Ken Harvey: Diet pills need weightier regulation

A RECENT review of diet and weight loss pills by the consumer group CHOICE has found few are rigorously tested, most contain active ingredients with no proven effectiveness, and some are potentially harmful to health.

Complementary medicine diet pills are extensively and uncritically promoted by some of the commercial television current affairs programs as well as on the internet and in print media.

Regrettably, many pharmacies also promote and sell these questionable products.

There is no good evidence that any complementary medicine weight loss product results in useful weight loss. However, they certainly lighten the consumer’s purse or wallet and are clearly a profitable exercise for the sponsors.

More importantly, false and misleading promotion of these products discourage overweight or obese consumers from adopting the more difficult lifestyle, dietary and exercise measures required to provide genuine health benefits.

Numerous complaints about the promotion of complementary medicines have been submitted over the years with little effect, largely because the regulatory system lacks a timely response and effective sanctions.

In 2002, the report of a review of therapeutic product advertising in Australia and New Zealand, which was supported by the Trans Tasman Advertising Expert Committee made up of industry, consumer and government representatives, recommended that:

• A new complaints panel be established with powers derived from the regulator to license, with a condition of the license being compliance with the single code and acceptance of any orders of the complaints panel
• The complaints panel have the powers to order both withdrawal of and corrective advertising
• The panel have powers backed by substantial accumulating fines for each individual breach if those orders are disobeyed.

These recommendations could have helped to reign in the claims of some complementary medicine advertisements, but no action has been taken, despite calls for the regulation of complementary medicines to be strengthened and additional consultations by the Therapeutic Goods Administration (TGA) on weight loss products and advertising arrangements.

As a consequence, sponsors appear to regard these products as money-making commodities,  not medicines that should be promoted ethically.

The TGA’s automated product listing provides easy and low-cost market entry for these products with minimal scrutiny, which encourages regulatory violations (up to 90% in recent TGA audits). Post-listing compliance reviews conducted by the TGA on listed complementary medicines have just been released showing that of 31 random reviews conducted, 20 medicines had labelling issues, including non-compliance with guidelines and misleading customers.

Aggressive marketing shows scant respect for the Therapeutic Goods Advertising Code. Indeed, the promotion of some complementary medicine products that have been judged by the TGA to be in breach of the code have recently won industry marketing awards (Bayer’s Berocca and Sanofi-Aventis’s Nature’s Own Complete Sleep).

The aim appears to be to out-market the competition with catchy slogans, flashy packaging and increasingly outrageous claims. There is no incentive for sponsors to do research or produce evidence-based products and there is a huge product churn (with an expected 2-3 year product life).

It has become a race to the bottom of ethical standards, encouraged by the fact that the regulatory system provides no effective sanctions against such behaviour.

Even worse, the response of some sponsors of complementary products to legitimate debate or complaints about their products has been to initiate SLAPP  (strategic litigation against public participation) writs.

Such legal action has the convenient effect of postponing the independent investigation of complaints by the TGA Complaints Resolution Panel. This is because Therapeutic Goods Regulations 1990-42ZCAJ says: “If, after a complaint has been made …, a proceeding begins in a court about the subject matter of the complaint, the Panel cannot deal with the complaint until the proceeding is finally disposed of.”

The end result is that the sponsor laughs all the way to the bank for as long as such court cases can be drawn out, complainants have the expense, inconvenience and distress of defending unconscionable legal action, and the public continues to be misled and ripped off.

There are now four recent and/or ongoing government reviews that include sections relevant to these problems:

• The TGA consultation on improving advertising arrangements focused on the co-regulatory system for advertising to consumers. A summary of the issues raised has been prepared by the TGA but has not yet been made public. Further work is being undertaken by the TGA on the pre-approval process for certain advertisements, the complaints handling arrangements, and sanctions and penalties that may be imposed for breaches of the advertising requirements.
• A Working Group on Promotion of Therapeutic Products was asked to align industry self-regulatory codes governing promotion to health professionals. It has delivered its report to the Parliamentary Secretary for Health and Ageing.
• The TGA Transparency Review, which has as one term of reference: “Improving the awareness of the advertising scheme and the transparency of TGA’s advertising decision making.” The review panel’s reporting date has been extended to 30 June 2011.
• A TGA Working Group (with external stakeholders) is currently reviewing the regulatory framework for complementary medicines.

By July 2011, it is hoped that the Parliamentary Secretary for Health and Ageing Catherine King, who is responsible for the TGA, will have reports from all these consultations and working groups, and the courage to make some decisions.

Dr Ken Harvey is an adjunct senior lecturer at the School of Public Health, La Trobe University, and the CHOICE consumer representative on the TGA Transparency Review Panel and the TGA Complementary Medicines Regulatory Working Group.

Posted 16 May 2011