Yasmin, Yaz Off-Label Promotion Discussed in Bayer Emails: Report
Internal e-mails appear to show that Bayer officials were looking for ways to sidestep federal law and illegally promote their controversial Yaz and Yasmin birth control pills, according to a recent report.
The company e-mails, obtained by Bloomberg News, reportedly show Bayer officials discussing the promotion of the birth control for the treatment of premenstrual syndrome (PMS), even though the FDA only approved the pills for treatment of the most severe form of PMS, known as premenstrual dysphoric disorder.
One of the e-mails, written by Matt Sample, who was a sales consultant with Bayer’s Berlex Laboratories subsidiary, pointed to a Woman’s Day article as an example of how to promote Yaz for the treatment of PMS in a broad sense, instead of sticking to the FDA’s narrow approval.
Sample instructed sales representatives to ask roundabout questions to doctors in a way that could be construed as promoting Yaz for off-label use. The representatives were told to ask the doctors they visit what percentage of their patients suffer from common PMS symptoms and then ask them what they thought the effect of Yaz would be on those patients.
Another e-mail from Berlex executive Kimberly Schillace, sent in 2002, flouted the fact that Dr. Judith Reichman, who had a legal contract with Berlex, was going to go on NBC’s “Today” show and promote Yasmin for non-approved uses. “She definitely will mention the off-label benefits of our products,” Shillace wrote.
Bayer has been warned at least three times by the FDA, in 2003, 2008 and 2009, over problems with Yasmin or Yaz advertisements. The drug maker has been cited for misleading the public through the use of ads that overstated the efficacy and benefits of Yaz and Yasmin, while minimizing serious risks associated with the drug.
In 2009, Bayer was forced to run a $20 million corrective advertising campaign to address problems with Yaz advertisements that stressed the potential benefits in treating acne and symptoms of PMS, while minimizing the potential risk of blood clots and other side effects of Yaz.
For the next several years, Bayer is now required to submit any future Yaz advertisements in the United States to the FDA for approval before they are aired.
Drug manufacturers are barred by federal law from promoting drugs for uses not approved by the FDA. A number of massive “off-label” marketing lawsuits have been brought against drug makers in recent years by the Justice Department over such tactics. Earlier this month, reports surfaced that GlaxoSmithKline had reached a $3 billion settlement with federal prosecutors over claims the company illegally marketed the diabetes drug Avandia.
The law does not apply to doctors, who are allowed to prescribe drugs for whatever purpose they wish. As a result, many illegal marketing cases have centered around drug representatives pitching off-label uses for their drugs to doctors, sometimes in very indirect, but deliberate, ways.
The e-mails were uncovered as part of the discovery process in hundreds of Yaz lawsuits and Yasmin lawsuits filed against Bayer by women who suffered injuries from the birth control pills, such as blood clots, strokes and gallbladder problems.
Several studies have suggested that Yaz and Yasmin increase the risk of blood clots, potentially causing pumlmonary embolism, deep vein thrombosis, and other life-threatening injuries. The pills contain the “fourth” generation progestin drospirenone, which research suggests may pose an increased risk when compared to older birth control pills.
An FDA advisory committee is scheduled to examine the data surrounding the risk of health problems from Yaz and Yasmin at a meeting next month.