Guest Post from Evil Slutopia

There are Tupperware parties, Passion Parties, Pampered Chef parties, and…Mirena IUD parties? Yes, apparently these events popped up early last year and were a joint effort from Bayer Pharmaceuticals and the mom marketing site Mom Central.

Here’s one mom blogger’s description of the Mirena party that she hosted:

Then tonight I hosted a party at my house with Mom Central. Mom Central had found me through this blog and asked me if I would be interested in hosting an event sponsored by Mirena. As I welcome any opportunity to sit down with some girlfriends with some free food and drink, I was happy to accept. Before the party started, I walked around nervously, terrified that only a couple of people would show up. We’re all so busy, and I worried that people would end up skipping a strange commercial-sounding event. But one by one, they rolled in and I began to relax.

We had an amazing evening, talking about sex, fashion, and living a simpler life. I realized that we don’t actually spend a lot of time talking about sex and relationships. We laughed a lot but also went home with some great tips.

If you’re thinking that “strange commercial-sounding event” sounds like an accurate description for a party like this, you won’t be surprised by what comes next. What this mom didn’t mention, possibly because she wasn’t aware, was the fact that the script used at these parties didn’t comply with FDA implementing regulations or the Federal Food, Drug, and Cosmetic Act, prompting the FDA to send a warning letter to Bayer at the end of last year. (Bayer is no stranger to FDA warnings – they recently had to “correct” ads for their Yaz/Yasmin birth control pills, which are also the subject of several lawsuits, after the FDA said they were unclear and misleading.)

Before I get into the specifics of the FDA violations in this case, let’s take a look at some more details about these events. First, let’s look at Mom Central. The main Mom Central site has forums, blogs, parenting tips, a product testing panel, giveaways, and so on, but it’s the Mom Central Consulting site that we’re really interested in. Here are some quotes from the site about what they do:

• Companies eager to tap the powerful, abundant, dominant women’s market are often challenged to target and reach Moms simply through their own internal “experts.” We at Mom Central Consulting are Mom Experts currently engaged in crafting messaging, marketing to mothers and reaching millions of Moms nationwide every month.
• TODAY’S MOMS REQUIRE TARGETED, HOLISTIC MARKETING APPROACHES that reach them where they are in their lives today. At Mom Central Consulting we create customer loyalty and word of mouth programs that: foster credibility, drive evangelism and engage Moms in irresistible brand experiences that drive sales and fuel profits.

  Our two-pronged targeted approach connects clients with our vast proprietary network of leading Mom Experts and Opinion Leaders and then activates Moms to become trusting, loyal advocates and consumers of your brand, product or service, making us experts at marketing to women.

• CORPORATE SPOKESPERSON BUREAU: We can draw from our pool of hundreds of talented media savvy spokespeople to create a customized corporate press campaign featuring credible experts within your product category.

So maybe the goal of the hosts and attendees at these parties was to have a fun night eating free food and talking about sex and relationships, but it’s important to keep in mind that that’s not the main goal of Mom Central or the product that they’ve been hired to represent. What they want to do is “activate” some Mirena evangelists.

In the case of these Mirena parties, the expert spokesperson that Mom Central used was Barb Dehn, Nurse Practitioner and member of the Mom Central Advisory Board. Barb is the author of a series of Blue Orchid Guides on women’s health topics like breastfeeding and menopause. In addition to those guides, Blue Orchid Press also has a Partner Program:

Blue Orchid Press provides partners with a non-biased, highly credible communication tool that physicians perceive as a true value-add to their practice and that patients actually use, enabling partners to deliver their messages directly to patients via the most trusted channel there is: the doctor. Physicians who see the value of the Blue Orchid Guides give them to all their patients, thus potentially expanding the target audience for partner products and services, and patients who receive the Guides from their physicians actually use them on a regular basis.

Benefits of an accessible reference
Unlike a typical sales brochure, the Guides serve as a constant, easily accessible reference; with increased usage comes increased exposure to the partner’s service/product without a “hard sell” – the products and services gain credibility from both the sponsorship of the Guides and from association with the perceived value of the content. Blue Orchid Guides are all fully endorsed and approved by leaders in their field.

So it’s sort of a targeted, holistic marketing approach that fosters credibility and activates women to become trusting, loyal advocates and consumers of your brand, product or service? That sounds familiar.

The Blue Orchid Press site has a list of Barb’s speaking engagements, including this one:

February & March, 2009: 3 City tour speaking with Moms about intimacy concerns

Based on the timing and the description, it seems likely that this is referencing the Mirena parties. So why doesn’t it say “speaking at Mom Central marketing events sponsored by Mirena”? I guess “intimacy concerns” sounds better.

Nurse Barb also has a blog, Barb’s Daily Dose, and last March she wrote a post called Contraceptive Convenience:

Have you ever forgotten to take your birth control pill? What about trying to track down a condom and squinting in the dark to make sure it hasn’t expired? What about not having enough time to stop at the drug store to pick up a new pack of pills? And how many times, have you tried to remember the first day of your period so you can try to guestimate if you’re fertile?

Wouldn’t it be nice if we didn’t have to worry about birth control?

You know what? There are 2 options out there that can eliminate the day to day, month to month scrambling.

Mirena IUD– This is method that is great for women who’ve already had a baby. It’s good for 5 years and is over 99% effective. If a woman wants to get pregnant, once the Mirena is removed, she can start trying right away. There’s no delay.

This is a small, flexible plastic device that releases a tiny amount of a non-estrogen hormone into the uterus every day. They are easily inserted into the uterus during an office visit. I’ve been inserting Mirena for years right in my office. They’re safe and reliable, and best of all don’t interfere with your spontaneity. Breastfeeding moms can use them too, because there’s no effect on milk supply and it doesn’t transmit any hormones to the baby.

To find out more on the Mirena IUD, please click on the following link: https://www.mirena-us.com

This was posted right around the time that she was speaking at the Mom Central parties. I think it would have been nice of Nurse Barb to disclose to her readers that she was promoting Mirena at sponsored events so that they could take that information into consideration while reading her enthusiastic endorsement, especially considering the similarities between this blog post and the script from the sponsored parties. She probably also could have added a sentence in there about how this “safe and reliable” birth control method does actually have some risks and side effects.

That brings us back to the FDA and the specifics about what was wrong with the Mirena/Mom Central party script. The problems were spelled out in a letter that the FDA’s Division of Drug Marketing, Advertising, and Communications recently sent to Bayer Pharmaceuticals. The letter identifies four different types of violations: “The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena.” Before detailing the violations, there’s some background info from the product labeling information (PI):

…The PI for Mirena also includes numerous contraindications, including “[u]ntreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled,” and “[c]onditions associated with increased susceptibility to pelvic infections.”

The use of Mirena is associated with a number of risks, including warnings regarding the increased risk of pelvic inflammatory disease (PID), ovarian cysts, and irregular bleeding and amenorrhea. Additional warnings include the risk of Mirena embedding in, perforating, or being expelled from the uterus, as well as the increased risk of ectopic pregnancy, and the risks to an intrauterine pregnancy that occurs with Mirena in place. Should a woman become pregnant while using Mirena, serious risks include pregnancy loss and a permanent loss of fertility.

In addition to the warnings noted above, the PI details the common adverse reactions that were observed during the clinical trials for Mirena. According to the PI, “Very common adverse reactions” (>10% of clinical trial patients) included “uterine/vaginal bleeding (including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea), and ovarian cysts.” Adverse reactions that were reported by 5% or more of clinical trial patients include, among others, abdominal/pelvic pain, nausea, headache, nervousness, back pain, weight increase, breast pain/tenderness, acne, decreased libido, and depressed mood.

The PI also includes precautions that patients should be counseled that Mirena does not protect against HIV infection (AIDS) or other sexually transmitted diseases, and that patients should be instructed to check that the threads attached to Mirena are still in place after each menstrual period, as there is no contraceptive protection if Mirena is displaced or expelled.

Additionally, in regards to patient follow-up following the insertion of Mirena, the DOSAGE AND ADMINISTRATION, Patient Follow-up section of the PI states (in pertinent part):

• Patients should be reexamined and evaluated 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.

Apparently it’s kinda hard to work some of that stuff into an “amazing evening talking about sex, fashion, and living a simpler life”. From here the letter breaks up into three sections to tackle the main problems with the script, so I’ll break it down the same way.

Overstatement of Efficacy/Unsubstantiated Claims

In other words, the script exaggerates the awesomeness of Mirena without sufficient evidence to back it up. I’m going to quote extensively from this section of the letter for two reasons. First, it gives us a clearer picture of exactly what the Mirena sales pitch was at these parties.

The Mirena program is a live presentation designed for a consumer audience of “busy moms.” The program is presented in a consumer’s home or other private setting (e.g. private restaurant party) by a representative from Mom Central (a social networking internet site) and a nurse practitioner (Ms. Barb Dehn). The script of this program submitted to FDA includes an introduction from the Mom Central representative, a presentation given by Ms. Dehn regarding the use of Mirena, and a “post-party” questionnaire for the audience.

The script includes the following statements to be delivered by the Mom Central representative (emphasis added):

• “This party was brought to you by Mom Central in partnership with Bayer HealthCare Pharmaceuticals’ Mirena which may help couples keep life simple!”

• “Barb Dehn is a practicing Women’s Health Nurse Practitioner, award-winning author and nationally recognized health expert from San Francisco. Barb is going to kick things off with a discussion about romance and how to find simple ways to reconnect with our partners.”

After the Mom Central intro, Nurse Barb gives her own intro, which reinforces the “romance” and “simple ways to reconnect” themes. Then it’s on to the sales pitch.

Following the introduction of the program, the script states that “Barb [Dehn] will begin presentation with an icebreaker – an interactive Q&A – which will touch upon issues such as busy schedules, barriers to intimacy and contraception” (emphasis added). The “icebreaker” questions include the following (in pertinent part; emphasis added):

•“How many of you feel so busy that you often can’t find time to take care of yourself? And do you think this impacts your level of intimacy?”
•“Do you ever feel so overwhelmed by your schedule that intimacy is much more of a “to do” on a list than a desire?”
•“If you didn’t have to worry about contraception, do you think you would be more likely to be intimate with your partner?”
•“Do you think if you didn’t have to worry about taking your birth control everyday, it would help you be more intimate?”

Immediately following the “icebreaker” questions, the script for Ms. Dehn states (emphasis added):

• “So you mentioned that convenience and reliability are among the most important benefits of your birth control method. One strategy that I recommend for busy couples is choosing a birth control method that allows for spontaneous intimacy and which you don’t have to think about every day, such as the intrauterine contraceptive Mirena®.”

I understand the pitch that Mirena is better for a busy mom because she won’t have to think about taking a birth control pill everyday, but I think the “spontaneous intimacy” thing is a bit of a stretch. It’s not like you need to take a birth control pill or insert a NuvaRing right before sex either.

The FDA felt that the claims went too far:

The above statements clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena. Mirena has been proven to be an effective intrauterine contraceptive device. While we note that Mirena does not involve a daily routine and is not a barrier method of contraception, FDA is not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners. Claims that state or suggest such quality of life outcomes, such as those described above, must be supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated patient assessment instruments to measure the outcomes of interest. If you do, in fact, have data to support these claims, you should submit them to FDA for review.

Now we come to my second reason for quoting so much from this one section. After reading this next part, I heard Kathy Griffin’s voice in my head saying “Jessica, send her a muffin basket!” There’s not too much I can add because this is basically pre-snarked for me:

We note that, according to the Mirena PI, at least 5% of clinical trial patients reported decreased libido as a side effect of Mirena use. Patients also experienced abdominal/pelvic pain, nausea, headache, nervousness, and depressed mood, which could adversely affect a woman’s feelings relating to romance or intimacy.

The script also includes the following statements, to be presented by Ms. Dehn (emphasis added):

• “But what this party is really about is looking at the whole picture and figuring out steps to take to simplify your lifestyle while still looking and feeling great. One of those ways is finding a birth control that is compatible with your busy lifestyle.”

The above statement goes beyond the suggestion of increased intimacy to suggest that Mirena can help patients “look and feel great.” Again, FDA is not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great. Patients using Mirena may experience various side effects, such as irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness, and acne, in addition to the side effects indicated above. The experience of these side effects can prevent patients from “looking and feeling great.” Such claims of improved patient-reported outcomes must be supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated instruments to measure these outcomes of interest. If you do, in fact, have data to support these claims, you should submit them to FDA for review.

First of all, I’m really looking forward to Bayer’s upcoming study on Mirena as magical pathway to intimacy. Secondly, I think it’s sad that this FDA letter more accurately reflects the likely reality for many of the women who attended these parties simply by being honest about the fact that birth control has a lot of side effects that have the potential to interfere with “spontaneous intimacy” or the desire for any kind of intimacy at all. That doesn’t mean that every woman is going to experience bad side effects or that Mirena won’t help some women to be more intimate more often. It just means that the script says the party is about “looking at the whole picture”, and the whole picture is exactly what the women in attendance deserved, but it’s not what they got.

Another blogger who is also a doctor recently wrote a post about these parties. Her opinion boiled down to this: “Using moms to sell pharmaceutucals? Bayer has gone too far.” I noticed that Nurse Barb Dehn actually found the post and added this comment:

HI, I’m Nurse Barb, a practicing Women’s Health Nurse Practitioner and I’m the person who presented at the party you wrote about. I’m very careful in all my presentations to talk about the entire range of birth control options because of the legal and regulatory laws from the FDA.

It was question and answer get together and as inevitably happens, lots of moms had questions about sex. I’m a health educator and saw this as an opportunity to answer their questions.

I thought the wording of this comment was interesting, beyond the obvious disconnect between her claim that she’s careful to comply with FDA regulations and the FDA’s opinion to the contrary. She says that she talks about the range of birth control options, but that’s not really the issue. The FDA’s warning doesn’t say that the script should have had more information about other birth control options, it says that the script should have had more and better information about the one birth control option that it was designed to promote. That brings us to the next issue raised in the letter.

Omission and Minimization of Risk Information

Here’s the risk presentation from the party script:

Only you and your healthcare professional can decide if Mirena is right for you. Mirena does not protect against HIV or STDs. Candidates for Mirena have had a child, and do not have certain cancers or acute pelvic inflammatory disease. In rare cases, perforation or embedment may occur. Mirena may become completely or partially dislodged. In the uncommon event you think you’re pregnant, contact your healthcare professional without delay. Ovarian cysts may occur and typically disappear. Changes in bleeding are common in the first few months followed by shorter, lighter periods. Periods, however, may remain irregular.

And here’s what that script left out, according to the FDA (emphasis mine):

The risk presentation omits the contraindications regarding untreated lower genital tract infections and conditions associated with increased susceptibility to pelvic infections, and does not adequately convey that should a woman become pregnant while using Mirena, she may lose her baby or her fertility.

The letter goes on to say that by focusing on themes like “intimacy” and “look and feel great” and downplaying or omitting information about the side effects and how common they are, the script minimizes the risks and the reality of Mirena. For example, there is a really big difference between ‘if you think you’re pregnant, contact your doctor without delay’ and ‘if you think you’re pregnant, contact your doctor without delay because your pregnancy is at risk and so is your future fertility’. There’s an even bigger difference between the FDA’s summary and the full explanation that’s in the Mirena PI (emphasis mine):

What if I become pregnant while using Mirena?
Call your healthcare provider right away if you think you are pregnant. If you get pregnant while using Mirena, you may have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death.

There are also risks if you get pregnant while using Mirena and the pregnancy is in the uterus. Severe infection, miscarriage, premature delivery, and even death can occur with pregnancies that continue with an intrauterine device (IUD). Because of this, your healthcare provider may try to remove Mirena, even though removing it may cause a miscarriage. If Mirena cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy.

If you continue your pregnancy, see your healthcare provider regularly. Call your healthcare provider right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection. It is not known if Mirena can cause long-term effects on the fetus if it stays in place during a pregnancy.

Now, the risk of this happening is low because the chances of getting pregnant on Mirena are very low. But it can happen, it’s extremely serious, and it’s something that women need to know, especially because it might not be obvious to all of the women at these parties since it’s not necessarily true of other forms of non-IUD hormonal birth control. It’s also not something that gets left out of a script by accident, in my opinion.

Again, I know that stuff like ‘you may lose your baby or your fertility’ doesn’t really fit in with the whole vision of a fun party where moms and mom bloggers talk about sex and relationships and how to look and feel great, but maybe that’s because a party like that is not the right venue for the promotion of pharmaceuticals in the first place.

False/Misleading Statements

Finally, the FDA takes issue with a claim in the script that “Mirena has no daily, weekly, or monthly routines to comply with as compared to the negatives associated with other birth control methods.” Actually, women are supposed to evaluated by their doctors four to 12 weeks after Mirena is inserted and then once a year (or more in some cases) after that. Also, you’re supposed to check the threads that are attached to the IUD every month after your period to make sure that they’re still in place, because it’s possible for Mirena to “become displaced or expelled, which would result in a loss of contraceptive efficacy”. Apparently the thread-checking is mentioned in a separate part of the script, but this particular claim is still inaccurate.

This error seems really avoidable to me. Would the ‘best birth control for spontaneous intimacy!’ sales pitch really have been hurt that much by being truthful about this? I think the women at these Mirena parties would have had no problem evaluating different birth control “routines” and concluding for themselves that Mirena’s is the easiest and least time-consuming.

That brings me to my main problem with this whole thing. I want to be clear about the fact that I’m not insulting the intelligence of the women who attended these parties or implying that they’re gullible or easily swayed by an obvious sales pitch, especially about something this important. A woman might decide to try a new Swiffer or a different brand of orange juice based solely on a sponsored party like this one, but she’s probably not going to get a hormone-filled foreign object inserted into her uterus without any further research just because you treated her to some free chips and dip.

I’m also aware that mom bloggers have been having intelligent discussions about how best to blog with integrity and navigate the world of “sponsored conversations” for awhile now. So I know that moms/mom bloggers/women in general are smart, perfectly capable of making the best choices for themselves and their families, and savvy when it comes to these kinds of marketing attempts. I’m just not sure that Bayer and Mom Central agree with me. If they did, wouldn’t they have written a script that was FDA-compliant and honest about the real benefits and risks of Mirena, and trusted women to weigh the pros and cons and make up their own minds? Giving women a free party is no substitute for respecting them enough to give them the truth.

This essay was first published February 7, 2010, at Evil Slutopia. Republished with permission.