Washington, DCBayer, the manufacturer of Yasmin and Yaz, is trying to get FDA approval for its blood-thinning pill, Rivaroxaban, which it hopes could eventually become a standard treatment for preventing heart attacks, pulmonary embolisms and strokes. Here's an idea: maybe the giant pharmaceutical company could profit by warning about blood clots on Yasmin and Yaz labels and TV ads—a warning it currently avoids like the plague. It could sell Rivaroxaban with every Yasmin and Yaz prescription.
In 2008 the FDA forced the giant pharmaceuticals company to air a new $20 million ad campaign for Yaz to clarify false information conveyed in its original ads, which claimed that Yaz could clear up acne and treat premenstrual syndrome (PMS). They did not mention that Yaz is approved only for the more severe premenstrual dysphoric disorder (PMDD), or that potential health risks include blood clots. In those ads, women sing "We're not gonna take it!" while kicking away visual representations of words like "irritability," "moodiness," "bloating" and "feeling anxious."
But the revised ads barely mention Bayer's previous mistakes. ''You may have seen some Yaz commercials recently that were not clear,'' says an actress as she looks into the camera. ''The FDA wants us to correct a few points in those ads.'' She explains that if you are taking medication that is also increasing potassium, you should have your potassium levels checked, but does not mention the increased risk of blood clots compared with other birth control pills.
''These ads should never have been out there," said Judy Norsigian, the executive director of "Our Bodies Ourselves".
"Until some of the drug companies [such as Bayer] feel monetary negative effects from putting drugs on the market prematurely, they will continue to do so, unless the penalty gets too high." It would appear that $20 million Bayer spent on the new ads isn't high enough. Bayer still did not admit that it had engaged in deceptive advertising or committed any wrongdoing.
Back in 2003, the FDA warned Berlex Laboratories (purchased later by Bayer) about TV ads using the tagline, "Ask about Yasmin and the difference a little chemistry can make." The agency said that the ads overstated the safety of the drug, and, unlike the boldface warnings in the package insert, failed to communicate the risks of increased potassium.
Between 2004 and 2008, over 50 deaths of Yaz and Yasmin users were reported to the FDA, including the death of a 17-year-old. Many women who were not of child-bearing age suffered gallbladder removal or sudden death after taking the pills to improve their acne—a classic example of dangerous off-label marketing. In Europe reports of pulmonary embolism and deep vein thrombosis were made soon after Yasmin was approved in 2000.
The wholesale price of Yasmin jumped by nearly $20, or 40 percent, since 2006—from $49.36 to $69. Bayer reported group sales up 3.6 per cent to 8.5 billion in the second quarter of 2008, compared to the same period last year. With those figures, $20 million is just chump change for Bayer.
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