Volume 189 - Issue 1
Commercialism, choice and consumer protection: regulation of complementary medicines in Australia
Author: Antonino Santoro
Med J Aust 2008; 189 (1): 50-53. || doi: 10.5694/j.1326-5377.2008.tb01902.x
Published online: 7 July 2008
Published online: 7 July 2008
To the Editor: I am writing in response to the recent article by Harvey and colleagues about complementary medicines in Australia.1
Rottapharm is the developer and manufacturer of DONA glucosamine, a patented form of glucosamine. DONA is a registered medicine in 54 countries, in many on the equivalent of the Pharmaceutical Benefits Scheme. DONA is the leading glucosamine product in the world measured by specific trial evidence, sales and registration approvals.
The fundamental issue is that different products that contain glucosamine and other complementary medicine (CM) products should be considered to be distinct products. Standards of active ingredients and methods of manufacture of finished products are substantially different between companies.
Specific clinical trial evidence for glucosamine is essential because of:
formulation differences (DONA glucosamine is a patented formulation of crystalline glucosamine sulfate, which is not comparable with glucosamine hydrochloride or other glucosamine sulfate formulations);
bioavailability of glucosamine sulfate (unlike all other formulations on the Australian market, DONA has proven plasma concentrations and synovial fluid levels consistent with a clinical effect at a dosage of 1500 mg once a day, and is the only glucosamine product available with proven human bioavailability and pharmacokinetics);2 and
results of specific clinical trials (studies of non-DONA glucosamine products [unknown formulations] have had mixed results while DONA has shown consistent efficacy across all trials, and has been assigned level 1A evidence by the European League Against Rheumatism).2-6
Not requiring sponsors to have evidence to support claims made about their products encourages low quality. For example, the market-leading glucosamine products in Australia have not been subject to independent peer review to establish whether they are effective. As the claims allowed on such products are identical to the claims allowed on DONA, there is no incentive for the industry to source the “real thing” or conduct their own clinical trials.
In the interests of their patients, we believe that health professionals have a right to be able to identify specific products that have been clinically proven. Use of CMs that is not evidence-based is likely to lead to failure to realise significant health benefits of CM for the Australian public.
References
- Harvey KJ, Korczak VS, Marron LJ, Newgreen DB. Commercialism, choice and consumer protection: regulation of complementary medicines in Australia. Med J Aust 2008; 188: 21-25.
- Reginster JY. The efficacy of glucosamine sulfate in osteoarthritis: financial and nonfinancial conflict of interest. Arthritis Rheum 2007; 56: 2105-2110. 0_i1091832
- Reginster JY, Deroisy R, Rovati LC, et al. Long-term effects of glucosamine sulphate on osteoarthritis progression: a randomised, placebo-controlled clinical trial. Lancet 2001; 357: 251-256. 0_pgfId-1744893
- Herrero-Beaumont G, Ivorra JA, Del Carmen Trabado M, et al. Glucosamine sulfate in the treatment of knee osteoarthritis symptoms: a randomized, double-blind, placebo-controlled study using acetaminophen as a side comparator. Arthritis Rheum 2007; 56: 555-567. 0_pgfId-1744900
- Altman RD, Abramson S, Bruyere O, et al. Commentary: osteoarthritis of the knee and glucosamine. Osteoarthritis Cartilage 2006; 14: 963-966. 0_pgfId-1744907
- Vlad SC, LaValley MP, McAlindon TE, et al. Glucosamine for pain in osteoarthritis: why do trial results differ? Arthritis Rheum 2007; 56: 2267-2277. 0_i1091838