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CWHN Writes the Minister of Health Re: Xenical Ads


Letter #1

Honourable Ujjal Dosanjh,
Minister of Health
House of Commons
Ottawa, Ontario K1A 0A6

March 30, 2005

 

Honourable Minister,

We are delighted to see your interest in improving drug safety through enhancing post-marketing surveillance, as well as improving reproductive health of women by increasing access to unintended pregnancy terminations. We thank you for your leadership in these matters.

Complaints About Xenical Drug Advertising
We are writing on behalf of the many individual Canadian women and women's organizations who have contacted us in the past few weeks to express their concern, if not outrage, about a series of troubling ads directed at Canadian consumers to promote the prescription drug, Xenical.

Xenical is approved in Canada only for the treatment of obesity. However, advertisements for this drug have recently been marketed widely to Canadian women suggesting use of this drug for mild (cosmetic) weight loss. We ask you to have the promotion of an off-label use of a prescription drug halted immediately.

The advertisements have appeared in many of Canada's national and regional newspapers, including the Globe and Mail (sample attached), the Toronto Star, the Winnipeg Free Press, and in Canadian magazines, such as Reader's Digest, Chatelaine and Maclean's, on television, including CBC TV, and on billboards in bus shelters, malls and on buses and in subway cars and stations across Canada in French and English. Clearly, this is no small campaign, but, rather, an aggressive national advertising blitz meant to target a wide range of women in the country.

We Urge Health Canada to Stop Illegal Drug Ads
As you will see from the sample ads attached, the key message presented in the advertising campaign is about losing a few pounds so that a woman may – as per their examples -- strip tease for her husband, wear a bikini or fit into their wedding dress. The ads ask: “What would you do with a few pounds less?” This message, and the images of slender women in the ads, clearly exceeds the bounds of application for which this drug was approved by Health Canada.

Xenical is only approved for the treatment of obesity and is intended for those with a Basal Metabolic Index (BMI) of 30 or over (or 27 and over IF there are co-existing medical conditions).

Further, the Xenical ads are preying on women's anxieties about body image, are demeaning, and are cashing in on weaknesses in the enforcement of Canada's laws around direct-to-consumer advertisements of prescription drugs. Health Canada needs to intervene.

What Xenical does to the body
While the ads do not mention the drug, Xenical by name, according to the Globe and Mail (column by André Picard, 02/24/05), the ad campaign is being funded by Hoffman-LaRoche, makers of Xenical. As with other prescription drugs, Xenical has undergone a strict approval process by Health Canada. Nevertheless, like almost all prescription drugs approved for specific purposes, there are “risks” as well as possible “benefits” for those who use it for the approved indications, and Xenical does have serious side-effects, both direct and indirect.
Xenical works by preventing the absorption of dietary fats from the foods one eats, with undigested fat removed through bowel movements. In the process, the absorption of some important fat-soluble vitamins and beta-carotene in the diet are blocked. Consequently, those taking Xenical must also take vitamin supplements to get the essential nutrients they are no longer able to absorb from the foods that they eat.
The most common side-effects of Xenical are the following:

  • Oily or fatty bowel movements (stools)
  • Increased number of bowel movements
  • Urgent need and/or inability to control bowel movement
  • Bowel movements that are orange or brown in colour
  • Gas with discharge
  • Oily discharge
  • Stomach pain
  • Irregular menstrual periods.

Xenical is also not recommended for those who are pregnant, planning to get pregnant, breastfeeding, or who suffer from chronic malabsorption syndrome or cholestasis. It would also be a most dangerous substance for women with an eating disorder who see its use as a way to further weight loss. Neither, with these extensive side-effects, is the drug intended to be used widely by healthy women who wish to lose a few pounds, the suggestion of the Xenical ads.

We urge Health Canada to act immediately to stop the campaign of this direct-to-consumer advertisement for Xenical in all Canadian media and to prevent any similar ad campaigns in the future. The advertisements are not only misleading (promoting an off label use of a prescription drug) and offensive (preying on women's body anxieties), but pose risks to public health and contravene the Food & Drugs Act.

 

Sincerely,

Anne Rochon Ford, Coordinator, Women and Health Protection

Madeline Boscoe, Executive Director, Canadian Women's Health Network

cc:
  • Diane Gorman, Health Products and Food Branch
  • Anne Szutke-Fournier, Marketed Health Products Directorate
  • Deanna St.Prix-Alexander, Bureau of Women's Health and Gender Analysis
  • Hon. Carolyn Bennett, Minister of State for Public Health
  • Hon. Liza Frulla, Minister of Canadian Heritage
  • Bonnie Brown, Chair, Standing Committee on Health
  • Anita Neville, Chair, Standing Committee on the Status of Women
  • Advertising Standards Canada
  • Canadian Radio-television and Telecommunications Commission
  • Canadian Broadcast Standards Council

 

Letter #2

Response from Minister Dosanjh (PDF 902k)

 

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