Yesterday, I gave an invited presentation to TGA staff in Canberra (and elsewhere by video-link). I reviewed how well Australia had implemented the 2007 World Health Assembly’s (WHA) Resolution 60.16:
“Wishing to promote evidence-based rational use of medicines by providers and consumers, (the WHA) URGES Member States to:
- Develop and implement programmes that will provide independent, non-promotional information about medicines;
- Enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines;
- Monitor promotion.
The presentation can be downloaded here (warning: it’s a large file with embedded video).
I made the following points:
- While Australia provides good objective, independent information about prescription medicines there is a problem with the proliferation of generic branded products. For example, with atorvastatin – brand names include: Atorvacol, Atorvastatin Sandoz, Chem mart Atorvastatin, Lipitor, Lordstat 10, STADA Atorvastatin, Torvastat and Trovas. These confuse both medical staff and patients and can result in inadvertent overdose when patients receive differently branded generic products containing the same active ingredient from different pharmacies. There is a simple solution; prohibit brand names on generic medicines and standardise the nomenclature: active ingredient (sponsor). This could be implemented as part of the TGA Labelling and Packaging Review.
- Consumers now spend as much money out-of-pocket on complementary medicines as prescription medicines yet no helpful information is provided about registered complementary medicines (apart from a list on the TGA web site). The small number of evaluated, registered complementary medicines should have AusPAR evaluation information, PI and CMI information to assist consumers (and health professionals). In addition, Arthro-Aid (glucosamine hydrochloride) should be removed from list or have a caveat added that information available after it was evaluated (in 1999) suggests that this product is no more effective than a placebo.
- The public summary of listed products available on the TGA web site often contains free-text information provided by the sponsor. There is no pre-market assessment of this information by the TGA and only limited post-marketing surveillance (that has shown a high level of non-compliance). As a result many of the indications listed on the public summary are not in accord with the evidence about the product’s ingredients. I suggested that public summary documents that have not had post-marketing evaluation and correction should have a prominent disclaimer that this information has been provided by the sponsor and has not evaluated by the TGA to see if it is accurate. In addition, product names that make implicit promotional claims that cannot be justified should not be allowed. Current examples include Celebrity Slim Fat Burner Forte Capsules, Fat Blaster, Fat Magnet, Undoit and many more.
- I reviewed the government’s preference for self-regulation of pharmaceutical promotion to health professionals and made the point that it is ultimately self-serving, has yet to produce a level-playing field among disparate industry codes and does not apply to non-members. The latter are often the worst offenders. I was pessimistic about any impact the government’s latest Codes of Conduct Advisory Group would make.
- I presented several case studies illustrating the ongoing problems of handling complaints about promotion targeting consumers. Since November 2010 there have been at least 88 complaints sent to the TGA because of non-compliance with CRP determinations but currently only 14 “outcomes” have been reported on the TGA web site. Some of these have taken several years to resolve while others are ongoing because of various appeals. I said that justice has NOT been done when a sponsor is allowed to escape publishing a retraction by refusing to comply with CRP requests and TGA “orders”, prolonging the process by appeals to various authorities and then, 18 months later, “voluntarily” changing the claims made. This may represent “due administrative and legal process” but it certainly does not provide consumer protection or a deterrent to other sponsors. The time taken by the TGA to process “Regulation 9 orders” does not engender confidence in the TGA’s current proposal to take over the work of the CRP.
- I also noted that since homeopathic products (such as the Kid’s Smart range) are not required to be listed on the ARTG they cannot even be cancelled for regulatory violations. The regulation of homeopathic products has been the subject of several consultations that have disappeared without any action being taken.
- I illustrated the race to the bottom by sponsors of multi-vitamins. For example, Blackmores latest Alive! formulations with 63 ingredients appeared to be designed to outdo the Swisse Ultivite range (a mere 52 ingredients) on the promotional principle that consumers might believe that “more is better”. There is no evidence to justify many of the small amounts of ingredients contained in these formulations, especially the fruits, vegetables and herbs. I noted increasing evidence that supplements are no substitute for a healthy nutritious diet (and some may even be harmful). I suggested that the required mandatory warning for vitamins be broadened and include all complementary medicines marketed as dietary supplements. For example: “Vitamin, mineral and other dietary supplements do not provide the same health benefits as a balanced nutritious diet. See the 2013 Australian Dietary Guidelines and Australian Guide to Healthy Eating“.
- As complaints about CM increase there’s an increasing trend to redefine these products as foods. This has the advantage that complaints are hand-balled from the CRP and TGA to State Food Authorities who often show less inclination to deal with them. For example, Souvenaid® is promoted as a “medical food” for “the treatment of mild Alzheimer’s disease”. It’s also said to be “clinically proven”. The sponsor has argued that Souvenaid® is a “Food for Special Medical Purposes” under Standard 2.9.5 of the Food Standards Code of Food Standards Australia New Zealand (FSANZ).The CRP and TGA have now handballed the complaint to the NSW Food Authority. All complaints about therapeutic claims should be handled in a timely and efficient manner by one regulatory authority.
- In short, the current “light-touch” regulation of listed CMs, especially the lack of timely and significant penalties for breaches of the Therapeutic Goods Advertising Code and the Therapeutic Goods Act, encourages unscrupulous sponsors to flood the market with shonky products and unethical claims. This makes it hard for consumers (and health professionals) to separate the evidence-based wheat from the hype-driven chaff. Research has shown that the public does not understand the difference between AUST R and AUST L labelled products. Thus, there is currently little incentive for CM sponsors to undertake expensive research, compile an extensive dossier and pay the higher fees required for TGA registration. A better return on investment comes from spending the money on celebrities, promotion and appeals.
- I reiterated that what consumers and many health professionals wanted was a regulatory system with teeth, for example:
- Mandatory labelling that explains the AUST L label , “This product has NOT been evaluated by Australian Health Authorities to see if it works”;
- Legislation to provide timely and meaningful sanctions for advertising violations (civil penalties, enforceable undertakings);
- Increased and better targeted post-marketing surveillance by the TGA, and
- Transparent reporting of problems and cancellations by the TGA.
- What we got was a four year program of incremental reform in which some of our key concerns are being “explored” by further consolations! The current TGA advertising RIS consultation is just the latest in a list of consultations that have being going on for over a decade without producing definitive action. While I outlined support for a number of the options listed in this RIS I also noted that, given the TGA’s current performance on dealing with Regulation 9 advertising issues, there was considerable doubt if the TGA was capable of implementing many of the options suggested.
I thanked Ray Cook for suggesting that I talk to TGA staff, Tony Hobbs and John Skerritt for approving the invitation and John McEwen for chairing the session.