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OPEN LETTER TO ALLAN ROCK: Alesse Drug Ads are Illegal

Direct to Consumer Advertising is illegal in Canada, a coalition of women's and consumer groups reminds the Minister of Health. An open letter to the Minister details the misleading and inaccurate features of a recently aired television campaign to promote an oral contraceptive.

"Canadian women need accurate information about contraceptive options," points out spokesperson Anne Rochon Ford, "and a comprehensive public health campaign on this theme is long overdue." In a related policy brief to the Minister, the Working Group on Women and Health Protection points to the disastrous impacts of consumer advertising on health care costs in America.

"Advertising is not the same as public information, which is why Canadian law prohibits the advertising of prescription drugs," says Ford.

The Working Group on Women and Health Protection represents over 20 women's and consumers' groups across Canada including the Canadian Women's Health Network, DES Action Canada and the Women's Health Clinic in Winnipeg.

Text of Letter to Rock follows:

The Honourable Allan Rock, MP , MINISTER OF HEALTH

Dear Mr. Minister:

We are writing you to call for an immediate halt to Wyeth-Ayerst's advertising campaign for its contraceptive Alesse (ethinyl estradiol and levonorgestrel) on Much Music, National Network Television, Cineplex Odeon, and on municipal transit in 15 cities in Canada.

Prescription drug advertising to the public is illegal in Canada under the Food and Drugs Act: "No person shall advertise a drug for sale to the general public if that drug contains any of the substances listed in the schedule to Division 10 (proprietary medicines)." The only exception is a 1978 amendment brought in to allow pharmacists to post prescription drug prices. This amendment states that "Where a person advertises to the general public a Schedule F Drug (prescription only), the person shall not make any representation other than with respect to the brand name, proper name, price and quantity of the drug."

The Wyeth Ayerst campaign, as described in their press materials, contravenes both the spirit and the letter of the law.

The Therapeutic Products Programme's 1996 policy, which outlines "the distinction between advertising and other activities," also clearly states that activities with the primary aim of stimulating product sales fulfill the defining of advertising, and are subject to regulation. In this case the regulation in question is a prohibition against targeting the public with prescription drug advertising.

Advertising that falls short of spelling out the indication for a product, but uses a variety of techniques to suggest it -- such as young women talking about sexual relationships with men and the photo of the 28-day pill dispenser -- clearly contravenes the prohibition against "any other representation." Similarly, advertisements that talk about birth control, the product's indication, and consciously use words that sound like the product name, such as repeated use of "a lesson in" and "less" are also examples of product-specific advertising. Finally, running two separate types of ads targeting a single audience in one media outlet, with both the product name and the indication mentioned, clearly comprises full product advertising.

The press kit released by Wyeth-Ayerst also contravenes the Food and Drugs Act. It includes a "fact sheet" on Alesse that only provides information about potential benefits of the product. No information is provided about side effects or risks.

This "fact sheet" states that higher dose contraceptive pills carry a higher risk of thromboembolic events, stroke and heart disease, without clearly stating that Alesse is also associated with these rare, serious adverse effects. The fact sheet does not include any statement about common side effects such as nausea and vomiting, which occur in over 10% of users, or any other commonly occurring side effect listed in the approved product labelling. The fact sheet states that any woman between the age of menarche and menopause can use this contraceptive. A few medical contraindications are listed, but no warning that women over 35 who smoke are at increased risk of serious adverse effects.

Information on potential benefits is also misleading. Only the effectiveness rate under ideal conditions of use is presented. Young women thinking of using a contraceptive need to know not only the highest possible effectiveness rate, but also observed effectiveness rates under normal conditions of use. The fact sheet also presents the drug as associated with a "reduced possibility of developing benign breast cancer.' There is no such disease as 'benign breast cancer.' As stated in the entry for Alesse in the Compendium of Pharmaceuticals and Specialties, contraceptive pills have been associated in observational studies with an increased risk of breast cancer, not a reduced risk.

This fact sheet contravenes section 9(1) of the Food and Drugs Act: "No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety."

An article in the Globe & Mail (6 May 2000) quotes a company spokesperson as saying that Advertising Standards Canada had approved this campaign. Advertising Standards Canada is responsible for the regulation of non- prescription drug advertising to the public, not of prescription drug advertising, which is illegal.

The Working Group on Women and Health Protection, representing more than twenty women's health and consumer organizations in Canada, calls on you to take immediate action to halt this campaign. We also call on you to impose maximum penalties on Wyeth Ayerst, MuchMusic and other companies involved in this advertising campaign if they fail to comply.

Working Group on Women and Health Protection c/o DES Action Canada, 5890 Monkland Avenue, Suite 203 Montreal, Quebec H4A 1G2 (514) 482-3204


staffwriter, May 9, 2000, CNW/via NewsEdge Corporation

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