Emails from Bayer officials seem to show that the company is looking for ways to get around federal laws and illegally promote its popular and controversial oral contraceptive Yaz.
Bloomberg News reportedly got ahold of the potentially damaging emails which are said to show the drug giant’s officials in talks to promote Yaz as a treatment for premenstrual syndrome (PMS) despite the fact that the FDA has not approved the drug for such use. One of those e-mails, which was written by Matt Sample (who was a sales consultant with Berlex Laboratories, a Bayer subsidiary), drew attention to an article in Woman’s Day to support the promotional effort. The article itself was meant to be viewed by the email’s recipient as an example of how to promote Yaz as a treatment for PMS in a broad sense.
It turns out that Sample even tried to get the sales reps to ask subtle questions to doctors so that their inquiries can’t be viewed as an attempt to promote Yaz’s off label use. The reps were also told to ask the doctors how many of their patients suffer from PMS and how they thought Yaz would fare in treating it.
Bayer seems to keep trying to get around federal regulations; company officials have been warned at least three times already for it by the FDA. In fact, the company has been cited for its previous marketing campaign that used ads as a means of promoting Yaz as a treatment for acne as well as PMS, while at the same time downplaying the dangerous side effects.
The FDA even went so far as to force Bayer to run a $20 million ad campaign designed to correct its old ads by including the drug’s risk of causing blood clots, strokes and other side effects. In addition, the company now has to run its ads by the FDA before they can air them. Still, Bayer is now trying to get around those rules. Since the law doesn’t apply to doctors (who can prescribe drugs for whatever they want to), it appears that Bayer is hoping to promote Yaz’s off-label uses to the doctors instead of the public. While this is a clever tactic by Bayer, patients may end up being harmed unnecessarily in the process.
