Author: Sylvia Pagán Westphal

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

    Sylvia Pagán Westphal
    Sylvia Pagán Westphal wrote:

    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 …Next Page »

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  • A Tangled Web of Self-Interest

    Sylvia Pagán Westphal
    Sylvia Pagán Westphal wrote:

    Boy, it’s good to be here, invading a tiny corner of cyberspace as the new life sciences columnist for Xconomy.

    It is a journalist’s dream to be given free rein, and unlimited real estate, to write about the subjects she thinks matter. As a newspaper reporter (more about me here) the pressure to keep stories short was frustrating. It was hard to land an article on the front page. With The Pulse, I’m glad to be free from these constraints, but I face a different predicament: I know I’m just a click away from oblivion. The world doesn’t need another pundit. So I’ll try my best to use this soapbox wisely. And I really want this to be interactive so please write to me (at [email protected]) or post below with feedback, tips, and comments.

    This is an interesting week to be launching my first column. Wall Street is again under scrutiny, thanks to the suit brought against Goldman Sachs by the Securities and Exchange Commission. At the center of the clash are complex debt structures (”collateralized debt obligations”—who comes up with those names?) that were concocted by Goldman, among other players, and sold as novel products to investors. It allegedly wasn’t completely transparent how these products were built, but that didn’t seem to matter. People trusted people. A product essentially set to fail was sold to the public, or so we’re told.

    From my financially unsophisticated 10-mile view, I wonder: how could something like this happen? How could companies sell to the public a product that they knew would likely fail?

    Come to think of it, that’s not too dissimilar from the question posed in 2004 to Merck & Co. as it stood accused by thousands of patients of knowing about the deadly side effects of Vioxx years before it recalled the drug. (The company never accepted liability and settled in 2007 for $4.85 billion.) Similarly, Guidant, which was later acquired by Boston Scientific, fueled public outrage in 2005 for allegedly selling cardiac defibrillators that it knew might be defective (that suit was settled as well). There are plenty more examples like these. Even the Food and Drug Administration has at times faced this kind of scrutiny–it has been admonished for approving drugs and devices despite advice to the contrary due to safety red flags. When those products turn out to have serious side effects, the outcry begins. How could they, people ask. Isn’t the FDA here to protect us?

    It’s always easy to look back. The prism of hindsight splits the world into us versus them, the righteous and the crooked, but that’s an illusion. The real question is, …Next Page »