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found, insurers should not be offering to subsidise homeopathy and any public resources going into that should also be withdrawn.”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.”


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.

Posted in Complementary medicine, Education, Senate | Tagged , , | Leave a comment

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

Posted in Complementary medicine | Tagged , , , , | 1 Comment

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


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:


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”.

Posted in Complementary medicine, Natural Therapies | Leave a comment

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:


> 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:

Posted in Complementary medicine | Tagged | 1 Comment

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.



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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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N.Z. Pharmacy pulls homeopathy after Advertising Standards complaint upheld

See this report from science based pharmacy.

On 14 April 2014, I submitted a formal complaint about the promotion of the same product (called Jet-ease in Australia) to the Therapeutic Goods Advertising Complaint Resolution Panel  (TGACRP).

I alleged that the information provided on Jet-ease web site breached a number of sections of the Therapeutic Goods Advertising Code, especially the statement that it had, “been proven effective in a clinical trial”.

I also noted that this product was promoted and sold in a large number of airport pharmacies, health stores and other outlets: http://www.jetease.com.au/auretail.html.

On June 2, 2014 I was informed the complaint had been sent to the Therapeutic Goods Administration “because of the possible breach of section 42DL(1)(g) of the Act (the product may not be on the Australian Register of Therapeutic Goods)”.

On June 19, 2014 the TGA acknowledged receipt of this (and other complaints about homeopathic products) but subsequently I have heard no more.

Meanwhile, promotion in Australia continues unchanged.

It would seem that the N.Z. regulatory system is much more efficient than the Australian one!

Posted in Complementary medicine, Pharmaceutical Promotion | Tagged , , , | 4 Comments

“No Advertising Please” NAP campaign (Prescribers need evidence, not marketing)

No Advertising PleaseA nice launch of this campaign helped by the responses from:

  • Medicines Australia (“the idea that you can ignore information from a pharmaceutical company that has conducted extensive research and development to help treat disease is laughable at best and negligent at worst”), and the
  • Australian Medical Association (“the campaign is a bit silly. It’s insulting to doctors. It’s also rather naive).

Good media coverage including ABC TV 7:30 report, The Guardian, Fairfax media, The Australian, The Conversation, Croaky, 6-minutes, OzDoc, the Medical Observer, MJA Insight, and more recently The Wall Street Journal.

See also the following YouTube interviews with:

And a press release from the Consumer’s Health Forum supporting the campaign.

No Advertising Please

Posted in Education, Pharmaceutical Promotion | Tagged , | 1 Comment

Self-regulation or government regulation of transparency?

In 2012, when edition 17 of Medicines Australia Code was released, the Australian Competition and Consumer Commission (ACCC) limited its authorisation to 2 years, rather than the 5 years sought, to encourage Medicines Australia to improve transparency around payments to individual health care professionals.

This was in accord with international developments such as the US Open Payments (the Physicians Payment Sunshine Act), which mandated full public disclosure of these relationships.

Edition 18 of Medicines Australia Code has now been submitted to the ACCC for authorisation. It “encourages” healthcare professionals to consent to disclosure. However, it also allows them to opt-out of disclosure while retaining the financial and related benefits of their interaction with member companies. As Senator Richard Di Natale noted, “The voluntary nature of disclosure makes the Code next to meaningless. It’s like making a breathalyser voluntary for drink drivers”.

Medicines Australia Code is weak because other therapeutic goods industry associations have not adopted transparency provisions in their own self-regulatory Codes and many have also opted out of ACCC Code authorisation (and thus being subjected to ACCC persuasive powers). In addition, there are increasing numbers of non-members of therapeutic goods industry associations (for example, the Indian generic company Ranbaxy Australia) who are not bound by any self-regulatory Code. Furthermore, Australian health professional organisations have also failed to address &/or incorporate transparency provisions in their own Code.  It’s therefore not surprising that many members of Medicines Australia were worried that attempting to force full disclosure would put them at a competitive disadvantage with other therapeutic goods companies, especially generic companies.

Medicines Australia argue that disclosing transfers of value from those health professionals who consent (and lumping together the total value of benefits received and the numbers of those who do not) is an incremental improvement (and public benefit) on the previous Code and thus their latest Code should be authorised.

The alternative view is that it would be to the public detriment to authorise a Code that fails to deliver on the key principles agreed to by Medicines Australia Transparency Working Group, including the key outcome raised by many interested parties in deliberations about edition 17 of the  Code: transparency on individual payments made to healthcare professionals (consistent with developments in the U.S.).

My own view is that the ACCC should not provide a fig-leaf of respectability to edition 18 of Medicines Australia Code by authorising the flawed outcome achieved. Rather they should defer authorisation and refer this mess back to where the responsibility lies: the Regulatory Policy & Governance Division of the Australian Department of Health, the Therapeutic Goods Administration (TGA) and the government, all of whom have failed to address the limitations of self-regulation.

A number of counties such as France, Portugal and Turkey have now embraced government regulation of transparency in addition to the USA. I also believe that Australian legislation should also make transparency (and other ethical considerations) a condition of market authorisation by the TGA.

My full submission (and others) can be found here. A (much) shorter version has published by MJA Insight.

If others wish to engage in this debate the ACCC is accepting submissions until August 1, 2014.

Posted in Pharmaceutical Promotion | Tagged , , | 1 Comment