Whacking moles, a pharmacist and the TGA

Dr Ken Harvey with the authors

Australia’s regulation of complementary medicines claims is badly flawed, write Sasha Hall and Tiana Moutafis

The regulation of listed complementary medicines has become an increasingly important consumer issue.

As part of a summer vacation scholarship, we have been working with Dr Harvey on this topic at the School of Public Health and Preventative Medicine, Monash University. Our first task was to join the “Whack-a-Mole” project; to write up a formal complaint about potentially misleading and deceptive advertising of a complementary medicine.

We were then asked to investigate the policy settings that allow such “moles” to keep popping up. Finally, we considered whether current government proposals will able to improve the regulatory system for advertising therapeutic goods.

We reviewed the promotion of Blooms Health Coenzyme Q10 150 Max product against legislation. Claims made on the sponsors website by Gerald Quigley (described as a pharmacist and master herbalist) included:

“Once the body levels of CoQ10 become more than 25% deficient, many disease states start to flourish. These can range from high blood pressure and heart attacks to deficiencies of the immune system and cancer;” and

“For heart health, stamina, performance and strength, 150mg of Blooms Coenzyme Q10 150 Max each morning is a great way to start the day”.

A search of the medical literature could find no sufficient evidence to support such wide claims, which therefore appeared to breach the Therapeutic Goods Advertising Code and the Pharmacy Board Code of Conduct. We also found previous upheld complaints against Blooms Health and Mr Quigley.

While a complaint can be lodged about such advertising, it can make little impact on the body of misleading and deceptive claims. The advertisement and product itself could merely be removed and renamed, or advertisers may simply refuse to comply with the requests of the Complaint Resolution Panel (as occurs in 40% of cases).

Hence the “whack-a-mole” project: no sooner is one misleading advertisement “whacked” than others pop up.

This is because the light-touch regulatory system for most complementary medicines involves no pre-market evaluation of scientific claims, trusts sponsors to obey the rules, and has no timely or effective penalties for breaching the regulations.

Compliance breaches are often only caught after lengthy investigations of complaints or TGA post-marketing reviews. This comes long after the advertisement has been aired to the public and influenced consumer perceptions.

For example, the TGA found compliance breaches in 73% of 212 post-marketing reviews in 2014-15 and 80% of 473 cases in 2015-16. In addition, in 2015-16, the Complaint Panel found 98% of 141 complaints justified. Labelling, advertising and evidence continued to be the major compliance breaches.

These statistics are a sad reflection on the failure of the TGA to bring this industry into check over many years.

Recently, the 2015 Expert Review of Medicines and Medical Devices Regulation (MMD Review) made 58 recommendations, of which 25 related to the regulation of complementary medicines and the advertising framework. In September 2016, the Government rejected or watered down several important recommendations, presumably due to industry lobbying.

Currently, seven recommendations concerning advertising are up for debate, of which three are the most important.

Recommendation Fifty-Five: Abandon pre-approval of therapeutic product advertisements in accord with the Government’s “Cutting Red Tape” agenda. This would be conditional on the implementation of other recommendations, such as increased post-market monitoring and stronger penalties for regulatory violation. However, most advertisements submitted for pre-approval require changes to avoid Code breaches; sometimes wholesale revisions. Pre-approval is the only defence between a misleading advertisement on prime-time television and the unwitting consumer. Complaints and post-marketing reviews take too long to remove misleading and deceptive advertisements. Thus, cutting pre-approval is controversial and has the potential to further hinder the efficiency of the system.

Recommendation Fifty-Six: A new body for managing complaints. The controversy lies in who should manage the new system. The TGA appears to be positioning themselves to take over; abolishing the current Code Council and Complaint Panel along the way. This would remove involvement of consumer, health professional, industry and media stakeholders. Additionally, some argue that the TGA is too close to industry, lacks a consumer protection culture, has failed to address long-standing regulatory problems, and is non-transparent about complaints it currently handles. One suggestion is to send a senior enforcement manager from the Australian Competition and Consumer Commission (ACCC) to the TGA to oversee the new system (and change the culture) while keeping the best of the current system (the Code Council and Complaint Panel) and fixing the flaws, such as the lack of power to enforce determinations.

Recommendation Fifty-Seven: Stronger compliance powers against misleading advertising. Sanctions and penalties must be sufficient to counter the commercial return that can be obtained by breaching the regulations. Those suggested in the consultation document should be adequate if imposed.

In conclusion, readers of the AJP might consider putting in their own submission to the TGA consultation here.

Sasha Hall and Tiana Moutafis are BMedSci/Law students supervised by Dr Ken Harvey.

The above material was presented at the University of Melbourne Secular Society Skepticamp on November 25, 2016 and at the 2016 Skeptics Annual Convention the following day. Both these presentations are available. Also, a complaint has been submitted to the Complaint Panel and the Pharmacy Board about the promotion described above.

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  1. Michael Khoo

    An anecdote: Some years ago an alternative health company thought it would be a neat idea to breed up a multi-antibiotic resistant strain of Acidophillus, then sell it claiming it would have some sort of therapeutic effect if taken along with antibiotics. I was curious to know what measures were taken to prevent the transfer of antibiotic resistance to other gut bacteria. The manufacturer seemed perplexed that anyone would ask, so I contacted the TGA to find out what safety testing had been done prior to approval of this product. I was astonished to be told that ” The product required no more testing than other probiotics, as Acidophillus has a well known safety profile” . I asked if any consideration had been given to the product having a strain of Acidophilus that was claimed to be resistant to penicillins, macrolides, quinolones and cephalosporins. I was told that someone would call me back… still waiting for that call after more than 10 years. The product was (apparently) changed to contain a regular Acidophillus strain, but who knows what that product may have done to the spread of multi-antibiotic resistance in the community?

    My mind boggles that it is left to someone like me to even have to question this sort of thing. We may well complain that the government treats Community Pharmacists like a bunch of overpriced shopkeepers, but until we begin to apply the impressive training we are given to all aspects of retail pharmacy, can we expect to be treated as anything else? And where would we be without Ken Harvey and his mole whackers?

    • Jarrod McMaugh

      I think Australia’s health system is very much in debt to Ken Harvey and the work he does (and the people he inspires). How is it that @KRV1944 only has 75 followers?

  2. Leopold Hamulczyk

    I commend Dr Ken Harvey for following his passion and holding to account claims made by manufacturers of complementary medicines. However, I wish his talents and passion would be better used holding others to account, where a bigger difference can be made.

    The advertising and marketing industries are little more than applied lying, regardless what it is they are advertising or marketing. However, cleaning up the complementary medicines industry in this regard has little public benefit. Most complementary medicines are likely to produce little to no harm, other than to one’s wallet, and even in that area the harm they may create is minimal. What’s more – preventing these products being marketed with no evidence to support the therapeutic claims made will not prevent these products from being purchased, as many people will find out all about the supposed benefits of these products through the alternative health media, Facebook pages and other sources. The total “bang for buck” is minimal.

    There is an area of mainstream medicine which needs cleaning up, where real harm is done and seriously big money is being sucked from the public purse and in some cases from patients and/or their families themselves. This area is cancer chemotherapy.

    Articles and studies pop up in medical journals every now and then discussing the ineffectiveness of cancer treatments and their costs, and most recently I would like to draw your attention to articles published in the British Medical Journal and in JAMA Internal Medicine.

    “Cancer drugs, survival, and ethics” BMJ 2016;355:i5792 doi: 101136/bmj.i5792 Published 9 November 2016)

    Notable line: “Newer drugs did not better: 48 new regimens approved by the US Food and Drug Administration between 2002 and 2014 conferred a median 2.1 month overall survival benefit.”

    More interesting, perhaps, are the reader’s responses, and the author’s responses, below:

    “I thank Dr Baum for his comment and will henceforth
    use his excellent term, ‘false dawns’ to express the hyperbole of pharma in the
    context of their brash announcements of ‘progress’ that actually do nothing but

    “Ms Mawer identifies the neglected supportive care, and
    so accurately perceives the continued need for comparisons of drug responses
    with supportive care alone – now mostly considered un-ethical. Her term
    ‘illusion of efficacy’ is another which I will use in my talks!!!”

    “Finally, Dr Dangoor and colleagues quote the
    non-approval by NICE for the use of erlotinib in pancreas cancer (it increased
    survival only by a median 10 days in the submitted US approval trials!). That
    was indeed a good decision. However, the FDA did indeed approve it, and it is
    used in the US.”

    A – RESEARCH LETTER – Quality of Life, Overall Survival, and Costs of Cancer Drugs Approved Based on Surrogate Endpoints: Tracy Rupp, PharmD, MPH, RD; Diana Zuckerman, PhD

    Published Online: November 29, 2016. doi:10.1001/jamainternmed.2016.7761

    “The QoL studies compared 7 drugs with placebo or observation groups and found that 2 drugs demonstrated worse effects on QoL, 4 drugs showed no statistical difference, and 1 drug had mixed results. Compared with another drug, 1 drug (ofatumumab) reduced OS, while 6 drugs had no OS benefit in comparison with placebo or observation groups.

    The average cost of the 6 drugs with no different or worse QoL was $87 922 per year (ranging from $20 237 to $169 836). Despite having no OS or QoL benefit compared with placebo or observation, while presenting significant risks for serious adverse effects, all but 1 of the drugs retains FDA approval. (FDA rescinded bevacizumab for breast cancer in 2011.) Of the 6 drugs with QoL data comparing them to another drug, 1 drug demonstrated better QoL, 2 drugs did not differ significantly from the comparator, and 3 had mixed results. There was no apparent trend in loss to follow-up that could have confounded the results.

    The estimated annual costs of the 18 drugs ranged from $20 237 for rituximab to $169 836 for cabozantinib-S-malate, and 13 drugs had annual costs that exceeded $100 000.”

    Surely exposing this would bring more benefit to the public (purse) and to individual patients both harmed and offered implicit promises of great potential benefit by these treatments, whilst in reality offering them little to no benefit in either overall survival or quality of life, at great cost to the government or to themselves and their families.

    Though no laws are being broken, as opposed to the advertising and marketing of complementary medicines, (and one reason why it may be more difficult to do anything about this), it’s about time someone kept the industry honest in this area. Australia’s future health spending depends on it. With the amount of money being spent per patient on oncology these days, attacking this would will make a much greater difference than attacking dodgy claims on complementary medicines.

    • Alan Windsor

      We are looking forward to the day when MEDICAL CANNABIS is finally in the hands of those who need it most. Yes there are a lot of pill companies peddling so called medicines with extreme side effects and cost who are doing their utmost to keep safe, effective and cheap medical cannabis out of the hands of the people who only want to be cured and not have their ailments prolonged for the benefit of BIG PHARMA.

      • Ron Batagol

        We are indeed indebted to Ken Harvey for the work he has done in revealing the deficiencies in the regulatory system of complementary products. Keep up the good work Ken! To me, a very important issue in this whole debate is the potential neglect of proper medical management that may occur when people rely instead on complementary medicines ( think acute infective conditions in children,and slow but insidious progression of undetected prostate disease). Sadly, this “alternative” approach is often fostered by some pharmacists ( with the obvious “spin-off” effect of the lowering of professional credibility of pharmacists by some peak health “movers and shakers” at a critical time for the profession!.

      • Jarrod McMaugh

        G’day Alan

        I too think that legitimate uses for canabidiol should lead to its use in a medical setting

        I think you should temper your expectations though. If you expect medical cannabis to cure anything, you will be disappointed. It is a treatment option in some instances, but cures nothing.

        • Alan Windsor

          Thanks for that Jarrod
          We have conducted extensive research (via the net) and have followed the research being done by prestigious medical universities throughout the world. When one looks at the results in curing or mitigating literally dozens of so-called non curable diseases one can only be amazed that this humble, ostracized and defamed plant can heal so much.
          I can understand, that when hundreds of billions of dollars are involved, there will be a lot of opposition allowing this plant to come into the market place.
          Unfortunately, this same opposition also deters most people from searching for their own truth.

          • Jarrod McMaugh

            G’day Alan

            If you’ve truly been cured, then good for you.

            2 points I’d like to make, although I’m not trying to challenge what you’re saying:
            1) i recommend that you conduct research far wider than internet searches. Connecting with universities Is a great start, corresponding with them and applying critical thought & skepticism to everything you read is a healthy way to keep expectations realistic.
            2) money is very good at driving business, but it’s not very effective at suppressing it. Research in this area WILL be utilised by pharmaceutical companies to some extent. Assuming that any company is suppressing research or utilisation of any potential medication isn’t realistic. On top of that, it implies that the health industry (and the professionals within it) are complicit in suppressing progress. That’s just not realistic.

            Progress is very complex, and we all want to witness a time when we have solutions for all health issues.

  3. Andrew

    Check out this crap;


    Being advertised very heavily during the school holidays….

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