Birth control maker disciplined over untruthful advertising

FDA says YAZ commercials exaggerate its efficacy and approved uses.

In a rare move by the Food and Drug Administration , a pharmaceutical company has been forced to recant on some of its direct-to-consumer advertisements and is spending $20 million on a counter-advertising campaign that began airing recently. Bayer HealthCare Pharmaceuticals pulled a pair of advertisements for the oral contraception YAZ last fall after the FDA issued its initial warning against the company. The advertisements in question “were deceptive and misleading, and promoted the drug for indications that were not approved,” FDA spokeswoman Rita Chapelle said. “It’s long overdue,” said Gary Schwitzer , associate professor of journalism and publisher of healthnewsreview.org, a website that grades health care journalism stories. “This is classic disease mongering.” YAZ is one of the most popular birth control pills in the country, and the advertisements are aimed directly at young women. In the commercials pulled by the FDA, symptoms of premenstrual syndrome were kicked, punched or simply floated away. “It’s, âÄòlet’s take normal states of health or normal variations of health and expand the scope of what our drug was actually approved to doâÄô,” Schwitzer said, adding that he thinks most young women probably feel things like fatigue, muscle aches or anxiety at some time or another. The FDA approved YAZ to treat premenstrual dysphoric disorder (PMDD ) but not regular PMS. PMDD is defined as being severe symptoms of PMS, to the degree of negatively impacting a woman’s life, but there is debate as to whether or not it deserves its own classification as a disease. Dr. June LaValleur, who has practiced as a board-certified gynecologist for more than 20 years, said the severe symptoms of PMDD affect less than 5 percent of patients. A letter sent to Bayer in October states, “The TV Ads suggest that YAZ is approved for acne of all severities when this is not the case.” The letter goes on to describe the commercial’s audio claim that “it can also help keep your skin clear,” which is paired with a woman with completely clear skin. According to the “indications and usage” section from the FDA-approved product labeling, “YAZ is indicated for the treatment of moderate acne vulgaris.” âÄúYoung women in America need to know that theyâÄôve got a bulls-eye on their back, painted there by Big Pharma,âÄù Schwitzer said. âÄúWe are feeding this âÄòpill for every illâÄô mentality.âÄù Leslie, a junior whose last name has been omitted in respect for privacy concerning her sexual health, said she has been on YAZ since she was in high school, and went on it largely to help her acne. “To be honest, I never really noticed a significant change in my skin,” she said. “You can blame the pharmaceutical companies,” Leslie said, “but at the same time, we all know there are certain things that you probably can’t cure with a pill. And I don’t think you should expect it.” She said young women need to be responsible in researching the drugs and talking with their doctors about it. “I didn’t expect my world to change,” she said, “but they definitely exaggerated things [in the ads].” — Emma L. Carew is a senior staff reporter