Kim’s FDA Kerfuffle

It’s always hard for me to come back from vacation and get reconnected with work, especially when I have had a great time, as I did. I spent the early part of this week trying to get my motivation back, including the impetus to restart the blog after a 3 week hiatus. There I was, searching for the story that would propel me to the keyboard, and, as always, it showed up in my favorite form – the messy collision of healthcare and pop culture.

You really can’t get more mainstream pop culture than Kim Kardashian. Her 43 million (!) Instagram followers know her better than her gynecologist, I suspect, so chock-a-block is her page with T&A. As those of you who religiously follow People Magazine and TMZ know, Kim is also married to hip hop impresario and Taylor Swift nemesis Kanye West. Together they get more publicity than Jesus, or so it seems. Maybe that’s why Kanye likes to refer to himself as God, but I digress.

So it appears that Kim has gotten herself into a bit of a kerfuffle with the FDA, which sounds like a sentence that should not exist. How in the world did these worlds collide, you may ask? Apparently Kim is pregnant with her second child (the second coming?) and experiencing some pretty severe morning sickness. Not shy about promoting her pregnancy and its effects, Kim publicized her delight in finding a drug, Diclegis, which made her feel better and got her back to the essential task of posting more naked pictures of herself. Duchesnay, the drug’s manufacturer, heard of Kim’s satisfaction with the product and signed her up to be their spokesnude. And that’s where the trouble started. Kim posted this message on Instagram:

“OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com.”

OMG indeed. The FDA was none too pleased about this because, since Kim had become a paid representative of Duchesnay, her communication about the drug must be accompanied by not just the benefits, but the risks of taking Diclegis. Duchesnay and Kim got warning letters from the FDA to this effect, noting the drug’s specific risks, to wit:

“DICLEGIS is contraindicated in women with knownhypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation, as well as in women who are taking monoamine oxidase inhibitors (MAOIs). The PI for DICLEGIS includes Warnings and Precautions regarding activities requiring mental alertness and concomitant medical conditions. In addition, the most common adverse reaction reported with DICLEGIS was somnolence.”

Somnolence, incidentally, is extreme sleepiness, which is, I am sure, one of the risks of getting an FDA letter when you are the general counsel for a pharmaceutical company. The FDA is silent on the risks of taking medical advice from Kim Kardashian, which include: being compromised by having to commune with Kanye West; finding that your children are named after points on a compass; and the very real risk that the all-powerful Taylor Swift wishes a curse on your house.

Somnolence:

One has to wonder whether Duchesnay took a calculated risk in letting loose Kim’s Instagram post. Not only did it get 450,000+ “likes,” and get exposed to 42 million people who intentionally clicked the “follow” button next to Kim’s name, but Diclegis got “a more than 500 percent increase in digital buzz in July,” according to AdWeek. One has to think the revenue bump will exceed any fines the FDA could have imposed. As they say, better to ask forgiveness than permission.

Here’s the thing that puzzles me even more than why pregnant women would be looking at Kim’s Instagram page, where the cleavage selfies are clearly more appealing to men: where exactly should the line be drawn between drug promotion that is and isn’t subject to the FDA’s reach? Kim had apparently spoken publicly about Diclegis before she signed on with Duchesnay. Anything she said as an unpaid private citizen was subject to no rules. The minute she took the drug company’s money, the FDA rules applied.

And yet, people, famous and unfamous, talk about medications on Twitter and Facebook and Instagram every single day without any limitation. There are entire websites, such as PatientsLikeMe and SmartPatients, dedicated to creating space for consumers to talk with each other and the world about their medical experiences and these sites are heavily subsidized by pharma dollars, but they are not subject to the same FDA disclosure rules.

And, on top of it all, my pal David Shaywitz, in our deep and meaningful conversation about Kim Kardashian (words I had hoped would never be spoken, god help me…and by “god” I do not mean Kanye), told me about a recent U.S. District Court decision, (Amarin Pharma Inc v. U.S. Food and Drug Administration), that allows pharmaceutical companies to engage in off-label marketing communication when the speech is truthful.   In other words, the justices said the First Amendment protected factual speech about drugs that used to be considered verboten, writing, “…the FDA may not bring an action based on truthful promotional speech alone, consistent with the First Amendment.” Wasn’t the fact that Diclegis made Kim stop barfing factual? She certainly thought so and she would know, at least theoretically. Of course, it is possible that just waking up next to Kanye is cause for nausea and that the fact of the pregnancy is correlation, not causation. But that would take a randomized clinical study to prove and no IRB is going to touch that.

Pharmaceutical companies, as with other healthcare companies, are feeling their way through the social media morass. Never has there been a more targeted, rapid way of reaching an audience and building a community around one’s product. Yet some pharmaceutical companies take an incredibly conservative approach (legal review of every single individual employee Tweet) while others are embracing the brave new world of over-sharing (good basic article HERE). My guess is it is going to be a messy evolution while the new rules of the game are written. And in the meantime, let’s hope people don’t follow these prescient Kanye West lyrics from his 2007 song Can’t Tell Me Nothing: “I feel the pressure, under more scrutiny / And what do I do? Act more stupidly!”