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Three girls are jumping, seemingly for joy. Their hands are outstretched and their faces are lit up with wide smiles. A fourth girl stands to the side, rooted to the ground. Her arms are held to her sides, and she looks dejected. Then you see it, a dark circle on her blue shirt — a pit stain!
“Embarrassed about excessive sweating?” the caption inquires. “You’re not alone. Find out what it could be and how others may just be coping with it.”
According to the website, www.CheckYourSweat.com, 15 million people suffer from hyperhidrosis, “a real medical condition” also known as excessive sweating. Curious if you’re one of them? The site points you to a quiz to assess your own sweatiness and “determine if it’s more than just ‘normal’ sweat.” Questions include, “In the last day, have you experienced excessive underarm sweating?” and “In the last week, did you ever have to change your shirt or clothes during the day because of underarm sweating?”
No matter your responses — even if you answer no to all the questions — the results are clear: If sweating bothers you more than you think it should, talk to a dermatologist. What’s less clear is why the eager-to-help website exists in the first place. Scroll all the way down to the bottom, and you’ll find a clue: 2018 Dermira, Inc. All rights reserved.
Dermira is the Menlo Park, Calif.-based biotech company behind Qbrexza, the only approved topical, daily use treatment for excessive underarm sweating. The drug was greenlit by the U.S. Food and Drug Administration (FDA) in June 2018, but the online Check Your Sweat campaign started six months earlier. The drug is never mentioned by name on the website, but it doesn’t really need to be. If the quiz spurs you to seek medical treatment for hyperhidrosis, Qbrexza is one of the only drugs available.
The Check Your Sweat website is a recent example of a long-standing marketing strategy the pharmaceutical industry uses. In industry speak, it’s called a “disease awareness campaign.” In layman’s terms, it’s an unbranded advertisement. And due to recent regulatory changes, they may soon be more common. As part of President Donald Trump’s blueprint to reduce drug prices, the administration has proposed a rule that would require manufacturers to disclose drug prices in television advertisements. If the proposal is finalized and drug companies comply, advertising money could be diverted to unbranded campaigns, according to Wayne Pines, a former FDA chief of consumer education and information.
Before a drug is approved, it’s common—and legal—for companies to develop an advertising campaign to alert people to upcoming or recently approved therapies for a previously untreated ailment. Often explicitly designed not to look as if they’re coming from a pharmaceutical company, disease awareness campaigns offer the freedom to appeal directly to consumers’ emotions. Branded drug ads must abide by a lengthy list of regulations dictated and enforced by the FDA, including listing a medication’s side effects. But unbranded ads, which don’t mention specific drugs or devices by name, exist outside the agency’s jurisdiction and don’t have to include the same caveats.
Early data suggests Dermira’s ads are successful. The company says it is expected to spend $35 million on its unbranded hyperhidrosis awareness campaign this year. More than a million people have completed the online assessment and more than 100,000 people have signed up to receive emails from the company, according to Lori Lyons-Williams, Dermira’s chief commercial officer. “It speaks to a massive unmet need in this condition,” she tells Medium. “People are looking for solutions.”
Critics see it differently, and argue that Dermira’s unbranded ads are what’s creating the demand. The practice of re-casting everyday discomforts as symptoms “can be highly effective in terms of getting people who are probably healthy, who likely don’t need a drug, to take it,” says Michael Carome, director of Public Citizen, a consumer rights advocacy group.
Matt Arnold, a principal analyst at the health care consulting firm Decision Resources Group (DRG), says unbranded advertising works well for conditions that aren’t commonly recognized as diseases. He likes to call the category, “Wait, that’s a thing?”
“Maybe you’ll go, ‘Oh, I have that! I didn’t realize it was a medical condition, and that it’s treatable,’” he says.
According to Eugene Bauer, Dermira’s chief medical officer, the company is trying to raise awareness about a little-understood condition that is causing distress for some people.“We want to make a vulnerable group feel as if there is something they can do,” he tells Medium. “I’ve seen far too many of these young women whose lives are miserable because they have this problem.” The campaign’s goal, he continues, is to provide the public with valuable information. Those who have the condition and are suffering will seek out treatment, while those who aren’t, won’t.
Matthew McCoy, a medical ethics professor at the University of Pennsylvania, disputes this argument. Sure, he says, disease awareness campaigns can provide the public with information about a disorder, but what are the chances it will be balanced? A drug company has a fiduciary duty to generate as much money for its shareholders as possible. Providing agnostic health information is “not what they are in the business of doing,” McCoy says. “They are in the business of selling drugs.”
Unbranded drug advertisements started nearly a century ago in the 1920s with the invention and marketing of Listerine. Developed originally as a surgical antiseptic, Listerine had a second life as an over-the-counter mouthwash. Advertisers coined an official-sounding name for the health problem Listerine could solve: halitosis (also known as bad breath), which at the time was an unknown medical term. Soon enough, halitosis was considered a highly common condition that, if left untreated, could lead to dire social consequences.
The 1990s saw the dawn of the “mother of all awareness campaigns,” says Steven Woloshin, co-director of the Center for Medicine and Media at the Dartmouth Institute. The condition was low testosterone, more colloquially called “Low-T” by advertisers, which was promoted by makers of testosterone replacement products, including Abbott Laboratories and AbbVie. While only officially approved to treat hypogonadism, a condition in which men have no or severely low levels of the hormone, the gels and patches could be prescribed off label to treat related “symptoms” of low testosterone, like fatigue and low libido.
“Don’t have the hops for hoops with your buddies? You might have a treatable condition called low testosterone or Low-T,” read one such commercial, paid for by AbbVie. The messaging worked: Prescriptions for testosterone gels and other products reportedly jumped from $324 million in 2002 to an estimated $2 billion in 2012.
Today, “Low-T” campaigns have largely gone dark after subsequent research into the products not only questioned their health benefits but also linked them to an increased risk of a variety of heart problems. In 2016, the FDA tightened product labeling requirements for the category, and a slew of lawsuits have claimed the drugs caused serious, sometimes life-threatening, complications in patients. Several manufacturers have since reached settlements. The companies have defended their drugs, pointing to clinical and safety data. AbbVie did not respond to requests for comment.
For the average person, it can be difficult to untangle the nuances of an unbranded drug advertisement. It’s even more complicated when the medical community joins forces with companies to support disease awareness campaigns. Pharmaceutical companies routinely pay doctors to serve as consultants, and give hundreds of millions in financial donations to non-profits and patient groups every year. Dermira is a listed donor for the International Hyperhidrosis Society and the American Academy of Dermatology Association, for example. Financial ties between drug companies and medical groups can be, by design, difficult to parse. Money can come in the form of grants, sponsorships, consulting fees, scholarships, and more, with varying degrees of strings attached.
There’s no better example of the murkiness between industry and the medical community than the 2015 approval of the drug Addyi for chronic low sexual desire in women. Addyi, manufactured at the time by Sprout Pharmaceuticals, became the first prescription treatment of hypoactive sexual desire disorder (HSDD) available in the U.S.
Before Addyi’s approval, a network of health and women’s organizations lobbied Congress to pressure the FDA to approve the drug. The coalition, called Even the Score, was presented as an organic grassroots effort driven by impassioned patients and activists who were fed up with society’s disregard for female sexuality. Such positioning deftly tapped into deep, well-documented issues of sexism in medicine, in which women’s experiences and symptoms are routinely dismissed, discounted, or ignored. “I’ll be damned if I had a condition that someone not living my reality told me ‘not to worry about,’” Sprout Pharmaceuticals CEO Cindy Eckert wrote Medium in an email.
But the independent nature of the campaign wasn’t an accurate representation. Started by a PR company, Even the Score was funded, at least in part, by Sprout. “I was very proud to be one of the 26 different women’s health and rights organizations that were part of the Even the Score Coalition,” Eckert wrote. “I’d encourage you to go back and look at every interview I’ve ever had about Even the Score and my transparent involvement.”
Even the Score wasn’t the only relationship between the manufacturer and seemingly independent health organizations. When Addyi was approved, the International Society for the Study of Women’s Sexual Health (ISSWSH) feted the FDA for “making their decision to approve flibanserin based on science.” Not mentioned in the corresponding press release was that then board member Irwin Goldstein, a sex-medicine doctor who would go on to serve as the organization’s president from 2016 to 2018, was a paid spokesperson for Sprout. In 2016, he made $9,648 in payments for activities related to the drug. “My financial involvement with these companies is clearly available online per the Sunshine Act,” Goldstein wrote in an email.
In April 2018, the ISSWSH released a report, published in the journal Mayo Clinic Proceedings, that was designed to provide guidelines for doctors on how to diagnose and treat HSDD. Goldstein is listed as a co-author, as are five other current or former presidents of the organization — all of whom disclosed financial relationships with one or more companies that have manufactured, sold, or are developing drugs to treat HSDD.
When I ask one of the co-authors, Sheryl Kingsberg, a clinical psychologist and former ISSWSH president, to address concerns over the report’s credibility given the authors’ financial connections, she tells me I have it backward. The algorithm, created by experts who are well versed in the condition, is designed to prevent overmedication by establishing a set of criteria, she says, adding that she’s careful to always disclose her industry ties, which include AMAG, Valeant, and, previously, Sprout.
“It doesn’t do a pharmaceutical company any good for a patient to take a drug that isn’t going to help them,” she says. Kingsberg says she has no vested interest in a single company or treatment. She wants women to have a variety of safe and effective options for addressing HSDD, including psychotherapeutic as well as medical treatments. “You’re putting me on the defensive for something I am proud of,” she says.
For some people, learning about new treatment options is a gift. “If your life is being disrupted because you have overactive bladder or irritable bowel syndrome, if you are not getting sleep, if you are mapping out your day according to the availability of bathrooms, then that information is probably important to you,” says DRG’s Arnold.
During the approval process for Qbrexza, Dermira developed an 11-point diagnostic scale for doctors to diagnose patients. But there’s no mention of it in the Check Your Sweat campaign. Dermira said the scale was not included because it is proprietary and risks conflating the company’s branded and unbranded campaigns. As a result, sweat is presented as a binary: normal or excessive.
This rejection of gradations is common in many unbranded campaigns. You either have chronic dry eye, restless leg syndrome, irritable bowel syndrome — or you don’t. (But if you take a quiz you might.) It’s not that these conditions aren’t real, says Dartmouth’s Woloshin. It’s that they often impact a far smaller percentage of the population than the companies would like. A nuanced analysis of a condition’s severity, and the careful weighing of a treatment’s benefits versus its risks, rarely translates into a spike in prescriptions.
So what can people do? Experts I asked advised paying close attention to signals of underlying financial connections, both on websites and social media posts and in messaging from seemingly benign health groups. Matthew McCoy, the medical ethics professor, says people should be vigilant if an organization’s funding sources and board members are obscured, or “if the life cycle of a group seems to perfectly match the push for FDA approval for a drug.”
It’s valuable advice. But it puts on the onus on patients, who shouldn’t have to know better.
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