Credible scientific evidence of clinical effectiveness should underpin the delivery of health care. Satisfactory health outcomes and cost effectiveness require this approach. In Australia however pseudoscience flourishes as regulatory bodies fail to protect consumers from health care fraud and a massive industry prospers as it convinces consumers to use expensive supplements they do not need. In this three part examination of the issue the extent of the problem is examined, as are the changes that would better protect consumers.
During negotiations for the Sixth Community Pharmacy Agreement in 2015 the Australian Government and the Pharmacy Guild of Australia made a commitment to conduct an independent Review of Pharmacy Remuneration and Regulation. A final report will be provided to the Minister for Health by May of this year. Preliminary reports suggest that about 50% of pharmacists believe they should not sell medicines for which there is no evidence for effectiveness. The other half of the profession suggest that they should give the public what it clearly wants including homeopathic preparations known to have no medicinal value. Many pharmacists say they personally are uncomfortable selling non-evidence based products but the pharmacist who owns the outlet insists that they do so. While we await the report we can examine the other major potential protector of the consumer from misleading promotion of medicinal preparations, the Therapeutics Goods Administration (TGA).
The TGA is responsible for ensuring that medicines, whether they require a prescription or not, are safe and marketed appropriately. They are also responsible for monitoring the quality of medical “devices” from bandages to diagnostic equipment. Before marketing all medicines must get a nod of “approval” from the TGA. There are two ways to do this with only one having anything to do with an examination of evidence for effectiveness. When an ‘over the counter” medicine is marketed and is backed by credible scientific evidence supporting any therapeutic claims The TGA will register the product. The manufacturer can add TGA-R to labels and include that designation in advertising his product. If a consumer had any understanding of what this means, and of course most don’t, they could have confidence in the marketing claims. There are only a handful of such products.
All other medicines, for which the manufacturer has not supplied up front evidence of effectiveness, are simply “listed” by the TGA and labeling will include, “TGA-L”. The TGA must list any medicine seeking a listing and in so doing tells the applicant that they must keep evidence to support marketing claims as, in a random process, they could be called on to provide that evidence to the TGA. Penalties would follow if no such evidence was provided. There are about 11,000 medicines with a TGA-L listing. This system offers little in the way of consumer protection as is obvious from the TGA’s own statistics which show that random checks each year find that about 80% of the claims examined are not supported by evidence.
Recently I was involved in an examination of the sale of medicinal products in duty free stores to Chinese visitors to our country. Translation of the pamphlets given to visitors revealed that not only where exorbitant prices being charged for nonsense products (extracts from Kangaroo testicles and sheep placentas, etc) but the TGA-L designation was accompanied by statements to the effect that the TGA had endorsed the claims made.
Pre-vetting of advertisements for likely accuracy by an external agency was, until recently, supported by the TGA. The system was far from perfect with many irresponsible advertisements slipping through the net but the government is now planning to remove that safeguard as it moves to reduce oversight bureaucracy in favour of industry self-regulation. All the evidence suggests that in terms of consumer protection, this is exactly the wrong direction to pursue. Currently there exists a TGA complaints resolution panel that acts independently evaluating complaints re misleading advertising. It has the power to force manufacturers found to have breached advertising standards to print retraction statements. It is very busy with almost all complaints upheld. There are many examples of manufacturers simply changing the name of a discredited product and continuing with the same advertising. The penalties available do not act as a deterrent for many. At this writing it is not certain that this valuable review panel will continue to operate.
For medical devices/instruments safety is the focus of the TGA’s efforts. While the TGA will make sure an instrument won’t electrocute you it shows precious little interest in claims made for the capabilities of a device. There are many bogus diagnostic devices on the market used mainly by naturopaths. So-called “Bioresonance” machines are popular as they can diagnose a myriad of problems you may be having through detection by electrodes of abnormal resonance patterns from your bodies’ cells. The machines can cure you by altering these signals. Recently the Medical Board imposed heavy penalties on a registered doctor for using such a machine in his practice but, despite requests, the TGA continues to give marketing approval to the machine!
Public hearings are being held at the moment examining the future role of the TGA. The organisation may be further emasculated by proposed moves to more industry self-regulation when, in fact to improve consumer protection, it needs a culture change to be more consumer rather than industry focused and to have the ability to use penalties that can act as a deterrent to unacceptable industry behaviour. After all the hallmark of successful consumer protection is just that, protection; stopping something unacceptable from occurring rather than responding to consumer harm after the event.
Professor John Dwyer is Emeritus Professor of Medicine, UNSW, and Foundation President of Friends of Science in Medicine.