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IBS ad puts drug promotion under scrutiny

BMJ 2003; 326 doi: (Published 26 June 2003) Cite this as: BMJ 2003;326:1464
  1. Melissa Sweet (sweetcom{at}, freelance journalist specialising in health and medicine in Australia

    John Dowden felt piqued when he saw an advertisement featuring young people enjoying the sunshine on a yacht, but not swimming because of various stomach problems. Dr Dowden, the editor of Australian Prescriber, had recently published an article noting that the advertisement's subject, tegaserod, a new treatment for irritable bowel syndrome, had been approved only for women with a less common form of the syndrome. He was concerned that the advertisement, published in the medical press last year, did not make these constraints clear, and lodged a complaint with the industry based committee that sets standards for marketing prescription drugs.

    Dr Dowden was surprised, then, to be rung by the drug's manufacturer, Novartis Pharmaceuticals, asking that he consider withdrawing the complaint. Any breach of the industry's code of conduct had been inadvertent, he was told.

    “It's like a closed shop”

    After a follow-up email from the company, Dr Dowden was on the verge of withdrawing his complaint when he noticed a media campaign promoting the drug as a breakthrough. The campaign made no explicit mention of the drug's limited indication. So he went ahead with the complaint, which was upheld. Novartis said, meanwhile, that it was not company policy to make such approaches to complainants and that this would not occur again.

    Dr Dowden's experience, which he relates in Australian Prescriber (, comes amid widespread concern about the regulation and impact of pharmaceutical marketing.

    In Australia, a recent study identified many shortcomings in pharmaceutical advertisements, prompting calls for them to include data on the absolute effects and costs of treatment ( and

    Meanwhile, Medicines Australia (formerly the Australian Pharmaceutical Manufacturers' Association) earlier this year announced significant new restrictions and sanctions in the 14th edition of its code of conduct. The 142 page code stipulates that companies should not provide entertainment to health professionals and that hospitality should be simple, modest, and secondary to education. The maximum fine for breaches has been increased to $A200 000 (£80 000; $133 000; €115 000).

    The changes were made as part of a regular review of the code. They also followed a Pfizer function featuring semi-naked dancing girls, which attracted widespread criticism when footage, provided by a general practitioner with a hidden camera, was aired on national television. A complaint was dismissed on appeal. But such a function would be a clear breach of the revised code.

    However, consumer groups and some health professionals remain critical of the code, saying that it is not sufficiently publicly accountable and is failing to tackle publicity campaigns directed at the general public.

    On 27 June the Australian Competition and Consumer Commission (ACCC) was due to deliver a decision on a Medicines Australia application for authorisation of the code's latest edition. Consumer groups opposed the authorisation, arguing that industry self regulation had failed to protect the public interest. They said that the code had not stopped companies from marketing to the general public, and was not sufficiently transparent. And they complained that they had been unable to obtain copies of the code's annual report, despite making complaints about breaches.

    Medicines Australia refused my request for a copy of the report. A spokeswoman said that it was currently only for the industry and health professionals, although there were plans to make it more widely available.

    The code's annual report does not publish who sits on its committee or appeals committee, simply listing the organisations represented. If a complaint is upheld, complainants are asked to keep this confidential in case of an appeal.

    “It's like a closed shop,” says Helen Hopkins, executive director of the Consumers' Health Forum.

    Dr Libby Roughead, a lecturer in pharmacy practice at the University of South Australia, says that it is difficult for health professionals and the public to make complaints because of the time required to identify misleading claims. She argues that a “third party watchdog to keep the regulators honest” is needed.

    Professor Ric Day, professor of clinical pharmacology at the University of New South Wales and a longstanding member of the code of conduct committee, supports the current model of self regulation, but believes that it should become more transparent and accountable.

    The ACCC's response to such concerns is eagerly awaited.

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