Two out of three Australians use complementary medicines to boost their nutrition, alleviate various symptoms and improve their overall health and well-being. There are around 10,000 products to choose from and they’re not cheap – the industry generates around $1.2 billion in sales each year.
Despite the availability and common use of these vitamins, minerals, herbal remedies, aromatherapy and homeopathic products, consumers can’t always be sure how effective they are.
While pharmaceutical companies are required to prove the quality, safety and efficacy of prescription drugs and over-the-counter medicines to the Therapeutic Goods Administration (TGA) before they’re “registered”, complementary medicines aren’t required to live up to the claims on their packaging.
Rather, complementary medicines are “listed” by the TGA after being reviewed for safety and quality only.
The quality requirement means the medicine is produced by a licensed manufacturer and adheres to the Good Manufacturing Principles. The safety requirement is important because the components and content of active ingredients can vary, particularly among herbal products.
The difference between registered and listed products, and whether they’ve proved their efficacy, is often not clear to the consumer. And as we saw with Ken Harvey’s recent battle with Sensaslim over allegations of false and misleading advertising, consumers can’t always believe the claims made by manufacturers about the efficacy of complementary medicines.
The public backlash after the Pharmacy Guild announced its (now defunct) plan to recommend Blackmores products to patients filling a prescription for four common ailments also shows consumers feel confused and misled about the efficacy of complementary products.
The TGA is expected to address this problem in the coming weeks by announcing that complementary medicines will soon have to carry a “not tested” label.
But labels alone wouldn’t provide enough information to consumers, who want to know whether the medicine works. For that, testing is required.
So how should these therapies be tested? And should the same rules that are applied to prescription and over-the-counter medicines be applied to complementary medicines?
Evidence-based testing
Pharmaceuticals are subjected to a series of randomised controlled studies to demonstrate their effectiveness. And while some complementary medicines have undergone similar rigorous reviews to demonstrate their efficacy, the idea of such evidence-based testing is problematic for many complementary and alternative medicine practitioners.
Practitioners of complementary medicines work in many different ways and their patients have varied goals.
Some complementary therapies, such as homeopathy and acupuncture, are based on the assumption that the human body has an energy level, with therapies having a physiological impact via the energy level. How could this be tested?
As Wainwright Churchill noted in an article in the Journal of Chinese Medicine, in order to test the efficacy of complementary medicines, you would first need to address some difficult questions:
Should the treatment that is researched be individualised for each patient?
Does it involve the personal relationship between the treating health professional and patient?
Does it involve the patient’s expectations, conscious or unconscious, of the treatment?
This leads us to the role of the placebo: Is the placebo effect a valid healing modality?
Sceptics deride the placebo. And yet, the placebo effect is powerful in all therapeutic relationships, in allopathic and complementary medicine. To be effective, placebos don’t even require conscious belief in a particular treatment.
Lesson learned
In determining a process by which complementary medicines should be evaluated, regulators should look to Switzerland for some lessons on what to avoid.
In the late 1990s, the Swiss government began a Program for Evaluating Complementary Medicine (PEK – Programm Evaluation Komplementärmedizin).
The findings of the evaluation were inconclusive but six years later, five complementary therapies were removed from the list of services covered by the national health insurance scheme. This occurred before all parts of the review had been completed and the process was far from transparent.
Recently, the Swiss government decided that from 2012 the five complementary therapies that had been removed from the health insurance scheme will be included again, at least for another six years. During that time, the organisations representing the five therapies will have to prove their effectiveness.
In Australia, consumers need reliable information about the effectiveness of all medicines, complementary or otherwise. The TGA’s plans to slap an “untested” label on complementary medicines simply isn’t enough.
It’s clear, however, that this world-first style of regulation won’t be easy. Regulators need to find testing methods that are acceptable to the majority of stakeholders – I’m not going to hold my breath but I hope we can one day achieve this goal.
Should complementary medicines be tested for efficacy? Share your comments below.
Join the conversation
Comments (43)
Susan Kirk
(Freelance Journalist)
I agree that consumers need to be safe when consuming complementary medicines. The solution, educate the consumers to consult qualified naturopaths or herbalists. They know of the efficacy and safety of herbal medicines, plus they will supervise the treatment.
This should mean more naturopaths/herbalists in chemists/supermarkets where these products are sold.
I am totally against having these products undergo the same sort of testing as pharmaceuticals. Here I agree with Russell Hamilton…
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Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
Susan says "The solution, educate the consumers to consult qualified naturopaths or herbalists. They know of the efficacy and safety of herbal medicines, plus they will supervise the treatment."
The problem is that they actually don't. Even the manufacturers of herbal medicines make incomplete or misleading claims about the medicines they produce, side effects and drug interactions are notoriously downplayed.
Complementary therapies in Medicine (2011) 19, 155-160
Susan says "There is plenty of…
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Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
Susan says: "Science doesn't know everything." This is true, but science has a pretty good idea of the difference between nonsense and plausible therapeutic effects.
Rey Tiquia
(Dr. at University of Melbourne)
Patients are now consuming this 'life energy' or 'qi' via the CAM clinical encounter. And the therapy they consume also embed this'qi'. CAM practitioners through their pedagogic training embody this 'life energy'.
Hence, we have here the three agential figures featuring in the CAM clinical encounter. It follows that in assessing the efficacy of CAM therapies, the patient diary; the practitioner's clinical case records and the N-of-1 type clinical trial can all be active participants.
gmopundit
(logged in via Twitter)
The indirect harmful consequences of misinformation and confusion still cause real damage to real people.The bad outcome for Steve Jobs's pancreatic cancer after his initial flirtation with complementary medicine is an example.
Complementary medicines that seemingly safe but ineffective --homeopathy comes readily to mind -- distract consumers from pursuing effective treatment for real diseases. Simon Singh in his fantastic book Trick or Treatment? explains this topic really well.
Fearmongering about synthetic pesticide traces is another cause of harmful health confusion. People don't get to focus properly on healthy life-style choices of exercise and sensible calorie intake because they spend too much energy on imaginary risks.
Susan Kirk
(Freelance Journalist)
Oh and 'the conversation' about the scoring tool. What an immature idea for such a grownup site : )
Luke Weston
Physicist / electronic engineer (logged in via email @gmail.com)
Those herbal medicines that actually work (which is the minority of them, but let's consider, say, St. John's Wort as an oft-cited example of a herbal medicine which is oft-cited as an example that has a some real degree of clinical efficacy) don't work because they contain some sort of magical happy plant powers. They work because the plant contains a pharmacologically active chemical.
Any herbal medicine which actually works does have a very real risk of very real side effects and very real potential…
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Luke Weston
Physicist / electronic engineer (logged in via email @gmail.com)
I forgot to add to the previous comment post... the same should also be applied to all other CAM modalities other than herbal products as well - evidence of safety and clinical efficacy should also be required for homoeopathy, acupuncture, chiropractic, and every other form of supplementary, complementary and alternative medicine.
Of course, when we say "evidence of safety" what we actually mean is an overall positive risk-benefit analysis, an overall benefit that justifies the risk, since no medical procedure or medicine or anything is absolutely free of any risk of adverse effects or complications.
Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
That is correct. There is a wide misconception that "natural" medicines aren't drugs, so consumers are not careful with them. Yet St. Johns Wort's active ingredients, Hyperforin and Hypericin, act in exactly the same way as fluoxitine (prozac), and have exactly the same side effects. Worse still, as people do not cionside them drugs, they will take alternative medicines with conventional drugs, which causes a significant risk of adverse effects. Probably one major reason that we don't see more adverse effects reporting is that most alternative therapies that have some physiological basis have too little active ingredients in them to have any effect.
Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
It is also important to realize that some herbal medicines have significant adverse effects by themselves, and can have adverse interactions with conventional medicines. St. Johns wort is an example of a herbal medicine that can have potentially lethal interactions. Ginkgo, taken by elderly people to help with their memory, can interact with the blood thinning medications many are on to produce sever bleeding.
Alternative medicines should not only be tested for efficacy but also for safety.
Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
I should also mention that several alternative medicines that have adverse health effects have no evidence for efficacy. Gingko, mentioned in my pervious post, has no effect on memory or Alzheimer's disease, but has the potential for significant adverse effects. This makes it MUCH worse than placebo. Automatically treating alternative medicines as placebos (relatively expensive placebos) is dangerous.
Tim Scanlon
(Climate and Agronomic Extension at Department of Agriculture and Food - Western Australia)
I'd like to see all of these "complimentary medicines" put through the same rigors of testing that every other drug or treatment has to go through. Ian, you missed the other big thing about these treatments, the ones that have some actual effective active ingredients can have compounding effects from normal drugs and treatments.
I'd also like to see the supplement industry undergo the same rigors. Currently there are mild poisons being marketed as weight loss supplements that when combined with some drugs will cause all sorts of health problems (e.g. heart failure).
Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
Hmm, I thought that "It is also important to realize that some herbal medicines have significant adverse effects by themselves, and can have adverse interactions with conventional medicines" covered all that (see also my reply to Luke Weston down below)
Stephen Lehocz
Mr (logged in via email @bigpond.net.au)
Hi Ian. You have raised some interesting points. But I must say, on some points you are very wrong.
Drugs are very much more expensive than herbs and supplements. The PBS cost us $8.3 Billion dollars in year ending July 2010. - That is one hell of a lot more than $1.8 billion for herbs and supplements. Remember our taxes, pay for the PBS drugs.
See - http://www.health.gov.au/internet/main/publishing.nsf/Content/pbs-stats-pbexp-jun10. and http://theconversation.edu.au/doctors-should-focus-on…
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Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
In 2004 the spend on complementary medicines was $1.8 billion, in 2004 the patient contributions to the PBS scheme was $0.9 billion (only twice as much, but this fall compared to previous estimates was in the wake of the Pan Pharmaceutics problem). We don't have reliable figures for the CAM expenditure in 2010, but given continuing growth of the CAM industry, and the underestimates of costs in previous studies of CAM expenditure, would suggest that the ratio of PBS spend to CAM spend is still quite…
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Stephen Lehocz
Interested public. (logged in via email @fastmail.com.au)
Ian, I was referring to he total cost of the PBS medicines, as you know that you and I as taxpayers pay for. The "out of pocketss" figure is a bit a phurphy really. The total costs of medical drugs far outways that of alt therapies, by a huge amount.
And are you saying that people are deluded in thinking that they have perceived a benefit from alt therapies?
One other point is that the placebo effect occurs in medical drugs as well too.
Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
You need to compare apples with apples, what the public actually spends themselves on conventional and complementary medicine.
Some therapies will be effective, mots are just expensive placebos.
Stephen Lehocz
Interested public. (logged in via email @fastmail.com.au)
But the public does spend money via the PBS Scheme, it is coming out of all our pockets via taxes as well as our wallets, so it IS comparing apples with apples.
I dare say most drugs are expensive placebos - with dangerous side effects - especially bearing in mind some of the ethically dubious activities the drug companies do. See the articles on Transparency and Medicine in The Conversation.
But they are sometimes they do work.
Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
The public cost of the PBS in taxes is spread out, so you personal spend is more representative of the cost to you.
"I dare say most drugs are expensive placebos" Really? lets take a random top 50 PBS drug, Enalapril, show us that it is no more than a pacebo with reference to clinician trials and meta-analysis.
Stephen Lehocz
Interested public. (logged in via email @fastmail.com.au)
I disagree on your costing. It's all a cost. Just because a pharmaceutical company sold it to the PBS does not mean we are not paying for it.
Enalapril - that's a bit unfair. I never said ALL drugs are expensive placebos, just most. But I will look it up
I make that assumption on the basis that I mistrust those trials which are done by the drug companies themselves, and especially when we don't have access to the raw data and all the results.
These articles highlight some of my concerns -
https://theconversation.edu.au/insight-into-how-pharma-manipulates-research-evidence-a-case-study-4071
https://theconversation.edu.au/why-data-from-published-trials-should-be-made-public-5599
Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
It's not unfair, it's simple statistics, if most drugs are placebos any random drug is likely to be a placebo. Just to be sure, here's rosuvastatin, clopidogrel, Insuin Galrgine (NOT plain insulin), Fentanyl and imantinib all randomly from the top 50 (well, not entirely random, I eliminated cancer treating antibodies as the stats are trickier and they are usually treatment controlled rather than placebo controlled). You can find meta-analyses for all of them.
Pharmaceutical companies don't "sell" anything to the PBS. Individual terms cost of the PBS in your tax is a small fraction (roughly 9%) of what you would spend on PBS drugs directly. And a chunk of your tax goes to supporting treatments like acupuncture, which are on the medical benefits scheme but don't actually do anything.
Stephen Lehocz
Interested public. (logged in via email @fastmail.com.au)
Well Ian, that's quite a task you set me. Give me some time on this.
Fair point on the PBS costs, but the figure I gave was actually of the cost of drugs to the PBS. Not the total cost of the PBS. My error.
"Pharmaceutical companies don't "sell" anything to the PBS." - are you sure? I know they do lobby and other similar marketing activities. To me that's selling isn't it?
But I think you missed the main point on my last comment, and that is the fact that the pharmaceutical companies do the testing themselves on their own products to present to the TGA and PBS. That does not seem right. There is a lot of money riding on the approval of these drugs. And there many indications of data manipulation etc, as those two links in my previous comment (above) shows.
Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
It's the sort of task you should have done *before* making your claims, It's not that hard, just search on "cochran collaboration meta-analysis" for each drug, but take your time to do it properly.
Drug companies can't lobby the PBS, it's recommendations are based on a panel of experts who take into account drug efficacy as well as risk benefit and cost benefit (also it's the TGA who registers drugs, they are separate from the PBS board).
Who else is going to do the testing? It takes between a quarter to half a billion dollars in testing, with mots of that cost being the safety and to bring one drug to market, do you as a tax payer wish to cover that cost for every new drug?
Stephen Lehocz
Interested public. (logged in via email @fastmail.com.au)
That's rubbish and you know it. I have more than enough data to voice my suspicions.
As you said, I need to take my time to research the drugs properly.
I very much dispute that drug companies cannot lobby the various agencies. Officially or unofficially a lot of pressure can be applied in various ways.
Who should do the testing? I'm not sure who/how exactly but it should definitely not be the companies themselves who are most decidedly capable of withholding vital data about a drug. It has been done before. It is illogical to expect them to hand out all the data when they have full control of it, and so much money is at stake. It is definitely possible that a lot of vital data is withheld.
There is certain to be dubiously ethical people in any area of endeavor.
Let's be clear about this, I am not saying all drugs are bad. But there is a lot of cleaning up to do in the pharmaceutical industry.
Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
No, it's not rubbish. The PBS board is set up to be independent from interference (I know someone of the boards, and they would not be pressured by outside interestests). The rate at which the PBS returns verdicts that drug companies are unhappy with suggests that drug companies do not have it their own way.
I approving drugs, the drug companies are required to hand over the original data to independent evaluators, who will then go through the literally boxes of data checking it is correct.
Stephen Lehocz
Interested public. (logged in via email @fastmail.com.au)
Ian, here is another article that illustrates my point that most drugs are expensive placebos, and most of them would have serious side effects.
http://www.nytimes.com/2012/04/11/opinion/drug-data-shouldnt-be-secret.html?_r=1
Found this article from the Cochrane Collaboration website. It is written by two their authors. Withheld data, and very dubious benefits for the drug Tamiflu, by the drug firm Roche. THIS IS ONE VERY EXPENSIVE PLACEBO.
Now for the side effects :
http://www.drugs.com/sfx/tamiflu-side-effects.html
Though it would be very unfair to decry Tamiflu on the basis of this last article, it does highlight the danger of withheld data by the drug companies, especially bearing in mind that there are psychiatric side effects as well. And Roche has been shown to withhold vital data.
Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
One example of a drug with exaggerated claims by the sponsor does not mean *most* drugs are placebos.
Tamiflu is not a placebo though see this anaylysis by the same people who did the NYT article
http://summaries.cochrane.org/CD008965/a-review-of-unpublished-regulatory-information-from-trials-of-neuraminidase-inhibitors-tamiflu-oseltamivir-and-relenza-zanamivir-for-influenza
It's moderately effective for prevention and treatment of symptoms of influenza, but doesn't seem to prevent person to person transmission (bummer)
To show that *most* drugs are placebos you have to show that at least 51% of all drugs are placebos. Showing that one (non placebo) drug has exaggerated claims is not that evidence.
Stephen Lehocz
Interested public. (logged in via email @fastmail.com.au)
Hi Ian. True, it's not proof of 'most drugs are expensive placebos with dangerous side effects’, but it does highlight the point about drug companies withholding data. And to show that more than 51% of drugs are placebos with serious side effects, would be a truly monumental task, due to the number of drugs available.
Also in that report your referencing, they also said this -
" .........There is evidence to suggest that both drugs are associated with harms (oseltamivir: nausea, vomiting; zanamivir…
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Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
Even if you think it is a lot (10% 20% how many exactly) you still need *evidence* that a significant number of drugs are placebos.
Where is this evidence?
Stephen Lehocz
Interested public. (logged in via email @fastmail.com.au)
I don’t know - what would satisfy you?
But the point also is that to get the hard ‘evidence’ would require some honest trials, wouldn’t it? I know I’m not going to run any trials. And the available trials have some flaws, as for example in the Tamiflu case as the Cochrane Collaboration pointed out. All I can give is some random sampling, of what I found, and some data would obviously be missing if some companies are not divulging all the data as highlighted in the above example of Tamiflu…
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Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
So use cochrane meta analyses, as I said in the first place.
Stephen Lehocz
Interested public. (logged in via email @fastmail.com.au)
Most definitely rubbish. I certainly have enough data to voice my suspicions, with a large degree of certainty that I am right.
As to the PBA and the TGA, I'm sure your are right, and that they are ethical and diligent, but pressure can still be applied in various ways as shown in these articles:
https://theconversation.edu.au/insight-into-how-pharma-manipulates-research-evidence-a-case-study-4071
https://theconversation.edu.au/insight-into-how-pharma-manipulates-research-evidence-a-case-study-4071
So I still most definitely question some of the findings of various trials. Just because they are published, accepted and agreed with by many of your colleagues does not necessarily mean they are well done , unbiased, complete and accurate trials.
Stephen Lehocz
Interested public. (logged in via email @fastmail.com.au)
Whoops the second link should have been this one :
https://theconversation.edu.au/pharmas-influence-over-published-clinical-evidence-5325
Susan Kirk
(Freelance Journalist)
Ian said: The problem is that they actually don't. Even the manufacturers of herbal medicines make incomplete or misleading claims about the medicines they produce, side effects and drug interactions are notoriously downplayed. (Complementary therapies in Medicine (2011) 19, 155-160)
Now we are getting caught up in the semantics of 'trust' This sort of statement can be attributed to pharmaceuticals. How about the issue of Doctors 'upselling' certain drugs for backhanders. The issue of ghostwriting…
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Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
No, it's not about the semantics of trust, it's about actually *knowing* what the side effects and hazards of herbal medicines are. You claimed that herbalists and Naturopaths know these things, but all evidence is that they don't.
Susan Kirk
(Freelance Journalist)
Ian, can you please show me the paper you are referring to that stipulates herbalists and naturopaths do not have adequate training. I assume that is what you are implying?
Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
In Australia herbalists and naturopaths are still allowed to practice with no qualifications or training. Even where there is training, courses are still being offered at the inadequate certificate and diploma level, many with as few as 6 months training, so having a document is no guarantee of adequate training for prescribing.
See
Complementary therapies in Medicine (2011) 19, 155-160 and
http://www.abc.net.au/unleashed/40276.html
http://www.homeopathyoz.org/downloads/Workforce%20Survey%202004.pdf
http://www.tga.gov.au/pdf/archive/committees-eccmhs-report-031031.pdf
Susan Kirk
(Freelance Journalist)
I also have to question this by the author of the article:
"The public backlash after the Pharmacy Guild announced its (now defunct) plan to recommend Blackmores products to patients filling a prescription for four common ailments also shows consumers feel confused and misled about the efficacy of complementary products."
I don't think there was any confusion or backlash from consumers. My understanding was the backlash came from the AMA full stop.
Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
Your understanding is wrong.
Russell Hamilton
Librarian (logged in via email @gmail.com)
Who knew, until The Conversation, how miffed academics are that CAM apparently solves problems that they can't.
You find just as many CAM practitioners in areas with highly educated residents as otherwise - does this prove that education doesn't help one think?
Perhaps academics should start to consider the large number of educated, intelligent, informed people who use CAM as, in fact, evidence. People don't usually want to waste their money, and are quite capable of trying something out to see if it works. I know what works for me, and don't care if the academic use of 'the scientific method' can't explain it.
Stephen Lehocz
Mr (logged in via email @bigpond.net.au)
Interesting article. I agree that special attention needs to be addressed to the efficacy of drugs, since when they are trusted to work, and don’t, the consequence’s are truly horrific i.e. deaths, suicides, major health complications, etc. http://www.newscientist.com/article/mg19125621.300-medical-roulette-dicing-with-death.html.
Even when medicines work, the side effects are sometimes worse than the ailments they are trying to cure. http://www.pharmacytechs.net/blog/8-pharmaceuticals-with-worse…
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Ian Musgrave
(Senior lecturer in Pharmacology at University of Adelaide)
If complementary medicines actually DID solve problems other medications didn't they would be used in standard practise. However, the vast majority of "complementary medicine" has no evidence of actually benefit (and some of actual harm).
Educated and intelligent people are just as capable of being fooled as the next person. I know highly intelligent people who didn't understand that herbal therapies were drugs (for example St. Johns Wort, whose active ingredient, Hyperforin, can cause significant…
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Stephen Lehocz
Interested public. (logged in via email @fastmail.com.au)
So your saying that anyone who perceives a benefit from complementary medicines is only fooling themselves?
And the only valid improvements that can be perceived by anyone are from drugs?
That's what you seem to be saying.