PROOF of effectiveness needed for all medicines

MANDRAKE

THE CASE

When a pharmaceutical company wishes to market a product in Australia, it must produce substantial proof that the medicine is safe. It must also show proof that it is effective. (In an ideal world, a new pharmaceutical should be shown have advantages in effectiveness and/or safety over existing products, but we don't live in an ideal world).

But when a company (called the sponsor) wishes to market a herbal, homeopathic or complementary medicine, such proofs are not required. The Therapeutic Goods Administration (TGA) is considering some new low level requirements:

2.1.4 ......At the time of Listing, sponsors must certify that they hold the evidence to support indications and claims included in the ARTG for the product. The indications/claims on Listed medicines are not subject to pre-market evaluation by the TGA at the time of Listing.

2.1.5 There should be increased random and targeted auditing of sponsors of Listed complementary medicines to ensure that evidence of efficacy is held.

These requirements are still not very onerous. They are not proofs, in the way that mainstream pharmaceuticals need rigorous proofs. Some of the evidence for efficacy can be weak in the extreme. They may reliance on small statistically insignificant trials, or on ancient herbals such as Nicholas Culpeper's Complete Herbal (1653). This does not mean these products are ineffective, just that there is no adequate proof that they are effective.


The phrase from the TGA above, "medicines are not subject to pre-market evaluation", allows products to be approved without anyone even examining what little proof they may have. The sponsor of such products can make a lot of profit selling their untested items even if they are eventually found out and forced to take the product off the market, years down the track.

Why do we have such a double standard? We have an expensive, rigorous, highly regulated standard for pharmaceuticals and a cheap, lax, and largely unmonitored one for alternate medicines. It does not seem fair or safe for the consumer. This poor monitoring has allowed many "snake oil" products to be marketed in Australia as I outlined in my article "Is that medicine Western or Chinese?" on the 28 November 2007, and these are the products that have been found out! imagine how many unsafe, mislabelled and ineffective products are out there, being sold to the trusting public - the mind boggles.

I am not alone on this. In the Medical Journal of Australia Ken Harvey of the La Trobe University published the results of analysis of alternate weight loss products. The study found:

"most contained multiple unevaluated ingredients (herbs, vitamins, minerals) of dubious efficacy"

and

"many consumers are unaware that listed medicines do not undergo the same stringent evaluation process as registered medicines"

The herbs, vitamins, minerals mentioned above are often commonplace and cheap items but listed with intentionally obscure and confusing names. For example:

"water" may be listed as "aqua" or "aq. dest"
"St John's Wort" may be "hypericum" or "H. perforatum" or "goat weed" or "tipton weed"

By this simple deception some suppliers feel free to charge huge amounts for fundamentally mundane products such as the contents of this real (but unidentified) weight loss and detoxification product:

apium graveolens dry leaf------------------------- is celery
camellia sinensis leaf dry---------------------------is tea
cichorium intybus dry root-------------------------is chicory
citrus aurantium dry fruit peel--------------------is orange peel
citrus bioflavonoids extract------------------------is lemon essence
cola nitida dry seed----------------------------------is cola
foeniculum vulgare fruit----------------------------is fennel
hordeum vulgare-------------------------------------is barley
ilex paraguariensis leaf------------------------------is yerba
oligofructose-------------------------------------------is fruit sugar
paullinia cupana seed--------------------------------is guarana

Not very exotic or innovative is it!

The literature says it "may aid weight loss by appetite suppression ... use in conjunction with calorie controlled diet and exercise". Indeed it may, so might a can of Coke or a black coffee. They don't provide any evidence for efficacy, and the word "detox" is completely unsupported. Don't waste your money.

Vested interests in the herbal, homeopathic or complementary medicine industries get very excited and defensive when there is any suggestion that their industry needs the values of the enlightenment applying to it. But why not? If the public is going to part with their hard earned cash for a product, then the product should at least be safe and work (even if it is vastly overpriced).

MY VERDICT

Over to you TGA. It really is unfair that companies can get away with making money out of unsupported and usually unsupportable allegations.