Regulation of homoeopathic products; TGA captured by industry?

by Ken Harvey

Adjunct Senior Research Fellow
School of Public Health, La Trobe University

My colleagues and I have been researching the regulation of complementary medicines in Australia, including homoeopathic products. We have been intrigued by the availability and
active promotion of products such as Homoeopathic DHEA (dehydro epiandorosterone), HGH (Human Growth Hormone) and and melatonin. Homoeopathic products are exempt from regulation by the Therapeutic Goods Administration (TGA) if they fulfil the definition of such products in the Therapeutic Goods Regulations. That is:

1. They are formulated for use on the principle that they are capable of producing in a healthy person symptoms similar to those which it is administered to alleviate, and

2. They are prepared according to the practices of homoeopathic pharmacy using the methods of serial dilution and succussion (hitting each diluted solution in a certain fashion).

http://www.tga.gov.au/docs/html/homeopat.htm

Clearly, the products listed above do not fulfill the first definition of a homoeopathic product as they are promoted on the basis of their conventional medical (allopathic) effects of relieving symptoms rather than the homoeopathic principle of producing similar symptoms.

For example, the promotion for Bioglan DHEA homoeopathic notes that, "DHEA is short for dehydro epi andorosterone, which is an important hormone produced by the adrenal glands. Production of this hormone peaks at age 25 and declines steadily thereafter". It claims "Bioglan DHEA assists in the maintenance or improvement of general well-being". Each tablet is said to contain: 6x homoeopathic potency of 3mg Dehydro epi androsterone (DHEA).

http://www.bioglan.com.au/vitamin.asp?productID=31

Blue Roc (Formerly Optigen) HGH homoeopathic promotion states, "HGH - Human Growth Hormone production begins to decline with age. It is suggested it declines severely after the age of 30 and by the age of 60 plus, the production rate is reduced by half. It is suggested that HGH therapy could delay the effects of Ageing process". Each tablet is said to contain 6X + 12C HhGH 8mg (24IU) Somatotropin (recombinant Human Growth Hormone) Hand Succussed (unbuffered HhGH).

http://tinyurl.com/yolbnc

Pretorius Melatonin Homoeopathic is claimed to be, "useful for establishing sleep patterns to overcome jet lag". Each tablet is said to contain 3mg melatonin 6X.

http://www.pretoriusvitamins.com.au/vitamin.asp?productID=70

Given the dilutions involved, none of these products can contain pharmacological activity. A 1X dilution is a 1:10 dilution. A 6X preparation results in a final concentration of 0.000001 of the original. A 1C dilution is a 1:100 dilution. A 12C dilution cannot possibly contain any of the original molecules according to the traditional laws of chemistry. However, homoeopathy practitioners apparently believe that when the last molecule is gone the diluent retains a "memory" of the original substance. It is also unclear how a 6C and 12C dilution can coexist as is claimed for the Blue Roc (Formerly Optigen) HGH homoeopathic preparation.

In short, the sponsors of these products have mixed allopathic and homoeopathic concepts in such a manner that neither evidence-based medicine or traditional homoeopathic practice (regardless of its
validity) can justify the claims made. It is doubtful that many consumers understand the subtleties of 6X & 12C dilutions. Rather, they are likely to look at the claims made for compounds they recognise, such as human growth hormone or melanin, and make their decision to purchase on this basis.

In my opinion, the current regulatory system supports sponsors making money out of water and consumers being sold a lie. In correspondence with the TGA they suggested that complaints about such products might be sent to the Complaint Resolution Panel that administers the Therapeutic Goods Advertising Code. Accordingly, a set of illustrative complaints has been submitted arguing:

1. That these products and their promotion breach the Therapeutic Goods Regulations 1990 (Part 1, Regulation 2, page 15) and thus the Therapeutic Goods Advertising Code Section 4(1)(a) because while they are advertised as homoeopathic products they do not comply with the definition of such products contained in the Therapeutic Goods Regulations.

2. The promotion of these products also breaches the Therapeutic Goods Advertising Code Section 4(1)(b), 4(2)(a), 4(2)(c), because they make claims that cannot be justified by either scientific evidence (or traditional homoeopathic practice).

However, given the large backlog of complaints currently confronting an under-resourced and overloaded Complaint Resolution Panel it is unlikely that any public ruling on these matters will be available within the next 4-6 months.

Increased regulation of homoeopathic products was recommended in 2003 by the Expert committee on complementary medicines in the health system.

http://www.tga.gov.au/docs/html/cmreport.htm

In my opinion, the failure of the TGA to act on these matters is yet another example of the current regulatory imbalance between supporting a profitable complementary medicines industry and protecting consumers.

--
Dr. Ken Harvey
Adjunct Senior Research Fellow
School of Public Health, La Trobe University
http://www.medreach.com.au
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