Merck Says FDA Should Approve the “One-Click Rule”

Merck submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

About 75% of Merck’s comments that specifically address FDA’s questions is devoted to an argument in favor of the “one-click rule” as it applies to space-limited digital product ads. For more background on the one-click rule, see "Pharma Prefers '1-Click Rule' for Presenting Fair Balance in Social Media & Other Internet-based Rx Ads."

When FDA issued those infamous 14 notice of violation letters last spring, the drug industry was stunned and immediately pulled back from branded search engine advertising (see "The 14 Letters. Who at the FDA Knew What and When? FDA Intern Wants to Know!"). Apparently, Merck revised its sponsored search ads to the help-seeking format “in March 2009 in response to DDMAC's enforcement letters on sponsored links.”

As a result, across several brands, Merck “observed an increase in click-thru rates with the unbranded, help-seeking format indicating that the format may have attracted more users seeking condition-specific information. However, the number of landing (product) site pages consumed after the click-thru consistently declined. For one brand, the number of page views by the searcher dropped by nearly 50%.”

Merck claims this "decrease in content consumption could indicate a lack of transparency between the advertisement and the linked to content” and “current unbranded, help-seeking sponsored links do not meet the needs of health information seekers using Internet search engines.”

I’m trying to understand Merck’s argument. This is the example “help-seeking” ad it presented in its comments to the FDA:

Merck did some market research to evaluate this and other ad formats, including this product-claim format that Google has made available to drug companies in beta tests (see "Is Google the New FDA?"):

Merck asked its study subjects “How do you feel about having to click on the link to gain access to the product safety information?”

For the Product Claim ad, 78% said they found it very or somewhat acceptable. For the Help-Seeking ad, however, only 34% said it was acceptable. Well, of course it’s not acceptable -- to get to the product information from the Help-Seeking ad, you first have to click through to the product web site. But this doesn’t mean that the Help-Seeking ad did not “meet the needs of health information seekers using Internet search engines.”

I think what Merck really means is that ITS needs are not being met by Help-Seeking ads!

Concluding its comments on the one-click rule for Product Claim ads, Merck says “the use of hyperlinks is an appropriate and effective way to disclose product use and safety information in limited space formats. FDA should adopt standards to be consistent with FTC guidelines and allow hyperlinks to fulfill the regulatory requirements for product use and safety information disclosures in digital media with space limitations, including but not limited to, banner advertising, mobile applications, text messaging and sponsored advertisements in search engines.”

AstraZeneca Urges FDA to Regulate the Whole and Nothing But the Whole SM Conversation

AstraZeneca (AZ) submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

Again and again throughout its comments to the FDA, AstraZeneca defends the concept that social media conversations by drug companies are just like real world conversations and should be similarly regulated; ie, FDA should consider the whole conversation, not just one part of it.

"It is our view that the FDA, in developing its guidance, should view such participation in a manner analogous to its existing regulation of in person and telephonic promotional activities," said AZ. "In that case, the FDA examines not just one part of the conversation but the entire conversation as a whole."

"It is similarly appropriate for the agency to view a social media conversation as a whole and not regulate each and every 'post' as if it were, in itself, a promotional piece," said AZ in its comments where it cites FDA's draft guidance on risk communication. AZ quoted this precedent from the FDA guidance: "FDA looks not just at specific risk-related statements, but at the net impression – i.e., the message communicated by all elements of the piece as a whole. The purpose of the evaluation is to determine whether the piece as a whole conveys an accurate and nonmisleading impression of the benefits and risks of the promoted product." [FDA's words]

AZ takes this concept to new heights, however, when it attempts to include all sorts of things in the "conversation": "We recommend a framework that understands that a conversation may include text, video, sounds, and other elements that are appropriate to consider together." These elements, says AZ, can appear together or as near as together as the site or format allows.

AZ cites Twitter as an example: "... on Twitter or another micro-blogging site, a sponsor might use multiple, simultaneous 'posts' to convey information on risks and benefits including using links or other reference marks or symbols."

I once posted several tweets one after the other in an attempt to mimic a particular kind of conversation in the real world, ie, Burma-Shave roadside advertisements. You may be too young to remember this outdoor marketing trick. Typically, six consecutive small signs would be posted along the edge of a highway, spaced for sequential reading by passing motorists. The last sign was the name of the product (ie, "Burma-Shave"; see this wikipedia entry.) Here's an example (imagine each of the following phrases on a separate roadside sign separated by 100 feet or so):

That big blue tube


is like Louise


it gives a thrill


with every squeeze


Burma-Shave!

Each sign is part of the "conversation," but looked at in isolation it makes no sense.

BTW, my Twitter experiment was a disaster. No one strung the tweets together to get the entire message. I looked like a complete idiot who did not know how to use Twitter to communicate!

How Did Pfizer Get So Many Twitter Followers?

Wow! Pfizer's official Twitter account, @pfizer_news ("The official site for Pfizer Inc., where we apply science and our global resources to improve health and well-being at every stage of life.") has over 5,000 followers, making it the MOST followed pharma Twitter account! And just this last December it had less than 1,000 followers (see chart below). How did Pfizer get so many followers so quickly?

 

This chart was created at twittercounter.com where you can find follower and tweet stats for any Twitter account. I compared stats for @pfizer_news with two other pharma-related Twitter accounts having a comparable number of followers (ie, @pharmaguy - me - and @swoodruff - Steve Woodruff).

Something unusual happened around Christmas last year - Pfizer somehow attracted about 3-4,000 NEW Twitter followers in just a few days! Did someone give Pfizer a Christmas present?

[Ha Ha! See comment about Pfizer PR people asking employees to follow. Maybe they sent employees a Christmas card?]

Perhaps Pfizer was spewing out a ton of informative Tweets that just naturally attracted 4,000 new followers. Oh, but wait, that can't be the reason. According to the stats, @pfizer_news has only posted 100 tweets since its launch last fall. It was practically silent around the end of the year in 2009.

More likely is that Pfizer got new followers by doing what it does best -- advertise! Kudos to them. What I want to know is how much did you pay per follower and where did you advertise?

Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media

Pfizer submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

The world's #1 pharmaceutical company stands alone in calling upon the FDA to develop new regulations for the Internet and social media rather than issuing guidance that puts an "interpretative gloss" on existing rules.

"FDA should not try to fit the square peg of Internet and social media communications into the round hole of the Agency’s existing rules developed for conventional media," said Pfizer in its comments. "Rather, FDA should develop comprehensive new rules describing the actions manufacturers must take in order for their online communications to be truthful and non-misleading in the specific context of the online environment. The Agency should ultimately establish these new rules not in guidance -- which by definition cannot change existing rules but can merely provide an interpretive gloss on those rules -- but rather in new regulations. As discussed below, the public health would be benefitted by the establishment of binding, legally enforceable new rules that have been developed by FDA specifically for new media."

Pfizer contends that "for FDA to regulate in this sensitive area through guidance instead of rulemaking inherently raises First Amendment concerns because of the nature of the process used to develop guidance, and the nature of the Agency pronouncements that result." Guidance, says Pfizer, is too vague and engenders "extensive litigation."

I don't know if that is a veiled threat or not, but Pfizer "believes it would be imprudent for FDA to repeat this pattern of seeking to address an entirely new field of conduct, where First Amendment rights are clearly at stake, without the discipline that comes with a rulemaking proceeding. Further, since the WLF litigation, the courts have only become more aggressive in policing FDA regulation of speech."

Ah Ha! WLF -- the Washington Legal Foundation, an organization "devoted to defending and promoting the principles of free enterprise and individual rights" (mostly for pharma companies) -- rears its head! I suspect, in fact, that the WLF wrote the first draft of Pfizer's comments or maybe it was Arnie Friede, former Pfizer Chief Counsel.

Pfizer predicts that vague guidance will inhibit companies from engaging in social media: "Many manufacturers simply will decide, as a risk management matter, that they will not engage, irrespective of any guidance from FDA, because the enforcement discretion reference means that the Agency regards that engagement as potentially violating a statutory or regulatory provision."

In other words, Pfizer believes guidance would stifle pharma's use of the Internet and social media rather than encourage it, which Pfizer implies should be the goal of FDA. "Such an approach [issuing guidance rather than new rules] would not be ideal, however, if FDA genuinely wants to encourage manufacturers to increase their level of engagement in online activities."

So the FDA is doomed if it does issue guidance and doomed if it doesn't. Either way, according to Pfizer, the FDA will stand in the way of free speech.

Google Defends Sidewiki Despite the Fact That It Is Worthless as a Social Media Tool, IMHO

Google submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

The search giant devoted about 3 pages to defending Sidewiki, which presents users with a vertical window on the left side of the web browser window, next to the relevant website, in which they can write and read commentary. I was one of the first people to use Sidewiki to attach comments to a drug.com website (ie, Viagra.com; see image on left; click for enlarged view).

According to Google, "The service uses an algorithm to identify the best comments, based in part on user ratings, and seeks to display only comments that are judged to be of high quality." I am honored, therefore, that ALL of my sidewiki comments -- including the bogus one about my arm falling off after taking Viagra -- has been judged by Google's rating system to be of such "high quality" that they are the ONLY ones on the first Sidewiki page. If you click "Next," you'll find a bunch of less worthy Sidewiki comments.

Google says "And while website operators cannot directly control or edit Sidewiki content created by users, they can choose to enter 'site owner' Sidewiki comments about their own websites, which will then appear at the top of the Sidewiki window when users visit that specific website. In this way, the website owner is guaranteed a voice in the discussion of their site, but not in a way that allows them to control content other users may wish to contribute to the discussion."

To date, Pfizer has not opted to "contribute to the discussion" and has NOT posted a "site owner" Sidewiki comment on Viagra.com. And Pfizer does NOT mention Sidewiki at all in its public comments to the FDA.

If you were at the November, 2009, public hearings (find transcripts here), you know that I called on Google to "tear down this Sidewiki" (it was the anniversary of the fall of the Berlin Wall).

But Google soldiers on and says "It is critical for regulation to avoid stifling the public participation and exchange of ideas that Sidewiki and similar innovations are intended to promote."

I, on the other hand, think SideWiki is a nusiance, not an innovation. At the FDA hearing I said "some people think that Sidewiki is a game changer. I really think it's a public health nuisance, if not worse. Pharma companies should demand that Google provide them and other healthcare companies with an option to block Sidewiki on their entire site with one simple registration of a URL."

Also see these posts:

My Opinion of Google's Decision to Foist Sidewiki Upon Us
Google's Wacky Wiki is Whack! Pharma Should Demand Ability to Block It!

PatientsLikeMe Reports High Rate of Adverse Event Reporting Among Its Members

 

PatientsLikeMe (PLM) -- an online community for people with "life-changing conditions" -- submitted comments to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

The most interesting comments are about PLM's experience with adverse events reported by its members. In short, PLM found that 7% of 500 randomly selected posts from the 364,000 posts contributed by patients within the PatientsLikeMe Forum during 2009 incorporated all four elements required for reporting an adverse event (an identifiable patient, a specific medication, an identifiable reporter and a reaction). This is 35 times the rate in the frequently cited Nielson study, which found only one such message in its random sample of 500 posts.

Recall that biopharma company UCB and PatientsLikeMe have partnered to create an online, open epilepsy community that captures real-world experiences of people living with epilepsy in the U.S. Part of this partnership includes a pharmacovigilance program to monitor the site for adverse events and report directly to the FDA adverse events associated with UCB products (see "Finally, a Drug Company Embraces Social Media, AEs Included!").

PLM said its study data "would extrapolate to approximately 20,000 events per year in our Forum alone. If we were to include data collected from all other sources (e.g. symptoms, treatment evaluations, side effects, annotations, private messages, research surveys) within PatientsLikeMe then the volume would be much higher. Given our current membership of approximately 55,000 patients representing only 15 diseases among hundreds that we plan to build, the contribution to drug safety and public health could be substantial."

PLM also reported that if patients were given the right tools that facilitate access to their personal medical data, the time required to report an AE to the FDA could be reduced by as much as 44% (from 36 minutes down to 20 minutes). In a pilot program in its 10,000 plus member Multiple Sclerosis community, 195 AERs were generated in one year. PLM found that "75% of these voluntary patient reports contained the four required elements for an adverse event and 24% reported a serious outcome."

Is this good or bad news for pharma companies hoping to cash in on the social media bonanza? Surely, many were bouyed by the Neilson data, which held out hope that AE's reported by patients on company-controlled or sponsored SM sites were not an insurmountable problem. The PLM data could bash those hopes.

But if drug safety is important for pharmaceutical companies, then they should welcome the opportunity that sites like PLM offer to improve the safety of their products. "Sites that integrate data collections systems and processes to capture the richness of patient experiences with drug products have an unprecedented opportunity to improve safety and outcomes for everyone who uses these products," said PLM in its comments to the FDA.

#fdaSM Survey Results

I worked all weekend to submit to the FDA the results of the Pharma Marketing News/Blog survey of readers about FDA's Regulation of Drug & Device Promotion via the Internet & Social Media.

As you may recall, the FDA asked for comments relating to the following 5 issues:

• Issue 1: Accountability
• Issue 2: Fulfilling Regulatory Requirements
• Issue 3: Posting Corrective Information
• Issue 4: Links
• Issue 5: Adverse Event Reporting

Under each issue, the FDA included several specific questions for which it was seeking answers.

Beginning on September 21, 2009, Pharma Marketing News/Blog hosted an online survey/ questionnaire that included all 19 of these specific questions. For most questions, the survey included specific choices that respondents could select as part of their answer. Each question also allowed respondents to enter comments. The goal of was to obtain both quantitative and qualitative answers to the questions posed by the FDA.

I presented preliminary results of the survey at the November, 2009, FDA hearing in two sessions:

• Session 1, covering FDA issues 1 (Accountability) and 2 (Fulfilling Regulatory Requirements); See it here: http://bit.ly/4KXzXl
• Session, covering FDA issues 3 (Posting Corrective Information) and 5 (Adverse Event Reporting); See it here http://bit.ly/5GwcPm 

The survey was closed on February 26, 2010 after collecting responses from 274 people. A summary of the results—including 731 comments—is available here: http://bit.ly/dhsqes Use code '82D2AF' for a discount!

Thanks to everyone who responded and submitted comments.