Why is the TGA supporting pseudoscience?
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Overindulge over Christmas? Can’t shake those extra kilos? Is your arthritis giving you trouble or are your hot flushes getting you down? Could it be your sex life needs a little help? Perhaps your Qi needs boosting or your charkas need balancing. Have no fear! There’s a product or two that maybe just right for you and they’re government approved — but does that really mean that they work? Search the Therapeutic Goods Administration (TGA)’s Public Summaries for fat and cellulite reduction and you’ll find 26 ultrasound and radio frequency machines. Many of these are described as “non-invasive alternatives for liposuction” that reduce fat cells by emulsifying them with heat producing energy waves. Costing upwards of $2000 for treatments, they are used by doctors and cosmetic therapists and they do seem to give a “temporary improvement in the appearance of cellulite”, but do they really remove your fat? A lower-cost option may be a magnetic therapy device that claims to increase your metabolism, but if you’re not into gadgets there are also about 1000 complementary medicines also making weight loss claims. Natural pain relief is always a big money spinner for the therapeutic goods industry. There are more than 60 magnetic therapy-based products approved by the TGA including mattress underlays, pillows, support straps, jewellery and shoe innersoles. Some of these products also state they can help allergies, arthritis, asthma, bed sores, blood pressure, carpal tunnel, chilblains, headaches, sciatica, sinusitis, shingles, toothache and tinnitus and that’s only half of the conditions listed! If your sex life needs a lift, there’s a “penile rigidity device”, which claims “to help overcome impotence and incontinence”. Consisting of four pieces of plastic with two metal bits (which you join together to clamp around your wedding tackle) they sell for more than $600. Apparently, as you walk, the galvanic current generated between the metal bits, supposedly improves your libido. If “period pain for pre- and post-menopausal women” is your problem then magnetic therapy might help. For other symptoms there’s black cohosh, dong quai, red clover and soy-based complementary medicines, that are meant to reduce them. If you want the benefits of acupuncture without the needles, there’s even a reflexology product approved as well, but if it’s your vital force that needs a boost, there are pills claiming to “strengthen kidney organ meridian energy to supply healthy liver Qi”. Despite all these products having TGA’s approvals there is no evidence to support any of these claims. Energy generating machines can’t remove fat or cellulite, magnets are a placebo and the concept of Qi, meridians and reflexology are all based on pseudoscientific nonsense. For the symptoms of menopause there is no convincing evidence that any natural product can help and some may even cause liver damage, bleeding complications or “harmful effects on hormone-sensitive tissue”. Some consumers and health professionals are fighting back with some success and new guidelines of evidence for weight-loss pills are to be implemented, which should clear the shelves of these products. There is also the TGA’s Complaints Resolution Panel, which has upheld complaints against many of the advertising claims for products including wave-generating machines and magnet therapy devices, but they have no power to enforce sanctions, so the advertising remains. The TGA is funded by the industry it is meant to be regulating and this is easy money for them, so there is no incentive for it to clean up its act. While this situation exists, creative sponsors will undoubtedly keep targeting vulnerable and gullible consumers, by obtaining TGA approvals that enable them to sell product that claim to treat real and imaginary conditions, with a growing range of pills, potions, photons and other placebos. *Loretta Marron, a science graduate with a business background, was Australian Skeptic of the Year for 2007. |
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Crikey's Guide to Julia Gillard
23 Comments
I don’t think approval by the TGA implies support of the product. Sort of the opposite. The TGA only certifies things that are ‘safe’. For me saying a medical product is ‘100% safe’ implies one thing; it does nothing.
Nothing is 100% safe at certain levels. Even water.
You should be very wary of products claiming to be 100% natural or organic too.
The TGA is not worth a pinch of goat shit, at least you can put goat shit on your garden as a fertiliser. My limited understanding that there is no quality assurance in relation to the therapeutic value of any product approved by the TGA other than the fact that it is not like to have any negative adverse effects on health provided you do not need its claimed therapeutic value.
Provided a quack facility is properly insulated or not poisonous it would appear that you can get the TGA “rubber stamp”. Accordingly any quack machine or facility can be licensed by the TGA provided it is not a direct threat to health.
The American FDA on the other hand has much greater capacity and powers, and it is my understanding that some of the quack machinery imported into Australia is illegal in the US because of their much tighter compliance processes.
One is forced to the inescapable conclusion that both sides of politics benefit from the backhanders from the purveyors of therapeutic goods otherwise a government of either persuasion would have cleaned up this mess years ago.
If the TGA is rubber stamping these pseudo-science products, fine, then they can also be sued in a court of law for medical negligence quid pro quo!
Nugget, you seem to have missed the point, which is that the TGA verifies (perhaps) the safety of the product when used as directed, but does not verify the products fitness for purpose.
The TGA is thus not liable for non-performance and, since there is no adverse safety outcome, then there is no medical negligence. Only a rip-off.
Neat, eh? Where do I apply for a job like that… “All care taken but no responsibility accepted”.
The TGA does only half of its job. It takes money for registration of certain goods about which others may or may not make fallacious claims. What it fails to do is to review these claims of therapeutic efficacy.
Where I come from, this used to be known as the Water Board Principle, “Do nothing and you will have done nothing wrong.” Clearly, the TGA does nothing wrong.
The TGA has a number of problems. The main one is that a funding system designed for political expediency by which the agency collects fees largely from the registration of new prescription medicines which supports a fairly thorough evaluation of clinical, chemical and toxicological data. This pool of money significantly cross subsidises ‘regulation’ of other sectors such as complimentary medicines and medical devices. The regulatory vigilance which is politically and financially supported for this is somewhat less than people might expect from the prescription medicine progtam.
In the case of complementary medicines the only purpose of the TGA process is to determine that the product is not toxic - the agency makes no assessment or claim about efficacy. In the case of devices, products are regulated against design standards rather than evidence of efficacy and not all devices are regulated to a ‘high’ level reserved for critical products like pace-makers. Despite the option for legislative sanction, advertisements are actually regulated by the relevant industries themselves within very broad limits.
Is TGA supporting pseudoscience ?- yes, it is supporting it to the extent that society as a whole is firmly into delusional pseudo therapies (homeopathy etc is big money) which are protected by strong lobby groups which have shaped TGA over a decade or more of political interference.
To fix it all that is required is political support for a funding system which is not captured by industry and for invervention in the market for dodgy products. Genenerally governments and the populace have little stomach for this except when, on occassion, the veil falls and things like the toxicity of HRT, anti-inflamatory drugs etc becomes apparant. I’m a fan of the skeptics, but their standard of evidence is not one which many Australians would support if applied to their treatment decisions. I personally like a regulatory tax on total industry turnover - a tiny fraction of a percent of turnover would be sufficient for a bells and whistles effort.
The situation is unfortunate, because while Australians all feel entitled to a free kick at ‘faceless bureaucrats in canberra’ they are well served by organisations like TGA to a greater extent that would be understandable given the political and commercial dominance of the regulatory system. Most of this good work is buried in confidential files about incidents which neither the pharmaceutical industry or the government are keen to draw to peoples attention.
Of course, rather than reform civic culture in this country we can take the other Australian option and hope someone else will do it for us. I know FDA has a great reputation, but it has most of the same problems if you look closely enough.
The real culprit is not the TGA, which as pointed out just confirms the device or ‘drug’ isn’t dangerous; very easy to do in the all too common case where it does nothing!
In fact the fault lies with the pharmacies who stock these non-sense products alongside things which might actually work. Trained pharamacists (who according to community surveys enjoy a high reputation and level of trust) are advising people to hand over good money for these kind of shonky things. This is where the attention needs to be focused.
I suffer from occasional terrible migraines and one time that I was buying medication for them, the pharmacist pointed out a roll-on remedy that he said was quite good. It wasn’t cheap at about $15 for a lipstick sized container, but the idea sounded plausible since it claimed to give a ‘cooling sensation’ which invoked to me the reverse of what you might get with deep heat rub. I’ve often used ice packs for really bad headaches which gives some relief. So I handed over my money and recieved the ‘remedy’.
Once I got home and investigated further, I saw those two horrible words in the fine print ‘Homeopathic preparation’. I was pretty angry that I’d been swindled, but never went back to point this out. I really should have! For the record I tried it a couple of times and can confirm that it is safe for use and that’s about it.
Sorry John but that is legal gobbledegook!
If the TGA is involved in verifying the “safety of a product” which is subsequently found to be unsafe, it is liable to prosecution under Australian law for negligence.
The Guidelines for Levels and Kinds of Evidence to Support Indications and Claims (1)
state that the kinds of evidence which may support claims are (a) tradition use and (b) scientific evidence (in that order) – page 7.
However on page 11 it states “Should scientific evidence be contrary to the evidence based on traditional use, the claim used must reflect the truth, on balance of the evidence available”.
I would like to know why traditional remedies can continue to state that they “may assist in [indication]” when meta-analysis of the research (as shown in the bottom line in the NPS recommended CM resources(2)) shows they are no better than placebos. Why are consumers being denied the truth?
Pharmacists know how to read monographs and should read up on what they are recommending (by implication because they are selling them) to assist their customers making informed choices. If the products don’t work they shouldn’t be selling them.
Loretta
1.http://www.tga.gov.au/docs/pdf/tgaccevi.pdf
2.http://nps.org.au/news_and_media/media_releases/repository/Highest_quality_complementary_medicines_resources_identified
Good article and response Loretta. Unfortunately this quackery (and other types) are often supported by private health insurers, which of course diverts their funds away from proper allied health treatments. It’s quite ridiculous to see a homoeopath or naturopath or other type of placebotherapist, and then get a rebate for a treatment that doesn’t even do anything (and possibly harm). And yet the private health insurers continually cry poor and seek to increase their premiums. I wonder how much influence they have as a group too?…a good way to get members is to offer useless remedies that have high rates of claiming.
It’s a gross generalisation Tomboy to lump Naturopathy and Homeopathy in the one bag. Naturopathy uses naturally occuring compounds; there are plenty of very powerful compounds which occur in plants. Homeopathy on the other hand, by their own admission, uses solutions so diluted as to contain ‘no active ingredients’.
However, plenty of studies have shown that homeopathic treatments work at a better rate than placebo. Most likely because the nature of the consultation most effectively leverages the placebo effect. I don’t know though if there’s ever been a double-blind homeopathic study that shows efficacy, once the consultative part of the treatment is removed.
One more thing. There is always a question of appropriate use, as with all medecine. Naturopathy is probably not your best bet for, oh I don’t know, a broken leg, or a brain tumour, but can be extremely effective with the slipperier chronic problems such as digestive problems and hormone regulating issues.
Plants are indeed fantastic chemical laboratories and many drugs used today were originally derived from them - in fact forests of Yew trees are grown in Europe to produce powerful chemotherapy drugs because scientists have been unable to synthesise them.
Herbalism, which is healing with plants and plant extracts, is not the same as naturopathy.
Naturopaths study herbalism but based on traditional use only with no regard from evidence-based research and meta-analysis (eg as you would find in a Cochrane Review).
Naturopaths also study disproven diagnostic techniques such as iridology (my local pharmacy offers 15 minutes free iridology) and their training may include homeopathy, reiki and reflexology which, according to reseach, have no proven benefits (apart from the foot massage from reflexology).
Prof Edzard Ernst, who is the Chair of the Complementary Medicine, Peninsula Medical School, Universities of Exeter & Plymouth, Exeter, UK co-wrote a book with Simon Singh called ’ Trick or Treatment - alt med on trial’ which gives the opinions based on the evidence for these therapies. For anyone who wants to know the history and evidence for a great number of commonly used complementary and alternative medicines and therapies, it is a easy to read and very informative.
Loretta
Loretta, some of this isn’t relaly my understanding, but it isn’t really of any import.
I was under the impression though that iridology did have some diagnostic benefit?
I’ll do some reading.
Yes that is why a number of these alternative medicine naturo/homeo/paths have been in court recently, charged and convicted of criminal negligence after deaths of patients in their care.
There is no scientific basis to their treatments, they are quacks, and the courts are dealing with them.
Oh and another thing while i am on the soapbox.
Don’t think that health funds do things that help people get better,they are insurance companies with only their own interests at heart.
In real terms health fund rebates have been reducing while their premiuns are increasing.
Expect to see some large buildings with fund names on them in the future as their CEOS fly around in private jets at your expense.
Hi Loretta
I’m sorry, I’m going to be rather critical of this piece. Not because I have any particular brief for most of the ‘alternative’ or ‘complementary’ products mentioned or alluded to, or because I am particularly enamoured of the administration of the TGA - there is much that could be criticised in both these areas. Rather, I am disturbed by what sounds to me like a rather uncritical allegiance to an orthodox model of scientific medicine which is in fact passing away even as its adherents push it ever more stridently. Has anybody on this forum heard of the ‘new biology’? Of epigenetics? Have you seriously thought of the implications of the way it turns out that our cells actually work - via complex and quasi-perceptual transactions through the cell wall, frequently at a distance - as opposed to the mechanical/chemical genetic deterministic model we were taught in high school?
Why do I bring this up? Because conventional medicine - what you are in practice so stridently supporting in this piece - has only two main ways to attempt to heal - via drugs and surgery. For many conditions, surgery has little or no value, and drugs, in the vast majority of cases, only affect the symptoms of diseases, leaving the causes untouched. This is why, for instances, medical science has had so little success with auti-immune diseases. What is worse, the side-effects of many drugs are as bad or worse than the conditions they attempt to address, and their interactions with each other are for the most part untested. This is a deadly situation, as can be seen by recent reports that iatrogenic conditions - caused by the correct administration of properly prescribed drugs - are now considered the leading cause of death in the US!!! (Up from number 3). Is it any wonder that people are keen to find alternative treatments?
Your piece leaves the strong impresison that the alternative and complementary treatments are all, or nearly all, anti- or un-scientific quackery, and I know for a fact that this is not so. For instance, a dietary supplement that I take has very recently been evaluated in a randomized, double-blind, placebo controlled human study as improving cognition and well-being in measurable ways. It is true that not a lot of these types of study (regarded as the gold standard of scientific tests) have been done on such things as dietary supplements, but that is partly a consequence of the cost and the fact that the pharmaceutical companies focus on drugs instead. It is hard to make monopoly profits on what is essentially food!
And about that dreaded placebo effect. Please think about what you are talking about here! We know for a fact that people sometimes - maybe often - get better from a disease or condition they definitely had, because they BELIEVED they were being given an effective medicine, when in fact it was a sugar pill. What does this tell us about the power of the mind, and why does conventional medicine ignore it as much as they do? It wouldn’t have anything to do with the lack of profits in sugar pills, would it? If you want an effect to dread, try the ‘nocebo effect’, where people get very ill or die because they believe they have a disease that they don’t in fact have.
From all this, you might conclude that I would advocate a ‘let it rip’ approach, which I in fact don’t. By all means test claims, and most certainly enforce ‘good manufacturing practices’ by which people can be sure that what they are buying is what is on the packet, in the concentrations stated. But in doing so, try to free your mind from outdated scientific dogma, and have a care that you are not blocking people from investigating possibilities which in some cases may actually save their lives.
All science asks for is evidence, precisely the opposite of dogma. When you speak of “quasi-perceptual transactions through the cell wall, frequently at a distance” you display a for more dogmatic belief without a single shred of evidence than any scientist has ever shown.
The history of Humanity reads as a succession of silly things that people believed without any evidence. Then along came the enlightenment and we realised there was a new way we could create knowledge, by proposing ideas and then verifying or refuting them through carefully empirical measurement. This was a liberating breath of fresh air given the way ‘knowledge’ had been derived in the past.
But it’s been a long time since then, and people are starting to forget what it was like when ‘Witches, Quacks and Lunatics’ ran the show in terms of medicine and remedies. Unfortunately there is an increasing desire to return to the bad old days, which the Internet is helping by making it easier to distribute disinformation (such as anti-vaccine conspiracies, ‘new Biology’ and other non-sense dreamed up by some loony).
Bogdanovist and Keith-in-Canberra,
Too many words!
Simply, faith is what drives Keith and science is that which is able to be demonstrated to be true.
Bogd… is correct.
KiC is clearly believes in faeries and his opinion must be disregarded by rational folk as the nonsense that it clearly is.
Hi Keith
I follow the principles of ‘Evidence-based medicine’ which in essence means that I can only look at the outcome of clinical trials (ignoring physics, chemistry, physiology etc) and that is also what Cochrane is all about.
(For example there are Cochrane reviews relating “Intercessory Prayer for the alleviation of ill health”) which could not be ignored if they had shown benefits (which they didn’t).
“Outdated scientific dogma” or any other scientific dogma, is not considered. Anyone can do a Cochrane review - they do not need any medical training, they just need a passion for their project (they even pay you).
The NPS study (mentioned in comment 9) to select a complementary resource, included a team from Bond Uni who run courses in ‘Evidence-based medicine’ and doing Cochrane reviews and was run by the group who man the hotline for Adverse Medicines Events at the Mater Hospital, so I refer to their recommended databases “with confidence”.
This does not mean that I am anti-CAM, only anti-CAM that is clinically proven to be ineffective by reputable trials - and most of the products sold in pharmacies such as glucosamine hydrochloride, red clover, saw palmetto, homeopathic remedies, magnetic therapy etc cannot be recommended.
I hope the product you are taking for memory is not Ginkgo, because a trial involving 3000 people was in JAMA December 23 2009 - ” Ginkgo found ineffective in preventing cognitive decline” .
http://www.ncbi.nlm.nih.gov/pubmed/20040554
I can only quote evidence-based medicine, so please don’t shoot the messenger.
Loretta
Keith in Canberra,
Without wishing to sound disrespectful I am at a loss trying to understand the connection of thoughts existing in the mind of a single person with a subsequent event can amount to proof.
Faith is a placebo, prayers are a placebo!
You are wasting your time preaching to the converted, try a pulpit, or better still try to get a Facility for Undergraduate Medicine that is stand alone for the ACT.
Well put Loretta. Sounds like your Skeptic of the Year award was well deserved.
John Bennetts, Bogdanovist, Nuggett:
I have left off putting up a follow-up post for a couple of weeks largely because I was a little taken aback by the sheer viciousness and abusiveness of your posts! This will also be my last post here, as, far from preaching to the converted (that’s Loretta’s role here, I think), I am more like a heretic preaching to the Inquisitor. Your lack of respect and of any attempt at understanding of what I said does you no credit at all. Nor does your sheer naivety about the history and philosophy of science, not to mention sheer disinterest in the new science that is, in fact coming down the pike right now, whether you want to acknowledge it or not. Not my problem.
I would just like to point out that to say that ‘all science asks for is evidence, precisely the opposite of dogma’ is rather naive, and if you would like to know why that is, try doing just a little study in the philosophy of science. In fact, empirical science, like all areas of human knowledge, assumes all sorts of things that it can’t, and could never, actually prove, both in theory and practice. Nothing wrong with that, but it points up the fact that (empirical) science is actually a lot less different to other disciplines, like for instance history, than some like to think. Every discipline has its own forms of evidence, and has to take some things for granted - on faith, as it were. Occasionally, though, some of those things that it takes for granted shift underneath it, and a paradigm shift occurs. Such a shift is about to occur in biology. Check it out.
More generally, you all oppose empirical science to sheer quackery and lunacy, as if these were the only options. THAT is not a position that could be demonstrated from science itself, or indeed in any other way, but in fact is a faith position, which you evidently hold with at least as much ferocity as some of the religionist etc positions that you decry. To see that there are other non-empirical scientific disciplines, consider mathematics - is that an empirical science? Free your mind from dogma!
Loretta:
If the product I am taking had happened to be gingko, what I said would be pointing to clinical evidence which was contrary to the study you cite, so further investigation would be warranted. It isn’t gingko, as it happens, but your remark betrays the fact that you discount my information, and are in fact behaving less rationally than you claim to be. The rational thing would have been to ask for my reference, which I am happy to give. Here it is:
http://www.informaworld.com/smpp/content~db=all~content=a917924800
Well, I am signing off from this for good. Guys, try to lay off the trolling. I leave you with the immortal, though archaically expressed words of Oliver Cromwell:
“I beseech you, in the bowels of Christ, think it possible you may be mistaken!”
Keith