On Twitter, professional race-car driver Charlie Kimball's nearly 1,300 followers monitor his every move: the countdown to key races; television interviews; dinner in Sonoma, Calif. It's hard not to be inspired by one crucial detail of Kimball's narrative: the 25-year-old is among the world's few professional racers to be diagnosed with diabetes. That's partly why Novo Nordisk, the Danish pharmaceutical giant, pursued Kimball for an elaborate campaign in which he regularly tweets about taking two of the company's insulin products. "Just used my Levemir FlexPen," he tweeted last June, referring to Novo Nordisk's disposable insulin injector. Levemir appears on the front of Kimball's racing uniform, his car and on his official Twitter page, racewithinsulin. "It's a great way to connect with the diabetes community," he says.
The racewithinsulin campaign has turned Kimball into a rock star within the diabetes community. It has also made him one of the most provocative examples of how pharmaceutical companies are cleverly navigating the emerging, largely unregulated social-media space. The Food and Drug Administration has stringent guidelines on how drugs can be marketed in newspapers and magazines, and only in 1997 issued rules for broadcast media chiefly, that companies must disclose basic information about a drug's known risks. But there are no such regulations for social media.
This month, however, the FDA is expected to issue guidelines on how drug companies market drugs, from Viagra to Ambien, on outlets such as Twitter, Facebook and Google. For these companies, it's no small matter. Pew Research Center's Internet & American Life Project estimates that 61% of adults get health information online. Analysts say online marketing accounts for a growing share of the roughly $4 billion pharmaceutical companies spend each year advertising their products. In the first half of this year, companies overall spent some $5.7 billion on so-called search ads on outlets like Yahoo!, according to the Interactive Advertising Bureau, a coalition of companies selling most online advertising in the U.S. "There's a lot at stake," says Jeffrey K. Francer, assistant general counsel for the Pharmaceutical Research and Manufacturers Association of America, a leading Washington, D.C., trade group.
Surprisingly, it's the pharmaceutical industry that's been at the forefront of moving the FDA to issue social-media rules. The companies realize their traditional websites and advertising strategies are no longer sufficient tools to promote products in a competitive marketplace in which doctors, pharmacists and consumers aggressively trade information about medicine on blogs. The companies are also aware that "if they can't fully participate in the social-media conversation, they get marginalized," says John Mack, publisher of Pharma Marketing Blog, which attracts about 25,000 industry readers a month. One impetus is to protect companies' credibility in the face of rogue online outlets selling dubious goods. Part of the push is to resolve practical challenges, like how to sufficiently explain a drug's risks within the bounds of a 140-character tweet. Or a sponsored Google ad's roughly two lines of text?
Last year, the FDA sent letters to 14 companies including Johnson & Johnson, and GlaxoSmithKline warning about the use of social media to market products, in some cases calling the efforts "misleading." One December 2009 letter went to Bayer regarding Mirena, a drug it promoted on the website Mom Central until February of that year. The campaign included a scripted conversation from a nurse practitioner, Barb Dehn, whose personal website bills her as "an award-winning author and a nationally recognized health expert." Mirena, Dehn told consumers, is "a birth-control method that allows for spontaneous intimacy." The FDA said the script "misleadingly" overstated "the proven efficacy of Mirena," and failed to mention the possibility that women who take the drug while pregnant may lose a baby or become infertile. Bayer no longer has a social-media campaign for Mirena. In another case, in November 2009, federal authorities sent a similar letter to an obscure Utah company whose website claimed to sell products preventing the H1N1 virus, with meta tags like "kill the swine flu virus" and "swine flu" all words frequently Googled by consumers. The FDA hadn't approved the product as a cure for the H1N1 virus.
In the absence of formal rules, some drug companies have been sheepish about entering the social-media space. That's why the case of Charlie Kimball is instructive. He began racing at age 16. Within a single week in the fall of 2007, while racing in Britain, Kimball says, he lost 25 lb. (11.4 kg). Doctors swiftly diagnosed him with Type 1 diabetes. "What's diabetes?" he recalls asking. Kimball, who is based in Indianapolis, was referred to Anne Peters, a California doctor who has been a Novo Nordisk consultant. Kimball says she suggested he tell the company his story. By April 2009, he'd signed a contract with Novo Nordisk to help promote its insulin. The company initially rebuffed his plans to discuss the medical treatment on Twitter. "I was finding it's a great way to pull back the curtain on the life of a racing driver to remind people I'm a person with diabetes who uses the two insulin [products] to manage my disease," he says. Ambre Morley, an executive at Novo Nordisk's office in Princeton, N.J., crafted a deal with the company's regulatory team. If Kimball mentions any of Novo Nordisk's products on Twitter, it should be followed by the drug's generic name, as well as a link to additional information about the drug's risks and benefits. "We're trying to do it correctly, so I can play by the rules," Kimball says.
But, again, there are no clear rules. Novo Nordisk is considering ways to expand Kimball's campaign. The company has also developed another social-media outreach targeting hemophiliacs. Unresolved is whether pharmaceutical companies are responsible for third-party claims about a drug's risks or benefits on outlets like Wikipedia. Until the FDA issues guidelines, it'll be like driving along a highway without signs making clear the speed limit.