Is it Time for the FDA to Chime in on Drug Company Tweets?

5/26/10

These days, when I least expect it, an e-mail pops into my inbox that I can’t ignore. It announces that someone is following me on Twitter. I’m still figuring out how it works (I have a measly 4 tweets to my name), which explains why, upon reading one of those e-mails, I usually succumb to curiosity and with some degree of giddiness I click on the link to find out who my new follower is.

It’s a little bit embarrassing to admit this recently acquired character flaw. But that’s exactly what makes Twitter work. It thrives on its power to make people feel connected and cleverly taps into the primal, if not exactly venerable, human need for adulation. You follow me, I follow you, and thus we go on to build ourselves a set of nifty bully pulpits, 140 characters at a time.

Given that I just started tweeting about a month ago, I consider myself a fairly late adopter of the technology. I’m still not sure, in fact, whether one year from now I will have totally embraced it. But I was surprised to find out I’m not the only one hesitating.

In life sciences, many companies have still not cozied up to Twitter-mania. Notable examples of companies without a Twitter presence are Abbott Labs and Biogen Idec. While companies in other industries have long since embraced Twitter to put out word of their products, initiatives, or latest sales, navigating the social media space is a matter of much debate for biotechnology and pharmaceutical companies. For many of their communication and marketing needs, the challenges posed by Twitter are only beginning to be understood.

Let me see if I can come up with a Twitter-worthy way to summarize the crux of the matter:

It’s hard to present balanced effectiveness and safety information for any drug in fewer than 140 characters, risking trouble with the FDA.

(I am tweeting those 140 characters today, just so I can have five tweets.)

Twitter is such a fantastic tool to spread news and information about a company, yet the reason why it’s so successful—the fact that people communicate in short and often cryptic sentences—is what makes it so hard to use for drug manufacturers. The FDA has long-standing rules for drug marketing that require companies to present fair and balanced information in advertising materials for a particular drug—meaning that effectiveness and risks must be properly explained. The agency has now asked companies and other interested parties to submit opinions on how it might regulate the promotion of products using social media and the Internet.

It’s an issue everyone is taking seriously. Research suggests that environments like Twitter might make it easier to skew the risk/benefit information linked to a drug. As pointed out in the March issue of Pharma Marketing News, the communications company WCG recently presented data to the FDA regarding online communications, and it found some interesting trends.

In its report, available here, the group analyzed over 100,000 online conversations involving 22 different drug brands. First, WCG looked at regular news articles and found a ratio of 60/40 benefit-to-risk mentions, meaning the news was skewed somewhat on the benefits side. When the group looked across social media sites, the ratio was 66.5/33.5 for the same drugs during the same time period. And when the sites were broken down by type, here’s what WGG found: in user forums the ratio was 67/33, blogs were 66/34, and Twitter was much higher: 74/26. In other words, tweets mentioning a drug, on average, tended to be more focused on benefits, and less on risks, when compared to other online communication tools—and were even more heavily skewed towards benefits than regular news articles.

To avoid some of these issues, many of the companies that have opened a Twitter account are staying away from possible regulatory trouble zones. Johnson & Johnson’s Marc Monseau has been tweeting on behalf of the company since 2009, but says he mostly focuses on corporate initiatives, staying away from particular product information.

Vertex Pharmaceuticals, which officially opened its Twitter account last week, is not discussing its development program via Twitter and is for now seeing it as a valuable tool to share disease awareness information. The company was, until recently, unsure as to whether it should even open a Twitter account, says spokesman Zachry Barber. It ran a two-week pilot Twitter effort back in January and, after accumulating over 200 followers in that short amount of time, realized Twitter could be a great way to stay in touch with people following the company’s progress, Barber says.

Richard Pops, CEO of Alkermes, has a Twitter account, even though his company doesn’t. “Because it is me, not Alkermes, I try to avoid bland corporate statements and links to press releases,” he says. He also doesn’t tweet about Alkermes’ products. “We have taken the position that tweeting about an Rx product, even with a link to more information, is not appropriate. Plus, I think people see right through self-serving comments that do not trigger more thinking and dialog,” he says.

To illustrate the challenge, here’s a recent tweet from Genentech, which has a Twitter page with over 3,000 followers:

“Genentech announces Ph III PRIMA study results: people with lymphoma stayed in remission longer with GNE medicine http://tinyurl.com/2cb9bfc”

The tweet takes us to the company’s press release, whose title is a little more nuanced: “Phase III Study Showed First-Line Maintenance Use of Rituxan® Improved the Likelihood of People with Follicular Lymphoma Living without Their Disease Worsening.”

I contacted the company to ask about its tweet, curious about how it decided on its slightly more user-friendly language for the Twitter version. The company declined to comment, but I wonder if it looked to the FDA for inspiration.

That’s because, ironically, even though it hasn’t issued rules on the do’s and don’ts of social media engagement for pharma and biotech companies, the agency itself is an avid Twitter user and keeps several Twitter accounts. Here’s a recent tweet from the FDA’s drug info page:

“FDA approved Pancreaze Delayed Release Capsules, a pancreatic enzyme product (PEP). Third PEP to receive approval. http://bit.ly/pancreaze”

Of the pharmaceutical companies, Pfizer seems to be taking the strongest stance, asking the FDA to provide clear regulations, and not just guidance, regarding the use of social media. Until the agency does so, Pfizer argues, a lot of companies will stay away from these kinds of activities for fear of litigation or regulatory action.

Keeping companies’ marketing tentacles from further creeping into cyberspace might not be such a bad thing, come to think of it, but the problem is that a lack of clarity regarding online communications affects much more than just advertising and drug promotion.

For example, companies are struggling to figure out what to do about adverse event reporting. Right now, patients who think they might be suffering from a drug side effect can report it directly to the FDA, or they can call manufacturer hotlines. Either way, the process is fairly standardized and certain criteria must be met in order for the complaints to be considered a true adverse event report.

But in the era of Twitter and Facebook, especially when users’ identities can be much harder to track, things could get a lot more complicated. Say a patient tweets that he has suffered a horrible side effect from a company’s drug. How far does the company need to go to track down the patient and proactively seek out a formal report? AstraZeneca says its policy is to report all adverse events, no matter the source. But without clear guidelines, one company’s definition of a case that deserves follow-up might be different from another, says Bob Perkins, AstraZeneca’s vice president of public policy, who wrote recently on the company’s blog about some of these issues. “That’s the kind of thing we’re going to need clear guidance for,” he says.

Sylvia Pagán Westphal is Xconomy's life sciences columnist. You can reach her at swestphal@xconomy.com or you can follow her on Twitter at http://twitter.com/sylviawestphal. Visit http://www.xconomy.com/author/swestphal/ for Sylvia's full bio and disclosures. Follow @

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