Whacking moles, a pharmacist and the TGA

Dr Ken Harvey with the authors

Australia’s regulation of complementary medicines claims is badly flawed, write Sasha Hall and Tiana Moutafis

The regulation of listed complementary medicines has become an increasingly important consumer issue.

As part of a summer vacation scholarship, we have been working with Dr Harvey on this topic at the School of Public Health and Preventative Medicine, Monash University. Our first task was to join the “Whack-a-Mole” project; to write up a formal complaint about potentially misleading and deceptive advertising of a complementary medicine.

We were then asked to investigate the policy settings that allow such “moles” to keep popping up. Finally, we considered whether current government proposals will able to improve the regulatory system for advertising therapeutic goods.

We reviewed the promotion of Blooms Health Coenzyme Q10 150 Max product against legislation. Claims made on the sponsors website by Gerald Quigley (described as a pharmacist and master herbalist) included:

“Once the body levels of CoQ10 become more than 25% deficient, many disease states start to flourish. These can range from high blood pressure and heart attacks to deficiencies of the immune system and cancer;” and

“For heart health, stamina, performance and strength, 150mg of Blooms Coenzyme Q10 150 Max each morning is a great way to start the day”.

A search of the medical literature could find no sufficient evidence to support such wide claims, which therefore appeared to breach the Therapeutic Goods Advertising Code and the Pharmacy Board Code of Conduct. We also found previous upheld complaints against Blooms Health and Mr Quigley.

While a complaint can be lodged about such advertising, it can make little impact on the body of misleading and deceptive claims. The advertisement and product itself could merely be removed and renamed, or advertisers may simply refuse to comply with the requests of the Complaint Resolution Panel (as occurs in 40% of cases).

Hence the “whack-a-mole” project: no sooner is one misleading advertisement “whacked” than others pop up.

This is because the light-touch regulatory system for most complementary medicines involves no pre-market evaluation of scientific claims, trusts sponsors to obey the rules, and has no timely or effective penalties for breaching the regulations.

Compliance breaches are often only caught after lengthy investigations of complaints or TGA post-marketing reviews. This comes long after the advertisement has been aired to the public and influenced consumer perceptions.

For example, the TGA found compliance breaches in 73% of 212 post-marketing reviews in 2014-15 and 80% of 473 cases in 2015-16. In addition, in 2015-16, the Complaint Panel found 98% of 141 complaints justified. Labelling, advertising and evidence continued to be the major compliance breaches.

These statistics are a sad reflection on the failure of the TGA to bring this industry into check over many years.

Recently, the 2015 Expert Review of Medicines and Medical Devices Regulation (MMD Review) made 58 recommendations, of which 25 related to the regulation of complementary medicines and the advertising framework. In September 2016, the Government rejected or watered down several important recommendations, presumably due to industry lobbying.

Currently, seven recommendations concerning advertising are up for debate, of which three are the most important.

Recommendation Fifty-Five: Abandon pre-approval of therapeutic product advertisements in accord with the Government’s “Cutting Red Tape” agenda. This would be conditional on the implementation of other recommendations, such as increased post-market monitoring and stronger penalties for regulatory violation. However, most advertisements submitted for pre-approval require changes to avoid Code breaches; sometimes wholesale revisions. Pre-approval is the only defence between a misleading advertisement on prime-time television and the unwitting consumer. Complaints and post-marketing reviews take too long to remove misleading and deceptive advertisements. Thus, cutting pre-approval is controversial and has the potential to further hinder the efficiency of the system.

Recommendation Fifty-Six: A new body for managing complaints. The controversy lies in who should manage the new system. The TGA appears to be positioning themselves to take over; abolishing the current Code Council and Complaint Panel along the way. This would remove involvement of consumer, health professional, industry and media stakeholders. Additionally, some argue that the TGA is too close to industry, lacks a consumer protection culture, has failed to address long-standing regulatory problems, and is non-transparent about complaints it currently handles. One suggestion is to send a senior enforcement manager from the Australian Competition and Consumer Commission (ACCC) to the TGA to oversee the new system (and change the culture) while keeping the best of the current system (the Code Council and Complaint Panel) and fixing the flaws, such as the lack of power to enforce determinations.

Recommendation Fifty-Seven: Stronger compliance powers against misleading advertising. Sanctions and penalties must be sufficient to counter the commercial return that can be obtained by breaching the regulations. Those suggested in the consultation document should be adequate if imposed.

In conclusion, readers of the AJP might consider putting in their own submission to the TGA consultation here.

Sasha Hall and Tiana Moutafis are BMedSci/Law students supervised by Dr Ken Harvey.

The above material was presented at the University of Melbourne Secular Society Skepticamp on November 25, 2016 and at the 2016 Skeptics Annual Convention the following day. Both these presentations are available. Also, a complaint has been submitted to the Complaint Panel and the Pharmacy Board about the promotion described above.

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