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TGA all bark no bite as Labor botches response to a series of reviews

The government has just announced its response to a series of reviews of the Therapeutic Goods Administration over the past 18 months. The announcement was brought forward after a summary of the reforms…

MP Catherine King, who announced TGA reforms on Thursday afternoon, speaks to reporters on Aug. 11, 2011. AAP/Melissa Lahoud

The government has just announced its response to a series of reviews of the Therapeutic Goods Administration over the past 18 months. The announcement was brought forward after a summary of the reforms was accidentally emailed to about a dozen people yesterday.

Transparency review and devices

Most recommendations of the TGA Transparency Review will be implemented. These include the establishment of an Australian therapeutic goods advisory council for oversight of the implementation, ongoing monitoring, and evaluation of review recommendations over the next four years. A dedicated communications unit will also be created within the TGA to inform and educate the public.

Some positive moves regarding the regulation of medical devices include reclassifying the load bearing component of a hip, knee or shoulder joint replacement from medium-high risk to high-risk. This means such devices will require more assessment before entering the market.

The information on medical devices on the Australian Register of Therapeutic Goods (ATGR) will be amended so sponsors will nominate names for each product. This will make it easier for consumers and health professionals to find information about specific devices. The amount of available product information on the TGA website relating to medical devices will also be increased.

However, a key concern of the Working Group on Promotion of Therapeutic Goods (to health professionals) that compliance with an industry code should be a condition of including a product on the ATGR was not accepted. The government’s view was that this departs from their prefered self-regulatory model. However, group members noted that the worst perpetrators of unethical promotion were usually not members of industry associations and these cowboys would be unlikely to sign up to code compliance voluntarily.

Without addressing this problem, the likely outcome of “strengthening” and creating a “level playing field” for self-regulatory codes is that the good guys (industry association members who are code compliant) will increasingly be restrained while the bad guys (non-members of industry associations) will laugh all the way to the bank.

Not addressing this concern also perpetuates the difference between health professionals and industry. Health professionals now have government-mandated national registration and must comply with Australian Health Practitioner Regulation Agency (AHPRA) code while the latter (non-members of industry associations) have no controls placed on them at all.

The recommendation that the effectiveness of voluntary registration be evaluated annually required government acceptance of a number of other recommendations, such as creating an advisory group. But apparently “[the government] is not yet persuaded there is a need to establish a permanent advisory group” and “aspects of the Report which require either Government assistance or legislative amendments to move towards co-regulation have not been accepted by the Government at this time”.

Given this background, I cannot see how it’ll be possible to evaluate the impact of Working Group on Promotion of Therapeutic Goods recommendations or how “longer term changes will be considered if necessary”. But perhaps that was the aim of rejecting these key recommendations. So what was the point of setting up a broad-based stakeholder “Working Group on Promotion” and then ignoring their key concerns and recommendations?

Complementary medicines

There are positive measures for the regulation of complementary medicines and information provision, which include:

  • amending the Therapeutic Goods Regulations with guidelines for the levels and kinds of evidence required to support claims;
  • changing the way products are electronically listed so sponsors can’t just add free text; and
  • working with stakeholders to create better labelling.

However, it’s disappointing that clear labelling requested by many has been assigned to further work with stakeholders. What’s required to assist consumers making decisions about complementary medicines is a clear statement on the label, on promotional material and above the shelves with complementary medicines that honestly reflects the regulatory reality.

Indeed, the TGA media spokesperson has recently been using an useful set of words, “The TGA does not evaluate the effectiveness of listed complementary medicines and cannot guarantee that these products work”. This labelling reform can and should be implemented now – why further delays?

Advertising reforms (promotion to consumers)

This was the most disappointing area of all. For the last decade, numerous reports to government and submissions from consumers and health professionals have highlighted the need to ensure that the Complaints Resolution Panel (CRP), on its own or along with the TGA, can readily apply escalating and effective sanctions on product sponsors who breach the Therapeutic Goods Advertising Code and Therapeutic Goods Act.

But the government response is – “changes to the approach of sanctions and penalties for advertising breaches, including civil penalty provisions which parallel offences and act as a deterrent, will be investigated.”

Currently, the CRP is under-resourced, overloaded and has no power to enforce sanctions. Sponsors are merely “requested to comply”. It takes between six and nine months for complaints to be heard and judgements to be made public. All this takes place while misleading promotion continues. The CRP also lacks resources to follow up its own decisions, which make them more easily ignored.

It often takes multiple complaints before non-compliance by a product sponsor is passed to the final regulator – the TGA. The TGA may write letters “ordering” compliance but, due to the low financial penalties available, it has never prepared a brief of evidence for consideration of prosecution (see ANAO report).

Paper tigers

Industry knows that the CRP and TGA are paper tigers, so serial advertising offenders and conmen flood the market with dodgy products, undeterred by escalating (and ultimately ineffectual) complaints.

Recently, SensaSlim (and other shonky products) have been referred from the TGA to the Australian Competition and Consumer Commission (ACCC), but this has, as yet, failed to stop the continued sale of these products or their imitators, or their use.

We need legislation to give the CRP and TGA timely and meaningful sanctions for advertising violations (civil penalties, enforceable undertakings) now. I cannot see why “further investigation” and “further input by stakeholders” is needed apart from the sake of letting sections of industry profit by continuing to rip off consumers unchecked.

Like the Curate’s egg, the government’s reform blueprint appears to be good in parts. But it also displays a timidity to grapple with key issues, such as therapeutic goods advertising reform, and that seems to be a common failing of this Labor government.

I’ve been a card carrying member of the Labor Party for some time. I worked hard to get rid of the Howard government and get Labor elected and I’ve sat on a number of the working parties and consultations that have made the recommendations outlined above.

But I can no longer be a member of the party when a Labor government fails to implement unanimous recommendations from its own working parties, and continues to procrastinate after a decade of calls for effective sanctions on advertising violations. I have today submitted my resignation.

Join the conversation

25 Comments sorted by

  1. Peter Fox
    Peter Fox is a Friend of The Conversation.

    Medical doctor

    Dr Harvey, great article. I agree, the alternative/complementary industry is in desperate need of a legislative shake up. Deeply disappointing that the TGA 'reforms' are so ineffectual. In the meantime, vulnerable consumers will continue to be conned by purveyors of snake oil.

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  2. Mark Dunn

    Publisher, AusPharm

    Nicely put Ken. I'm appalled that the unchecked promotion of snake oil, particularly with respect to weight loss products, is set to continue and consumers will continue to be (no other way to put it) ripped off big time.

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  3. Tim Scanlon

    Author and Scientist

    There should be something stopping snake oil merchants. Right now anyone with no scruples can start a company selling just about anything and there is nothing to stop them.

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  4. Oliver Frank

    GP 0.6 time, researcher 0.4 time

    Rather than dividing medicines arbitrarily into 'medicines' and 'complementary medicines', with different requirements for evidence of the safety and effectiveness of the medicines in each group, the most logical approach would be to have only category of 'medicines', with the same requirements for the manufacturer or promoter of each medicine to show evidence of the safety and the effectiveness of that medicine. Then the listing for each medicine could say something like:

    "Proposed indication(s): X
    Evidence of safety: Y
    Evidence of effectiveness for each proposed indication: Z"

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    1. Russell Hamilton

      Librarian

      In reply to Oliver Frank

      But Oliver, I think most of us do consider them to be different things. If I go to the doctor with a bad cut and he gives me a tetanus injection and antibiotics, I think about those antibiotics differently than I would, say, about drinking ginseng tea every day (which I don't).

      On an earlier thread we saw that there apparently isn't any evidence that complementary medicines have done the people taking them any harm, so perhaps it should just be on the basis of harm that any of these substances should be regulated. I guess we wouldn't want antibiotics sold from supermarket shelves, but do we need to worry about ginseng tea?

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    2. Stephen Prowse

      Research Advisor at Wound CRC

      In reply to Russell Hamilton

      If a person want to sell snake oil they should be free to do it, just as people sell olive oil, so long as it causes no harm. Clearly the problem arises when the snake oil salesman claims the product cures something without evidence. It is in this case the TGA should be able to be in a position to take action. It is a sorry state of affairs that this seems not to be the case.

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    3. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Russell Hamilton

      You shouldn't think of them as separate things, any substance which changes physiological function is a drug, St. John Worth has the same mechanism of action as Prozac, and has a very similar spectrum of side effects. People who take St. Johns Wort and Prozac together, thinking the herbal is "not a drug", can have very nasty, if not fatal, interactions (providing of course the bottle labelled St. Johns Wort actually contains a significant amount of the herb).

      And you misrepresent what happened on that other thread, you simply misunderstood the language used in the references. The fact that a given product, be it herbal or conventional) will not always have an adverse event does not mean adverse events are unimportant.

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    4. Russell Hamilton

      Librarian

      In reply to Ian Musgrave

      No, I don't think I misrepresented what happened ... I asked for evidence that people who had been taking complementary medicines had been harmed by them, and you responded with mostly references about possible harm.

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    5. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Russell Hamilton

      Again, you didn't understand the language, when 20% of Indian herbal products have toxic levels of lead or mercury in them (which they do), we will still say an individual taking Indian herbal medicine *may* be harmed, as not everyone will ingest a toxic level of lead.

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    6. Russell Hamilton

      Librarian

      In reply to Ian Musgrave

      Again, you don't understand my question. Who / how many people in Australia took those Indian herbal products, and how were they affected?

      And is there a mechanism for relaying your concerns to naturopaths? I would guess that all naturopaths would run a mile from products that might have toxic levels of lead or mercury in them. (That said, I still use Mercurochrome since it works better than anything else).

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    7. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Russell Hamilton

      If Naturopaths subscribe to the TGA adverse events reporting system (and only 1% of them do), then they would get the ADR reports that come through, such as the one alerting people to heavy metals in Indian Herbal products.

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  5. Cris Kerr

    Volunteer Community Health Researcher, Advocate for the value of Patient Testimony

    Yes, and it makes sense to collect the evidence... whether a product works (does what it says it will do) or doesn't work... is safe or isn't safe... those who use it know what the outcomes are.

    If consumers were able to self-report their health outcomes in their own ehealth records (free of influence by conflicts of interest), the volume of data would build over time into a reliable, valid aspect of health outcomes evidence.

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  6. Oliver Frank

    GP 0.6 time, researcher 0.4 time

    Russell Hamilton said:

    "On an earlier thread we saw that there apparently isn't any evidence that complementary medicines have done the people taking them any harm".

    Are you sure about this? There is substantial good evidence of many 'complementary', 'natural', 'herbal', alternative' or 'traditional medicines causing adverse effects. In five minutes' searching I have found:

    http://www.tga.gov.au/hp/aadrb-0502.htm

    http://tiny.cc/hnl01

    http://www.mja.com.au/public/issues/mar1/boyd/boyd.html

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    1. Russell Hamilton

      Librarian

      In reply to Oliver Frank

      Hi Oliver,

      Nope, I'm still not convinced because you haven't provided evidence that there has been any significant level of harm from people using complementary medicines. Articles that say that such and such a herb might interact with such and such a drug aren't a reason to stop a large proportion of the population indulging their preference for whatever their naturopath prescribes for them.

      One of your articles is about some people who had an allergic reaction to echinacea. I think that that…

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    2. Russell Hamilton

      Librarian

      In reply to Russell Hamilton

      I should have added that when you write :

      "If you were contemplating a nice cup of oleander leaf tea next, make sure that you Will is up to date, because your family will need it within a few minutes of your drinking that cup of tea. Even ordinary tea and coffee can cause problems for some people with four cups per day. "

      I think that's an argument for my side of the debate. Had naturopaths prescribed anything like oleander leaf tea for their clients, then naturopaths wouldn't have many customers. But they haven't. And as you say, things like tea and coffee (almost anything really) can be overdone, but that isn't a reason to deter everyone who enjoys them in moderation from doing just that.

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    3. Ken Harvey

      Adjunct Associate Professor, School of Public Health and Preventive Medicine at Monash University

      In reply to Russell Hamilton

      Complementary medicines (CMs) are regarded as "relatively low risk" medicines by the TGA. However, low risk does not mean NO risk as other commentators have pointed out. The key message here is to mention ALL the medicines you are taking to your health provider, no matter whether GP or naturopath, and do not assume that "natural" necessarily equals "harmless".

      The other point I have tried to make is that although there are good evidence-based CMs out there is also a lot of rubbish because of the…

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    4. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Russell Hamilton

      It certainly *does* matters if people have an allergic reaction to a drug, this is a very serious matter. Dying of an anaphylactic reaction is not what most people would expect from a "natural" anti-cold medicine, a non-lethal anayphylactic reaction is still very serious. Even if these reactions are very rare, they are of such consequence that we need to keep close watch on the substances that cause them. In the case of echinacea, there is no good evidence that echinacea has any effect on cold and…

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    5. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Ken Harvey

      And I should also point out that, just as for conventional medicines, risk can be re-evaluated and the designation changed when more evidence is accumulated.

      Kava and ephedra containing products are now banned because of the unacceptable risks they posed, despite many people "enjoying their use". At the very least St. john's Wort should be re-evaluated because of it's level of risk (it's just another SSRI, with all the benefits and risks that entails from SSRI's).

      Naturopaths and Herbalists were quite happy to prescribe Kava and ephedra products, because they did not monitor or evaluate adverse effects systematically.

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    6. Russell Hamilton

      Librarian

      In reply to Ken Harvey

      Ken - true, low risk is not no risk, but my point is do we need massive government regulation for low risk activities? I would rather government concentrate its resources where the knowns harms/risks are considerable - I mentioned alcohol.

      St John's Wort is often mentioned for its risks and it quite likely needs more regulation - but you can't generalise from that to all the complementary medicines on the market. I'm all for doctors and hospitals keeping records of any bad reactions to anything, and if there enough cases, the substance should be properly investigated and if necessary regulated. But that evidence doesn't exist for, what, 99.9% of the products in your local health shop? What this looks like is a demarcation dispute, or professional jealousy. Unless there's evidence that significant harm is being done, I don't think we need any more protecting the public from themselves in this area.

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    7. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Russell Hamilton

      Yes, yes we do because these things are being used as *medicines*, and we expect a higher standard of care with medicines than with peanut butter. Echinacea is a case in point, a herbal remedy *which does nothing* but which rarely causes of death, severe anaphylaxis, and asthma attacks. Even though this level of risk is small , why should consumers be exposed to any level of serious risk for something that has *no* benefit.

      Is your argument that we should wait until we have enough evidence that…

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    8. Russell Hamilton

      Librarian

      In reply to Ian Musgrave

      Well, Ian, we'll have to agree to disagree about this - when you write "You shouldn't think of them as separate things, any substance which changes physiological function is a drug", I just do think of them as different things: coffee is not heroin, quite different risks, though both 'drugs' to you.

      Similarly with the peanut butter you mention - should it be moved from the supermarket shelves to the pharmacy shelves because a very few people are allergic to it?

      As for waiting for evidence that…

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    9. Ken Harvey

      Adjunct Associate Professor, School of Public Health and Preventive Medicine at Monash University

      In reply to Russell Hamilton

      Russell asked, "do we need massive government regulation for low risk activities?"

      That is not what is being proposed!

      All that has been requested is that gross violations of the Therapeutic Goods Advertising Code should have meaningful sanctions imposed to deter repeated offenders and that labelling should reflect the regulatory reality; complementary medicines are not assessed by the TGA to see if they work!

      See ABC Radio National Interest:

      http://www.abc.net.au/radionational/programs/nationalinterest/health-watchdog-gets-a-few-more-teeth2c-but-still-lacks-bite/3723236

      Also (concerning harm):

      http://www.theage.com.au/opinion/we-all-lose-when-healers-take-everything-from-the-sick-20111212-1orbn.html

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    10. Ian Musgrave

      Senior lecturer in Pharmacology at University of Adelaide

      In reply to Russell Hamilton

      Yet coffee and heroin act much the same way, one binds to adenosine receptors to cause stimulation (or rather blocks the inhibitory effects of the adenosine receptors, it also blocks the ensyme phosphodiesterase), the other binds to opiate receptors to produce analgesia and mood changes.

      Coffee was one of the first useful treatments for asthma (2 demitasse cups of espresso taken first thing in the morning was used in the 19th century) because of the caffeine in it, and a variant of caffeine, theophyline, is used in asthma therapy today. It's harder to overdose on caffeine than heroin, but at least one student this year has found that lethal overdoses of caffeine are possible (and the likelyhood of abuse of "Enrgy Drinks" is a worry).

      Relative risk is not what defines a drug, otherwise paracetamol, statins, diuretics and angiotensin receptor antagonists would be by your definition, not drugs.

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    11. Russell Hamilton

      Librarian

      In reply to Ken Harvey

      Fair enough Ken. Your plea for curbing the advertising for dodgy products is reasonable.

      Ian and I have drifted off into debating whether complementary medicines generally need to be treated as pharmaceuticals. I'm not sure about your second link - yes, some, (very few?) people will hear from somewhere of miracle cures and do stupid things. But is that an argument for treating everyone as if they were likely to do that? I think that if my local naturopath convinces me that I need to buy spirulina from her, well, that's just an act between two consenting adults, and nobody needs to worry too much about it.

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    12. Russell Hamilton

      Librarian

      In reply to Ian Musgrave

      Agree, 'relative risk is not what defines a drug', but relative risk should probably determine how we regulate it. Given that the population has been using vitamins and herbs for a long time and there isn't concerning evidence of harm, I don't see the need for exhaustive testing or any further regulation.

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