On November 12-13, I took part in a Washington D.C., hearing organized by the FDA on how pharmaceutical companies can use the Internet and social media to communicate with consumers. The hearing was a source of excitement in the healthcare industry – the FDA received more than 800 requests for 350 seats.

Over two days, more than 60 speakers – representing pharmaceutical companies, agencies, research firms, search and social media websites along with consumer organizations – shared their thoughts on how companies can responsibly engage consumers online, as well as questions and areas that need clarification from FDA.

Despite the variety of industries and agendas represented, I was surprised by the amount of consistency in the presentations and recommendations. Through the two days of the hearing, a few key themes emerged:

• No one can ignore the explosive power of social media.
  Several speakers shared great data about how often the Internet is used as a source for healthcare information. With patients, caregivers and doctors alike going online for healthcare information, it simply is not an option for pharmaceutical companies to remain separated from this discussion.
• No one company can be expected to monitor the whole of the Internet.
  In our Nielsen BuzzMetrics dataset of health-specific CGM sites, we collected an average of 83,000 messages per day over the past six months. This volume will only continue to grow, and no one can expect to monitor all of it.
• Pharma is ready to listen, but confusion persists.
  Most pharmaceutical companies would like to listen and even respond to consumer feedback online. However, there is confusion among pharmaceutical companies about how and when it is appropriate for them to engage with consumers online, and what responsibilities they have in doing so. This confusion often results in companies holding back on engaging in social media and sometimes even in listening to what their consumers are saying online.
• Adverse events are a red herring.
  Companies that have not done social media listening often have a fear that they will see a high volume of adverse events in online consumer conversation. (And for pharmaceutical companies, there is a requirement that these events are followed up and reported to the FDA.) In fact, the number of adverse events in online discussion is very low and manageable within the reporting systems that pharmaceutical companies already have in place.

This last point was the basis of my testimony at the hearing. In 2008, Nielsen analyzed online healthcare discussion to define the number of adverse events and found that just 4 of 500 messages contain adverse event information, and only 1 of those messages contained all of the criteria that are required for AE reporting.

For me, the key takeaway from the FDA hearing was this: More and more consumers are online looking for information on their health. Some of the information they find online is good, but some is not, and it’s not always easy to tell the difference. Right now anyone can contribute to the online health discussion except the pharmaceutical companies, who are waiting for guidelines from the FDA about how to engage online in an appropriate and responsible way.

There was a sense of hope among attendees at the hearing that the FDA will provide new guidelines on the Internet and social media relatively soon. When that happens, not only do we empower the pharmaceutical companies to interact with consumers online, but we give them a sense of duty to contribute to the conversation in a responsible way. Of course it’s not appropriate for pharmaceutical companies to get involved in every consumer discussion about healthcare online. But where these companies can contribute value to the discussion, let’s empower them to do just that.

Like many of my colleagues in the pharmaceutical/healthcare field, I look forward to watching and participating as the discussion continues to unfold.

• Download a healthcare-focused whitepaper authored by Melissa Davies: Listening to Consumers 101, How Marketers Can Leverage Consumer-Generated Media

The Boehringer-Ingelheim drug, which treats male urinary symptoms due to BPH, offered two creatives last season that were recalled at a rate 42% greater than the average based on all newly-launched prescription drug ads.  These latest installments of Flomax’s direct-to-consumer TV campaign feature men at a baseball game and men playing on a golf course.

“With relevant and consistent visuals that stand out from the rest, the Flomax ads prove that marketers can still be creative and memorable even within the restrictive pharmaceutical category,” said Fariba Zamaniyan, senior vice president at Nielsen IAG, Healthcare.

Cialis (Eli Lilly) and Gardasil (Merck) tied for second on the list with 32% greater recall than the average drug ad launched last season. The ad for Cialis, which treats erectile dysfunction in men, was an extension of its “What are you waiting for?” campaign and featured its iconic outdoor tubs and a variety of male and female couples. Gardasil, which guards against cervical cancer and HPV in women, filled its creative with images of moms and their daughters who “chose” to get vaccinated engaging in a variety of activities such as surfing, shopping and swimming.

Wyeth’s “Wind-Up Doll” TV campaign for Pristiq for the treatment of depression “winded up” the top three.  It was the only newcomer at the top of the DTC ranking this past TV season, with a recall index of 128.

A key takeaway from the rankings, said Ms. Zamaniyan, is that DTC advertising is not just successful when symptoms of the ailment treated by the advertised drug are shown.  Any prescription drug ad, she says, can still be memorable without the display of symptoms and still  connect with the audience while staying within FDA guidelines.

“The bar for creativity shouldn’t be lower for pharma because of the regulations in place,” Zamaniyan argues. “In fact,  it should be higher given the level of investment and volume of competitive activity on the airwaves.” 

Nielsen’s recall index is limited to responses among adults 18+ who correctly recalled the storyline of the ads they were exposed to within 24 hours after airing. Only ads airing during entertainment and sports programs on the five broadcast networks (ABC, CBS, NBC, FOX and CW) on Broadcast prime time,  Evening News, Late Night and Syndicated Prime Access (Jeopardy, Wheel of Fortune, Access Hollywood, Entertainment Tonight, Extra, Access Hollywood) were included in the ranking.  The ads are measured at comparable media weight to control for differing weight levels across the campaigns.

Jim Mansfield, Customer Development, The Nielsen Company

Contributors: Melissa Davies, Jennifer Wehringer, Gabrielle Gibbs, Dale Norton, Robert Buckeldee, Meghan Palestis, Mike Hudak and Allison Fitzenreiter

SUMMARY: The U.S. Food & Drug Administration’s warning for the use of acetaminophen sent temporary shock waves across online chat rooms, which resulted in cautious consumers holding back purchases. While levels returned to normal about four weeks post announcement, online discussions continue to be significant. In the age of instant communications, marketers need to stay ahead of the curve with tactics that educate consumers quickly, accurately and proactively.

On June 30, 2009, the U.S. Food & Drug Administration (FDA) issued a recommendation and warning for the use of acetaminophen. Citing concerns of potential overdose and liver injury, the advisory committee recommended lowering the daily recommended dose of acetaminophen. The commonly used pain- and fever-reliever is found in several nonprescription cough and cold remedies as well as prescription products.

Pain business is big business. Nielsen reports an estimated $732M was spent on total media for the pain category (excluding online) for the year ending June 2009, with more than half (56%) allocated to over-the-counter brands and the remainder to prescription products. With the widespread use of the drug and strong media attention, Nielsen analyzed consumer reaction to the announcement and the resulting impact on sales.

Rising concerns
Immediate consumer reaction to the news of the FDA advisory committee meeting drove a noticeable spike in both branded and generic online discussions of acetaminophen, as the chart below indicates. A review of online chatter for June and July shows buzz volume for acetaminophen. Branded discussion was also significant, with the most chatter among the brands that are most recognizable to contain acetaminophen.

However, in the two-week time period following the advisory committee’s meeting, more than half (58%) of generic acetaminophen discussions was centered on risk information, while only one-fifth of branded product’s online chatter discussed health threats.

After three to four weeks following the announcement, consumer online buzz began to return to a level prior to the warning.

Interestingly, the online buzz and market impact generated was not combined with any broader overt advertising campaign. Nielsen reviewed commercials that aired for products within the pain category and did not find ads indicating specific safety messages in response to the FDA recommendation. However, Nielsen did find an increase in the mention of acetaminophen in advertisements in the weeks after the announcement.

A review of TV commercial spots of prominent pain reliever brands revealed that a few brands aired new creatives and modified prior advertisements with both a voice over and/or an “acetaminophen free” message. The changes seen in these advertisements took place the same week and continue through the most recent available period in September 2009.

Buyer beware
Immediately after the FDA warning was announced, sales of the entire pain category began to decline. Four weeks post announcement, Nielsen estimated that units declined approximately 0.5% (about 2.3 million units), but dollars increased 0.3%. The statistical model incorporated the promotion trends over the period, which was believed to cause the increase in dollars.

In the nine weeks following the announcement, sales resumed, with units and dollars up 1.3% and 0.8% respectively. It appears that consumers initially reacted and paused purchasing any pain product, but as they became more educated of the risks, purchases resumed (approximately five weeks after the warning). As a reference, the average consumers purchase cycle for pain remedies is approximately 50 days, which is within this analysis period.

To determine the predicted dollar and unit sales impact on the pain category, Nielsen employed a statistical method (multiple linear regression) to account for the multiple market levers that were occurring, which included promoted dollars, percent of promoted dollars, total promotion expenditures, online buzz, and gross rating points.

The analysis showed that some brands were more impacted than others. Two directional themes emerged that manufacturers and retailers should consider as the acetaminophen recommendations evolve. First, the brands and store brand products with the most affiliation with acetaminophen were the most impacted by the warning. Second, some brands with dosage instructions that require the consumer to take fewer pills per day appeared to grow.

Feeling the pain
Were consumers who suffer from pain more “tuned-in” to the news surrounding the FDA recommendation? Nielsen analyzed the reach of broadcast and cable programming among ailment suffers who treat their conditions with either a combination of prescription and non-prescription remedies or just non-prescription remedies—in June prior to the acetaminophen announcement and post-announcement in July.

Seven ailment conditions that are treatable with medications that contain acetaminophen were analyzed: Allergies, Osteoarthritis, Rheumatoid Arthritis, Migraines, Chronic Tension headaches, Joint/Neck/Back pain, and Muscle Pain/Spasms.

Both broadcast and cable reached Adults 18–69 during this time period with a 96.75% reach in June and a 95.43% reach in July. However, across Adult (18–69) ailment sufferers whose conditions can be treated with acetaminophen, reach was slightly higher both before and after the announcement at the end of June. Perhaps the segment of sufferers with ailments that cause pain have an increased media reach due to the elevated awareness of the acetaminophen warnings.

Global implications
Global manufacturers and retailers of acetaminophen should take note as countries outside of the U.S. review the use and dosage recommendation of acetaminophen. As it turns out, there are unique differences with regards to how consumers in different countries ensure the appropriate use of non-prescription medications.

A March 2009 Nielsen study revealed that close to half of all U.S. respondents (48%) said they ensure the proper use of non-prescription medications by reading the instructions on the pack. Only 15% said they refer to the product leaflet in the pack, and 12% consult with their pharmacist. These results compare starkly with consumers in Europe, for example, where (on average across 22 countries) fully one-third (32%) of consumers ensure responsible usage by referring to the product information leaflet in the pack, one-fourth (26%) through a dialogue with their pharmacist and only 16% from reading instructions on the pack.

These findings underscore the importance of understanding regional nuances when marketing in a global landscape. Strategies and tactics must reflect these differences to ensure optimal engagement with consumers and proper education on the benefits and safety of acetaminophen.

Cautious consumers
While the initial consumer reaction to the recommendation caused an increase of consumer generated media (online buzz) and decreases in the purchasing of over-the-counter pain products, these trends were later reversed. However, the consumer reaction to “back to normal” should be cautioned. Although consumers believe acetaminophen products are safe, they did show a strong reaction to a call for caution.

The Internet has enabled instant communication where word travels far, wide and deep. As made apparent with the acetaminophen warning, consumers readily seek out information—even without an overt advertising campaign to support it. Manufacturers and retailers have a responsibility—and an opportunity—to properly educate consumers and healthcare providers (pharmacists, physicians, etc.) via multiple media channels and product packaging that is most appropriate for the target audience.

Insights for manufacturers, retailers, and industry groups
The acetaminophen warning, albeit brief, affected the entire over-the-counter pain category. While consumers did return back to the category quickly, the same rebound may have not occurred as rapidly if the discussion of warnings and risks continued for an extended period of time.

In advance of future acetaminophen recommendations, Manufacturers, retailers and industry groups should consider the development of a consortium-like educational initiative about the safety of over-the-counter pain medications for consumers, pharmacists, physicians, and other healthcare providers. An educated healthcare system will be more engaged to repurchase the pain category vs. one that is less understood.

That’s not to say every ad in the category was unmemorable. An ad for Claritin featuring Nascar’s Carl Edwards was judged slightly more memorable than last year’s top ad for the category featuring the Nasonex bee. Still, the Claritin ad failed to motivate customers to consider Claritin to the same degree as the Nasonex ad.

Why didn’t this year’s ads leave a strong impression? They just weren’t as good, said Fariba Zamaniyan, senior vice president at Nielsen IAG, Healthcare. “This collectively weaker performance suggests that the creative strength of the advertising is not as strong as it used to be” she said. “In these economic times especially, if you’re going to advertise on TV it has to be memorable. In a high-clutter category like allergy, you can’t afford to miss. Being average isn’t good enough.”

There were more advertisers overall this year (nine, up from seven a year ago) but fewer ads (20 this season, down from 24 a year ago). Ad spending for traditional media within the category from January to April declined 17 percent from a year ago, according to Nielsen Monitor Plus data. That’s about in line with spending declines in other categories, Zamaniyan said. At the same time, allergy advertisers sought the efficiencies they perceived cable TV programming could provide. Nielsen said the allocation to cable ad spending during the January-April period increased 20 percent from a year ago.

The most-recalled ad this year among allergy sufferers aged 25-54 was Claritin’s 15-second “Carl Edwards interview.” No. 2 was Zyrtec’s 30-second “bicycle” ad, which showed a woman taking her bicycle out of storage for a ride now that her allergy symptoms had abated. A year ago, the Nasonex “Bee next to a bottle” was No. 1, followed by Sudafed’s “Teacher head balloon,” which showed a woman’s head blowing up like a balloon as her congestion increased.

Creative quality also is taking the blame for this year’s ads doing less to motivate allergy sufferers to seek remedies. Nielsen IAG found intent to ask the doctor about the prescription brand advertised was down 40 percent from a year ago. Purchase interest declined nearly 20 percent. “Weaker creative which limits the ads’ potential to be recalled has ultimately resulted in lower call to action levels this season,” Zamaniyan said. “Again, the number of ads on air is consistent vs. year ago so, we can’t blame it on clutter – it’s the creative.” She discounted the notion that the down economy could be totally to blame. “It may be one of the factors,” Zamaniyan said. “Advertisers and their agencies often blame the economy, but the takeaway here is that before the advertiser can influence behavior, it has to break through.” As the number of brands advertising increased, she said, that becomes critical. “If the ad is not a unique execution that stands out from the rest and connects with the viewer, then the ability to drive purchase interest or doctor contact is suppressed no matter how recognizable the brand name is,” she said.

Last month, we were honored to win a ‘BOBI’ award for “Most Innovative Approach” from the British Healthcare Business Intelligence Association for our recent work with Pfizer. Their challenge was to monitor what consumers were saying online about Champix, the company’s smoking cessation aid, and to that end, we created a research methodology using our BuzzMetrics solutions.

Whilst winning is, of course, fantastic, what was most important for us was that the client was so happy with the work that they submitted us for the award in the first place.

What’s so unique about helping a brand monitor understand what’s being said in the CGM space? Well, the prescription healthcare industry faces unique regulations from the European Union, which have resource implications that effectively prohibit pharmaceutical companies from benefiting from the consumer-generated realm. The regulations center around the requirement of pharma companies to “make every effort” to follow up on all ‘Adverse Events’ – consumer comments around experiences not intended by the drug or its usage – including contacting the consumer concerned, as well as notifying the Drug Safety Group.

We created a bespoke research methodology using BuzzMetrics that was able to comply with these regulations as well as provide a unique new source of business intelligence for Pfizer. According to the judges, our solution was “a unanimous and clear winner” and demonstrated innovation in two ways: by overcoming daunting internal challenges to the research and delivering a pragmatic, practical solution and by leveraging an emerging methodology to monitor online consumer discussions.

Michael Goff, Business Intelligence Manager, Pfizer U.K had this to say about the Buzz solution: “Apart from the obvious relevance for our brand, the general value to the pharmaceutical industry of understanding consumers’ opinions of prescription medicines is evident for all to see. The research offered us the opportunity to understand what consumers were hearing about our brand, how this was being interpreted, and what impression of the brand was being created on-line for potential future users. Its most obvious business impact was that a potentially expensive marketing program was demonstrated not to be necessary.”

Ultimately, this project to measure buzz has brought new light to Pfizer in terms of an ongoing understanding of all areas of drug products and uses – a veritable goldmine they can tap into to help improve their strategy, marketing, consumer insights and many other critical areas of the business.

Download the entire case study.

“These numbers confirm the acceptance and attractiveness of mail order. Indeed, one in two German respondents in the Nielsen European OTC survey said they had ordered medicines over the Internet in 2008,” said Bernd Wilhelm, Director of Pharma & Healthcare at Nielsen in Frankfurt.

In the first six months following its launch (January to June 2008), Zyrtec OTC shook up prescription and OTC allergy medication markets in the U.S.   Prescription allergy drug sales declined sharply, while over-the-counter allergy drug sales increased significantly.

By June 2008, prescription sales of Zyrtec had declined to nearly negligible levels.  Meanwhile, the OTC form quickly gained acceptance, capturing almost one-quarter of the OTC allergy medication market — the same share held by market leaders Benadryl and Claritin OTC, which have been available for several years. 

More than 60% of Zyrtec OTC’s business came from patients who had not used an allergy product in the previous two years, or who use Zyrtec OTC concomitantly with other products, according to Nielsen and Wolters Kluwer. 

Another 40% of Zyrtec OTC buyers switched from a competing prescription or OTC allergy medication.  Among this group, 84% of patients switched specifically from another OTC product.

Perhaps most surprisingly, while OTC products typically lure consumers with their cost savings, 68% of patients who switched to Zyrtec actually spent more than they did on their prior prescription or OTC allergy treatment, Nielsen and Wolters Kluwer found. 

Nielsen and Wolters Kluwer tracked the market transition behavior of 57,000 consumers vis-à-vis Zyrtec over a 30-month timeframe.

Read the related white paper.

Learn more about prescription-to-OTC pharma trends: attend Nielsen’s Webinar, “Revealing the Landscape of Rx-to-OTC Switching,” on November 18, 2008.

The Pew Internet & American Life Project today released the results of its latest survey into how and when Americans use the Internet to gather health information. In The Social Life of Health Information, Pew reports that Americans are turning to an increasingly broader array of online and offline resources in their search for health information.

Highlights from the report include:

• 83 percent of online adults have looked on the Web for health information. (Since 2002, Pew Internet Project surveys have consistently found that 75-83 percent of Internet users look online for health information.)
• Half of online health inquiries are done on behalf of someone else, such as a family member or friend.
• 57 percent of e-patients say that their most recent online health inquiry had an impact on their own healthcare or the way they care for someone else.
• 60 percent of e-patients say they or someone they know has been helped by following medical advice or health information found on the Internet (a significant increase from 31 percent in 2006).

This survey also finds that the Internet does not replace healthcare professionals — a finding that echoes results of Nielsen’s 2008 study into the online and offline resources that people use as part of the healthcare decision-making process. Instead, e-patients take the health information they find online and use it to inform their offline conversations with healthcare professionals, family and friends.

As is always the case, Pew Internet Project’s latest report is a fascinating look at our online behavior, and I am looking forward to the chance to dive further into the data.