Pfizer Pamol Advertisement Causes Headache

"In a bizarre ruling, the Advertising Standards Complaints Board has effectively said that Pfizer's practice of referring consumers to its parked Pamol website for product information is OK," says risk & policy analyst, Ron Law.

Paracetamol is one of the most toxic substances resulting in more calls to the Poisons Centre than any other substance in New Zealand; two-thirds of all paracetamol poisonings are in children under the age of 13. Pamol is a leading brand of paracetamol -- especially in the children market.

Historically, paracetamol products have resulted in over 400% more calls to the National Poisons Centre than the next most commonly reported substance so companies, such as Pfizer, need to exercise extra social responsibility in providing consumers with product information.

"Pfizer's Pamol label and packaging refer consumers to a website [ http://www.pamol.co.nz] for further product information, but that website is simply a parked site preserving the pamol.co.nz domain name. In reality, it does not exist; to refer consumers to a non-existent website for information on a product containing such a dangerous ingredient as paracetamol is being socially irresponsible," says Ron Law.

The Advertising Standards Complaints Board has used a decade old ruling on eggs as an excuse for not considering a genuine complaint... the ruling ignores the labelling component of the complaint, as well as the legal definition of a medicinal advert.

"This ruling is anathema to the Advertising Standards Authority's codes of practice," says Ron Law, "It simply defies logic; it defies commonsense; it defies any rational thought process regarding the term, 'social responsibility'."

The complaint related to both the label on the bottle of Pamol Paediatric Drops as well as the packaging whose sole purpose is to maximise product exposure on pharmacy shelves. Yet whilst the ruling notes that the complaint related to both labelling and packaging, it dismisses the complaint because of a 1992 ruling on the packaging of eggs.

The ASA's Therapeutic Code of Practice states that advertisements must comply with the medicines act.

Section 56 of the Medicines Act 1991 defines an advertisement as being;
``Advertisement'' means any words, whether written, printed, or spoken, and any pictorial representation or design, used or appearing to be used to promote the sale of medicines or medical devices or the use of any method of treatment; and includes any trade circular, any
label, and any advertisement in a trade journal; and ``advertising'' and ``advertised'' have corresponding meanings:

In declaring that the packaging of Pfizer's Pamol product is not an advertisement, and therefore beyond the ambit of the Advertising Standards Authority, the ASCB has effectively given marketing gurus free license to make false, misleading claims and even fraudulent claims -- so long as they are safely incorporated on the packaging.

"This ruling is simply dumb, and leaves a great deal of egg on the Advertising Standards Authority's claim to being the guardian of the consumer and truthful claims,"says Ron Law.

The ASA has redefined the term "social responsibility" and has ruled that fraudulent claims on packaging are socially OK. How absurd!

To make matters worse for consumers, even though Medsafe has been aware of Pfizer referring consumers to a sham website for further information for some time, it has stated on 20 October 2004 [correspondence on file] "As I have said before, I intend to follow up the website issue with the company. Please be aware that due to present workloads, this may take some time."

"If this complaint had been against a dietary supplement company, Medsafe and the ASA would have moved heaven and earth to 'protect the public from such shameful practices," says Ron Law.

"If a lazy regulator is not protecting the public from false advertising, and the self appointed guardian of truthful advertising is not protecting the public from false advertising, then who are they protecting?" asks Ron Law [ 09-832 4773] "Why do they impose themselves on industry at great inconvenience and cost if they are going to be AWOL when needed to protect consumers?"

This ruling leaves egg all over the ASA's face and leaves them with a headache. The ASA needs to urgently revisit this irrational decision if it is to have any chance of remaining a credible organisation. This ruling is absurd, irrational, socially irresponsible and opens the door to any charlatan wanting to circumvent any ASA Code of Practice.

As a risk analyst, my advice to clients in future will be, "If you want to make false, falsified, or fraudulent claims about anything, make them on the product packaging and you'll avoid scrutiny."

"I will not be appealing the ruling," says Ron Law. "Why should I waste my time? It's clear that neither the ASA nor Medsafe are interested in protecting consumer interests."

As the editorial in the New Zealand Herald said recently [18-11-2004], "US intelligence. Yeah right."; "There's nothing wrong with the Advertising Standards Complaints Board." Yeah right.

To that we can now officially add the following to the Tui Award nominations. "The Advertising Standards Complaints Board protects the interests of the consumer. Yeah right."; "Medsafe protects the interests of consumers. Yeah right."; and "For further information on Pamol products access our website http://www.pamol.co.nz. Yeah right."

If the ASA's headache is too severe, perhaps they should take a Panadol and rethink their decision in the morning.

As for Pfizer, well perhaps they have more important headaches to deal with at the moment, like helping Medsafe defend the safety of a number of its drugs such as Celebrex and Bextra, and trying to prevent voluntary organisations from making truthful statements about links between meningococcal disease and paracetamol use.

Note to Editors:

The complaint to the ASA was as follows... [attachments available on request.]

Interpretation...

For the purposes of the Codes: (full Interpretation attached)
The word "advertisement" is to be taken in its broadest sense to embrace any form of advertising and includes advertising which promotes the interest of any person, product or service, imparts information, educates, or advocates an idea, belief, political viewpoint or opportunity.

This says that the word advertisement is to be taken in its BROADEST sense to embrace ANY form of advertising.

Principal 1 of the Therapeutic Advertising Code states... "Particular attention is drawn to the advertising provisions in the Medicines Act 1981 and the Medicines Regulations 1984."

The ASA states explicitly (See attached Code for Therapeutic Advertising)
"General Note: Sections 56, 57, 58, 59, 60 and 62 of the Medicines Act 1981 and Regulations 7, 8, 9, 10 and 11 of the Medicines Regulations 1984 contain certain statutory requirements for advertisements. A copy of these provisions (and Section 4 of the Act) is available by clicking on the indicated link below."

By linking the statutory requirements for advertisements to the Code for Therapeutic Advertising the ASA explicitly includes product labelling as an advertisement as it is defined as such in s56 of the Medicines Act. (see attached)

This in turn makes rulings such as 04/281 irrelevant in terms of interpretation of the Code for Therapeutic Advertising as the Therapeutic Advertising Code includes specific legal requirements and definitions which may not be the case regarding a different Code and a different Act.

Therefore, the label and packaging of Therapeutic Products is legally and explicitly covered by the ASA Code for Therapeutic Advertising.

As such, I now make a formal complaint to the Advertising Standards Authority regarding Pfizer's Pamol Paediatric Drops (see two attachments)

Pfizer's Pamol product and packaging labelling breaches

Principle 1 - Advertisements should comply with the laws of New Zealand and the appropriate industry Code of Ethics.
Guidelines

1(a) All advertisers are expected to abide by the rules of the appropriate industry Code of Ethics in addition to this Code. Particular attention is drawn to the advertising provisions in the Medicines Act 1981 and the Medicines Regulations 1984.

Principle 2 - Advertisements should observe a high standard of social responsibility particularly as consumers rely on therapeutic products and services for their health and well-being.

The Code states that consumers must be notified where they can get additional product information...

2(a)(ii) Notify consumers that additional product information can be obtained, and the methods for doing so. Such information shall include the name and quantities of the active ingredients, authorised uses, appropriate precautions, contra-indications, and adverse reactions. Various acceptable methods include, but are not limited to, instructions for consumers to contact their doctor, pharmacist or health professional; packaging of the product; provision of a toll-free telephone number; the advertiser’s Internet web site address; the advertiser’s postal address; and referring consumers to advertisements with full information appearing concurrently in other media.

Pfizer's Pamol attempts to meet that requirement, but fails to be socially responsible in that...

1. The persons answering the 0800 number provided on the bottle and the package have, on two occasions, been unable to locate any product information. On Tuesday 28th September I phoned the second time. I was asked repeatedly why I wanted the information. After three minutes of discussion the telephonist conceded that they had no information. He put me on hold to go and find information for me. After a further 9 minutes of silence, he came back and apologised as he could not find any product information on any of Pfizers websites.

In other words, the 0800 number provided on both the bottle an the package (0800 225 574) was a sham as it did not enable the consumer to obtain additional information.

2. The website provided on the bottle and package does not exist. Therefore, it is a sham and does not enable the consumer to obtain additional information.

As a matter of comment, the Pfizer website has no product information either... just pretty pictures (http://www.pfizer.co.nz/ProductsConsumer.aspx)

If Pfizer claims that Pamol is a "Heritage" brand, as reported in the Sunday-Star-Times on 26 September 2004, then it has an extra social responsibility to not mislead consumers.

I therefore ask that the complaint be referred to the ASCB for consideration, that Pfizer be required to

1. Provide consumer information via the 0800 number and website as implied on the bottle and packaging, or
2. Change the wording on the package and bottle to direct the consumer to an actual source of information, and
3. Make any changes as may be required regarding false information on other Pamol products, and
4. Publish an appropriate apology to the public of New Zealand for misleading them, and
5. Take any other remedial actions deemed appropriate by the ASCB.

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