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1 September 2011, 6.42am EST

Flogging a dodgy cancer ‘cure’? Say what you like, the TGA won’t stop you

If a manufacturer claimed its product was “clinically proven” and could relieve your symptoms of bloating and fatigue, would you believe it? What about if you were chronically or terminally ill and had tried almost everything else? The latest audit of complementary therapies found as many as nine out…

Mickey_liew — Complementary medicines need tighter regulation. Mickey Liaw

If a manufacturer claimed its product was “clinically proven” and could relieve your symptoms of bloating and fatigue, would you believe it?

What about if you were chronically or terminally ill and had tried almost everything else?

The latest audit of complementary therapies found as many as nine out of ten companies made misleading claims about their weight loss products, vitamins, lotions, pills and gadgets.

The release on Tuesday of the Australian National Audit Office’s (ANAO) report on the Therapeutic Goods Administration’s (TGA) performance as regulator of complementary medicine products makes for alarming reading.

The current system of regulation relies on benign oversight from the TGA in what is essentially an “honour system”.

Manufacturers or importers of products (known as sponsors) are simply asked to state that they have evidence that their product is, in some way, effective and is not dangerous to consumers, even if used improperly.

It appears that many manufacturers are happy to provide these assurances but can’t produce the evidence to back them up when the TGA comes knocking.

It’s hard to picture an industry in greater regulatory disarray. So what went wrong?

The ANAO report states that back in 2005, when the regulatory processes were being finalised, the government believed that limited audits would be enough to monitor compliance.

They didn’t foresee that 70 to 90% of sponsors across the entire range of products would mislead consumers.

Around a third of the cases were rated by TGA as “moderate” or “significant”, which includes claims that a product can cure cancer or other serious diseases.

Since 2003, the TGA has allowed sponsors to apply online for listing on the Australian Register of Therapeutic Goods (ARTG). This listing means the product is deemed safe for sale, but does not mean it is deemed effective by TGA.

The process is overseen by a piece of software called the Electronic Listing Facility (ELF).

Since the late 1990s, more of the processing has been done by ELF, and the current version (called ELF 3) has fully delegated powers to approve products for sale if they pass its electronic filter during the listing process.

ANAO identifies a number of problems with this approach, not least of which is that “some sponsors may, on occasions, be entering incorrect information into the ARTG intentionally.”

Back in 2005, the government instructed the TGA to collect, and make public, the clinical evidence that sponsors had provided to demonstrate their products were safe and effective. This hasn’t occurred and the TGA can’t explain why.

There’s an enormous amount of clinical trial evidence about the effectiveness or ineffectiveness of many complementary medicine treatments. But consumers can’t possibly be expected to do their own high-level research.

Sponsors currently take advantage of this by failing to update their advertising claims as new trials are completed and the results published. They know the average Australian isn’t reading academic health care journals.

To add to that, the TGA’s Advertising Code is regularly breached with impunity. In fact, for 2011 alone, out of 82 complaints made about complementary medicine products, all but two have been upheld. (The two that were dismissed were brought by a rival company to the one complained about).

So how can this troubled regulatory process be turned around?

On top of improvements to the TGA’s internal procedures, software and website upgrades (some of which are already underway), ANAO recommends the TGA take a more proactive approach to finding breaches of the regulations.

ANAO investigators did their own trial of “proactive regulation” by searching online for the terms “TGA approved” and “safe”. Both terms are unlawful to use in the advertising of complementary medicines but the report found thousands of examples from Australian websites.

Three examples were so outrageous they reported them to TGA, which promptly ordered the advertising to be changed. When the ANAO checked the websites before finishing their report, two of the three had not complied.

This illustrates the disrespect that the TGA is up against. There’s clearly a need for greater powers of enforcement – but unfortunately this wasn’t recommended in the final ANAO report.

All sides of politics will need to add complementary medicine regulation reform to their long-term health care agendas if any useful change is to be achieved.

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9 Comments sorted by

Thomas Marshall

Postgraduate Student

I think there is an element of natural selection here.

over 1 year ago report
Jon Wardle

NHMRC Research Scholar, School of Population Health at University of Queensland

For an article that goes into so much detail of this long acknowledged issue (in fact it was reported by the Department itself in the infamous Red Book briefings for the incoming government last year) I have to say I am incredibly surprised that the article makes hardly any mention of long-standing TGA acknowledgement of the issue and the significant changes the TGA are currently making to the listing process to counter the very problems Dr Vagg raises. Methinks the disrespect the TGA faces is in many ways being fomented by articles such as this by overplaying what has happened in the past and underplaying what is currently happening or developments that will shape what happens in the future.

over 1 year ago report
1. Michael Vagg
  
  Clinical Senior Lecturer at Deakin University School of Medicine & Pain Specialist at Barwon Health
  
  In reply to Jon Wardle
  
  The ANAO makes extensive mentions of the lack of progress on a number of longstanding projects, so I believe my comments are fair.
  
  Some of the deficiencies of TGA internal practices are remarkable for a body which regulates a $2bn (or so) a year industry, eg not reporting outcomes of investigations to TGA executive, not communicating outcomes to complainants and so on.
  
  I do acknowledge in the article that some of the recommendations were to speed up or complete projects already underway within…
  Read more
  
  The ANAO makes extensive mentions of the lack of progress on a number of longstanding projects, so I believe my comments are fair.
  
  Some of the deficiencies of TGA internal practices are remarkable for a body which regulates a $2bn (or so) a year industry, eg not reporting outcomes of investigations to TGA executive, not communicating outcomes to complainants and so on.
  
  I do acknowledge in the article that some of the recommendations were to speed up or complete projects already underway within TGA. If it surprises Jon that I think the TGA should have been doing more over the last 6 years, I can only add that it seemed to surprise and disappoint the ANAO as well.
  
  The TGA is held in very high regard by the Australian public, health professionals and most of the industry that it constituted to regulate. The disrespect I speak of is that shown by Sponsors who try to game the system and shirk their responsibility to their customers. I think everybody agrees that we should see a TGA whose maximum penalties are a proper deterrent to substandard or cynical operators rather than a laughingstock.
  
  over 1 year ago report
2. Jon Wardle
  
  NHMRC Research Scholar, School of Population Health at University of Queensland
  
  In reply to Michael Vagg
  
  I maintain my comment that you have not fairly reflected the significant current reform in this area by the TGA, including software, procedural and structural modifications, and as I understand a more proactive approach. I think that your comments are unfair to the TGA, government ministers (especially Mark Butler) and the countless stakeholders who are working and have worked hard to bring about improvements to the situation. I can only assume that you seem to think that the ANAO report is an indictment…
  Read more
  
  I maintain my comment that you have not fairly reflected the significant current reform in this area by the TGA, including software, procedural and structural modifications, and as I understand a more proactive approach. I think that your comments are unfair to the TGA, government ministers (especially Mark Butler) and the countless stakeholders who are working and have worked hard to bring about improvements to the situation. I can only assume that you seem to think that the ANAO report is an indictment of this reform, rather than being a part of the process of it.
  
  It certainly takes time but given the enormity of the changes I think that it is understandable. I also don't think that the report or your article fairly took into account the disruption in implementation as a result of the failure of the development of a Trans-Tasman agency, which had been a focus of the TGA for a long time, in many respects the TGA is just recovering now.
  
  You can either make changes quickly and dramatically, or you can follow process and do them properly, which is much better for addressing long term. Very few people understand the time good policy takes to develop. There is much work to be done, but the TGA actually has more stringent requirements than any other jurisdiction for CAM, and I think this is something that should also have been acknowledged. It needs to be built on, yes, but at least unlike most jurisdictions there is at least something there. Given that Australia is the first jurisdiction to face up to these problems, it is understandable that it will also be the first to encounter new problems in CAM regulation, and to the TGA's credit it regularly develops new arrangements when problems are made explicit.
  
  I agree that the current listing processes and advertising arrangements (in which notable problems exist for all DTCA, not just CAM by the way) are too weak and not enforced, and made such comments as such in my public submission to the recent TGA consultation, in fact many of my comments were very similar to the ones that you've mentioned.
  
  However, despite writing this article I note that you had made no public submission consultation, though you are a regular complainant to the TGACRP. If you were as interested in substantial long-term change for public health benefit, rather than short term superficial victories, I would suggest that working with the TGA to develop changes, not just complain they don't make them fast enough.
  
  It may also be of interest to note that both TGA and Ministerial sources have acknowledged that responding to co-ordinated and activist individual complaints campaigns have significantly diverted resources that would otherwise have been devoted to the very reform you seek, and have been a major part of delays in implementation. They may provide public short-term victories, but they are essentially pyrrhic and do little to help protect public health in the longer term.
  
  It's easy to point out and publicise the problems, it's not so easy to be constructive in facilitating proper change.
  
  over 1 year ago report
Stephen Lehocz

Mr

One does not need to read academic health journals to decide if something has relieved or cured their condition or made it worse. The general public is actually very intelligent and they are capable of quickly seeing what works and what does not.
A quick search by me on google, has failed to find any deaths from herbs or vitamin supplements. Even before the creation of the Therapeutic Goods Administration (TGA) there were few/no deaths. I’m sure there would be some that could be discovered with a…
Read more

One does not need to read academic health journals to decide if something has relieved or cured their condition or made it worse. The general public is actually very intelligent and they are capable of quickly seeing what works and what does not.
A quick search by me on google, has failed to find any deaths from herbs or vitamin supplements. Even before the creation of the Therapeutic Goods Administration (TGA) there were few/no deaths. I’m sure there would be some that could be discovered with a deeper search. Personally, I do recall up to three reports in the media of deaths attributable to herbs/supplements, over the last 15 years.
Yet there are many deaths and serious side affects, attributable to medically prescribed (hence medically and professionally supervised) taking of drugs. Even over the counter drugs. Even a quick search on google will find information on this.
This would tend to indicate that herbs and supplements are relatively safe and that drugs, even medically prescribed and supervised are highly dangerous. Does this not show where the real dangers lie? And that the attention of the TGA and other regulatory organizations should be more focused on drugs and the people prescribing them?

Don’t get me wrong I have the greatest admiration for the medical profession for the work they do, what they have achieved, the responsibilities they bear and what their drugs can achieve. But they should accept (and many do) that herbs and supplements are very safe with no side affects.
As Dr Karl on the ABC put it 'don't take antibiotics unless you really, really need them. And conversely, if you need them, do take them.’

And if the medical profession has stated something cannot be cured by them, who are they or anyone else for that matter, to tell patients there is nothing that can be done, or that nothing else will help?
It is not always a cure that a sufferer is looking for, sometimes it’s just something to alleviate the discomfort and make their life a bit more comfortable. And I and many others have found that herbs and supplements can do this. At very little financial cost and no side affects. This is from our personal experiences. Four billion dollars a year spent on alternative health products (see http://theconversation.edu.au/alternative-therapies-without-evidence-they-do-more-harm-than-good-1547) would tend to indicate that a vast number of Australians find this to be true.

over 1 year ago report
Bayne A M Geikie

water quality specialist

Complimentary medicine may have it problems with overzealous claims, but, orthodox/mainstream medicine has been shown to posses an industrial scale corruption when it comes to falsifying results & reports, not to mention the stupendous fines they pay when occasionally caught out...which doesn't really stop the corrupt activities. TGA doesn't really go after them either - yet the health consequences are far more devastating considering the scale of deceit.

over 1 year ago report
wilma western

logged in via email @bigpond.com

Experts and government complain about generally anti-science attitudes in the community , and yet the sale and promotion of unproven if generally harmless pills and potions is apparently done with the imprimatur of the TGA and their o.k. depends on inputs( which may be deliberately inaccurate according to ANAO ) by the companies hoping to profit from their remedies into a system called ELF!! Fairies at the bottom of the garden anyone ? Even if quack cures are harmless in themselves , when they replace properly accredited medical care they can be downright dangerous. As some commentary already shows, unproven remedies are often promoted not just on their claims of efficacy but also on misinformation about mainstream medicine, even downright defamation of mainstream medicine and science ( I do know you can't defame a group of people, but what else do you say about accusations of corruption relating to established medical institutes , bodies like the CSIRO and others? )

over 1 year ago report
Ken Harvey

Adjunct Associate Professor of Public Health at La Trobe University

John Wardle states that both TGA and Ministerial sources have said that responding to co-ordinated and activist individual complaints campaigns have significantly diverted resources that would otherwise have been devoted to the reforms they seek.

I have been engaged with the TGA, both formally and informally, for many years. A decade after problems with the promotion of Listed medicines and the regulation of complementary medicines were first documented, I acknowledge that a few measures to redress…
Read more

John Wardle states that both TGA and Ministerial sources have said that responding to co-ordinated and activist individual complaints campaigns have significantly diverted resources that would otherwise have been devoted to the reforms they seek.

I have been engaged with the TGA, both formally and informally, for many years. A decade after problems with the promotion of Listed medicines and the regulation of complementary medicines were first documented, I acknowledge that a few measures to redress these issues have been implemented and many others are currently under consideration. But progress has been slow as the ANAO report makes clear.

In my experience, the first response of many bureaucrats to those who report problems is to do nothing; they hope that the problem will go away or the complainants will give up. The only effective response by health activists to this strategy is to submit more complaints and continue to publicise the problem.

The next response of some individuals and bureaucracies is to argue that, given limited resources and a risk-based regulatory system, prescription medicines, are more important than shonky complementary medicines and gross violations of the Therapeutic Goods Act and the Therapeutic Goods Advertising Code. To which health activists respond that Australian National Medicines Policy embraces complementary medicines; that a medicine consists both of the ingredients and the information provided, and removing unethical promotion is just as important as removing dangerous ingredients.

Now, we are being told that activist campaigns to publicise the above problems have significantly diverted the resources required to fix them! To which I say, once the problems are fixed the complaints and campaigns will stop. Health activists want results, not just more reports that document problems and make recommendations that previously have been ignored.

I reiterate, fix the problems and the campaigns will stop!

Dr Ken Harvey is Chair of the Governing Council Of Health Action International, Asia Pacific (HAIAP) and is currently in Penang, Malaysia for the HAIAP annual meeting of regional health activists.

over 1 year ago report
Stephen Lehocz

Mr

Thank you Mr Harvey. I’m gratified to learn that the TGA is looking at the drug companies to ensure they comply with the law as they do with herbs/supplements and so is doing its job.

Australia has spent over $8 billion on the Pharmaceutical Benefits Scheme from 2009 to 2010 (see http://www.health.gov.au/internet/main/publishing.nsf/Content/pbs-stats-pbexp-jun10) and with the herbs and supplements market being over $4 billion/year the TGA is responsible for a market that is well over $12 billion…
Read more

Thank you Mr Harvey. I’m gratified to learn that the TGA is looking at the drug companies to ensure they comply with the law as they do with herbs/supplements and so is doing its job.

Australia has spent over $8 billion on the Pharmaceutical Benefits Scheme from 2009 to 2010 (see http://www.health.gov.au/internet/main/publishing.nsf/Content/pbs-stats-pbexp-jun10) and with the herbs and supplements market being over $4 billion/year the TGA is responsible for a market that is well over $12 billion (AU) a year. Note:-This $12 billion figure does not include over the counter drugs.

Drug companies in the USA are under investigation and/or prosecution by the Federal Drug Administration (FDA) for false or fraudulent claims, kickbacks and misleading advertising. With fines so far totaling over $9.5 billion (US) in America. (2001 to 2010). Merck Sharpe and Dohme Merck is under going investigation in Australia regarding Vioxx. See http://www.mja.com.au/public/issues/194_09_020511/fau11387_fm.html#0_CHDHCBJH

These same companies dominate the Australian market.

From the above figures and the dangers posed by the misuse of drugs it would be logical as to where the bulk of the attention of the TGA should be. So fixing the problem would consist of fixing the whole medicine industry, not just supplements and herbs.

over 1 year ago report

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Thomas Marshall

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Michael Vagg

Jon Wardle

Stephen Lehocz

Bayne A M Geikie

wilma western

Ken Harvey

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