Louise Roe has denim that’s ripped in all the right places, a bikini-ready body year-round, a husband and baby who look like they were picked from a catalog, and 698,000 Instagram followers. She also has the skin condition psoriasis, a chronic autoimmune disease defined by flaky, inflamed red or white patches of skin, and she wants you to know all about it.

Actually, she needs to tell you about her psoriasis on Instagram; otherwise, her paid partnership with Celgene, a biotechnology company that produces the patent-protected psoriasis medication Otezla, would presumably be canceled.

In recent years, businesses have adapted their advertising strategies to the rise in social media use, specifically on Instagram. The app is one of the most popular social networks, surpassed only by its parent company, Facebook, and is projected to have more than 1.1 billion users in 2019 — more than half of whom are between ages 18 and 29. The high level of Instagram user engagement gives companies an opportunity to capitalize on users with thousands of followers, aptly dubbed “influencers,” through paid advertising partnerships.

These Instagram ads, for which influencers can be paid an estimated $1,000 per 100,000 followers, are selling not just a product but an entire lifestyle. Rather than buying a single-page ad or a minute-long TV or radio spot, companies benefit from the candor and storytelling on influencers’ feeds. However, selling a pair of shoes or luggage as part of a lifestyle is far different from selling pharmaceuticals, medical devices, and other health-related products. Nevertheless, pharmaceutical and biotech companies and Silicon Valley health startups see the opportunity Instagram presents and are increasingly using influencer-advertising as a way to increase their bottom lines.

In a pink tutu against a pink backdrop, Erin Ziering, wife of former 90210 star Ian Ziering, advertises Allergan breast implants and Botox side by side in a December 2018 post — the same month the company pulled its textured implants from European markets in response to a notice from the Food and Drug Administration that individuals with breast implants are at risk of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).

Ziering’s post uses #Ad near the top of her caption, but what follows focuses on breast cancer awareness and not either product’s risks and benefits. Instead, users need to click through multiple photos to find this information, which elides the risk of BIA-ALCL. Neither Allergan nor Ziering responded to requests for comment.

“The blatant pushing of a product that preys on women’s insecurities doesn’t sit well,” says one woman who underwent breast reconstruction and experienced complications associated with BIA-ALCL. Speaking with Vox about Ziering’s post on the condition of anonymity, she said that by combining Botox and Natrelle in the same ad, “the company is trying to profit or push a product [Botox], which is literally a toxin, while promoting breast cancer awareness … sounds contradictory.” When asked about the post-tutu photos, which contained relevant risk-benefit information, she said she “didn’t even realize that there were more pictures.” The FDA issued another letter about BIA-ALCL to health care providers on February 6.

Allergan is not the only company that markets to and, inevitably, tries to take advantage of vulnerable women. Bloomlife is paying mommy bloggers like Alyson Owen and Stephanie Peltier to tell fellow pregnant women that they can save a trip to the hospital by monitoring those pesky contractions at home. The device does not require FDA approval, only registration, as its intended use, according to the company’s website, is as a “health and wellness device and not a substitute for medical attention.” However, neither Owen nor Peltier’s post includes this important advisory; Owen’s goes as far as labeling it the “world’s first clinically validated wearable contraction monitor,” a phrase that may be misinterpreted as “FDA-regulated” by the average consumer.

When reached for comment, Bloomlife would not clarify the intended meaning of “clinically validated” and noted it does not have a large paid-influencer program, labeling it “more organic.” Only Peltier offered comment on her paid partnership with Bloomlife, noting her positive experience working with them. She said the company sent her “guidelines explaining a bit more about the product and … what I could and couldn’t say. … [T]hey wanted to be very careful that, as an influencer, I wasn’t making a bunch of unsubstantiated claims,” like calling the product a “medical device.” Beyond these recommendations, Peltier was free to write her own caption and accompanying blog post.

By omitting or misrepresenting critical health information or failing to present multiple options for treatment, as a physician would do with their patients, influencers run the risk of leaving their followers with a possibly dangerous, largely incomplete kind of hope. There is no doubt that this type of health care advertising-cum-storytelling is effective — and is frequently compliant with federal regulations. But there’s a more important question we need to be asking: Is it ethical?

Health care sponcon is here to stay, but at whose expense?

What’s being advertised matters as much as how it’s advertised. Technological advances have led to a boom in the pharmaceutical and medical device space. The treatments we see hashtagged are new to market or still under patent protection, and therefore, manufacturers need to make a compelling case as to why their product is better than an older but similar generic option supported by years of research.

These generics, whose active ingredients are the same as their brand-name counterparts, are preferred by insurers and physicians because of the product’s cost and research that support its benefits. While generics compete based on price alone, brand-name treatments depend on name recognition and storytelling in order to recoup the $1 billion or more spent on development of each new product.

By enlisting influencers to market their health care products amid a stream of Facetuned photos, pharmaceutical and biotechnology companies co-opt narratives that give social media users a sense of how healthy they can be, if only they had this product. This is why Roe, who did not return requests for comment, is the perfect ambassador for Celgene. There’s no sight of psoriasis on her Instagram feed; her skin is clear, perfect even, and she’s smiling in every picture — and the message implies that if you buy Celgene, you can have that too. In selling Celgene, Roe is also selling a life — her life — but what she does not tell you is Celgene does not work for everyone and it certainly won’t give you her life.

The pharmaceutical giant, which was recently acquired by Bristol-Myers Squibb for $74 billion, is no stranger to deceptive advertising. In 2016, the FDA Office of Prescription Drug Promotion notified the company that a TV ad for Otezla, the same drug Roe promotes, was “misbranded” and “creates a misleading impression” about the drug’s safety. The agency’s reasoning was that the ad’s “compelling and attention-grabbing visuals and SUPERs, all of which are unrelated to the risk message … compete for the consumers’ attention.” The same could be said of Roe’s multiple paid posts for the brand. Bristol-Myers Squibb referred Vox to Celgene for comment; Celgene did not respond.

The goal of a successful ad campaign is to minimize the degree to which it appears like an ad. This is especially true for ads targeting millennials, who make up the largest group of Instagram users and will accrue $1.4 billion in spending power by 2020. Instead, it needs to tap into consumers’ needs, buried deep in their subconscious. With respect to Instagram advertising, this can be problematic because a consumer might associate a product with an influencer’s entire feed rather than the information presented in a single ad. To add insult to injury, some patient influencers — who have every financial incentive to promote their products “authentically” — may omit critical health information, thus deceiving potential patients.

Who’s responsible for regulating these posts? Good question.

In 1905, author Samuel Hopkins Adams published a series of articles on “patent medicine evil” in Collier’s Weekly titled “The Great American Fraud.” It brought to light the addictive and poisonous ingredients in medicines marketed for children. Soon after, the 1906 Pure Food and Drug Act was passed, which charged the FDA with regulating how companies communicate the risks and benefits of every drug and medical device that the agency approves — but only on the labels attached to those drugs. Before 1962, the advertising of prescription drugs and medical devices remained the responsibility of the Federal Trade Commission.

The FTC is responsible for consumer protection in all industries; within health care that includes the entire non-prescription side of the business and certain classes of prescription devices (all of which are registered with the FDA), according to an FTC spokesperson. Historically, patients and consumers were considered separately, but now that advertising targets specific patient populations in broadcast, print, and online media — giving them the information and power to demand a particular medical intervention — consumers require different protections, and both agencies fall short in providing them.

Both the FDA and FTC have federal rulemaking authority, which means they can create guidelines for advertisers that support laws already passed by Congress, and health care sponcon falls under the purview of both agencies. However, the guidelines both agencies publish are, as per both agency’s spokespeople, intentionally vague.

According to the FTC Advertising Practices Division, the agency does not “tell people exactly how they should phrase things in most cases, but [does] tell them what choices they have and what range of options they have if they want to stay on the right side of the disclosure line.” Similarly, nearly every guideline published on the FDA website is labeled as a draft and begins with the following disclosure: “[The guide] does not create or confer any rights for or on any person and does not operate to bind FDA or the public.”

Despite the leeway companies are given, federal guidelines do have an impact. Now, when we see Ray Liotta appear on television explaining how he quit smoking using Chantix, it is apparent the ad is regulated — and that Liotta was compensated for his endorsement — because of the disclosures scrolling along the bottom of the screen. The same risk-benefit and financial disclaimers are applied to social media advertising. According to the FDA, advertisements for pharmaceuticals and medical devices must give a balanced description of the product, meaning an ad cannot focus solely on the benefits of its use if there are known risks that could alter the patient’s decision to use a particular product.

Unfortunately, says Jonathan D. Moreno, a professor of medical ethics and health policy at the University of Pennsylvania, that disclosure is not enough to protect patient-consumers. In a conversation with Vox, he said, “[A]s a default position, you can also hide behind [disclosure]. You can say, ‘Oh, there’s transparency’, and that’s the end of the story. But ethically, [influencers] who do this do take on some personal responsibility, quite apart from the legal side. They take on some personal responsibility for promoting a product or process that could change somebody else’s life.”

How influencer pharma marketing works

Social media enables its users to connect over shared interests, locations, and even illnesses. Using this formula, health care companies locate potential influencers who can use these commonalities to reach and build trust with an audience. Although they have massive followings, Moreno distinguishes influencers from celebrities through what he calls the “social network proximity.” Celebrities are people we project fantasies on, while influencer communities make those fantasies attainable because “they are based on some kind of emotional linkage.” By inviting us into their personal lives through social media, they bridge a gap that once existed. Influencers occupy a strange space: they’re celebrities — sort of — who also act like our friends.

Lesley Murphy, a former contestant on The Bachelor and current travel blogger, uses her platform to disseminate information that benefits people like her who are affected by a BRCA genetic mutation, which increases a person’s risk of breast, ovarian, and pancreatic cancers. Murphy, who did not respond to requests for comment, documented her experience of undergoing a preventive double mastectomy on Instagram. Now she advertises ReSensation, a surgical technique launched in October 2018 that may help women undergoing breast reconstruction to retain some or all sensation in their breasts, to her 422K followers. Although ads for most surgical procedures are under the FTC’s purview, ReSensation’s use of human nerves also gives the FDA jurisdiction over Murphy’s Instagram and blog posts.

When asked how the influencer program was developed, Annette Ruzicka, a spokesperson for AxoGen, the company that developed ReSensation, said, “The only request of contributors was to write openly about their breast reconstruction process, and to also share factual information with their followers about the ReSensation technique. We shared publicly available information about the ReSensation technique to ensure that all content shared with the public was accurate. We provided no other content requirements for contributors.”

Murphy, who is not the only ReSensation influencer, has not undergone the procedure herself. But her followers may not realize this detail until they reach the end of her Instagram caption, where she directs readers to a blog post where, at the very end, she discloses her personal inexperience with the technique. Though this does not violate federal guidelines, nor those put forth by AxoGen, it does speak to the ethical obligation an influencer has to their followers.

The reality star’s Instagram post about the technique received almost 11,500 likes, giving ReSensation considerable exposure, yet Murphy omits disclosures required by both the FTC and FDA. She uses the term #partner to disclose that she is a compensated influencer, but the term is considered too vague, even for the FTC, for a user to clearly understand the relationship. She also fails to offer any information about the technique, disregarding federal guidelines to disclose risks and benefits that may impact patient decision-making. Instead, she directs followers to her blog where she discusses “a new technique designed to restore sensation in breasts after surgery,” lamenting the numbness in her breasts since her mastectomy and reconstruction.

Her blog post is where we finally learn the technique was not used on Murphy and cannot be used in conjunction with implant reconstruction, the most common and least complicated form of breast reconstruction, and the type of reconstruction Murphy underwent. Neither Murphy’s posts nor the ReSensation website discloses the success rate of the technique, instead focusing on an insecurity that has plagued mastectomy patients for decades: numb breasts. Up to this point, the lack of peer-reviewed studies on large populations of women who underwent free-flap breast reconstruction with sensory nerve repair makes any claims to successful restoration of sensation in breast reconstruction inconclusive.

To read Murphy’s entire Instagram caption, users must click “more,” where they’ll read that the crux of the post is actually on her blog. Although her caption directs readers to the link in her bio, that link has now changed, making it even more difficult to find the relevant information. After reviewing the post, Moreno explained to Vox: “Readers shouldn’t have to click through to discover that the person posting hasn’t actually used the product. Requiring multiple clicks begins to cross the line to deceptive advertising, especially considering that [they] are using their own illness as clickbait. This is emotional exploitation combined with the seeming intimacy of social media.”

Advances in social media are surpassing government regulation

Including phrases like “paid for” and “risks include” at the top of an influencer’s caption don’t exactly scream authenticity, but this is what the FTC and FDA ask of companies in their advertisements. However, paid influencers use different techniques to convey intimacy of each post while toeing the line of compliance. One influencer, who is compensated by a variety of brands outside of health care and preferred not to be named due to existing partnerships, confirmed the tactics used by some Instagrammers to “authentically” sell a product. Some bury the #sponsored tag deep in the copy or shorten it to #spon, despite the FTC guideline for disclosures to be “clear and conspicuous.”

In 2017, the FTC hosted a live Q&A on Twitter where influencers and advertisers could ask questions about requirements for disclosure on social media and personal websites. The answers were then published as an addendum to a preexisting endorsement guide, though the responses are not a definitive guide on acceptable disclosure. While the FTC’s “living documents” have been updated within the past two years, the FDA lags behind. Its most recent document on social media advertising, published in 2014, does not mention Instagram and still defines Twitter as using 140 characters, instead of the current 280 limit. Broadly speaking, the guide asks advertisers to convey a fair balance of risks and benefits in the same character-space-limited communication — i.e., the same tweet or caption.

Although the FTC says the words  “partner” or “ambassador” are “ambiguous and confusing” because they do not make the financial relationship between a company and influencer as clear as #XYZ_Ambassador does, it does not ban their use outright. The FDA does not offer comparable guidance for financial disclosures. Before referring Vox to the FTC guidelines, an FDA spokesperson said the agency “has not issued guidance regarding disclosure of the financial interests of spokespeople in prescription drug or medical device promotion, including disclosures by social media influencers acting on behalf of a medical product manufacturer.”

Federal regulatory agencies are trying to keep up with social media-savvy advertisers, which is why their guidelines are considered “living documents,” but they are not there yet. To not hem in companies on what they can do, both agencies offer general ideas about what they can post and generally recommend, for those doubting their compliance, that more disclosure is better. When evaluating posts, the former “will look at whether it is easily noticed and understood,” while the latter wants to see “whether benefits and risks are presented in a comparably prominent manner.” However, neither is explicit in saying how far into a post is too far for disclosure to be easily recognized.

In fact, both the FTC and FDA guidelines are just that: guidelines.

Complicating matters even further, most of the guidelines are for manufacturer-to-consumer advertising and have not yet adapted to influencer-to-consumer advertising. Outlined in the FTC’s “DotCom Disclosure” guide, advertisers must have “reasonable programs in place to train and monitor members of their network,” i.e., influencers. The FTC also asks that companies make a “reasonable effort” to know what their paid marketers are saying — an expectation that is clearly not being met.

Most companies provide their influencers with guidelines for each post but don’t write or review the copy in advance, in order to give the content a genuine voice. But an authentic voice could inadvertently be misleading. Chandler Coleman, a consumer insights investigator with ConsumerSafety.org, says “[m]ost times, these promoters are not health care professionals or experts in the medical field. Due to low communication barriers, however, consumers are less likely to know the source of the information they are receiving. Instead, they may be prone to blindly trust these online manufacturers and ‘experts,’ as they believe them to be professionals.”

Influencers are building trust online

One wonders why a company would assume the risk of misinformed patients, as they are responsible for what their paid endorsers say. The reason is simple: One in three consumers in the US consult social media for health-related matters. As the average consumer’s access to scientific and medical information increases by way of online media, Moreno argues that consumers become less reliant on their physician’s expert opinion. Instead, consumers, especially those with an illness, search for people whose experiences mirror their own.

Although social media influencers are often strangers to us IRL, their online candor can create a deep connection with their followers and puts them in a unique position to influence decision making. It can also strengthen an ad campaign by engendering unpaid, organic content, which is what happened when the pharmaceutical company Dexcom launched its #DexcomWarrior campaign during Diabetes Awareness Month.

With the help of a PR firm, Allison+Partners, Dexcom used sponsored posts from key influencers to generate organic content from other users. Using the tag #DexcomWarrior, posts by Derek Theler, an artist with 691,000 followers, and Jay T. Maryniak, a self-described public figure on Instagram with 434,000 followers, demonstrate how powerful a narrative of overcoming illness can be. Quickly, unpaid Instagrammers began using the same tag to share their own struggles with Type 1 diabetes and how a Dexcom device had changed their lives.

The campaign earned Dexcom PR Daily’s 2018 award for the best “Social Media Campaign” of the year, as measured by engagement analytics. Allison+Partners and Dexcom declined to comment on their influencer campaigns, and Theler and Maryniak did not respond to our requests.

The campaign promoted the company’s continuous glucose monitoring system (CGM), which launched in June 2017. The system allows patients to monitor glucose data in real time using a smartphone app that connects with their device. Their devices require a prescription but are covered by 98 percent of private insurers and Medicare, according to a Dexcom spokesperson. By contrast, a patient can purchase a similar device from a pharmacy without a prescription for as little as $20.

These devices fall into a regulatory gray area, explains the FTC. “The FDA has primary jurisdiction over the labeling of all devices and the advertising of restricted devices, whereas [the FTC has] primary jurisdiction over the advertising of non-restricted devices. A prescription device may or may not be a restricted device.” The company’s newest device, the G6 CGM, is a class II non-restricted device according to an FDA database.

The difference between the posts Dexcom paid Theler and Maryniak to create and the free content generated from the #DexcomWarrior hashtag is that Theler’s and Maryniak’s are subject to FTC and FDA guidelines. Although the organic content may be incorrect or misleading to consumers, there is no regulation prohibiting someone from giving their unpaid recommendation. And while posts from Theler and Maryniak use the #sponsored hashtag, neither included the device’s known risks, which include the “potential for blood-glucose readings that miss hypo- or hyperglycemic states,” conditions that could be the difference between life and death to a diabetic if left untreated.

In an interview with Vox, Alan Regenberg, the director of outreach and research support at Johns Hopkins Berman Institute of Bioethics, expressed concern over the gray area of disclosure in social media marketing as well as the difficulty in parsing the true intentions of a post. Whether or not a post is ethical “comes down to the sincerity of the claim,” he said. “The dividing line is if it’s somebody who is making the claim because they’re being compensated to make it versus somebody who personally experienced it.”

Regenberg says the ethics of influencer marketing depend on other options available to patients. Whether the treatment advertised is the only one of its kind or proven effective, or the product’s cost and availability are accessible to the targeted population, are, according to him, the deciding factors of ethicality. When there are few options for treatment, a patient is likely to be deceived because they are more desperate for solutions than the same patient with many available options for treatment.

Advertising new-to-market medical devices and prescription drugs is problematic because their efficacy in the long term is unknown. But when confronted with studies that may negatively impact sales, some drug and device companies shirk their responsibility of keeping patients informed of all recalls or previously undisclosed risks, which is how Allergan reacted to the link between breast implants and BIA-ALCL.

The company encouraged patients to “have a comprehensive conversation with their surgeon about all potential risks and benefits, allowing for a fully informed decision.” Prior to the FDA’s notice to physicians in February, which Dr. Jennifer Ashton called “unprecedented” in an interview on Good Morning America, Allergan ramped up marketing its Natrelle implants on Instagram during Breast Cancer Awareness Month. Moreno, the bioethicist, noted that “one of the risks is [social media marketing] starts to substitute for long-term monitoring because nobody has any skin in the game.”

The consequences for irresponsible pharma sponcon? Not much.

Although the FDA and FTC are regulatory agencies, they “do not attempt to survey all influencers or influencer posts, either alone or with [the help of] social media platforms,” according to the FTC Advertising Practices Division. In order to fully police their guidelines, the agencies would need to comb millions of posts to determine which are paid advertisements and whether they’re compliant. While it is their responsibility to make sure health care companies comply with advertising regulations, social media is an advertising black hole with limited tools to search and report non-compliant posts. In lieu of improving their own monitoring systems, the agencies rely on consumers to report non-compliant ads, though most consumers are not experts in federal advertising guidelines.

What’s also disturbing is that there are no immediate consequences for omitting information required by the regulatory agencies, especially since they do not review every post. So, while a drug company could rightly be sued if incorrect or incomplete labeling on a drug or device causes a patient harm, according to the FDA, an influencer likely would not face the same legal repercussions for omitting this information in an advertisement. Although an influencer is, per federal guidelines, an agent of that company, the FDA will appeal directly to the company, and any adverse consequences to the influencer are at the discretion of the company and will likely depend on their contract with the company.

The FTC would not disclose how its investigations are conducted, but when a violation is found, a letter of complaint is sent. These letters include an order agreeing not to engage in this conduct again and put a compliance process in place. Civil penalties are not typically brought on the first violation. However, if these terms are violated, penalties of up to $41,000 per day per violation can be brought. To put that into perspective, millions of people view these posts each day, and each one of those views could be considered a violation.

Similar penalties and grievances are employed by the FDA. This was the case when Kim Kardashian created a post sponsored by Duchesnay, the manufacturer of Diclegis, a medication that treats nausea and vomiting in pregnant women. Kardashian’s original post received an anonymous complaint that was submitted to the Office of Prescription Drug Promotion’s Bad Ad Program because of her failure “to communicate any risk information associated with [Diclegis] use and it omits material facts.” According to Robert Dean, the division director of the FDA Office of Prescription Drug Promotion, Kardashian failed to include that “Diclegis has not been studied in women with hyperemesis gravidarum,” which is a rare but serious condition characterized by severe nausea, vomiting, fainting and dizziness, weight loss, and dehydration.

Kardashian corrected her ad, under threat of further “FDA regulatory action, including seizure or injunction” against Duchesnay, though the manufacturer continued to partner with famous pregnant women, like The Bachelor’s Emily Maynard, to promote the drug. Maynard’s post requires substantial scrolling to get to the fine print Kardashian originally left out: “Limitation of Use: Diclegis hasn’t been studied in women with hyperemesis gravidarum.” For women struggling with morning sickness, this is important information that should, according to federal guidelines, be closer to the top of post to better inform the public, regardless of the detriment to authenticity.

Using influencers to sell products to the sick can be a particularly insidious form of marketing in large part because of the vague parameters set by the FTC and FDA. With today’s ambiguous regulations, health care sponcon will continue to saturate our feeds with posts that appear sincere but end up being misleading. Consumers looking for remedies to what ails them should not be expected to differentiate nuances in regulatory wording between “clinically validated” and “FDA-approved.”

For consumers to protect themselves in ways regulatory agencies cannot, they must be reminded that influencing is a job — one that only can only be done effectively if the stories influencers tell are relatable to the average user. Our clicks and likes and follows may or may not improve our own lives, in spite of what captions lead us to believe, but our engagement will always benefit the bottom line of influencers and the companies they work for.

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