Healthy Skepticism Library item: 845

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

Hawaleshka D.
Diane's fear factor: A controversial drug's ad campaign fuels anger
Macleans.ca 2005 Mar 4

Full text:

Jackie Baisley thought the medication was safe. In 2000, the Oakville, Ont., resident saw her doctor for what she admits was “pretty mild”
acne. The doctor prescribed Diane-35, and Baisley’s skin soon cleared.
She took the drug for 18 months, in part because it also works as birth control, though Health Canada has not approved it for that. Then a friend told Baisley, now 31, about the potentially fatal blood clots associated with the medication. “It kind of freaked me out a little bit,” recalls Baisley. “I just decided the risk was too great for me to be on it.”

Diane-35, manufactured by Berlex Canada Inc. and the subject of a controversial advertising campaign, contains two sex hormones.
Cyproterone acetate inhibits male hormones naturally found in women and reduces gland activity associated with acne; ethinyl estradiol, found in common birth control pills, regularizes menstrual cycles disrupted by cyproterone. Diane-35 is approved by Health Canada for severe acne, but only after all else fails, and for women who, because of hormone problems, suffer from excess hair on the face or elsewhere. (While Health Canada approves drugs for certain conditions, doctors are free to prescribe them as they see fit under a practice known as “off-label” use
— hence the prescription for Baisley.) In a written statement, Berlex says Diane-35 is “a very safe drug that has been used since 1985 by more than 40 million women worldwide.” The Pointe-Claire, Que., company maintains there is “no convincing trial data” to suggest Diane-35 is any more dangerous than conventional birth control pills, which are known to slightly increase women’s risk of blood clots.

Nevertheless, Health Canada and Berlex put out two warnings about
Diane-35 — one in 2002, another in 2003. The former noted Diane-35 to be four times more likely to cause blood clots than ordinary birth control pills. The latter said the clots are “rare, but still justify caution.” Health Canada says that between the drug’s introduction in
1998 and last year, 88 suspected adverse drug reactions were reported — including eight deaths.

What’s caused outrage is the TV ad campaign for Diane-35 that until mid-February ran on MuchMusic, whose audience is primarily young (until the end of the month it was also on other Canadian stations). The ad featured fresh-faced girls preening in front of mirrors, and ended with a shot of a package of Diane-35 — strikingly similar to the packaging for birth control pills. Barbara Mintzes, an epidemiologist at the University of British Columbia, along with other advocates for women’s health, has written Health Minister Ujjal Dosanjh to complain. They say the ad inappropriately targeted impressionable teenage girls, luring them with the promise of a clear complexion and pregnancy prevention.
The commercial, argues Mintzes, promotes an “unnecessarily risky product to young girls.”

A Health Canada spokeswoman said the department will investigate the claims, and noted a review of the legislation covering direct-to-consumer drug ads is already underway. CHUM Ltd., MuchMusic’s owner, declined to be interviewed, but issued a statement: “Advertising running on our stations is screened and approved by the appropriate bodies endorsed by Health Canada.” Berlex, meanwhile, stood by its ad.
It noted that the container for Diane-35, known as “blister packaging,”
is, in fact, “a standard form of pharmaceutical packaging for products of all sorts.” And it said its campaign was “targeted to young adults who have the highest prevalence of severe acne and are in greatest need of therapy.”

Falling sales may have something to do with it as well. IMS Health Canada, a drug-market watcher, says Diane-35’s popularity peaked in 2002, when 835,000 prescriptions were filled for almost $36 million. In early 2003, though, the blood-clotting story got a lot of play, and by 2004, sales had dipped to 668,000 prescriptions, worth $29 million.
Running ads might attract new customers, but Baisley’s had her fill. Her lesson in all of this? “I’ll do more research on the pills that are prescribed to me.”