September 14, 2010

Petition against Bayer IUD contraceptive MIRENA

New study shows up to 60% of women discontinue using Mirena within 5 years due to unscheduled bleeding, pain and/or systemic adverse effects

Last year Bayer set up in-home parties to tout their Mirena IUD as a way to improve romance, energy, even looks. In December, the Food and Drug Administration sent a letter ordering Bayer to stop making false and misleading claims (Download: FDA_Warning_Mirena_Dec30_2009.pdf). Bayer’s Mirena party script (Download: Mirena_Promo_Material.pdf) contained guidance such as: How would you categorize yourself? Hot and sexy with a lot of spontaneity or too tired with little time to be intimate?

More than 1700 women have signed the Mirena Awareness Petition which urges Bayer to publish the alarming number of side effects that Mirena can cause.

The following adverse reactions appear ONLY on the physician information for the Mirena: abdominal/pelvic pain, vaginal discharge, nausea, headache, nervousness, vulvovaginitis, dysmerorrhea (cramps), back pain, weight increase, breast pain/tenderness, acne, decreased libido, depressed mood, cervicitis (vaginal infection), hypertension, migraine, vomiting, anemia, dyspareunia (painful intercourse), alopecia (hair loss), eczema, pruritus (itchiness), rash, urticaria (hives), abdominal distension, altered mood, hirsutism (abnormal hair growth), edema (swelling).

Although doctors are instructed to share this information with the patient, they often do not. In many cases, even when specifically asked, doctors are denying a possible link between Mirena and these symptoms. Patients are consistently told there are "no side effects," and that the synthetic hormone (levonorgestrel) contained in the mirena cannot be harmful because the hormone release is localized to the uterus.

The reluctance of doctors to acknowledge the many possible adverse reactions to the Mirena, including the ones documented by the manufacturer, suggests that they are alarmingly ill-informed or purposely obtuse--resulting in prolonged patient suffering and extensive medical expenses while seeking diagnosis/treatment of Mirena-related issues.

Inside the Mommy-Blog-Industrial Complex, Where Chemical Companies Write Posts for Parents

By Jim Edwards, BNET | September 13, 2010

When a Reuters investigation showed that the FDA had just 57 people reviewing 75,000 pharmaceutical ads a year, making sure drug companies don’t make false or misleading claims, it wasn’t surprising that Bayer (BAY.DE)’s marketing was Exhibit A. The company had sent out a nurse, a fashion stylist and a blogger to parties in private homes that promoted Mirena, Bayer’s IUD contraceptive:
“Here you have a company hiring a third-party to invite people into a home like a Tupperware party,” said Thomas Abrams, whose department oversees pharmaceutical marketing reviews at the FDA. “That was extremely, extremely concerning to us because this product has risks — risk of infection, loss of fertility. Huge risk.”
The company received a warning letter from the FDA, asking them not to do that again. You can see Bayer’s Mirena party script here; it contained such medically accurate gems as:
How would you categorize yourself? Hot and sexy with a lot of spontaneity or too tired with little time to be intimate?
Bayer, of course, has a history of lax marketing when it comes to women’s reproductive health. It’s currently fighting 2,000 lawsuits over the contraceptive Yaz (plaintiffs allege it causes lethal blood clots) and the company was once required to spend $20 million advertising a correction to its previous misleading Yaz advertising.
What was surprising, however, was the involvement of a web site called MomCentral. MomCentral looks like one of those mommy blogs where harried parents trade tips on diapering, fashion and time-out strategies. However, MomCentral is also a marketing consultancy with Big Pharma clients. It has provided promotional material to Mylan (MYL) for its EpiPen auto-injector for severe allergic reactions, and it counts Johnson & Johnson (JNJ) as a client.
In addition to hosting Mirena parties for Bayer, MomCentral also posted this item on its blog. The article appears to be a Q&A with Stacy Kaiser, a relationship expert, and Jennie Finch, an Olympic gold medalist. The pair chat about how bringing your BlackBerry or laptop to bed with you is a pretty good way to kill intimacy with your husband. Although the article mentions a survey sponsored by Mirena, and it says that Mirena “teamed” with Finch and Kaiser, it doesn’t become clear until the very end of the article — where it says “Advertorial Content” in a line of type separated from the article by several inches of white space — that the whole thing has been sponsored by Bayer. Finch endorses Mirena, and you can see a similar version of the Finch-Kaiser yak-fest on Bayer’s site.
The MomCentral article is undated, and as such potentially infringes the FTC’s new rules that require bloggers to make it crystal clear to readers any connections between sponsors and the content they’re providing.
MomCentral did not respond to an email and a phonecall requesting comment. However, CEO Stacy DeBroff told Reuters the Mirena parties were like a focus group, and that “her website won’t partner with any other drugmakers until the FDA clears up its rules.”
Fair enough. But let’s also note that MomCentral has carried advertorial content defending high-fructose corn syrup here and here. The latter article counsels women that avoiding high-fructose corn syrup is “not the magic answer to keing your children healthy.” Both articles claim HFCS is not to blame for America’s obesity crisis. Neither article mentions that the author, Dr. James Rippe, is a consultant for the Corn Refiners Association.
Perhaps it’s time that MomCentral made its commercial ties more obvious to its readers, before everyone starts calling it ChemicalMomCentral.