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ON 30 January, La Trobe University announced that it had signed a memorandum of understanding with the Swisse Wellness company.
The partnership would be a first step in establishing a centre to subject “complementary” medicines to rigid scientific testing for efficacy. Emphasis would be directed at testing Swisse’s own products.
Surely a good news story?
One suspects that the university — or at least its deputy vice-chancellor for research, Professor Ken Nugent — would have been amazed at the immediate storm of criticism that greeted the university’s initiative.
Genuine drama characterised the controversy when the university’s own Professor of Public Health, Ken Harvey, publicly resigned in protest.
He and many other commentators were concerned by the potential conflict of interest, with numerous studies emphasising how such arrangements can, and often do, produce biased results.
Professor Harvey has long been the leading advocate for the use of complementary medicines to be evidence-based and has been a long-time critic of the claims Swisse makes for many of its products. Ironically the university had published his criticisms in its own journal.
Perhaps the most interesting and disturbing questions that emerge from this planned partnership involve the apparent failure of a major university to subject the track record of its proposed partner to “due diligence”.
Why was their “in-house” expert on all things Swisse not consulted? Did the university know that Swisse had been rebuffed when it approached Bond, Monash and Sydney universities with the same deal?
Did La Trobe know that Swisse had been severely criticised for offering GPs financial incentives to supply special versions of their products for sale in doctor’s surgeries?
A Therapeutic Goods Administration (TGA)-sponsored review panel would not accept that studies sponsored by Swisse supported the claims being made in its advertising. Indeed, the panel decided that many of the claims made by Swisse breached the TGA’s advertising code.
It could not be seriously argued that Swisse is really interested in the evidence base for their claims. If they were, why haven’t they asked the TGA for registration rather than listing for their products? Registration requires that any therapeutic claims undergo independent scientific evaluation.
La Trobe’s Professor Nugent, an outstanding physicist, with an enviable and well deserved national and international reputation, took the controversy to the Australian public with an article in The Age, asking consumers if they would like to know if the supplements they are taking are really doing them any good?
This would suggest Professor Nugent knows as little about the myriad of excellent studies on the questions he asked as I know about quantum mechanics and chaos theory. Good science tells us that average Australians taking supplements will get no relief from stress or more energy by taking vitamins and they do not need to regularly detoxify their liver.
Clinical scientists would support an initiative at La Trobe that facilitated the conduct of independent and disinterested scientific evaluations of alternative and/or complementary therapies where the anecdotal evidence for benefit is strong and the proposed method of action is plausible in the light of established knowledge and therefore does not involve pseudoscientific concepts (eg, homoeopathy). After all, this is how scientifically validated therapeutics have been developed and become so important in modern medicine.
The Swisse claims for the contents of its products have been thoroughly tested and found wanting and require no additional research. The Swisse deal should be abandoned.
It would not be fair to suggest that Swisse is the only culprit in misleading Australians about the need for supplements. Many other companies are similarly guilty, if not to the same extent.
Clearly we doctors need to do more to convince Australians that they cannot neutralise an unhealthy lifestyle with supplements and with out-of-pocket health care costs soaring they could collectively save themselves $2 billion a year by only buying these supplements if they are advised to do so by their doctors.
Professor John Dwyer AO is the president of the Friends of Science in Medicine and emeritus professor of medicine at the University of NSW.
This is the first of a two-part series by Professor Dwyer on complementary medicine.
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A simple response to all this controversy surrounding complementary medicine..
If there is a general opinion that it is not a worthwhile to pursue other methods than those based on “evidence”, why then one might ask why are major pharmaceutical companies as well as several world universities, conducting trials in other forms of treatment than drugs.
The real issue is that, in general, stakeholders prey on the public’s “search” for “alternatives”, portraying these as treatment alternatives, which they are not, and to play the “doctor” which they are not. Promoting that good health requires a diverse diet and exercise with care is in everybody’s interests. What supplements do is another issue. Evaluating a “chemico-(pharma)-ceutical” happens all the time. We have come to associate scientific design with head to head or controlled studies, randomised and double blind to account for any variables, measured or unmeasured, yet even this may not be consistent with best practice and does not ensure clinically meaningful research (CMR). The basis of the paranoia that surrounds pharmaceutical company involvement and advertising is the stringency of these requirements and the assumption that scientific stringency is consistent with CMR, which is not necessarily the case. For clinical relevance it makes sense to test the combination if that is what will become marketed. Brands comparisons, and placebo and double blind studies are possible even with grouped formulae. Combination therapy is now common practice.
We do not see a mention of the Johnson & Johnson to pay $2.2 billion to end U.S. drug probes. (Nor from 1999 through 2005, J&J and its subsidiary Janssen Pharma promoted Risperdal for unapproved uses, including controlling aggression and anxiety in elderly dementia patients and treating behavioral disturbances in children and in individuals with disabilities. The marketing of the anti-psychotic drugs Risperdal and Invega and the heart drug Natrecor over several years.) J & J’s conduct “recklessly put at risk” the health of children, dementia patients and others to whom the drug was prescribed at a time it was only approved by the U.S. FDA to treat schizophrenia. BEIJING (Reuters) Jul 11 – Executives of GlaxoSmithKline in China confessed to charges of bribery and tax law violations, the country’s security ministry said, in one of the most prominent graft cases involving a foreign company in three years. I am sorry, but let us put things in context here. Yes we know there is bribery and corruption everywhere. What we really need here is a tightening of the law to stop this type of activity. One suggestion was that the CEOs of these companies be indicted and imprisoned for falsifying evidence of efficacy where trials are shown to be flawed. However, people who live in glass houses should not throw stones – a solution would endear everyone to the public who want ‘natural alternative medicines’ rather than spending such energy in criticising, which is seen by some as an effort to outlaw CAM. I have no vested interest as I do not take CAM nor Allopathic medicine in my life at this time, and hope to keep it that way – but I have a healthy respect for both.
Further interesting discussion of this partnership is given by Paul Biegler in the Conversation article http://theconversation.com/alternative-medicine-research-must-be-publicly-funded-23293 .
There was much back slapping between the La Trobe Vice-Chancellor and his senior staff over this deal. Like tge cats that found the cream and got a wonderful deal ahead of other universities. Now we hear that the respectable universities had closed their doors on this! We’re not happy here at La Trobe.
La Trobe has a key priority to establish a rural medical school with Fiona Nash/Nationals support (although the financial burden may well sink the ship) so maybe this is considered important health research to underpin this bid?
La Trobe has unfortunately not performing well in the ranking stakes (including research) and is today listed as last of 13 Australian universities (down places in a year to #88) in the top 100 universities under 50 years of age. This Swisse project will only distract them from the kind of respectable research they need to deevlop to address with this slip in the important rankings.
http://www.timeshighereducation.co.uk/world-university-rankings/2013/one…
Deakin also turned down the Swisse offer because Deakin apparently insisted on double blind testing and this was not favoured by Swisse. It’s so good to have universities who remain true to their core purpose and responsibility. The general public, medical profession and taxpayers value the stand.
The watershed for deciding whether La Trobe would be conflcited or not would be to ask:
“If independent trials undertaken by La Trobe found a product was not beneficial for the indication advertised and tested for, would Swisse stop marketing it?”
If not, then this becomes a one-way ratchet: the company would only use good results (in marketing) and ignore the bad. And so the only way we could be assured that this wasn’t simply a marketing exercise would be a prior sign off by the company to stop peddling ineffective treatments.
Is that likely?
I dont think due diligence was conducted on either side. la Trobe’s lack of due diligence is referred to above, but Swisse seems not to have conducted due diligence. La Trobe has a self-professed $65m “budget black hole” and a recently self-professed $30m cashflow shortfall/error. Complementary medicine research is not a La Trobe strength and is certainly not listed in its strategic plan (Future Ready) as something it sought to grow. Seems opportunist and ill informed poor judgement by the leadership of both parties in this unfortunate partnership.
I fail to understand why certain medical professionals are wasting their time on trying to put Complementary medicine out of business. Could it be that they are not proficient enough to divert their efforts and time to other topics? Supplements have been around for a very long time, albeit not as sophisticated as they are today, most have sound physiological and pharmacological background, and there is not much hope that they will be put down.
Besides, we in glass-houses should not throw stones. ‘Scientific medicine’ and Phamacological companies manufacturing such medicines, table details about their products, but do prescribers really care to study these before they presribe and do they care to stop prescribing if or when adverse effects are noticed? I doubt it.
Bruni said, “Manufacturers of complementary medicines sold in Australia still have to comply with quality and safety standards for their products and have some evidence to back up their claims.”
In fact, the TGA runs a trust-based system in which sponsors of Listed products (most complementary medicines) self-certify compliance with the above requiements. The National Audit Office has reported that limited post-marketing surveillance by the TGA has shown a high level of non-compliance, see: http://tinyurl.com/7qwtfja.
In addition, a recent survey of 121 herbal medicines available for purchase in South Australia found 22 (18%) products were not Listed on the Australian Register of Therapeutic Goods (ARTG) despite this being a legal requirement for their sale. Of the remaining products 59 (60%) had differing ingredient concentrations on the website compared to their ARTG listing. Only three of the 15 purchased products had ingredient concentrations which were consistent between the website, ARTG listing and product packaging. See: http://www.sciencedirect.com/science/article/pii/S1752928X14000092.
Manufacturers of complementary medicines sold in Australia still have to comply with quality and safety standards for their products and have some evidence to back up their claims. For more information on the Government rules for complementary medicines sold in Australia, see the Therapeutic Goods Administration’s The regulation of complementary medicines in Australia – an overview webpage.
Complementary therapies are widely used in Australia. A survey conducted by NPS Medicinewise in 2008 revealed that 65 per cent of Australians had used one or more complementary medicines in the previous 12 months.
Complementary therapies are often based on traditional knowledge, which is why there is sometimes less scientific evidence available about their safety and effectiveness.
However, the increasing use of complementary therapies has begun to trigger scientific research and some complementary therapies now have some scientific evidence about their safety and effectiveness, as well as a history of traditional use. Sometimes, they are less invasive and more cost-effective than conventional medical treatments. Nonetheless, it’s still important to ask about both potential benefits and potential harms of any therapy.
Natural and complementary medicines can be bought without prescription; however, they may still have side effects or interact with other drugs, or they may not be the most effective treatment for you. So yes, I would check with a doctor who doesn’t have an aversion to using complementary medicine to ensure I get the treatment I want. And I would like to see more unbiased research in this area.
Ever heard of Cochrane??? see “Trick or Treatment” by Edvard Ernst Professor of Complementary Medicine University of Essex UK.
This discussion is not purely about whether there is any role for industry collaborating with academia – it is also about the governance structure of such a collaboration, and the characteristics of the participants. This company has a track record, documented publicly, of complaints upheld by the investigators – easily found with the most basic search. Many of these products are not new discoveries, they are re-packaging of existing substances – supplements, vitamins and herbs (including simple ground cassia), which already have their roles and physiological activity documented.
Only small people are subject to laws and principles. Doctors are increasingly accused of conflicts of interest when they accept “support” from industry to speak at or attend meetings. But $15million dollars? What price now conflicts of interest? And on a related topic…. Drs soliciting bequests for their institutions from sick patients? The push for greater accountabiliy of front line medical staff is characterised by hypocrisy and hidden agenda. Accountablity should be a founding stone of civil society but has become the catch carry of those seeking to justify their bureaucratic existence by the harvest of easy targets. It seems you wish to cheat, aim big and ally yourself to a legal infrastructure where cheating is given a legalised whitewash.
I remember in my university days a group came into the biochemistry laboratories and proceeded to video a product. Can’t recall the product but I then heard an ad for that product saying university tests prove…..
A serious error of judgement by the senior leadership of La Trobe University. If they are short of funds or need a good project for the resumes, why compromise a university with a proud tradition of research in many areas. $15m aint enough.
Mokely’s seemingly reasonable argument is betrayed by his two inclusions “Good science should always be welcome” and “A head in the sand attitude to further proper research can only assist the current problem of shonky claims,…”
As Ken Harvey clearly shows, good science will always welcome but excludes window-dressing science, which seeks to use universities and their credibilty for spurious ends by avoiding the clear and well understood scientific protocols by which disinterested research should be conducted. Dr Harvey, even in his letter of resignation, provides clear indications as to how such research could be conducted in a university in ways that avoid the problems of conflicts of interest and more. Nobody arguing against this arrangement is putting their head in the sand, but they do want ato avoid having the wool pulled over their (and everyone else’s) eyes.
La Trobe University will have an actual conflict of interest, not merely a potential one. It will be obliged to please its pay masters so that it does not lose funding, and obliged to make sure that research is being done. As for Swisse, the can use La Trobe in their marketing even before the first trial has started! The scheme is just crazy.
The problems with research on specific branded products include
(a) the design of the research, which may be done in such a way to promote the particular product
(b) the publication of results, which may not occur if the results are unfavourable to the supplement
I support La Trobe (and other Universities) being involved in complementary medicine research; my concerns were about receiving money from Swisse to specifically assess their products.
Would we really want University researchers to spend their time assessing, for example, Swisse Men’s Ultivite which contains 52 “premium quality” vitamins, minerals, antioxidants and herbs in a potpourri of ingredients many of which lack any logic (and are present in non-standardised, sub-therapeutic amounts) but presumably are included in the hope that “more is better” has marketing appeal? What about Swisse “Liver detox” and “Ultiboost Hunger control” (the subject of a 2013 ABC Checkout program)?
There are a few Australian sponsors of complementary medicines, such as Flordis, that are doing the hard yards; commissioning expensive high quality clinical trials and then getting their products registered by the TGA (which requires a full evaluation of their quality, safety and especially efficacy). These are the sponsors that a University should be assisting (&/or partnering with).
In addition, natural products can be a source of useful new medicines when the active ingredient is isolated, identified, standardised and subjected to appropriate clinical studies. A recent example is artemisinin, a life-saving antimalarial isolated from Sweet Wormwood. This is another type of research that should be pursued by university–industry collaboration.
However, these were not the kinds of research proposed by the La Trobe University–Swisse collaboration!
The complaints about Latrobe University are to my mind rather purist. Good science should always be welcome & repetition is surely not a problem in this case, as the public penetration of existing trial data has been so limited that spurious marketing flourishes.
Keep shining the light! But just make sure that the trial designs are sound & independent. Maybe some good will flow from further sound results that are then well publicized.
A head-in-the-sand attitude to further proper research can only assist the current promotion of shonky claims, especially if they can be propped up by statements that scientists won’t accept the challenge offered.