Tuesday, October 21, 2008

Why Pharma Fears Social Networking

Why Pharma Fears Social Networking

Oct 19, 2008

By Jim Edwards (Brand Week)

Although a majority of marketers have embraced online social media and user-generated content efforts, one industry is conspicuously not taking advantage of the gold rush: pharmaceuticals.

Drug brand Web sites almost never carry the features that marketers usually are desperate to give their customers: bulletin boards, chat rooms, blogs and Web-page hosting.

The reason: Marketers fear that user-generated content will include complaints about injuries caused by their drugs' side effects. The law requires these "adverse events" to be reported to the FDA. The FDA's adverse-event databases are regularly combed by lawyers looking for potential class-action suits.

Thus, drug marketers have stuck with a decidedly Web 1.0 model, in which customer interaction is kept to an absolute minimum.

This head-in-the-sand approach may be about to change. A debate is raging in the drug business as to whether companies should   adopt a Web 2.0 strategy. On one side are digital agencies telling companies that online customers generate far fewer adverse event reports than drug companies might expect.

On the other side are brand managers, whose every published word must survive a thicket of in-house lawyers, some of whom aren't Internet savvy.

Dori Stowe, chief digital strategist at Grey Healthcare Group, New York, recalls speaking with a pharma company's legal team about a campaign, "and somebody raised their hand and asked, 'What's Google?'" Stowe, whose clients include Boehringer Ingelheim, said that once brand managers are shown the full extent of what patients are doing online, they're keen to learn more.

When told that companies should embrace such activity, adverse event reporting becomes their immediate worry. "The legal departments will say it's just not an area we can play in," said Jason Rogers, vp/account services at Catapult Marketing, Westport Conn. His clients include Novartis and Pfizer.

Bill Drummy, CEO at Heartbeat Digital, New York, agreed: "We've talked about this with our clients for literally five years and in every case that has been shot down by regulatory and legal folks." His clients have included Abbott Labs and GlaxoSmithKline.

In many cases, clients agree with their agencies but nix projects anyway. "Part of this is understanding the brand manager caught in the middle, with agencies saying you have to do it and the regulatory group not understanding it," said James Pietz, vp/group director at MicroMass, Cary, N.C. His clients include Merck and Shire.

The pressure for drug companies to evolve is growing. "Drug companies need to begin embracing ways to look for adverse events instead of hoping they don't stumble across them," said Peter Pitts, an svp at Manning, Selvage & Lee, New York, who keeps a blog that champions the industry. "I think the attitude of 'there's safety in ignorance,' or active ignorance, is no longer actionable or responsible."

Bruce Grant, svp/business strategy at Digitas Health, Philadelphia, which has worked for Wyeth and Pfizer, thinks there may be a legal advantage in giving consumers more input into drug marketing. "Early warning signals that there may be a safety issue really puts the company in a stronger position in terms of potential exposure to product liability suits," he said.

Grant cites a survey from Nielsen BuzzMetrics, New York, of 500 messages on health-related Google and Yahoo! sites. Only one reportable adverse event was found, suggesting a "volume that is entirely manageable within companies' broader [adverse events] monitoring programs." (BuzzMetrics and Brandweek are divisions of Nielsen Co.) That is disputed by some, who believe the volume will be much higher and therefore more onerous and expensive.

One company is attempting to prove it either way: Johnson & Johnson, which in March acquired Childrenwithdiabetes.com, a community site for parents of kids with diabetes. The site has open bulletin boards and even takes ads from competing companies.

Joe Natale, vp-new media, said J&J monitors the site for adverse events and people who give incorrect medical advice, but aside from that anyone can post whatever they want. "The best way to destroy that community would be to in any way hamper or infringe upon the way they create content or share information. If [a company thinks] that every post for every user has to be reviewed and copy-cleared in advance, I will tell you not to waste your time."

Natale said the site gets 10,000 unique visitors a day, and the expense of monitoring for adverse events runs from $100,000 to $1 million, depending on the size of the site. So far he has encountered fewer adverse events than he expected. "There are enormous risks. I don't want to send the wrong message. It's extremely intimidating," he said. "Some companies will say, 'It will cost us money, cost us some investments.' But I think it will be worth it."

buzz this

FDA Warning to Diovan on Banner Ad ... will there be more?

FDA Issues Warning Letter to Novartis for Diovan Banner Ad
I am sure this is not the first time the FDA issues a warning letter to a pharmaceutical company regarding a banner ad for a prescription product (http://www.fda.gov/CDER/warn/2008/Diovan_Letter.pdf), but what I find particularly interesting in this letter is that the FDA explicitly states that despite the links to the PI and PPI in the banner they feel the banners "fail to communicate any risk information".  As far as I can recall, this is the first time I have seen the agency take a specific stance on the use of a link to the safety info VS actually including the extensive (and often difficult to comprehend) verbiage in the content of the banner (oftetimes we see companies address this in the way of adding additional frames to a banner or include the copy in a scrolling text box).  Upon careful review of the words in the FDA's letter, it appears they are insisting on the inclusion of risk information, warnings, precautions, and the most frequently reported adverse events INSIDE the actual banner -- at least in this particular case (which will probably set a precedent).  I think publishers might need to rethink their banners specs if they expect pharma to stay in compliance.  Fortunately, adding an additional :15 seconds in the online channel doesn't have the same cost implications as :15 seconds on TV.  On the other hand, it means less rotations which reduces impressions (aka "ad inventory").  So perhaps pharma banner ads cost will end up costing more in the long run.  We probably won't see the impact of this much in the next 6-12 months as the general state of the economy is affecting media spends across the board (the first time we have actually seen an overall decline in several years).  This would probably not be a good time to hike prices.

FDA Writes: "... The banners, however, entirely omit all risk information, including the warnings, precautions,and the most frequently reported adverse events from the PI. We note that a link to the PI and Patient Product Information (PPI) is included at the bottom of the banners. However, this does not mitigate the misleading omission of risk information from the banners. For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any effectiveness or safety claims made in that part. By omitting the most serious and frequently occurring risks associated with the drug, the banners misleadingly suggest that Diovan is safer than has been demonstrated."

This letter came in late August 2008.  More recently, we recently have seen a warning letter on Shire's Adderral video on YouTube. Is this going to be a growing pattern?  It will be interesting to see if the FDA begins to more actively monitor the Internet (beyond Web sites).  How will the agency review more complex platforms like social networks, widgets, and other Web 2.0/syndicated technologies?  Will someone at the FDA function in this dedicated role?

This is definately worth keeping an eye on.

Fabio Gratton
Chief Innovation Officer
Ignite Health

buzz this

DDMAC warns Bayer on YAZ TV ads

DDMAC warns Bayer on YAZ TV ads

by Matthew Arnold (Medical Marketing & Media, Oct 7 2008)

The FDA slapped Bayer HealthCare Pharmaceuticals with a warning letter on two 60-second TV ads for its YAZ contraceptive.

The agency's Division of Drug Marketing, Advertising and Communications (DDMAC) said the spots, “Not Gonna Take It” and “Balloons,” “are misleading because they broaden the drug's indication, overstate the efficacy of YAZand minimize serious risks associated with the use of the drug.”

In particular, the agency said the ads exploit overlapping symptoms to “misleadingly suggest that YAZ is appropriate for treating women with PMS,” for which it is not indicated. YAZ is indicated for treatment of premenstrual dysphoric disorder (PMDD), a more severe mood disorder related to the menstrual cycle, as well as birth control. Both ads show women kicking, punching or puncturing symptoms common to PMS and PMDD.

Moreover, the agency said distracting visuals, scene changes, background music and other “competing modalities” threaten to distract viewers from serious risk disclosures during the major statement.

DDMAC is currently evaluating the impact of distracting visuals on comprehension and retention of risk information in TV ads.

Bayer told MM&M the "Balloon" ads ran in 2007 and are not currently airing. The company will pull “Not Gonna Take It” and vowed to work with the agency on other promotions for the brand.

DDMAC has been on a tear of late, issuing five warning and untitled letters on promotions for ADHD drugs last month, along with an untitled letter on consumer-directed materials promoting Boehringer-Ingelheim's Mirapex's restless leg syndrome drug. In August, the agency issued a warning letter on a journal ad for Forest's Bystolic and an untitled letter on banner ads for Novartis' Diovan.

buzz this