product within the scope of my clientele.
Should I consider purchasing such a product, I will then research the ingredients and their clinical trials via independent databases/search engines (Eg. Pubmed, E.Mims and other respected information sources) to verify the manufacturer’s information. This approach is as taught within a science based degree at University level, as per my tertiary qualification, and reflects the sound ability of a Naturopath and Herbalist to independently research the data, and exercise specialist judgment when treating patients with an advertised Therapeutic Good or advising a patient on the use of an advertised Therapeutic Good.
To remove manufacturer’s advertising of such goods is to deny Naturopaths and Herbalists the same style of information as is provided to Medical Practitioners via E.Mims and other Therapeutic Good producer-based information, and constitutes discrimination based on ignorance by the TGA. The TGA should avail itself of the knowledge it needs to discern the level of qualification and expertise of Naturopaths and Herbalists by investigating the necessary Tertiary qualifications and Continuing Professional Educational (CPE) standards of all recognized Practitioner professional associations, rather than making a blanket statement that it cannot be assured that these practitioners are able to correctly discern and utilise such advertising information in clinical practice.
Should the removal of advertising commence as proposed, the result will be increased time imposts on my practice in researching and gathering data.
2) Removal of advertising would then flow on to preventing Naturopaths and Herbalists from attending industry seminars, where research is presented with relevant clinical information. This is similar to seminars as attended by other NRAS health professionals, and represents an industry standard. Completion of CPE points for Naturopaths and Herbalists would then, unfairly, be harder to achieve than for other health professionals (Eg Pharmacists), and would constitute discrimination, again based on ignorance by the TGA.
3) Failure to complete CPE points disqualifies Naturopaths and Herbalists from maintaining membership of professional organisations. This prevents them from both purchasing Therapeutic Goods, and from offering clients consultation receipts for reimbursement via private health funds. The flow on effects of these points are obvious; loss of product purchasing ability removes the tools of trade that makes Naturopathic and Herbal medicine successful and safe in treating client disease or maintaining client wellness, as well as providing a large percentage of income. Loss of the ability to offer health fund receipts will reduce the number of clients attending consultations, again markedly dropping financial viability for Naturopathic and Herbal Medicine Practitioners.
4) Resulting loss of Naturopaths and Herbalists from the marketplace will not only significantly affect them and their families, but will limit the freedom of choice of clients to select a Naturopath or Herbalist as a viable form of healthcare. Limiting such freedom of choice in healthcare to the general public will be the ultimate result of this proposal, and will oppose a basic democratic right of the people. For many people, Naturopathic and Herbal Medicine is the best option for their particular need, and a future lessening of options in this type of healthcare will expose them to greater levels of disease through the application of inappropriate forms of medical treatment. With this occurrence, the TGA will be seen as contravening its own stated object of promoting the safety of the public, and thus will have failed in its relevance to the populace.
Handing over the responsibility of the interpretation of advertising of therapeutic goods, and the advising on their use or their prescription to NRAS health professionals raises the likelihood of danger to the client through lesser clinician knowledge and resulting inappropriate prescriptions.
While the TGA places the responsibility for policing this on each NRAS professional’s Registration Association, a brief perusal of one of these (The Podiatry Board of Australia Code of Conduct for Registered Health Practitioners) states…
“Practitioners have a responsibility to recognise and work within the limits of their competence and scope of practice. Scopes of practice vary according to different roles; for example, practitioners, researchers and managers will all have quite different competence and scopes of practice. To illustrate, in relation to working within their scope of practice, practitioners may need to consider whether they have the appropriate qualifications and experience to provide advice on over the counter and scheduled medicines, herbal remedies, vitamin supplements, etc”. (emphasis mine).
Within this statement, responsibility is loosely placed on the Podiatrist to consider their own level of expertise in providing supplements including therapeutic goods. This includes no form of policing of educational or experiential ability or relevance, and includes no external framework of reference to ensure that such self-consideration is based in fact.
For the TGA to propose removal of therapeutic goods advertising from Naturopaths and Herbalists with University level or other tertiary qualifications, (including science based degrees that offer 4 years of intensive education in the chemical, physiological and pathological basis for the safe and relevant utilisation of these products), and to hand the responsibility over to NRAS practitioners with no relevant tertiary education and a self-assessment of ability not based on fact indicates 2 things;
(a) The TGA is displaying disregard for true client/public safety, against its own tenets and purpose of existence and,
(b) The TGA displays strong and apparently willing ignorance to investigate the truth behind the relevance of qualifications of differing health professionals before making such an irrelevant and potentially dangerous proposal
TGA COMMENT REGARDING ADVICE OF & USE IN TREATMENT OF THERAPEUTIC GOODS
In Option 1 under “disadvantages”, the TGA has commented that;
“The TGA would not be assured that the non-NRAS registered health practitioners are able to exercise specialist judgement when either treating patients with advertised therapeutic goods, or advising them about the use of advertised therapeutic goods”
This suggests that the TGA is not only concerned about the ability of these practitioners to interpret the advertising material correctly, but is concerned with the ability of such practitioners to advise about and treat with such goods (Practitioner Only Products). The inference is that the TGA will not stop at preventing the advertising of therapeutic goods to Naturopath, Herbalists and Homeopaths, but will also target the products’ utilisation in practice by these practitioners. While this may be seen as inference only, in order to allay suspicion and provided the transparency the TGA purports to offer, the TGA needs to answer;
a) Why are the terms “treating patients with” and “advising them about the use of” included in the proposal?
b) Will the TGA make a written guarantee to not remove Therapeutic Goods from the clinical utilization of Naturopaths, Herbalists and Homoeopaths should option 2 proceed?
CHANGING OF TERMS OF REFERENCE IN THE PROPOSAL
The TGA’s proposal to;
“replace the current lists of ‘health professionals’ in section 42AA of the Act with references to ‘health practitioners’ who are registered with a National Board that is a signatory to a Health Profession Agreement under the National Registration Accreditation Scheme (NRAS). Advertising to groups of practitioners who are not registered with NRAS would be regulated in the same way as advertising to the general public” is of particular concern. This infers that those left off the accepted list of NRAS “Health Practitioners”, viz; Naturopaths, Herbalists and Homoeopaths, will not be referred to by the term. As the proposal is related to Therapeutic Goods (Practitioner Only Products), this appears to set the ground for the TGA to disallow the use of (Practice) such products to those not even recognized as Health Practitioners. While this may be supposition, there are 2 aspects the TGA needs to answer to allay suspicion of its motives in making this change in terms of reference under proposal 2;
a) Why is this change of terms being proposed?
b) Why are non NRAS professionals not referred to as “health practitioners”, but rather “practitioners” linked to the general public within this proposal?
c) Can the TGA give written assurance that it will continue to view Naturopaths, Herbalists and Homoeopaths as “health practitioners” should proposal 2 be passed?
TIMING AND TRANSPARENCY OF THE PROPOSAL – TGA CONTRAVENED 3 OF ITS OWN GUIDELINES
Against the guidelines written in the Best Practice Regulation Handbook Appendix C, the TGA released this proposal;
1) With no general media release, despite the public logically being stakeholders in the potential outcome of the proposal
2) Across a National School Holiday period
3) Over an end of financial year, despite the primary stakeholders being small businesses.
The TGA has clearly contravened its own guidelines in releasing this proposal in such a manner and time. While a caveat is provided that such guidelines may be contravened in matters requiring prompt attention due to public danger, the investigations and background to this proposal have been occurring over a great deal of time.
By contravening these guidelines, the TGA shows;
1) It has contempt for reasonable guidelines and is prepared to operate outside such guidelines without reasonable justification
2) It has contempt for stakeholders, including the public it purports to be protecting from danger, and Health Professionals who have every right to be a part of the consultative process and who should have been given the opportunity to research and consider the proposal without the constraints of staff holiday times or end of financial year housekeeping.
Based on this, the TGA should stop the proposal, and relaunch it with the correct media release and timing the public and industry deserves.
Note that this matter has been brought to the attention of industry leaders and politicians, and will form the basis of a future possible legal defense against the proposal.
When all above aspects are combined, the TGA appears to have released this proposal without due research or desire for true consultation, and specifically and unfairly targets Health Professionals who are providing a valid and scientifically quantifiable mode of healthcare, the effects of such a proposal placing the public at risk of greater danger and reducing its freedom of choice in personal and self-funded healthcare. The proposal should be relaunched appropriately, and option 1 chosen to leave the system in its current and workable status until such time that registration under NRAS can be provided for Naturopaths, Herbalists and Homoeopaths.
My online petition regarding this has garnered a strong public and industry response, and reflects the great deal of concern and anger among those whom the TGA purports to protect; the public. This is evidence of a strong reaction that the TGA perhaps tried to avoid by releasing the proposal in contravention of its own guidelines. Please note the 18,855 signatures attached, and take note of the public’s concern and reaction to your proposal. Further to this, my petition and signatures will be presented to the Senate at the next sitting (Mid-August), and should option 2 of the proposal go ahead, we will seek a reversal of the decision based on the TGA’s lack of transparency and the potential negative impacts of the proposal on both industry and the public. Ultimately, should the proposal go ahead, there will be grounds for legal action against the TGA based on a wrongly released proposal that is founded on ignorance, and that unfairly and significantly affects myself and others in my industry.
Naturopath & Herbalist
“TGA THREATENS PUBLIC CHOICE IN HEALTHCARE”
The TGA’s current proposal to stop the advertising of therapeutic goods to Complementary Medicine practitioners threatens the public’s right to freedom of choice in healthcare (Consultation: Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public 31 May 2013 proposal 6 option 2). The proposal has been released with no public media statement, across a holiday period and end of financial year, contravening three of the TGA’s own guidelines. Apparently attempting to achieve its purpose with little public or industry awareness, the TGA is trying to limit scientific and clinical information being available to Naturopaths, Herbalists and Homoeopaths, reducing their ability to treat clients with safety and efficacy. The TGA says it cannot be assured that such practitioners can exercise specialist judgment in advising clients or prescribing Therapeutic Goods. Should the proposal be passed, Complementary Medicine Practitioners risk having these supplements removed from their use in clinical practice, thus reducing their financial viability and ultimately, taking away the public’s right to this effective mode of healthcare. My online petition at change.org has raised public awareness of this issue and gained 16.000 signatures in 16 days, many petitioners expressing fury at their potential loss of freedom of choice in personal healthcare. All credit to local opposition MP Ian McFarlane for pursuing this matter in Parliament. With the deadline for public comment on July 19 at 5pm, I urge the public to sign my petition, (http://chn.ge/12dqk7x), contact their MPs and make comment on the proposal on the TGA website to express opposition to this subtle assault on Australian’s freedom of choice.
The TGA is seeking to stop Australian Naturopaths receiving advertising about therapeutic supplements, or advising about or prescribing the products to their clients. This will effectively delete the industry as such products form the basis of Naturopaths providing safe and successful treatment for their clients, as well as maintaining financial viability in the market place. The premise for such action? …Despite degree level science based tertiary Naturopathic education, the TGA quotes that they cannot be sure that Naturopaths are qualified to give such information or prescriptions. The alternative? …Hand over such prescribing to other health professionals registered under Australia’s NRA (National Registration Authority). This includes podiatrists, dental hygienists and a range of other professionals typically non-qualified to give such advice and prescriptions. This is an issue of threat to public safety, and incredible arrogance and injustice to the Naturopathic Industry, despite the industry performing a vital role in maintaining people’s health without costing the public health system a cent. Note that Naturopaths typically receive rigorous education in Australia prior to qualification, and are subject to ongoing annual educational standards and regulatory measures via their professional organisations. The TGA is proposing this regulatory change with no fanfare and a very short time for the public to respond (by July 12th 2013). Your support of this petition is necessary and urgent, as well as greatly appreciated.