Healthy Skepticism Library item: 16677

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Harvey K
Therapeutic goods reform a bitter pill
The Australian 2009 Oct 24
http://www.theaustralian.news.com.au/story/0,25197,26245931-23289,00.html

Full text:

CONSUMERS’ Health Forum executive director Carol Bennett recently told an industry-government forum that current self-regulation and co-regulation models for the promotion of therapeutic goods did not ``enjoy the confidence of consumers or the Australian public’‘.

Speaking on ABC radio, federal parliamentary secretary for health Mark Butler said advertising regulations and complaints resolution mechanisms are ``deeply unsatisfactory’‘. He asked the Department of Health and Ageing to provide advice concerning the promotion of therapeutic goods. ``We are committed to having a root and branch look at this,’‘ he said … and rightly so.

There are eight codes and complaint systems covering the promotion of so-called innovator prescription medicines, generic medicines, over-the-counter medicines, complementary medicines, biotechnology, medical devices, cosmetics and food. There are different standards and gross inconsistencies between various codes, their complaint processes, timeliness, transparency, sanctions, monitoring and effectiveness.

Industry promotes self-regulation but I’m unaware of any evidence that it works.

Companies large and small offend and re-offend against codes of conduct. For example, Pfizer Australia has had 17 complaints against the Medicines Australia code upheld during 2005-09.

Although one of these complaints received the maximum fine of $200,000, over this time the fines averaged only $50,000. There’s no evidence that such modest fines have reduced code violations by industry.

By contrast, last September Pfizer agreed to pay $US2.3 billion — the largest healthcare fraud settlement in the history of the US Department of Justice — to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products.

That’s a sanction likely to concentrate the mind of industry and is why Choice (the Australian Consumers Association) and others argue MA should increase the maximum fine to at least $1 million. But in its latest review MA made only a token $50,000 increase in the maximum fine.

Cat Media (now owned by Pharmacare Laboratories) sponsors complementary medicines such as Fatmagnet, Fatblaster, FatblasterMax and Horny Goat Weed. It has had about 18 complaints upheld by the Complaint Resolution Panel in the past few years, but the panel lacks enforcement powers. Little wonder Butler says over half the advertisers found in breach by the CRP ``have refused to comply’‘.

In theory, if self-regulation fails, co-regulation provides a backstop via the Therapeutic Goods Administration. I’ve had numerous complaints about therapeutic goods advertising upheld by the CRP, only to fall into a TGA black hole. Complainants hear no more and if action is taken, it’s never publicised.

The result: complainants are disillusioned, sponsors know they can usually offend with impunity, and unethical promotion continues.

Analysis of successful complaints for complementary medicines shows they are clustered around categories such as weight loss, memory enhancement and arthritis relief.

In 2007, the TGA was asked to review the efficacy of the small number of ingredients used in weight-loss products, hoping upstream evaluation would reduce downstream complaints.

Industry concern apparently reduced the review’s scope to the production of anodyne guidelines for industry on evidence required to make claims for weight loss. They were put up for comment by the TGA earlier this year and extensively criticised. Six months later another version has emerged. It has no detail on how the guidelines will be implemented and misleading products eliminated.

Consumer and medical groups argue it’s time this mess is sorted by creating one code applicable to all therapeutic claims and promotional practice, regardless of industry sector, product or media. There’d be one complaint (and appeal) process, one monitoring process, and one set of sanctions, including corrective advertising orders and fines related to the sales income of the product and company involved.

Government would oversee the code — funded by industry using a fraction of product registration fees — and an independent representative stakeholder committee would administer it. The system would be enforceable under the Therapeutic Goods Act.

In May 2007, Australia and other member states adopted a World Health Assembly resolution calling on them to ``enact new, or enforce existing, legislation to ban inaccurate, misleading or unethical promotion of medicines and to monitor promotion of medicines’‘.

Given widespread dissatisfaction with the status quo and Butler’s expressed interest in root-and-branch reform, that would be a good place to begin. Efforts to confront the self-interest and self-regulatory rhetoric of the therapeutic goods industry and to control unethical promotion are long overdue.