Complaint by Complementary Medicines Australia

See also:

An overview of the Monash University course complained about can be found here as can my lecture to the students.

My full response to the CMA allegations follows.

From: Ken Harvey [mailto:k.harvey@medreach.com.au]
Sent: Thursday, 29 September 2016 11:26 AM
To: ‘Carl Gibson’ <carl.gibson@cmaustralia.org.au>
Subject: RE: Formal complaint regarding the conduct of Dr Ken Harvey

Dear Carl,

Thank you for forwarding me the substance of a complaint you had previously sent to what you termed was the Therapeutic Goods Administration (Complaints Resolution Panel), the Therapeutic Goods Advertising Code Council and Monash University (appended).

I should be grateful if you could pass this response on to the Board of Directors of Complementary Medicines Australia. I also have cc’d it to the Chair and CEO of the TGACRP and TGACC, my Head of Department at Monash University, and the CEO of Choice (whom I represent on the TGACRP & TGACC).

First, I point out that the Therapeutic Goods Advertising Complaint Resolution Panel (TGACRP) is not a committee of the Therapeutic Goods Administration. Rather, both the TGACRP and TGACC were set up under the Therapeutic Goods Regulations 1990; Division 3, Regulation 42R, and Division 2, Regulation 42A, respectively. The regulations note that both the TGACRP and the TGACC are to have, as a member, one person nominated by the Australian Consumers Association (Choice). I have been so nominated by Choice to bring consumer concerns to both bodies. I regularly report and discuss relevant matters arising from these bodies with Choice management in order to represent their interests.

Second, the CMA Board allege that I have a conflict of interest, relating to my roles on the TGACRP and TGACC, as represented by my behaviour and public comments about complementary medicines, which is compromising the integrity of these committees as functional instruments.

The TGACRP has 9 members and the TGACC has 15. The membership of both bodies contains a broad mix of people representing a variety of stakeholder interests including industry, health professionals and consumers. I submit that it is inconceivable that one individual could, “compromise the integrity of these committees as functional instruments”. Neither am I aware that such a view has been expressed by members of the TGACRP and TGACC at meetings that I have attended.

In addition, it is a standard procedure for members of the TGACRP to declare possible conflicts of interest when assessing complaints. Accordingly, when a complaint has been submitted from Friends of Science on Medicine (FSM), I declare my membership and leave the room while this is being discussed. Other members of the TGACRP, for example industry members who may have been consulted on a product being complained about, do the same.

Third, the CMA Board allege that I have “anti-complementary” views as represented by my public comments.

I agree that I have made public statements expressing concern about aspects of the Australian complementary medicine industry. These include the fact that recent figures available from the TGA concerning random and targeted post-marketing reviews of listed complementary medicines show around 80% were not in compliance with the regulations. In addition, of all complaint determinations assessed by the TGACRP, 98% are upheld.

I have also expressed public concern that the current “light-touch” regulatory system makes it more profitable for sponsors of complementary medicines to invest in marketing hype and celebrity endorsement rather than research and development of evidenced-based products. The end result is a market flooded with products of doubtful value with claims that often go far beyond the limited (or absent) scientific evidence that sponsors are meant to hold in order to justify their claims.

However, I have also made public statements and submissions about how such problems could be redressed. I have supported providing incentives for sponsors to develop research-based products, such as the new TGA assessment criteria that are less rigorous that than for registered products. I have argued for more innovative consumer education, such as awarding a distinctive logo to products that have an evidence-base, to enable consumers to more readily distinguish them in the marketplace.

In addition, in my lectures to students and the public, I have pointed out that one of the winners of the 2015 Nobel prize for medicine was a Chinese researcher (Youyou Tu) who, through exploring Traditional Chinese Medicine texts that recommended the use of Artemisia annua (sweet wormwood) for fever, was able to extract Artemisinin, a drug that has significantly reduced the mortality rates for patients suffering from Malaria. In short, I support well conducted research into traditional and complementary medicines.

Fourth, the CMA Board allege that I have used my position in the School of Public Health and Preventive Medicine, Monash University, to solicit enrolled students to become involved in a political anti-CM campaign in league with the anti-CM lobby group Friends of Science in Medicine (FSM) under the guise of academic training.

I deny that I, or my colleagues at FSM, are anti-CM. Rather, we are pro-science. Which is why I was awarded the 2016 ANZAAS medal, “for contribution to science which go beyond normal professional activities”. I encourage people to read my entire address on receiving this award rather than the selective quotation used in this complaint. The full address titled, “Recommitting to the sanity of evidence” is available at: http://www.doctorportal.com.au/mjainsight/2016/34/recommitting-to-the-sanity-of-evidence/.

My mention of colleagues in the TGACRP was merely a reflection of the fact that the deliberations of the TGACRP are always based on a dispassionate view of the evidence presented by both the complainant and the product sponsor complained about. I deny that the TGACRP has been “factionalised”.

I also make no apologies in pushing for regulatory reform which inevitably involves engagement with the political processes (as do the CMA with their own political lobbying). There is a famous quotation by a German physician and public health advocate, Rudolf Virchow, “Medicine is a social science, and politics nothing but medicine at a larger scale”. See: https://www.ncbi.nlm.nih.gov/pubmed/19052033.

The student course that the CMA Board complained about is a legitimate academic exercise to provide students with practical experience of the role of regulators in protecting the public from false and misleading therapeutic claims, both by product sponsors and health practitioners. I have attached the course overview and the lecture I gave to the students. I am currently marking the student’s projects. The standard of submissions is high. The vast majority of teams have done an excellent job of documenting potentially suspect advertising claims, researching the literature, critiquing the claims and suggesting sections of the various Codes and regulations that are likely to have been breached. When faced with little or no published articles to verify the claims made, a number of students (as suggested) have contacted the companies involved (many of whom are members of CMA) to ask if more information was available.  It may be that this legitimate contact prompted the recent complaint from CMA. I have appended one small example of the student’s work. In my opinion, this exercise is innovative, it has certainly engaged the students and it will assist in policy reform. It also has the support of my Head of School and senior members of the School of Public Health at Monash University.

In conclusion, I deny the allegations the CMA Board has made. I reiterate that, as a consumer member representing Choice on the TGACRP & TGACC, I have the right and responsibility to put the views detailed above to these bodies and to the public.

Sincerely,
Ken

—————————————————-
Students: names redacted.

Biosun Ear Candle; ARTG: 19479

Sponsor: Biosun In Australia Pty Ltd

Postal address: 35 Station Street, Malvern, Victoria, 3144

The Chemist Warehouse promotion of Biosun ear candles claims that “BioSun Hopi Ear Candles (appendix 1a attached):

  • “May be beneficial in temporary relief of symptoms of sinus problems, earache, glue ear, swimmer’s ear, some chronic headaches, ringing in ears, hearing difficulties, headache, irritations in the ear, sore throat and allergies”
  • “Will aid in the removal of excessive earwax.”
  • “May also help relieve the pressure after flying, deep sea diving, or whenever an imbalance of pressure has occurred”
  • “May help to relax and calm, relieving symptoms of stress and anxiety”

In regards to BioSun ear candles we believe the claims listed above are in breach of these sections of the Therapeutic Goods Advertising Code, 2007

  • 4(1)b: must contain only correct and balanced statements which the product sponsor has verified
  • 4(2)a: must not arouse unrealistic or unwarranted expectations of product effectiveness
  • 4(2)c: must not mislead or be likely to mislead
  • 22(5): must not refer to therapeutic uses not included on the Australian Register of Therapeutic Goods (ARTG) for the advertised goods

A nice review of the literature followed.

  • Seely D, Quigley S, Langman A. Ear Candles-Efficacy and Safety. Laryngoscope. 1996 Oct;106(10):1226-1229.
  • Hornibrook J. Where there’s smoke there’s fire—ear candling in a 4-year-old girl. NZ Med J. 2012 Dec 14;125:138-40.
  • Zackaria M, Aymat A. Ear candling: a case report. The European journal of general practice. 2009 Jan 1;15(3):168-9.
  • Rafferty J, Tsikoudas A, Davis BC. Ear candling: should general practitioners recommend it? Canadian family physician. 2007 Dec 1;53(12):2121-2.
  • SchellenBerg R. Application Observation to prove relaxation effect by means of quantitative electroencephalogram. 2005. BioSun Gesundheit & Wellness.

My comment:

Complaints about these products keep on keeping on, despite the fact the TGACRP has made determinations about these products on 38 previous occasions.

The U.S. FDA and Health Canada have taken more definitive action against manufacturers of ear candles that the TGA, including import alerts, seizures, injunctions, and warning letters:

In Australia, at least 16 “Ear Candles” continue to be included / listed on the TGA’s ARTG. As with listed medicines there is no pre-market evaluation by the TGA of Class 1 medical devices. Sponsors can, and do, say whatever they like on the ARTG public summary document.

Ear candling is associated with real risks, non-existent or minimal health benefits and continued misleading and deceptive claims about its benefits.

It is my view (as a Choice consumer representative) that it’s time the TGA took similar action to the U.S. FDA and Canadian regulators.
—————————————————-

From: Carl Gibson [mailto:carl.gibson@cmaustralia.org.au]
Sent: Wednesday, 28 September 2016 5:11 PM
To: Ken Harvey <k.harvey@medreach.com.au>
Subject: Re: Formal complaint regarding the conduct of Dr Ken Harvey.

Ken,

After consulting with my President and Vice President, I can confirm that the Board of Directors of Complementary Medicines Australia requested that I submit compliant letters to the Therapeutic Goods Administration (Complaints Resolution Panel and the Therapeutic Goods Advertising Code Council).

The full details of the complaints were made in confidence, but I have been asked to provide you with an overview summary:

The complaints referred to a conflict of interest as a member of the CRP and TGACC calling into question the independence and objectivity of these committees and hence their ability to fulfil their functions under Subdivisions 2 and 3 of the Therapeutic Goods Regulations 1990 (the Regulations).

CMA considers that the anti-complementary medicine conflict of interest represented by the behaviour and public comments relating to your roles on the CRP and TGACC (outlined below) is compromising the integrity of these committees as functional instruments.

Furthermore, it appears other parties on the CRP and TGACC have become factionalised in support of the anti-CM campaign – which you had alluded to in your public comments (outlined below).

FSM media release, 15 August 2016:

On 15 August 2016, FSM issued a media release announcing that Dr Harvey had been awarded the ‘Australian and New Zealand Association for the Advancement of Science (ANZAAS) Medal’ for 2016.

Dr Harvey stated):

“A number of purveyors of complementary, alternative and integrative medicine also make unethical claims. So what to do? Marshal the evidence; flood the regulators with complaints, engage the media and agitate for policy change. In these endeavours, I have been encouraged and supported by many like-minded groups, colleagues and friends: Therapeutic Guidelines, Health Action International, Friends of Science in Medicine, Australian Skeptics, AusPharm, the Australian Consumers’ Association, Consumers Health Forum, Therapeutic Goods Advertising Complaint Resolution Panel and colleagues from the School of Public Health at both La Trobe and more recently Monash University”.

We feel that there is an implication of a collusion between anti-CM political activities and the function of the CRP itself, as well as conflating other CRP member bodies as part of the campaign: the Australian Consumers Association (Choice) and Consumer Health Forum (CHF).

This further questions the independence and integrity of the entire CRP process.

In addition, I was requested to notify Monash University of the complaint to the Therapeutic Goods Administration because of the relevance to the University.

The complaint alleges that you are using your position in the School of Public Health and Preventive Medicine, Monash, to solicit enrolled students to become involved in a political anti-CM campaign in league with the anti-CM lobby group Friends of Science in Medicine (FSM). By recruiting Monash students to this cause, under the guise of academic training, they are becoming complicit in your anti-CM campaign and we question the breach of government statutory conflicts of interest provisions.

We asked Monash to consider the reputational risk relating to this issue and consider whether your position at Monash is consistent with the University’s standards of ethical conduct.

Regards,
Carl

Carl Gibson  | Chief Executive Officer Complementary Medicines Australia
Natural Health and Wellness
PO Box 450 Mawson ACT 2607 | Tel: +61 (0)2 6260 4022 | Fax: +61 (0)2 6260 4122 |
Email: carl.gibson@cmaustralia.org.au| Website: www.cmaustralia.org.au

On 28 Sep 2016, at 10:01 AM, Carl Gibson <carl.gibson@cmaustralia.org.au> wrote:

Ken

If the organisation had submitted any representation, then it will have been done with the agreement of the Board of Directors of Complementary Medicines Australia.

I am consulting with my President and Vice-President before responding to your request, as I believe any representation or complaint, if any, would have been submitted in confidence.

Carl

Carl Gibson  | Chief Executive Officer | Complementary Medicines Australia
Natural Health and Wellness
PO Box 450 Mawson ACT 2607 | Tel: +61 (0)2 6260 4022 | Fax: +61 (0)2 6260 4122 |
Email: carl.gibson@cmaustralia.org.au| Website: www.cmaustralia.org.au

On 22 Sep 2016, at 10:39 AM, Ken Harvey <k.harvey@medreach.com.au> wrote:

Hi Carl,

I understand that you have submitted a format complaint about me to the
Monash VC.

I was disappointed that you lacked the courtesy of sending me a copy of your
complaint.

Please send it to me now.

Sincerely,
Ken

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About Dr Ken Harvey

Public Health Physician, Medical activitist
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