Health Care Interventions – Choosing Wisely

Lecture notes for this 8 week U3A Melbourne course.

The course outline is available here.

The timetable (based on participants feedback on possible topics) is also available.

Week 1: Topics – Improving communication between consumers / patients and their health care providers. Assessing the risks, benefits and costs of interventions.

Week 2: Topics – Screening to detect cancer, e.g. Bowel (Faecal occult blood test, Colonoscopy), Prostate (PSA test), Breast (mammography).

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Complementary Medicines Australia calls for “Light Touch – Right Touch” Regulation

The industry body, Complementary Medicines Australia has responded to the Government’s call for Submissions on the Regulation of Complementary Medicines by arguing for appropriate regulation commensurate with the low risk profile of these products.

My own submission agrees with some but not all of CM Australia’s suggestions.

I agree that industry’s regulatory burden could be reduced by abolishing the current inconsistent and incomplete advertising pre-approval system delegated to industry associations. The Therapeutic Goods Advertising Code would still need to apply; all complaints would be sent to a strengthened TGA Complementary Medicines Branch (thereby eliminating the Complaints Resolution Panel) and the TGA needs the power to apply timely and meaningful sanctions capable of deterring repeated regulatory violations. In short, option 2 of proposal 3 and 4 in the 2013 “TGA Consultation Regulation Impact Statement: Regulating the advertising of therapeutic goods to the general public” needs to be implemented. Recommendations from the TGA to government based on this consultation have remained unactioned for far too long!

In addition, post-marketing reviews by the TGA needs to be at least doubled.  The TGA Complementary Medicine Compliance Review for January to December 2014 showed 190 reviews initiated (9.5% of around 2000 new listed medicines or 1.5% of all 12300 listed medicines). Substantial levels of non-compliance continue to be detected (61% of 181 target reviews; 27% of 41 random reviews). In addition, these figures do not include many reviews aborted by sponsors de-listing the products upon notification of a review (and then often re-listing the same product).

It’s doubtful that the current TGA post-marketing regime is achieving its aim of minimising exposure of consumers to non-compliant complementary medicines. I have suggested that the number of post-marketing reviews conducted by the TGA needs to be at least doubled with (as said before) substantial penalties for regulatory non-compliance. If the fees paid by the complementary medicine industry need to be increased to make this happen, so be it.

It is accepted that complementary medicines are relatively low-risk products, but that does not mean that they are without risk including the production of adverse effects and drug interactions. In addition, without independent assessment of the effectiveness of these products (and their side-effects and interactions) how can consumers and health professionals make an appropriate assessment between risk and benefit? There is a need for approved and consistent consumer medicine information (CMI) for complementary medicines that provides this important information.

I have suggested a small addition to the current regulatory system: make the sponsor add a summary of the evidence they use to self-certify the indications and claims for their product to the ARTG Public Summary document (and the sponsor’s web site) together with appropriate Consumer Medicines Information (CMI). This would assist the TGA in conducting post-marketing reviews; allow 3rd parties such as consumer organisations and health activists to more readily check the information provided, and educate consumers about product risks and benefits.

In addition, as consumers organisations have suggested in many submission, all AUST L product labels and promotion should be required to show a disclaimer similar to that used by the U.S. FDA, for example, “The claims made for this product have not been evaluated by Australian health authorities”. A similar large sign should also be placed above the shelves of pharmacy and health food shops containing these products.

I do not agree with the proposal for mutual recognition of overseas regulators to facilitate the entry of new Listable substances. Both Canada and the USA have been suggested. The former licences homeopathic vaccines purported to prevent polio, measles, and pertussis while the latter’s regulation of dietary supplements also has numerous flaws.

Finally, I agree that there is a need to incentivise innovation in complementary medicines. Currently, sponsors get a much greater return on investing in hype and celebrity endorsement rather than research.

Public health research on complementary medicines / dietary supplements has largely concluded that the evidence to support routine supplementation for primary and secondary prevention of chronic diseases is inadequate. However, the variability in the composition of complementary medicines makes extrapolating results obtained from controlled clinical trials challenging. For example, an Access Economic report noted that it is unlikely that all St John’s wort products marketed are equally effective. They suggested that standardisation of St John’s wort products would be required before these products could be recommended as an alternative to pharmaceutical anti‐depressants for mild to moderated depression.

Without appropriate regulation to ensure product quality, safety and effectiveness, the preponderance of evidence collected on complementary medicines / dietary supplements may be confounded by unmeasured variability in the products used and therefore lack validity.  In addition, the value of the substantial expenditure on these products remains unsubstantiated.

In conclusion, a touch more regulation is required before Australian consumers and health professionals can have confidence in complementary medicines.

 

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U3A Melbourne City Short Courses

http://www.u3amelbcity.org.au/

Health Care Interventions – Choosing Wisely – Dr Ken Harvey

THURSDAY, 10.00 – 12.00
16th April – 4th June
GAA House
8 sessions, 25 places

Medical advances have helped many of us live longer and have a better quality of life. Yet a number of studies have shown that around one third of what we spend on health care is probably unnecessary, wasteful and sometimes harmful. This is especially true for medical interventions near the end-of-life. Ironically, many doctors die differently from their patients. They don’t want fancy treatment, expensive chemotherapy offering little benefit or cardiopulmonary resuscitation (CPR). They know the downsides and they just say no.

This course encourages consumers to ask questions of their healthcare professionals about the risks, benefits and costs of certain medical investigations and procedures. It will discuss the evidence for and against certain interventions.

It’s based on the U.S. Consumer Reports “Choosing Wisely” campaign. Topics that may be covered (depending on interest) include cardiopulmonary resuscitation (CPR), cancer chemotherapy, screening for breast, colorectal cancer and prostate cancer, testosterone therapy in ageing men, polypharmacy (multiple medications), antipsychotics in dementia and the use of antibiotics for upper respiratory tract infection.

Dr Rodney Syme will also join us for two sessions to discuss dying with dignity, dementia, advance healthcare directives, refusal of treatment and enduring medical power of attorney certificates.

Complementary Medicine – Exploring the Issues – Dr Ken Harvey

THURSDAY, 10.00 – 12.00
11th June – 25th June
GAA House
3 sessions, 25 places

Complementary medicine (CM) fits within a diverse group of health care systems, practices and products not usually considered part of conventional medicine, such as vitamin supplements, chiropractic, homeopathy and traditional Chinese medicine.

Issues to be explored include: the regulation of products and practitioners; the current review of the private health insurance rebate for natural therapies; evidence for and against specific therapies for certain conditions; sources of good information about CM, and key messages for consumers with respect to using CM safely.

Course participants might like to share what types of CM they have used and for what condition. This information could focus group discussion on topics following the initial overview.

Ken is a public health physician and consumer advocate with a particular interest in medicines policy (you may recognise him from the ABC The Checkout program). He has also been a member of the government’s recent Natural Therapy Review Advisory Committee.

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Homeopathy industry urged to contemplate its ethics

From Australian Doctor, March 11, 2015

Health professionals offering homeopathic treatments should consider the ethics of their practice, says the lead author of an NHMRC review that has concluded there’s no robust evidence showing homeopathy works.

Following two years’ work, the nation’s peak medical research body released a statement on Wednesday declaring there were “no health conditions for which there is reliable evidence that homeopathy is effective”.

The statement is the NHMRC’s final word on the issue and comes a year after its initial draft paper — which contained similar findings — that was put out for public consultation.

The wording is likely to put pressure on pharmacists that sell homeopathic treatments and health funds that use taxpayer rebates to pay for homeopathic care for their members, to stop doing so.

Professor Paul Glasziou, who chaired the NHMRC Homeopathy Working Committee, said he hoped the finding would prompt those in the homeopathy industry to think long and hard about whether what they offered was ethical.

“The aim should be for any clinician, any university or any insurer to look at the evidence about the effectiveness of the treatments they offer, and to offer to the public only those treatments that have proven effectiveness,” said Professor Glasziou, a professor of evidence-based medicine at Bond University on the Gold Coast.

“I hope they would all reconsider their position that unless they have evidence that counters what the NHMRC has found that, like any clinical professional, they should be reconsidering what treatments they use or teach about or provide as an insurer.

“Universities that currently teach homeopathy courses should definitely reconsider in the light of the NHMRC’s findings whether they should continue such courses.”

Related News: Homeopathy degrees under scrutiny.  See also appended.

The findings, which are based on the analysis of 57 systematic reviews, had strong implications for health insurers, he added.

“Unless there’s evidence that we haven’t found, insurers should not be offering to subsidise homeopathy and any public resources going into that should also be withdrawn.”

Professor Glasziou said homeopaths — and their associated professional bodies — should look at the review and “ask is it reasonable to continue to use homeopathy as a treatment for conditions”.

“For Australia, I think it’s quite a game changer in terms of the completeness of the evidence review. It’s consistent with what other bodies have found around the world,” he said.

“I think it will probably have more clout and people will listen to this.”

25/02/2015 EDUCATION AND EMPLOYMENT LEGISLATION COMMITTEE

This extract starts at page 99

Senator KIM CARR: Could I turn to the question of homeopathy—one of my favourite topics, as you know, Professor. I would like to deal with a specific case. I understand that Dr Ken Harvey has sought by FOI matters relating to the reaccreditation report for homeopathy offered by ParaPharm in Western Australia. Do you have any detail of that matter?

Prof. Saunders: I have some detail of that matter, yes.

Senator KIM CARR: As I understand it, there are two degree courses offered in homeopathy, one in Western Australia by ParaPharm, and there is one on the east coast as well, is there?

Prof. Saunders: By the Australian College of Natural Medicine, yes.

Senator KIM CARR: Is it the case that the NHMRC has released a finding of the committee reviewing homeopathy which has found that there is no good evidence to actually support the discipline?

Prof. Saunders: That is correct.

Senator KIM CARR: Do take any note of that?

Prof. Saunders: Absolutely, I take note of that. It was conducted by somebody I have a great deal of respect for.

Senator KIM CARR: Who is that? Can you refresh my memory.

Prof. Saunders: Paul Glasziou, from Bond University.

Senator KIM CARR: There was no trick question there.

Prof. Saunders: It was a very thorough examination of the evidence at hand.

Senator KIM CARR: There was also a committee chaired by the Chief Medical Officer. Is that the case?

Prof. Saunders: I think that relates to something else. I think it relates to the funding of these.

Senator KIM CARR: The Review of the Australian Government Rebate on Private Health Insurance for Natural Therapies.

Prof. Saunders: Yes, that is correct.

Senator KIM CARR: Not an unrelated topic, I would have thought. I understand that the report of the committee chairman has been with the government for some while. Are you aware of that.

Prof. Saunders: No, I am not aware of the delays or whether there have been delays.

Senator KIM CARR: I understand the two homeopathy programs that I have referred to were in fact accredited by state authorities originally. Is that the case?

Prof. Saunders: Originally; that is correct, yes.

Senator KIM CARR: They are now up for reaccreditation with your agency. Is that correct?

Prof. Saunders: Yes.

Senator KIM CARR: In fact, the Western Australian course was up for reaccreditation at the end of last year— Prof. Saunders: Yes.

Senator KIM CARR: and I understand the Sydney course—the Endeavour college course—comes up for reaccreditation in a couple of months time.

Prof. Saunders: Yes.

Senator KIM CARR: What is the process you will be using to reaccredit this particular program?

Prof. Saunders: It is the process that we would use for all course accreditations. It is a mixture of our own assessment as well as sending the courses to external experts.

Senator KIM CARR: How many external experts?

Prof. Saunders: It would depend, but in general terms we would send a course to two experts. If there is a suite of courses we might actually send it to more experts than that. Sometimes we do not use experts at all.

Senator KIM CARR: If you do not use experts at all, who does the assessment?

Prof. Saunders: We sometimes have internal expertise, the background of people within TEQSA; sometimes we are assessing the fifth course in a single field of, say, a business field and we have confidence in what the external experts have said previously.

Senator KIM CARR: Am I correct in saying that while a course is under the process of reaccreditation it is entitled to continue?

Prof. Saunders: That is correct.

Senator KIM CARR: Have you made a decision in regard to the Western Australian course?

Prof. Saunders: No, we haven’t. We are in the process of making that decision, and it would not really be appropriate for me to say much more.

Senator KIM CARR: No, but you have not made it.

Prof. Saunders: We have not made a decision on that.

Senator KIM CARR: And the provider can continue while that process is underway.

Prof. Saunders: That is correct.

Senator KIM CARR: The second course—I have a date here of 2 April 2015 for reaccreditation—have you commenced the process for that?

Prof. Saunders: I would have to take that question on notice. The submission usually has to be made six months prior to the expiry of the date, so yes we would have at least received that.

Senator KIM CARR: So it is a reasonable expectation that that has commenced as well. Are there any courses in alternative therapies that you are examining at the moment?

Prof. Saunders: At the moment, we have courses from Study Group Australia. To my knowledge, that is the only other application coming from providers we have not already mentioned.

Senator KIM CARR: How many students are involved in Study Group?

Prof. Saunders: I would have to take that question on notice.

Senator KIM CARR: That is based where—in Melbourne?

Prof. Saunders: I would have to take that question on notice. I think Study Group has multiple campuses, but I will have to take that on notice.

Mr Griew: You may be interested that there are also nine complementary medicine degrees at universities.

Senator KIM CARR: Yes, there are some issues there too, I am sure. When will you get to look at those?

Prof. Saunders: If it is relevant, we will look at those at the time of reregistration.

Senator KIM CARR: Dr Ken Harvey has sought advice from you in regard to the re-accreditation report. Is that correct?

Prof. Saunders: The re-accreditation of?

Senator KIM CARR: ParaPharm in Western Australia.

Prof. Saunders: That is correct.

Senator KIM CARR: Did the document provided back to Dr Harvey under FOI include the name of the external reviewer—who, I am told, is a naturopath—used by TEQSA?

Prof. Saunders: The response to Dr Harvey had to be considered in the context that this was an application that was still under assessment. There had to be processes that were fair to the provider. There were also commercial-in-confidence considerations in that what we were considering was the intellectual property of the provider, and there were a range of other matters that had to be taken into account. So the material released to Dr Harvey was very limited.

Senator KIM CARR: How long would you sit on a report of this type?

Prof. Saunders: We do not sit on reports.

Senator KIM CARR: When was the report finalised?

Prof. Saunders: We have not finalised the report for this particular provider. As I said, this is a process that is ongoing. It would not be appropriate for me to talk about any particular stages.

Senator KIM CARR: But you did provide Dr Harvey with a document concerning the process that TEQSA was using, including the name of the external reviewer?

Prof. Saunders: Yes.

Senator KIM CARR: You have indicated that you are mindful of the NHMRC review?

Prof. Saunders: Yes.

Senator KIM CARR: Have you adopted a policy of prioritising the commercial interests of private providers over the public’s right to know what the bases of accreditation decisions are?

Prof. Saunders: Absolutely not.

Senator KIM CARR: Why is that?

Prof. Saunders: We believe there needs to be a balance between considering the interests of both the provider and the public. All our FOI decisions are based on those considerations.

Senator KIM CARR: That is in regard to the FOI decision. I am asking you in regard to your accreditation process.

Prof. Saunders: We do not take commercial considerations into account at all in assessing a course or a provider. As I said, the assessment is done against the standards. The standards refer to matters to do with financial viability but not to the commercial interests of the provider.

Senator KIM CARR: In regard to the re-accreditation of ParaPharm, why did only a single person—not a panel—undertake the review of the course?

Prof. Saunders: That relates to a technical issue with regard to the FOI request.

Senator KIM CARR: How does that work?

Prof. Saunders: We were assessing a number of courses. Dr Harvey asked for information about one course. So we gave Dr Harvey the relevant information about one particular course, but we had other people involved in the assessment of the other complementary— Senator KIM CARR: The other things at the institution—I see. Can you indicate to me why it was that your expert witness—who I would prefer not to name at this point, but you know the person I am referring to. Is that right, Professor? You are aware of the details of that expert— Prof. Saunders: I would have to take that on notice. I have seen the report; I just cannot carry the name of the person in my head at the moment.

Senator KIM CARR: All right. Can you indicate what was the basis of the appointment of that particular individual—who as I say, is a naturopath—to examine the operations of this particular college.

Prof. Saunders: That person would be on the TEQSA register or we would have had advice from people who were on the TEQSA register of experts as to who we might approach in this particular circumstance. Finding assessors who are experts in the field of complementary medicine is not easy. We have a range of people that we can go to. We have taken steps in the last six months to try and expand the range of people that we can choose to do those assessments, and I think I will leave it at that. If I may make a comment about the whole issue here— Senator KIM CARR: I look forward to your comments.

Prof. Saunders: I think it is important that we separate out assessment against a set of educational standards against the recognition, registration and regulation of clinical practitioners. Unfortunately, or fortunately, TEQSA has no role to play in the latter. What we have to do is take a course and look at it from the point of view of the standards, and nowhere in the standards does it talk about the need for material or the course to be scientifically based. Nowhere does it have any content-specific standards. What it says is that the body of knowledge upon which this is drawn has to be coherent and it has to actually have scholarship associated with it, and there are other standards in there about intellectual inquiry of students and promoting those sorts of critical appraisal skills and the like. So, when we apply the standards to something like a course in homeopathy, we are not asking the question as to whether the science or the clinical outcomes of homeopathy are appropriate. What we are asking is: does this course position homeopathy in the field such that students who are studying this understand that there is a controversy and that there is strong evidence that it is in fact not an effective clinical regime? We are expecting students to understand the criticisms of homeopathy, not just simply to study in a modular sort of way the tenets of homeopathy. We would use our judgement applying those standards to the accreditation of courses like this.

Senator KIM CARR: Yes. Thank you for that. Do I take it from that there is a degree of discomfort about the way in which this now operates?

Prof. Saunders: No, I do not think there is. If there is discomfort, it would be the same discomfort about accrediting bachelors of theology. We use educational standards about the experience of the student, the coherence of the course, the build, the framework, the learning outcomes that are being achieved and whether it fits with the Australian Qualifications Framework. These are educational standards.

Senator KIM CARR: In terms of publishing the accreditation report for homeopathy, what are you doing about that? When will you be publishing this report?

Prof. Saunders: What we do is that, once we have done our assessment, we then publish the decision of the assessment. We would then be declaring whether or not the assessment has led to a reaccreditation of the course; if it is reaccredited, what are the conditions that are applied on that course; and whether the course has been accredited for a maximum period of 7 years or a shorter period of time. And there is a public notice that we always publish as a part of the national register that actually explains why we have taken those decisions.

Senator KIM CARR: Yes. Now the difficulty here is—and this particular issue has been experienced with regard to ESOS registration and it has been experienced with regard to VET registration—in this particular case, with students that are being enrolled in 2015—given that I take it you have had this process underway for at least six months?

Prof. Saunders: Yes.

Senator KIM CARR: I take it that you must have completed your work, your— Prof. Saunders: We are in the final stages of discussion with the provider about provisional findings, yes.

Senator KIM CARR: So what do they do about enrolments for 2015?

Prof. Saunders: They are free to make enrolments until a decision is taken by TEQSA, and if the decision—

CHAIR: Senator Carr—

Senator KIM CARR: I will just—

CHAIR: Senator Ruston has one quick question.

Senator KIM CARR: Yes, sure. My concern, though, is that I take it you have actually decided to allow them to continue?

Prof. Saunders: No, we have not made that decision at all.

Senator KIM CARR: So what do you do with the students, then, if you choose to close them down?

Prof. Saunders: Then they have to have a planned and supervised teach-out of that. Now that would require them to transfer their students to another provider— Senator KIM CARR: There is only one other provider.

Prof. Saunders: Yes.

CHAIR: All right, can we continue this after dinner if you have more questions for TEQSA, Senator Carr? Senator Ruston, you have a quick question?

Senator RUSTON: Just one.

CHAIR: But I will just double check. Sorry, Minister? Hello, Minister? We just have a question from Senator Ruston.

Senator Birmingham: Sorry, Chair. I was just confirming one point there with Professor Saunders about the course that Senator Carr was asking about the provider for. Being a bachelor course, it is a multi-year course. So the phase-out-type provisions that Professor Saunders was just talking about would have had to apply regardless of the timing of when a decision is made, where a decision has been made in that type of area.

Senator RUSTON: Professor Saunders, I am just wondering in the discussions about the accreditation whether there were any alternative medicine courses already being offered at public universities?

Prof. Saunders: Yes, certainly. Alternative medicine courses are offered by a number of public universities: Central Queensland University, Charles Sturt University, Macquarie University, Murdoch University, RMIT, Southern Cross University, University of New England, University of Technology Sydney and the University of Western Sydney. Chiropractic is the most common course that is being taught in the public universities, but as well as chiropractic they cover naturopathy, traditional Chinese medicine, acupuncture, osteopathy and western herbal medicine, and a couple of those public universities offer a Bachelor of Health Sciences with a generic complimentary medicine stream.

Senator RUSTON: And one assumes that the process of accreditation is exactly the same?

Prof. Saunders: They are self-accrediting institutions, so they would have put these courses through their own proper academic governance processes.

Senator RUSTON: Okay, thank you, Professor Saunders.

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ACCC targets alleged false and misleading Nurofen claims

In 2010 CHOICE (Australian Consumers Association) awarded Nurofen caplets targeting migraine, back, tension headache and period pain a Shonky award.

In 2011 the Therapeutic Goods Advertising Complaint Resolution Panel (CRP) upheld a complaint by Professor Paul Rolan that the claims “targeted relief from pain” and “goes straight to the source of the pain were misleading. Reckitt Benckiser (Australia) was requested to withdraw them. The company declined to do so.

In 2012 additional complaints were submitted and upheld by the CRP but still the company declined to comply. The matter was referred to the TGA and certain orders were made. More complaints ensured.

In 2013 “The Checkout” with the help of Andrew McLachlan (Professor of Pharmacy for the University of Sydney) tackled this issue.

In 2014 the TGA made further orders to which Reckitt Benckiser (Australia) said they would comply.

In 2015 the ACCC has instituted legal proceedings against Reckitt Benckiser (Australia).

In summary, it has taken 5 years for the regulators to cope with Reckitt Benckiser intransigence; a nice example of our ineffective therapeutic goods advertising complaint system.

See also this report in “The Guardian“. The ACCC Press release (5 March 2015) follows:

“The Australian Competition and Consumer Commission has instituted proceedings in the Federal Court of Australia against Reckitt Benckiser (Australia) Pty Ltd (Reckitt Benckiser), alleging that it made false or misleading claims that its Nurofen Specific Pain Products were each  formulated to treat a specific kind of pain, when the products are identical.

The Nurofen Specific Pain Product range consists of Nurofen Back Pain, Nurofen Period Pain, Nurofen Migraine Pain, and Nurofen Tension Headache.

The ACCC alleges that Reckitt Benckiser made representations on the packaging of each Nurofen Specific Pain Product, and on its website www.nurofen.com.au(link is external), that each product:

  • was designed and formulated to treat a particular type of pain;
  • had specific efficacy in treating a particular type of pain; and
  • solely treated a particular type of pain.

The ACCC alleges that these representations were false or misleading because the caplets in all four Nurofen Specific Pain Products are identical and each contain the same active ingredient, ibuprofen lysine 342mg. All four products are also approved on the Australian Register of Therapeutic Goods as being suitable for treating a wide variety of pain types.

“The ACCC takes false or misleading claims about the efficacy of health and medical products very seriously,” ACCC Chairman Rod Sims said.

“Indeed, truth in advertising and consumer issues in the health and medical sectors are ACCC enforcement priorities in 2015.”

“In this case, we allege that consumers have been misled into purchasing Nurofen Specific Pain Products under the belief that each product is specifically designed for and effective in treating a particular type of pain, when this is not the case,” Mr Sims said.

“The retail price of the Nurofen Specific Pain Products is significantly above that of other comparable analgesic products that also act as general pain relievers. Recent price sampling conducted by the ACCC revealed that these products are being sold at retail prices around double that of Nurofen’s standard ibuprofen products and standard products of its competitors.”

In Australia, Reckitt Benckiser markets and supplies a range of consumer health and household brands, including Nurofen, Mortein, Clearasil, Finish, Airwick and Gaviscon.

The ACCC is seeking declarations, injunctions, an order for the publication of corrective notices, penalties and costs.

This matter is listed for a case management conference on 31 March 2015 in the Federal Court of Australia in Sydney.

The ACCC recently released its Compliance and Enforcement Policy which identified truth in advertising and consumer issues in the health and medical sectors as key areas of priority for 2015.”

Figure 1. Composite screenshot from Nurofen website (www.nurofen.com.au) 26 September 2013. Nurofen have since amended the page.

Composite screenshot from Nurofen website (www.nurofen.com.au) 26 September 2013

Release number: 

MR 25/15

Media enquiries: 

Media team – 1300 138 917

 

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Should pharmacists stock homeopathic products?

There has been recent debate in AusPharmList about this topic which has also involved a discussion of their regulation.

Currently, any homoeopathic preparation that is more dilute than a one thousand fold dilution of a mother tincture (i.e. 4x or greater), and is not required to be sterile, is exempt from TGA GMP requirements and also from listing on the Australian Register of Therapeutic Goods (ARTG).

The historical basis for these exemptions dates back to the development and implementation of the current Regulations, when it was considered that homoeopathic preparations did not present a significant health risk to the general public, and hence minimal regulation was appropriate. However, this has meant that homeopathic products are not subject to the same level of post-market scrutiny that applies to other low risk medicines.

Exemption from TGA regulation has seen the marketing of purported homeopathic products such as homeopathic somatropin and homeopathic melatonin and marketing claims that are inconsistent with TGA evidence guidelines (a homeopathic product may claim that it is in accord with the homeopathic tradition (if it is) but this cannot and should not be converted to a claim for efficacy).

Increased regulation of homeopathic products (and better public education) has been proposed by numerous expert committees since 2003. It has yet to eventuate despite a TGA paper recommending specific changes in 2008. Most recently, the TGA have said they are awaiting the final NHMRC report on homeopathy (the draft report was released for public consultation from 9 April to 2 June 2014).

The other regulatory problem is the TGA’s lack of effective penalties for advertising claims that breach the Therapeutic Goods Advertising Code.  Companies often refuse to comply with “requests” by the Complaint Resolution Panel (CRP) for removal of claims (and the publication of retractions) when complaints have been upheld. The CRP then refers these complaints to the TGA who conduct their own assessment of the complaint and, when upheld, “order” the company to comply.

The company can continue to not comply. Another approach by companies is to appeal, first to the Minister and then to the AAT, a process that can take several years. Meanwhile, the offending promotion continues. The final route for complainants is to convince the ACCC to take the offender to court which takes several more years.

For example, a complaint about the promotion of homeopathic immunisation first lodged in 2011 was referred to the TGA by the CRP later that year. The TGA then “ordered” a retraction (which was not complied with in 2012) where upon a complaint was sent to the ACCC who finally got a Federal Court judgement in late 2015. See: http://www.medreach.com.au/?p=1215.

Once again, this problem has been the subject of numerous reports over the last decade. The latest was in May 2013 in which specific recommendations were made to give the TGA more powers. Apparently this report is still being considered by government in light of their de-regulation agenda.

Meanwhile, consumers continue to get taken in by these products. I remain convinced  that an important role for pharmacists is to have the knowledge and the will to provide their customers with the facts about such products.

Whether they should stock them is an ethical decision for individual pharmacist owners and chains and I accept that opinion on this will vary. However, a recent poll (15/04/2014) in Auspharmlist (below) appeared to show that opinion is changing.

AusPharm poll on stocking homeopathic products

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ABC 7:30 report – Should alternative medicines have their government rebate cut?

http://www.abc.net.au/7.30/content/2015/s4161774.htm

Regrettably a typical TV short report that provided the opinions of all and could not deal with the key issues in any depth.

Clearly there is a difference between exercise modalities  such as Yoga, Pilates, Tia Chi and therapeutic modalities such as homeopathy and iridology!

The former are sensible (and recommended) preventative health modalities even if there was little evidence from the NHMRC review about their effectiveness in various diseases (which was a different question). See:

http://www.shapeup.gov.au/start-shaping-up/physical/getting-active

The latter have considerable evidence (over a long time) of their ineffectiveness. Hence my concern about lumping them all together with the statement that, “the absence of evidence does not mean that the therapies evaluated do or do not work”.

I go to the local council gym 2-3 times a week for preventative health reasons but there is no private health insurance rebate for that!

I agree with ADAM STANKEVICIUS (CHF): “I think the Government needs to as soon as possible release the report, so that we know exactly what we’re talking about and then we need a good public debate on exactly what it is that’s covered by private health insurance”.

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Federal Court judgement: Homeopathy Plus

In response to a case brought by the ACCC the Federal Court declared (on Dec 22, 2014) that Homeopathy Plus! Australia Pty Ltd ACN 134 266 149 and Frances Mercia Sheffield have engaged in conduct that was misleading and deceptive, or was likely to mislead and deceive, in contravention of section 18 of the Australian Consumer Law.

The full judgement is now posted at:

https://www.comcourts.gov.au/file/Federal/P/NSD256/2013/actions

> Consumer protection > Court events and Orders > View judgement.

This complaint was first lodged with the Complaint Resolution Panel (CRP) in 2011 and referred to the TGA by the CRP later that year. After a new investigation, the TGA “ordered” a retraction (which was not complied with by 2012) where upon a complaint was sent to the ACCC who finally got a Federal Court judgement in late 2015.

My 2012 complaint to the ACCC can be found here.

See also:

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U3A Melbourne November Complementary Medicine Course

PDF files of the material presented are now available for download below:

Background reading:

Course material (2 slides per page)

Two Monash Summer Research Project students (Grace Jackel and Aaron Kovacs)  researched the questions that participants wanted answered in the 3rd session. They are shown below together with the U3A co-ordinator (Julie Nankervis) and myself.

U3A_November_course

 

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Australian docs who accept pharma money must be named – ACCC

Australia’s competition and consumer watchdog (ACCC) has demanded that drug companies publicly name any doctor who accepts consultancy or speaker fees or free travel and accommodation.

Unless this condition is complied with the ACCC will not authorise Medicines Australia’s latest Code of Conduct (edition 18).

In light of the U.S. Sunshine Act, the ACCC had previously limited authorisation of the 17th edition of Medicines Australia Code to two years (rather than the five years sought) in the expectation that this would allow the industry to improve transparency provisions.

The 18th edition of Medicines Australia code merely “encourages” health-care professionals to consent to disclosure, while allowing them to opt-out and retain financial and other benefits of their interaction with pharmaceutical companies.

Numerous submission to the ACCC from consumer groups and others argued that this was not good enough; those who failed to agree to voluntary disclosure were likely to be those we wanted to know most about.

The ACCC is seeking submissions in relation to this draft determination before making its final decision.

See also:

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