MD, PhD, FMedSci, FSB, FRCP, FRCPEd

This post is based on an article by Ken Harvey, Associate Professor, School of Public Health and Preventive Medicine, Monash University, Australia. I took the liberty of slightly modifying his text for the purpose of this blog. The article informs us about the regulation of nonsense which, as I have often argued, is likely to result in nonsense.

Australia’s drugs regulator seems to be endorsing unfounded claims about homeopathy and traditional Chinese medicine as part of its review of how complementary medicines are regulated. In the latest proposed changes, the Therapeutic Goods Administration (TGA) is looking at what suppliers can claim their products do, known as “permitted indications”. An example of a “low level” permitted indication might be “may relieve the pain of mild osteoarthritis”.

If approved, suppliers will be able to use the permitted indication to market their products. The resulting problem is obvious.  For instance, despite the TGA’s Complaints Resolution Panel upholding complaints of a lack of evidence that magnesium and homeopathy “relieve muscle cramps (and restless legs)”, this permitted indication is on its draft list. Other examples of dodgy claims include “supports transport of oxygen in the body”, “regulates healthy male testosterone levels”. The list contains around 140 traditional Chinese medicine indications, such as “Harmonise middle burner (Spleen and Stomach)”, “Unblock/open/relax meridians”, “Balance Yin and Yang”. None of them have any basis in fact or science. There are also around 900 additional indications for unspecified “traditions”.

Traditional medicines are not necessarily safe, as emerging data highlights how common adverse reactions and drug interactions really are. For example, Hyland’s homeopathic baby teething products were recalled by the US Food and Drug Administration and then the TGA because they contained high levels of belladonna alkaloids which caused adverse events in hundreds of babies. In China, out of the 1.33 million case reports of adverse drug event reports received by the National Adverse Drug Reaction Monitoring Center in 2014, traditional Chinese medicine represented around 17.3% (equivalent to around 230,000 cases).

Listed medicines are supposed to contain pre-approved, relatively low-risk ingredients. They should be produced with good manufacturing practice and only make “low-level” health claims for which evidence is held. However, the TGA does not check these requirements before the product is marketed. To safeguard shoppers, consumer representatives, suggested the proposed list of permitted indications should be short and only contain wordings such as, “may assist” or “may help”. For consumers to make an informed purchase, claims based on “traditional use” should always have a disclaimer along the lines of what the US Federal Trade Commission uses for homeopathic products. For example, “This product’s traditional claims are based on alternative health practices that are not accepted by most modern medical experts. There is no good scientific evidence that this product works”.

MY CONCLUSION

As I see it, the problem is that the evidence for many of the claims which are about to be allowed is either absent, seriously flawed or negative. Yet, the purpose of any regulation of this kind must be to protect consumers from purchasing ineffective and sometimes dangerous products. Regulators are keen to balance this aim against another aim: helping an industry to thrive. It is never easy to get such a balance right. But to allow nonsense, pseudoscience and overt falsehoods to creep in, must surely be wrong, unethical and illegal.

 

19 Responses to The sale of alternative medicines: proper regulation of nonsense will inevitably result in nonsense

  • It is really interesting, because just yesterday I’ve written a letter to the TGA expressing my concerns based on the article by Ken Harvey. I’ve copied the applicable parts below, for what it is worth:

    “It is important that the TGA fulfils its mandate to protect the public, and as such, should not allow ineffective and/or dangerous medicines on the market. Unfortunately, as soon as you allow pseudoscientists a foot in the door, I am afraid that fulfilling this mandate will become problematic. For example: To have a Chinese Medicine Practitioner as Chair of the TGA CAM committee for many years, will open the door for ineffective medicines to be listed, and as any scientist will tell you, an ineffective medicine is unsafe by default – its called the risk-benefit ratio (there is of course much more that can be said about this aspect). There is a good reason why the EU have made it difficult for these products to be registered because they seem to understand the risks involved.

    I am therefore quite sad to see that the TGA has again appointed another Chinese Medicine practitioner to the CAM committee. It is as if TCM has now been fully legitimised and elevated to the level of medicine, after intense lobbying for the statutory registration of TCM practitioners in 2012 – this was obviously also the plan all along. And again we can see the impact of this if we look at the latest TGA list of ‘permitted indications’. It is full of pseudoscientific indications; “The list contains around 140 traditional Chinese medicine indications, such as “Harmonise middle burner (Spleen and Stomach)”, “Unblock/open/relax meridians”, “Balance Yin and Yang”. There are also around 900 additional indications for unspecified “traditions”. These include, “Renal tonic”, “Helps healthy liver regeneration”, “Emmenagogue”, “Vermifuge” and “Vulnerary”. – this is what you get when you allow pseudoscientists a foot in the door. These people want to sell more and more of their, mainly ineffective and pseudoscientific, products to the Aus public. And I am afraid that the TGA is apparently allowing this to happen, so I have to ask; where will it stop?

    I am also quite sad to see that the extensive letter that I’ve written to the TGA on 16/02/2016 detailing the many concerns regarding how these pseudoscientists operate, what they want to achieve, and what the impact on the public will be, seemingly has had absolutely no impact on the TGA. So, all I can suggest at this point in time, although it might be futile, is that the TGA focus in getting more scientists on board and please do not allow more pseudoscientists a foot in the door.”

    http://www.ahpra.gov.au/Registration/Registers-of-Practitioners.aspx?q=CMR0001739374&t=oIT8dfekbIWOqyNcyJgc (Chair of the TGA CAM committee)

    https://www.westernsydney.edu.au/newscentre/news_centre/story_archive/2014/professor_alan_bensoussan_wins_complementary_medicine_industrys_highest_award (detailing the many years he has spend on the TGA panel)

    https://www.tga.gov.au/committee/advisory-committee-complementary-medicines-accm (lists a TCM practitioner)

  • Dear Sirs,

    The reason I subscribe is because I am fascinated by how you manage to condemn all alternative treatments to Big Pharma’s cocktails. I eagerly wait for every email to see what you are condemning next.

    I would love to see you take on the Emotional Freedom Techniques (www.emofree.com) and Dr. Greger (www.nutritionfacts.org), energy healing, and the successful natural treatments for diseases, such as cancer, diabetes, etc. Would you please consider doing this?

    Thank you for your time.

    My warmest regards,

    Peter

    • so sorry to hear that you are unable to think straight!

    • As usual, one waits in vain for evidence of these ‘natural’ treatments.
      Surely you must have learned when you left childhood behind that just claiming something to be true doesn’t automatically make it so.
      The best that can be said about your comment is that it was polite( if exaggeratedly so), and that you didn’t descend to the swearing and abuse that is all too prevalent among altmeds ( I can add a couple of recent ‘assholes’ ‘ to the ‘twat’ that I have already been called).
      I’m quite envious of Edzard’s ‘wanker’, especially since that one came from a qualified doctor.
      Early days.

  • We already have Trading Standards, the Fraud Squad, our English Law Courts, Her Majesty’s Prison System…what more regulation does AltMed require?

  • Your defiant stance against alternative cures to illness, and support for ChemMed, illustrate a flaw. Why do you have to have medicines, i.e. ChemMed or indeed any pills or medicines at all, to cure and prevent illness? Surely you know that a major element of the arsenal of alternative treatments for illness isn’t actually pills or medicines at all. You can prevent illness through foods and cure serious illnesses through various kinds of foods. If you care to explore the work of Dr. Greger at http://www.nutritionfacts.org, you will come across an abundance of scientific research studies about the benefits of foods to cure illness. It is easy to find a report from somewhere around the world, which “proves” that an alternative treatment doesn’t work. But you fail to mention all the reports, which indicate that a particular alternative treatment does work and has done so for many, many years. You will be aware, I hope, of the several medicineless hospitals in China, which use a variation of chigong to cure 180+ illnesses, including cancer. Chigong is an energetic alternative treatment. If you look up on YouTube, the video by Gregg Braden called “The Power of Emotion, you will see a video of a woman’s bladder cancer disappearing in 3 minutes. The head of the hospital wanted the video released so that mankind would know that people can cure themselves without medicines and ChemMed. Compare that medicineless treatment to the ChemMed treatment of cancer, which has a failure rate globally of 97.2%. I’m referring to the use of the Big Three cancer treatments. Ask yourself: in view of the failure of ChemMed cancer treatments and the success of alternative treatments, if you had cancer, would you choose ChemMed or an alternative treatment because the chance of surviving from ChemMed is 2.8%. Why do so many Americans go to Mexico for alternative treatments instead of having the useless ChemMed treatments? I expect you are aware of what is going on in Mexico regarding successful alternative treatments. Lastly, if you reply to this comment, please restrain yourself from being rude, like you were last time. I can think straight even though you said that I can’t.

    • ” If you care to explore the work of Dr. Greger at http://www.nutritionfacts.org, you will come across an abundance of scientific research studies about the benefits of foods to cure illness”
      I did not find a single one; why don’t you provide a like to one or several?

      • Yeah, but he does lots of videos, though…

        • True, but as far as I recall, every video of his shows references to scientific research papers about the healing effect of the particular food in question.

          It is not the case that a food item will necessarily cure an illness on its own. The medicineless hospitals in China, for example, use chigong (qigong) as well as teach the patients about food and teach them energy healing techniques. The same goes with me. If I have knee joint pain, for example, I eat certain vegetables, such as broccoli, and combine it with an energy healing technique to clear up the problem in 1-2 days at the most.

          If I get a headache, I mix ginger powder with lime and warm water and the headache will be gone in 30 minutes tops. If the headache is stress-related, then I tap on the endings of the body’s energy pathways using the EFT technique and the headache is guaranteed to go very quickly. 5-10 minutes at the most. No need for any foods or medicines.

          There is no need for any scientific reports about many alternative medicine techniques. They just work.

          • Did I tell you about the bloke who sold a powder that could cure a headache in half an hour instead of the usual thirty minutes it takes for it to go away by itself?

          • I realise that I am an oddity on this blog and that everyone here only believes in Big Pharma’s concoctions as the only way to cure illness, but I don’t mind.

            Ginger isn’t a “powder”. It’s natural. You can use slices instead, if you wish, instead of ginger powder, to cure a headache. No pills. In fact, you don’t even need to wait 30 minutes. But as I have said, EFT makes the headache go away in 5 minutes, just by tapping on the endings of the body’s meridians. In this way you clear the energy out of the energy pathways, and the headache goes at once. But this is the future of medicine, not the present, because the Newtonian worldview is dominant, not the Quantum worldview. There is no money for the Big Pharma corporations with the Quantum worldview, so they will try to keep everyone locked into the Newtonian, pill and surgery paradigm as long as they can. They can’t peddle pills in the Quantum worldview because that sees the world as energy.

            Alternative cures for illness invariably come from Nature, which is a source of frustration for Big Pharma, because they can’t patent natural elements and cures. I include energy under Nature here because everything is made of energy. Though this seems to be unknown to Big Pharma and their fans. Energy healing can be very effective. But don’t hold your breath while waiting for Big Pharma to do a scientific study about the body’s energy system and energy medicine. It’s all about ka-ching (money) for them.

            People on this blog seem to want a scientific study for everything. Who is going to fund them? Big Pharma? Unlikely. They don’t want people to know about AltMed and natural cures. Who cares, if a natural “powder” cures pain, and Big Pharma has not carried out a scientific study about this, if the pain goes away with no side-effects and with minimal cost?

            That’s all for now. I’m sure this will attract a flood of replies.

          • “… everyone here only believes in Big Pharma’s concoctions …”
            only a half-wit can come to this conclusion

          • FFS! “If I get a headache, I mix ginger powder with lime and warm water and the headache will be gone in 30 minutes tops.” And if I get a headache I simply suffer the symptoms, confident that it will be gone in 30 minutes tops (view NHS Choices).

            “If the headache is stress-related, then I tap on the endings of the body’s energy pathways using the EFT technique and the headache is guaranteed to go very quickly. 5-10 minutes at the most. No need for any foods or medicines.” I truly don’t know if my (very rare) headaches — you do realize, don’t you, that headaches are almost universally common and nothing to worry about normally — are stress-related, or derive from reading drivel from incredulous fans of pseudo-medicine, but most of them are gone within 5-10 minutes; 30 minutes, tops.

            Please enlighten us, what is an ‘energy pathway’? What is EFT technique (if it has nothing to do with food then your comment is seriously misleading)? Where are the ‘endings’ of an ‘energy pathway’? Do you understand any basic biological science at all? Do you not appreciate the hard work of serious researchers over the past couple of centuries to improve our (real) understanding of how the body works? What do you think about astrology? Flat earthism? Walking under ladders? The number thirteen? Are you comfortable to fly in an aeroplane? Ride in a vehicle propelled by internal combustion or electricity? I really think the readers of this blog are entitled to know.

            Headaches that are in any way severely debilitating, or persist for long periods, or are accompanied by prostration or vomiting require medical attention, and cannot be relieved by eating ginger powder and horse manure.

            “There is no need for any scientific reports about many alternative medicine techniques. They just work.” The list of expletives that characterize my reaction to this imbecilic statement would get me banned from commenting on this blog. I’ll be generous: you’ve clearly indicated that “a food item will necessarily cure an illness on its own.” So which food item cures an atrial septal defect? gangrene? AIDS? tuberculosis? Diabetes mellitus? Coccidioidomycosis? Meningitis? Systemic lupus erythematosus? Infantile onset encephalomyopathy mitochondrial DNA depletion syndrome (a currently topical illness in the UK)?

            If none of this makes you feel that maybe you’re actually out of your depth when it comes to medicine, then I fear for you and those around you.

          • Peter McAlpine said:

            I’m sure this will attract a flood of replies.

            Why? All you’ve given are the same old fallacies and conspiraloon nonsense that have been debunked so many times before.

          • @Peter
            Try looking up the term “sarcasm” in a dictionary. You might learn something new.

          • Peter McAlpine,

            The adjective “Newtonian” is capitalized because it means: relating to or arising from the work of Sir Isaac Newton. Whereas the noun “quantum” is capitalized, then used as an adjective, by people who understand neither quantum mechanics nor English language.

            “If a sentence has the word ‘quantum’ in it, and if it is coming out of a non-physicist’s mouth, you can almost be certain that there’s a huge quantum of BS being dumped on your head.
            —Physicist Devashish Singh, quoting a colleague[1]”

            Quantum woo is the justification of irrational beliefs by an obfuscatory reference to quantum physics. Buzzwords like “energy field”, “probability wave”, or “wave-particle duality” are used to magically turn thoughts into something tangible in order to directly affect the universe. This results in such foolishness as the Law of Attraction or quantum healing. Some have turned quantum woo into a career, such as Deepak Chopra, who often presents ill-defined concepts of quantum physics as proof for God and other magical thinking.

            When an idea seems too crazy to believe, the proponent often makes an appeal to quantum physics as the explanation. This is a New Age version of God of the gaps.

            Quantum woo is an attempt to piggy-back on the success and legitimacy of science by claiming quack ideas are rooted in accepted concepts in physics, combined with utter misunderstanding of these concepts and a sense of wonder at the amazing magic these misunderstandings would imply if true. A quick way to tell if a claim about quantum physics has scientific validity is to ask for the mathematics. If there isn’t any, it’s rubbish. [My emphasis.]

            http://rationalwiki.org/wiki/Quantum_woo

            Please read the article Quantum Quackery by Professor Victor J. Stenger.
            http://www.csicop.org/si/show/quantum_quackery

            You do indeed have a “Quantum worldview”: a coarsely-quantized worldview that is unable to delineate the boundary between fact and fiction.

        • @Alan Henness on Wednesday 02 August 2017 at 14:23

          “Yeah, but he does lots of videos, though…”

          So does Pete; https://www.youtube.com/channel/UCjaOJYDEcpwozogKhBLBENw

          This one is of great comedic value; https://www.youtube.com/watch?v=pD4KcP74dKU

          One A-grade loon.

  • @Peter McAlpine, the grand master of consistency.

    If I get a headache, I mix ginger powder with lime and warm water and the headache will be gone in 30 minutes tops.

    [Comment dated Wednesday 02 August 2017 at 15:18]

    Ginger isn’t a “powder”. It’s natural.

    [Comment dated Thursday 03 August 2017 at 02:37]

    Errm, you seem to be very confused. Any solid substance, whether natural or man-made, can be milled into a powder, cut into slices (of which you approve) or compressed into a pill (which you apparently think doesn’t apply to ginger).

    I realise that I am an oddity on this blog and that everyone here only believes in Big Pharma’s concoctions as the only way to cure illness, but I don’t mind.

    That’s very generous of you, Peter. But you clearly haven’t looked very hard at many of this blog’s discussions. Supporters of Big Snakeoil’s concoctions are to be found everywhere. Not surprising when you read that the market for homeopathy alone was estimated at US$ 386 million in 2015.

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