Australian University Calls for Tougher CAM regulations

[athon]

Latrobe University (http://www.latrobe.edu.au/news/2008/mediarelease_2008-1.php):


La Trobe University Adjunct Senior Research Fellow of the School of Public Health, Dr Ken Harvey, and his co-authors say controls on the supply and promotion of complementary medicines in Australia are weak.
Complementary and alternative medicines (CAM) are classified by the Therapeutics Goods Administration (TGA) as 'listed goods' and are not evaluated for efficacy. In contrast, ‘registered medicines' are individually evaluated by the TGA for quality, safety and efficacy before market entry.
'Despite the widespread and increasing use of CAM, many consumers are unaware that listed medicines do not undergo the same stringent evaluation process as registered medicines,' Dr Harvey says.

I don't see much happening as a result, but it's still good that somebody is saying something.

Athon

[Phytotherapist]

Athon - How would you regulate CAMs ?

[athon]

Athon - How would you regulate CAMs ?

How do you regulate any novel medical treatment or pharmaceutical? At the moment the regulations are thin, as they fall under the TGA (Therapeutic Goods Act). Current regulations mean:

Overall control of the supply of therapeutic goods is exercised through three main processes:

Auditing and assessment of the quality of their manufacture.
Pre-market assessment of the goods
Post market monitoring of compliance with standards once the goods are supplied on the market.

Note, while evidence of efficacy is required...

Consistent with low risk, Listed complementary medicines may only carry indications and claims for the symptomatic relief of conditions (other than serious disease, disorders, or conditions), health maintenance, health enhancement and risk reduction. The indications / claims on Listed medicines are not subject to pre-market evaluation at the time of Listing. However, the Act requires that, at the time of Listing, sponsors certify that they hold the evidence to support indications and claims made in relation to Listable goods. The evidence held by sponsors must be sufficient to substantiate that the indications and claims are true, valid and not misleading.

Now, guess how often these are checked? Whatever number you supply, go lower.

Also note:
A complementary medicine is defined as a therapeutic good consisting wholly or principally of one or more designated active ingredients each of which has a clearly established identity and a traditional use. Traditional use means use of the designated active ingredient that is well documented, or otherwise established, according to the accumulated experience of many traditional healthcare practitioners over an extended period; and accords with well-established procedures of preparation, application and dosage. Complementary medicines in Australia are not subject to the standards and guidelines of the Codex Alimentarius Commission.

Essentially, the product does not have to do as required. There is nothing on proven efficacy in the current standing 1989 TGA (or 1990 revisions). There is room for prosecution if it is demonstrated to be toxic, uses banned products (such as human foetal cells) or contravenes other codes, but other than claiming it must do as you say, there's no teeth to enforce it. It relies solely on people believing that it has been used as a medicine in a culture for a 'long time' (which has to be three or more generations, IIRC).

What would I have them do? Quit this nonsense of a therapeutic good needing only be demonstrated to be understood as a traditional medicine, and have any good sold be treated as it is. A drug or medical treatment. It must be reviewed for efficacy before becoming legal. Period!

See: http://tga.health.gov.au/cm/cmreg-aust.htm
As well as the TGA of 1989 (http://www.comlaw.gov.au/ComLaw/Management.nsf/current/bytitle/470A4D2EDB75C676CA256F710006B348?OpenDocument&mostrecent=1). It's a long read, though.

Athon

[EHLO]

The MJA article makes for an interesting read, if not more than a little depressing. I doubt it will be picked up by any mainstream media, and I won't hold my breath for any of their proposed solutions to be considered by the powers that be.

(thanks for the CSIRO Science by Email link too!)

[athon]

The MJA article makes for an interesting read, if not more than a little depressing. I doubt it will be picked up by any mainstream media, and I won't hold my breath for any of their proposed solutions to be considered by the powers that be.

I fully agree. This isn't the first academic to call out, and won't be the last. The government's attitude is 'so long as nobody gets hurt, you can claim what you want'. Pretty pathetic, really.

(thanks for the CSIRO Science by Email link too!)

Cool. Next issue out Friday, about lunchtime.

Athon

[Phytotherapist]

I think the real problem are the practitioners of CAMs that often convince their clients (patients?) to give up conventional therapies (even in serious conditions) in favour of unproven CAM therapies.

How can your goverment know that nobody is hurt? e.g. The so called Macrobiotic diet that many practitioners prescribe increases the chances of getting gastric cancer (and other diseases), etc.

[Georg]

I think the real problem are the practitioners of CAMs that often convince their clients (patients?) to give up conventional therapies (even in serious conditions) in favour of unproven CAM therapies.


Could you give me some examples of proven CAM therapies, please?
I thought as soon as a therapy is proven to work, it will find its way into the "conventional" catalogue. Or, in other words, how do you define CAMs?
CAM is a needless term in my opinion, there are just two types of therapies, the ones that have proven to work, and then there are the others............

[Phytotherapist]

Georg - You're right. Phytotherapy is, in my opinion, the only complementary therapy that works. It is complementary to the conventional pharmacological therapy. In Italy it can be practiced only by doctors and the Florence Medical School has a Master in Phytotherapy, while Pharmacognosy is part of the modern Pharmacology.
Homeopathy, on the other hand, is considered alternative (to what?)and is of no therapeutic value except for the placebo.

You're also right when you say that CAMs is a needless term but but when used you'll have an idea of the meaning.

[athon]

Georg - You're right. Phytotherapy is, in my opinion, the only complementary therapy that works. It is complementary to the conventional pharmacological therapy. In Italy it can be practiced only by doctors and the Florence Medical School has a Master in Phytotherapy, while Pharmacognosy is part of the modern Pharmacology.
Homeopathy, on the other hand, is considered alternative (to what?)and is of no therapeutic value except for the placebo.

You're also right when you say that CAMs is a needless term but but when used you'll have an idea of the meaning.

I must admit, my knowledge on phytotherapy is limited to the basics. Conceptually, it seems sound, however it still concerns me that it is seen as CAM.

I don't think there's any disagreement that certain actions, in addition to, say, pharmaceutical treatment, are unwarranted. Doctors will often say to get rest, improve diet, quit smoking...are these all 'complimentary' treatments? I dare say they are part of treatment - treating conditions is a whole-package approach. Since the very definition of 'disease' involves the nature of one's ability to cope in an environment, changing aspects of the environment - including aspects of the individual's outlook and lifestyle - will undoubtedly contribute to improvement.

From what little I understand of phytotherapy, it seems to suggest that taking herbal extracts has benefits over processed pharmaceuticals by way of 'synergy', where some chemicals work better (only?) in conjunction with others. While this makes perfect sense on one level, I'm curious as to why it has remained seen as CM. The idea seems significant to pharmacology as a whole.

Nonetheless, perhaps that's a different discussion. I personally agree with the above statements that there is no such thing as CAM. Either there are beneficial treatments at the disposal of a medical practitioner, or there aren't. Either these options have good, double blind, controlled evidence backing them up, demonstrating their parameters and risks as clearly as possible, or they don't. It's this point which needs to be legislated by the government.

Athon

[Mobyseven]

I must admit, this is a good bit of news. I'd been feeling a bit depressed about the whole situation since one of the people at Melbourne University expressed favourable opinions of CAM, especially *shudder* homeopathy.

Wouldn't have been so bad if he hadn't been my tutor. My logic tutor.

[Georg]

I must admit, this is a good bit of news. I'd been feeling a bit depressed about the whole situation since one of the people at Melbourne University expressed favourable opinions of CAM, especially *shudder* homeopathy.

Wouldn't have been so bad if he hadn't been my tutor. My logic tutor.

:dl:

My first laughing dog ever. I understand that you´d been depressed, but I am still giggling. I can only hope the tutor got a nice intellectual spanking as a response.........
A logical tutor defending homoeopathy.....is that something like a human oxymoron?

P.S.: Phytotherapist, thanks for your answer. I have no problem with phytotherapy in principle, as long as it is regulated as every other medical treatment.

[Rolfe]

Yeah, including proof of efficacy and safety, to the same standards as all other pharmaceuticals - which I think you may find Phytotherapist has some problems with.

Rolfe.

[Phytotherapist]

Rolfe - Do you know what are the second, third and fourth generation of Phytotherapy? If you are unable to find the proof of safety and efficacy of Phytotherapy then you don't have the slightest idea of what is Chemistry, Pharmacology, Pharmacognosy, Medicine and Phytotherapy. Phytotherapy in France, Italy and some other countries is part of conventional medicine and can be practices only by MDs.

[Rolfe]

Your claims, you produce the evidence.

Rolfe.