The 14 Letters. Who at the FDA Knew What and When? FDA Intern Wants to Know!

"My sources inside the agency (but outside of DDMAC) tell me they were caught by surprise by these new DDMAC letters," says Peter Pitts, author of Drug Wonks, which is widely read by the pharmaceutical industry (see "Sponsored Links: Implications & Applications").

"What does this mean? Does it expose the probability that this important social media issue was not discussed at higher levels? You be the judge – but you can bet they will be now. In fact, I wouldn’t be at all surprised to see this issue discussed at a sitting of the Risk Communications Advisory Committee."

MY sources tell me that FDA Intern is tracking down who discussed these letters at higher levels in the FDA.

Yes, it's FDA Intern! Strange visitor from an Ivy League school who came to FDA with powers and ability far beyond those of Janet Woodcock or even former FDA commish Andy von Eschenbach!

FDA Intern! Who can change the course of mighty clinical trials, approve drug ads faster than a speeding bullet, jump through Congressional Subcommittee hoops of fire and ire, and who disguised as Emily Jameson (no relation to Jenna Jameson), mild-mannered intern for a great regulatory agency, fights a never ending battle for fast-track drug approvals, pharmaceutical company user fees, and the FDA way!

(Click for an enlarged view. Print it and show your friends!)

"In fact," says Pitts, "[the issue] should have been discussed before the letters were sent out in the first place – that’s what advisory committees are for. But that’s just my opinion."

Better be careful Mr. Pitts! You might just get what you wish for and MORE -- ie, Sydney Wolfe sitting on that advisory committee!



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Protection from Brand Infection: Research Survey

On behalf of the CMO Council, I am pleased to pass along to my readers an announcement of the formation of a new thought leadership initiative titled "Protection from Brand Infection." Protection from Brand Infection is a new area of exploration to determine the degree to which senior global marketers are sensitized to, and concerned about, brand hijacking, product piracy, cyber fraud, and other Internet reputation risks.

I emphasized "Internet reputation risks" because that is often my focus in discussions on this blog.

According to Donovan Neale-May of the CMO Council, "the program will focus on Enterprise Brand Protection and take a deep dive into the brand image and integrity issues, implications of online counterfeit sales, gray market knock-offs, phishing attacks, cyber squatting, email scams, online brand and trademark abuse, domain kiting, pay-per-click fraud, copyright and patent infringements, as well as product piracy and fakes."

As part of this initiative, CMO Council is currently hosting the Protection for Brand Infection survey, which I encourage my readers to take. In return, CMO Council will give us an exclusive look at the results of interest to the pharmaceutical industry.

Here are some finding so far:

29.4% of respondents (so far) see cybersquatting, or the illegal use of trademarks or brands in domain names online, as the most prevalent infringement on business and reputation. However, only 18% are plagued by replication of goods, fashion labels, apparel or products.

Where do you fall? Are you among the nearly 40% of marketers who are leaving this brand problem up to legal? Or are you one of the marketers with an eye on those who are looking to profit from your brand’s reputation?

We are nearing the end of our research for a CMO Council initiative, Protection From Brand Infection, and are looking for your insights to round out our peer-led audit. You can access the survey at http://www.brandsecuritycenter.org/survey/protection/

The CMO Council is closing this research within the next week, so time is of the essence. All participants will receive a free copy of the report upon publication.

Take part in this benchmark of how marketing is taking control and securing the trust in our brands!

There's a New Crop of Pharma People Who Are Not So Savvy About Social Media!

This morning I posted some results from the "Social Media Pharma Marketing Readiness Self-Assessment" survey that seemed to indicate that Pharma's "Social Media Readiness" Score had improved (see post here).

But looking at the data from three different time periods, I find something perhaps interesting: the score increased from Dec-2007 to Nov-2008, but decreased afterwards as if there were some kind of "Social Media Readiness Recession" going on in the pharmaceutical industry.

Here's the chart (click on it to enlarge):


The chart reflects data collected during the following 3 time periods:

• Period 1: 26-Dec-2007 through 31-May-2008
• Period 2: 1-Jun-2008 through 30-Nov-2008
• Period 3: 1-Dec-2008 through Today (6-Apr-2009)

The "Knowledge" category is the most telling. The new crop of respondents don't seem to have as much social media knowledge as the 1-Jun-2008 through 30-Nov-2008 respondents, who were much more knowledgeable than the first group.


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Pharma's "Social Media Readiness" Score Improves

The "Social Media Pharma Marketing Readiness Self-Assessment" survey has been hosted by Pharma Marketing News since December 2007 and to-date about 390 people from pharmaceutical companies, pharma vendor companies and other interested parties have taken the survey and compared their scores with the average score.

The survey asks respondents several questions to gauge readiness in 3 categories:

Regulatory Environment of respondents company
Their company's Corporate Culture viz-a-viz comfort with social media
Respondent's personal Knowledge & Opinion of Social Media

You can read more about the details of the questions and get a summary of the results through 26 March 2008 by downloading this Pharma Marketing News article reprint: PMN Reprint #73-05.

At the time I last reviewed the data (March 2008), only about 108 people had taken the survey. Today, approximately 400 people have responded.

It occurred to me that I could compare the responses collected during the last 12 months (ie, 1-APR-2008 through 31-MAR-2009) and compare them to the first set of responses (ie, 26-DEC-2007 through 31-MAR-2008) and see if the scores improved.

They have! See the following chart (click on it for an enlarged view):


These data are from PHARMA respondents only (ie, people who claim they are employed at FDA-regulated Pharmaceutical/Biotech/Medical Device companies). The "2008" data were based on 46 responses and the "2009" data are based on 86 responses.

I should really look at 6-month chucks of responses and see if there really is an upward trend. Come back after lunch for an update!

Overactive Bladder: "Pharmacia instrumental in creating new disease" says Former VP

I just received a link to an old Powerpoint (PPT) presentation that was featured at an October, 2002, Pharmaceutical Marketing Research Group (PMRG) conference. The presentation was entitled "Positioning Detrol (Creating a Disease)" and the presenter was Neil Wolf who, at the time, was Group Vice President at Pharmacia, the drug company purchased by Pfizer. As you may know, Pfizer is preparing Toviaz, a follow-on drug to Detrol, for marketing (see "Detrol v. Toviaz: Marketing Replaces Innovation at Pfizer!").

The presentation outlines the strategies used to convert a "niche product into a Mass Marketing Opportunity." Download it here.

I was gratified to get my hands on this PPT because I remembered being present at the 2002 meeting and how shocked I was that a pharmaceutical VP would actually be so transparent in discussing how "overactive bladder" was a "new" disease that he and his company created specifically to increase the sales of Detrol! Often, I wished I had a copy of that presentation to prove that I wasn't imagining things and now here it is.

The introductory notes state:

How many have seen
How many have heard of overactive bladder?
How many have overactive bladder???

Overactive Bladder now a lexicon in American culture
-cocktail parties / media / sitcoms / talk shows

Most importantly, routinely discussed between patients and their physicians
Not the case 4 years ago

Pharmacia instrumental in creating new disease
-improving lives of millions around world

Some critics of the pharmaceutical industry say that overactive bladder (OAB) is an example of "disease mongering," a term that was coined by the late journalist Lynn Payer to describe what she saw as the confluence of interests by some doctors, drug companies, patient advocacy groups and media in exaggerating the severity of illness and the ability of drugs to "cure" them (see "Disease Mongering -- Is it real or not?").

I believe this presentation is a classic "disease mongering" case study.

Slide #20 shows how by creating a "new" disease, the potential market for Detrol could be increased 2.7-fold!


Slide #22 states the "Critical Success Factors" for the Detrol launch in the US:

This is now the classic formula for creating greater demand for an Rx product than would normally be the case. As you can see, "education" of PCPs (primary care physicians) is a critical component as is DTC and PR (public relations).

NOTE: Influencing Prescribers
The American Medical Women's Association (AMWA), which is cited as a resource on the Detrol product Website, is currently promoting an "Overactive Bladder Initiative," which includes a "comprehensive continuing medical education curriculum" that provides "primary care providers with the latest discoveries concerning etiology, epidemiology and treatment of urinary incontinence, with particular emphasis on practical management strategies of overactive bladder, particularly as it affects women." AMWA lists Abbott, Novartis, Astrazeneca, and Wyeth (recently purchased by Pfizer) as corporate sponsors.

Slide #30 in the deck clearly shows that Pharmacia understood the need to achieve the "confluence of interests by some doctors, drug companies, patient advocacy groups and media" as well as REGULATORY people to achieve its aims:


To get payors (ie, insurance companies) to place Detrol on their formularies and pay for OAB treatments, Pharmacia convinced them that OAB was "a serious medical condition, not just a 'lifestyle' disorder" citing "Skin and soft tissue infection," "Falls and fractures," "UTIs," and "Significant co-morbidity with depression and sleep disorders" (slide #39).

Interestingly, none of these "serious" conditions was ever mentioned in the DTC marketing of Detrol. That might be just too much education for consumers to swallow!

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Listen to this WHYY radio segment, which aired Monday, April 20th, 2009:

"Inventing a disease"