It seemed like the perfect combination:
▪ A newly approved medication for the treatment of nausea and vomiting in pregnancy
And it was ... for a while. Last month, Kim Kardashian Instagrammed and tweeted that Diclegis, made by Duchesnay USA, had helped her morning sickness tremendously and was completely safe for her baby. She also disclosed that she was compensated by the manufacturer. Hundreds of thousands of women “liked” the post, and thousands commented, many stating that they called their doctors and asked for the medication after reading the post.
OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried… https://t.co/5nA8eoDvl6
This week, though, the FDA sent Duchesnay USA a letter stating that the Instagram post was in violation of the Federal Food, Drug, and Cosmetic Act due to misleading claims of efficacy without including any mention of its risks. Whether in its entirety in the printed prescription labeling information that accompanies medications or the extremely abridged version that appears in TV commercials, the ethical and medical imperative of informed consent requires a balanced discussion of risks and benefits. This ubiquitous legal-ese is so widely known that it’s even become fodder for parodies. Since Kardashian’s post had neglected to mention any potential risks or contraindications, the company immediately complied with the FDA’s order, telling Kardashian to take down the post, which she did.
Direct-to-consumer advertising is certainly not new. Paying celebrities to endorse prescription drugs isn’t, either: Golfer Phil Mickelson supports Enbrel, which treats his psoriatic arthritis; former Sen. Bob Dole promoted Viagra; actress Sally Field endorses Boniva for osteoporosis. While we can argue that we should not be listening to celebrities for our medical advice, pharmaceutical companies continue to pay top dollar because the marketing research demonstrates that it is effective. (That effectiveness can go both ways. For example, Jenny McCarthy helped ignite an anti-vaccination movement after she started blaming vaccines for her son’s autism.) And as long as that means increased revenue for the pharmaceutical company, you can bet Larry the Cable Guy is going to continue to be paid to promote Prilosec OTC.
So why was Kim Kardashian’s compensated post so different? The answer has more to do with the medium through which she promoted the drug.
The tiny words at the bottom of the magazine advertisement or end of the TV commercial fulfill the legal requirements to discuss the potential risks of the medication as well as warn consumers that there may be medical contraindications to the prescription drug. On Instagram, though, there’s no fine print hashtag to click on. Sponsored social media posts are an entirely new form of celebrity endorsements for prescription drugs.
Direct-to-consumer advertising, whether on TV or on your cellphone, turns patients into consumers. Using a celebrity who’s immediately recognizable and convincing to the target demographic group may be a brilliant business tactic, but it is not necessarily good medicine. Removing the fine print altogether on social media only exacerbates this problem. While the rushed listing of medical terms at the end of a TV commercial certainly isn’t the ideal informed consent conversation, at least it reminds viewers that choosing medication is not the same as deciding whether to get turkey or ham on your sandwich at lunch. Rather, it is a choice that is personal, unique to your situation and may come with consequences that should be discussed with your health care provider.
Advertising on social media, where Kardashian’s endorsement blends in seamlessly with both her other posts about her lifestyle and users’ friends’ own images, sends the message that making the decision to start a prescription medication is easy, casual and quick. Just as quickly as your Facebook feed displays advertisements for workout clothes after you Google “home gym equipment,” so, too, can your morning sickness be cured by taking the same medication a celebrity is using. But every medical decision is potentially complex, and they should not be made lightly, especially in pregnancy, given the potential to affect both the mother and the developing child.
Finally, no medication is completely safe, no matter who endorses it. While it is true that Diclegis is the only Category A medication for morning sickness in pregnancy, that does not promise 100 percent safety. The designation by the FDA of Category A in pregnancy means that well-designed studies in humans have failed to show risk to the developing fetus. So we can’t promise that it is safe, but the best evidence we have makes us think that it likely isn’t bad. It’s a small difference, but an important one for patients to know. While ultimately, patients will have a full discussion about medication with their health care providers, the false expectations that may be set through social media can change the tenor of this conversation significantly.
To be clear, celebrity endorsement and direct-to-consumer advertising can be beneficial. Health care providers in their offices can’t reach out as quickly and effectively to the number of people that advertising can; nor can they make the same kind of personal connection that’s possible on social media. However, as the American Medical Association states, with that comes the responsibility to ensure that these advertisements are accurately representing risks, not creating false expectations or undue pressure to prescribe an unnecessary medication and referring patients to their physicians for more information. That may seem like a lot to fit into 140 characters or an Instagram caption. But patient safety and medical ethics depend on it.
Shah Arora is an obstetrician-gynecologist at MetroHealth Medical Center and bioethicist at Case Western Reserve University in Cleveland, Ohio.