Wednesday, September 30, 2009

Google's Wacky Wiki is Whack! Pharma Should Demand Ability to Block It!

Have you heard of sidewiki? Sidewiki is Google's new browser sidebar that "enables you to contribute and read helpful information alongside any web page. It is available as a feature in Google Toolbar" (You can find Google sidewiki here).

The "helpful information" Google is talking about is sidewiki entries that other people have written about the page. Anyone can write a sidewiki comment attached to any page on YOUR website and you CANNOT do anything about it! You cannot edit it and you cannot delete it, no matter how damaging it may be to you (unless it is obscene). Think of the implications for the pharmaceutical industry!

"If there are no entries," says Google, "you can be the first to write one!"

Of course, I could not pass up the opportunity to be the first person to write a sidewiki entry attached to a major drug.com website! It took me only about 10-20 seconds to download the Google sidebar, which included sidewiki, and start using it.

It also took me only about 10-20 seconds to decide which drug.com wsbsite should have the honor of being the first to be graced with my sidewiki comments: www.viagra.com!

Here's my very first sidewiki comment, which is now attached to the homepage of www.viagra.com:
TITLE: Viagra is Bogus!

COMMENT: I've tried Viagra and it caused my right arm to fall off! That would have been fine, except it also did not give me an erection!
A nifty feature of sidewiki is the ability to "share" your comments on Twitter and Facebook! Here's what was posted on Twitter when I shared my comment:
"Just wrote a Sidewiki entry on 'Erectile Dysfunction (ED) Treatment - VIAGRA ® (sildenafil citrate)' http://bit.ly/2x0QE0"
How cool is that! A branded Tweet with a Twist!

If you have the new Google toolbar with sidewiki, you can view my comment when you visit www.viagra.com. You'll have to click on the little sidebar arrow to open up it up and view it. I expect, however, that by the time you read this, Pfizer will have had a talk with Google and arranged to have my comments expunged (more on that below). So, here's a screen shot I took today at 8:00 AM (click for an enlarged view):



I did this to prove an obvious point: Google's sidewiki allows any anti-pharma wacko to append unsubstantiated adverse events on any drug.com website. 

So far, 1 out of 5 people reading my sidewiki have found it useful and 2 other people have submitted comments (shown in the screen shot below):



I note with a certain amount of pride that MY sidewiki entry is on the FIRST PAGE of the sidebar, whereas these others are relegated to page 2! "Sidewiki uses a quality algorithm and user ratings to determine the order of the entries that appear in the sidebar for a given page," says Google. "The entries that are scored as being the most helpful and pertinent are more likely to display. Sidewiki entries with lower quality scores may not appear on the first page of the sidebar."

BTW, the other 2 entries were written by people who I contacted directly or who follow me on Twitter where I ranted about this subject. You may remember Ayre Sachs as the "erectile projectile" man who was sued by Pfizer for trademark infringement (see  "Viva Viagra Missile Guy Vows to Continue His Quixotic Fight Against Pfizer").

I learned about Google's sidewiki from Steve Woodruff, who writes Impactiviti Blog (see "Google's Sidewiki - Game-changer for Pharma Social Media?"). Steve and I had some back and forth conversation via Twitter about sidewiki and whether or not it was a "game changer."

Is It a Game Changer?
No new technology is a "game-changer" for the pharma industry until zillions of people use it on a regular basis (or it just seems that way because pharma has been slow to understand how all new media is a game changer). I mean, how many people will ever see my comment? You have to be geek enough to download the Google sidebar and learn how to use it. For me, that's pretty simple. But it's not something your typical Web surfer would bother with.

Some of my colleagues remind me that we are talking about Google, a company that is used to having its software used by millions of people. Suppose millions of people started using sidewiki tomorrow? In my humble opinion, that would NOT bode well for the Internet as a powerful tool that consumers can use to find useful, credible health information. If you believe that pharmaceutical companies provide a good share of such information, then that information is in danger of being corrupted by wiki comments from people with an anti-pharma agenda -- people motivated enough to use new technology like Google sidebar.

What was Google thinking when it developed sidewiki? It is thinking to put paid ads in that sidebar alongside the highest scoring sidewiki comments -- ie, comments just like mine! Google's scoring algorithm is agnostic when it comes to quality health information. I just proved that with my viagra.com wiki comment, which has a high score (so far).

But Google is forgetting that one of its biggest advertisers is the pharmaceutical industry. I am sure this industry is not going to be happy about how sidewiki can hijack their content and even perhaps allow competitors to post content or ads in the sidebar of their web pages. Google is biting the hand that feeds it.

Block It Danno!
I fully expect -- and hope -- that the drug industry will talk some sense into Google. The first thing the industry should do is to insist that Google make an exception for the pharmaceutical industry and allow it to block sidewiki from working on its websites. After all, if Google can carve out an exception to its rule against redirected URLs in adwords for drug.com paid search ads (see "St. Google Slays the FDA Dragon?"), it can carve out pharma URL exceptions for sidewiki. Case closed.

Tuesday, September 29, 2009

What Techniques are Used by Pharma to Monitor Adverse Events on Social Media Sites? Survey says...

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and social media tools with regard to monitoring adverse event information about their products??
The survey asks respondents to choose one or more of the following responses (and/or add additional comments):
  • Use of automated keyword searches of selected social media sites by specialized agencies and/or professionals
  • Intermittent searches of selected social media sites performed by company personnel or agents
  • Intermittent searches of SEARCH ENGINES performed by company personnel or agents
  • Routine and automated keyword searches of TWITTER (eg, performed by SocialOomph or other services)
  • Use of social media monitoring tools that do not include keywords.
  • None of the above
  • Don't Know
Of course, this question is most appropriate to be answered by someone within a pharmaceutical company. Some outside vendors/consultants may also know from their own experience working for pharmaceutical companies.

The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents vs. Agency respondents).


AE Monitoring

Many comments were submitted in response to this question. Some of these comments include:
  • The pharma industry should produce one mass media campaign to inform end users how to get accurate information.
  • They should not be responsible for policing these conversations individually. A central industry funded monitoring hub should be established as a clearing house for monitoring public health impact of post marketing issues.
  • Adverse events reports about prescription medicines should be made trhough doctors only. For OTC approved medicines different possibiities could be applied
    I write for the company blog on adverse reactions, counterfeit drugs, and recalls.
  • I am not aware of what any companies are actually doing, as opposed to what they say they are doing. However the five options mentioned are worthy of consideration, although I would prefer not to see intermittent searches but rather searches that are conducted on a prescribed routine.
  • I do not believe pharma should be required to search for adverse events. For those events where complete information is available, companies must report them when they become aware of the event. FDA should proceed in allowing individuals to file adverse event reports directly to the agency. By doing this, I believe more patients will report events and make the AE reporting more robust. Requiring the companies to chase down every potential report is asking too much.
  • Adverse events should be monitored and reported by physicians who prescribe treatments and follow up patients. The physician in contact with the patient should be the filter and the ultimate person who should decide and perform the reporting.
  • Currently companies are probably not monitoring social media as much because of the uncertainty about adverse event reporting.
  • Have specific site for direct reporting of adverse events. Do not depend on open searches. If something is picked up then direct to adverse event home page.
  • I believe entities are using various tools or employing agencies to search what's being said about their brands, but not necessarily for AER however.


WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Find links to more results here.

Monday, September 28, 2009

Who Should Be Responsible for Submitting Adverse Event Reports to FDA?

The FDA is asking for comments from the public about how it should regulate drug promotion on social network sites (see survey/questionnaire). Several of the questions FDA asks concerns the issue of monitoring, processing, and reporting adverse events that are found on social media sites (see here, here, and here). The pharmaceutical industry is concerned that the floodgates would open if it were responsible for reporting all the adverse events it encounters on social media.

If only the FDA would not insist that manufacturers submit Adverse Event Reports (AERs), then all the industry's worries would be over. But how would FDA get this information? What about making physicians responsible for submitting all AERs?

That's exactly what Miguel A. Tovar, journalist and author of Blogaceutics Blog suggested. In a comment to the post "Challenges Handling Adverse Events Found on SM Sites. Survey Says...," Tovar questioned the responsibility placed upon pharmaceutical companies to report adverse events to the FDA:
"In my opinion," said Tovar, "it doesn't make much sense to put responsibility of reporting on the manufacturers. I think adverse events should be evaluated and reported by the physicians who prescribe and/or follow up patients treatments and they should report by filling up an online application connected to an FDA database to which pharmaceutical companies should have access for further analysis and evaluation.

"Reports should include all the relevant information as a description of symptom/s experimented by patient and/or detected by physician, drugs being taken by patient, dosage, etc."
Currently, only a small percentage of AE reports received by the FDA comes directly from physicians. Let's look at the data.

According to the FDA, "Reporting of adverse events from the point of care is voluntary in the United States. FDA receives some adverse event and medication error reports directly from health care professionals (such as physicians, pharmacists, nurses and others) and consumers (such as patients, family members, lawyers and others). Healthcare professionals and consumers may also report these events to the products’ manufacturers. If a manufacturer receives an adverse event report, it is required to send the report to FDA as specified by regulations" (see "Adverse Event Reporting System (AERS)").

AERS Reporting by Healthcare Providers and Consumers by Year
How many adverse events reports does the FDA receive from physicians, consumers, and drug companies? You can find the most up-to-date data on that here. The data (current as of June 30, 2009) are plotted in the chart below:



AERs received by FDA: physicians vs. consumer source


These data describe information about the reporter – the person who submitted the report to FDA, or the person who submitted the report to the manufacturer (who then sent the report to FDA). Physicians and pharmacists are the healthcare providers (HCP) who submit reports to FDA most frequently (in 2008, 57% of HCP reporters were physicians). Other Healthcare Providers include nurses, dentists and others. Consumer refers to any reporter who is not documented in the report as a healthcare provider. This figure includes only data where reporter information is known, and some adverse event reports may contain more than one reporter.

Only a very small fraction of adverse event reports received by the FDA are submitted directly by HCPs and consumers. The following chart shows the number of reports submitted directly to FDA (not submitted through manufacturers) vs. the number submitted by manufacturers (who may have received some portion of them via consumers and/or HCPs). The data (current as of June 30, 2009) can be found on the FDA site (see "Reports Received and Reports Entered into AERS by Year").



Direct vs. Indirect Sources of AERs


Consumers actually "report" (ie, are reporters of) more adverse events than do physicians (see chart below):



AERs received by FDA: physicians vs. consumer source (%)


The percent of AEs from consumers (direct or indirect) increased between 2002 and 2007 and has leveled off since then. You would expect a continued increase in the consumer % if social media were a factor AND if drug companies were monitoring social media and honestly reporting AEs found there. Could it be that pharma companies are studiously avoiding monitoring social media for adverse events?

Keep in mind that very few consumer-reported AEs found on social networks meet the requirements for filing an AER (see "Uncertainties Regarding Reporting Adverse Events Found on Social Media Sites: Survey Says...").

Sunday, September 27, 2009

How is Adverse Event Information from Social Media Sources Processed by Pharmacos? Survey says...

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
How is adverse event information from these sources being received, reviewed, and processed?
The survey asks respondents to choose ONLY one of the following responses (and/or add additional comments):
  • Special group within the company is responsible for receiving, reviewing, and processing AEs (Internal Group)
  • Receiving and processing AEs is outsourced to a specialized agency; review is handled in-house to determine which AEs need to be reported as required by law (Outsourced)
  • The information is usually incomplete and does not meet the requirements for submitting a meaningful AER (not actionable)
  • We have no SOP (standard operating procedure) for receiving, reviewing, and processing AEs from these sources (No SOP).
  • None of the above
  • Don't Know
Of course, this question is most appropriate to be answered by someone within a pharmaceutical company. Some outside vendors/consultants may also know from their own experience working for pharmaceutical companies.

The image below shows how respondents answered this question (ALL respondents vs. PHARMA respondents vs. Agency respondents).




AE Processing



WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Find links to more results here.

Saturday, September 26, 2009

Challenges Handling Adverse Events Found on SM Sites. Survey Says...

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
What challenges are presented in handling adverse event information from these sources?
The survey asks respondents to choose one or more of the following responses (and/or add additional comments):
  • The amount of information from these sources is potentially too vast to be processed economically (lack of resources)
  • Finding adverse event information from these sources is like finding a needle in a haystack (too daunting)
  • The information is usually incomplete and does not meet the requirements for submitting a meaningful AER (not actionable)
  • There are many potential issues that won't fully be known until the practice of monitoring social media for AEs is more prevalent (unknown issues).
  • None of the above
The image below shows how respondents answered this question.



AE Reporting Challenges




WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Find links to more results here.

Friday, September 25, 2009

Uncertainties Regarding Reporting Adverse Events Found on Social Media Sites: Survey Says...

In preparation for FDA's public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools, the agency is asking for comments on 19 specific questions (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media"). These questions are included in my ongong online survey/questionnaire, which you can access here.

I am following the results of this survey closely and will provide updates. Here, I focus on this question:
What uncertainties are there regarding what should be reported from these sources to meet FDA adverse event reporting obligations?
The survey asks respondents to choose one or more of the following responses (and/or add additional comments):
  • Usually, there is uncertainty regarding the true identity of the reporter (anonymous source)
  • Usually, there is uncertainty regarding the true identity of the patient (no patient named)
  • Usually, there is uncertainty regarding the identity of the drug (eg, reporter refers to "sleep pill" rather than brand name of drug)
  • Usually, there is uncertainty regarding the seriousness of the event reported
  • None of the above
The image below shows how respondents answered this question.


AE Reporting Uncertainties




WANTED: Answers to FDA's Questions Regarding Pharma's Use of Social Media
SPECIAL REPORT: FDA Regulation of Social Media

Find links to more preliminary results here.

Some Pharma Marketers Can't See the Unbranded SM Forest for the Branded SM Tree

Are some pharma marketers so focused on figuring out how to promote brands via social media that they are not seeing the plainly obvious unbranded opportunities out there?


SM branded Tree


Some time ago, I accused Novo Nordisk of engaging in Twitter "spam" when it posted a Levemir-branded tweet via its @racewithinsulin twitter account (see "Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!"). You can argue whether or not this was "spam" or "sleazy" or "sleazy spam," but my main point was that Novo missed an opportunity to support people with diabetes using Twitter and social media tools. This may not be appropriate for the @racewithinsulin twitter account because of its focus on Charlie Kimball. But just as inappropriate was the branded tweet.

Of course, pharmaceutical companies -- including Novo Nordisk -- are using social media to do unbranded consumer-focused campaigns (see, for example, "Pharma and Healthcare Social Media Wiki"). But are they focusing enough on the many ways they can use social media to support the patients who are prescribed their products? I asked this in a previous post (see "Twitter for Brands: Beyond Marketing.") and in the survey "What's Your Opinion About Branded Patient Support via Twitter?"

The issue came up again today during the #hcsmeu Tweetup. The question posed was: Can EU lead way in SM adoption in healthcare?

In the EU, pharmaceutical companies have learned how to communicate with consumers without focusing on branded messages. Therefore, I suggested that "EU pharma can lead way for SM in HC because it is not focused on branded msgs as is US, lots of experience w DA - better app for SM." Translated from Twitterese, what I meant was that EU pharma's lead in disease awareness communications makes it easier for them to see the unbranded social media forest than it is for US pharma marketers who are almost catatonically focused on the branded social media tree.

In the US, the only way for pharma to move ahead with social media is to figure out how to get the branded messages into the mix. Without FDA guidance, however, this is not going to be easy. There is hope that the November, 2009 public hearing will move this forward, but history could repeat itself (see "Get Your FDA Social Media Public Hearing T-Shirt!").

The FDA could take a small step and define the industry's responsibility to report adverse events (AEs) they come across on web sites -- including social media sites -- under their control. It's not really a technology issue. That guidance could simply be something like "No self-reported AEs on social media sites need to be reported by pharma on Form 2253 under the following conditions..." Under a "tit-for-tat tithe" program, the conditions define a "safe harbor" available to pharma companies who commit to spending 10% of their marketing budgets to non-branded disease awareness programs approved by an independent 3rd party." (See "Tit-for-Tat Tithe on Pharma Marketing. How It Can Work.")

One safe harbor condition might be placing an AE reporting widget on a product website as in this Ignite Health mock up. (Click on image below for an enlarged view; better yet, visit the web site mock up - the widget actually works, in a demo mode.)



Any way, that's about as far as I can take this discussion right now. But I do welcome your comments here to this blog post and urge you to take a look at the "Branded Patient Support via Twitter" survey.

Thursday, September 24, 2009

Internet Surpasses Newspapers in Gobbling Up the Decreasing DTC Ad Spending Pie!

It was the best of times [for the Internet], it was the worst of times [for newspapers].

For the first time that I can remember, the pharmaceutical industry is spending more of its DTC advertising budget on Internet display ads (excluding search) than on newspapers (see chart below; source is TNS Media Intelligence). [We're only talking about Q1 data, 2009 v. 2008.]

DTC Ad Spend Q1 2009 v 2008

Comparing Q1 2009 to Q1 2008, spending on Internet ads increased by 154% (from $21.0 million in Q1 2008 to $53.4 million in Q1 2009). No wonder there are so many new interactive agencies knocking on pharma's doors these days!  That's a dollar increase of $32.3 million. Meanwhile, spending on TV decreased by almost the same amount; ie, $31.4 million.

You could say that pharma took money out of TV to put into the Internet. But don't count TV out just yet.  The percent of the DTC budget devoted to TV actually increased from 62% in Q1 2008 to 66% in 2009. The percent of the budget devoted to Internet display ads in Q1 2009 was 4.8% compared to just 1.7% in Q1 2008!

Overall, there was a 9.7% decrease in DTC spending in Q1 2009 copared to Q1 2008.

Get Your FDA Social Media Public Hearing T-Shirt!

If you are planning to attend the November 12-13 FDA public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see here and here), then you should order this T-shirt:



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I Went to FDA's Social Meeting Hearing & All I Got Was This Lousy T-Shirt

Hoping for Helpful Guidelines, but Not Expecting Any

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Tuesday, September 22, 2009

Are J&J Agents Trolling for Adverse Events on the Internet?

The FDA is interested in learning more about how pharmaceutical companies track adverse events on the Internet and have asked the public to submit comments in preparation of the November hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see here and here).

Specifically, FDA needs answers to these questions about social media/Internet and AE reporting:
  1. How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and social media tools with regard to monitoring adverse event information about their products?
  2. How is adverse event information from these sources being received, reviewed, and processed?
  3. What challenges are presented in handling adverse event information from these sources?
  4. What uncertainties are there regarding what should be reported from these sources to meet FDA adverse event reporting obligations?
Today, someone sent me a message through an online form (contact me) informing me of an interesting post made on the Arthritis Foundation Forum. If we can believe the poster -- someone who says he/she is a am a member of BzzAgent, an online networking site that offers free trials or products to people as a means of marketing.

Here's the post:
Since it's been discussed here....pharm. co's...

For those that don't believe in "Big Pharma"

I am a member of BzzAgent, an online networking site that offers free trials or products to people as a means of marketing. They basically send you info and either coupons or free samples (or both) to help you convince other people to use the product in question (i.e. I did one for dog food and one for an OTC anti-histamine). Kind of like grassroots marketing. You only get offers targeted for your demographic group, of course.

I just took a survey through BzzAgent for Johnson & Johnson, which basically was more of a "contract" where if chosen, I agreed to notify J&J if I became aware of any negative talk about their products. It was all couched in terminology implying that I would only be doing this as a representative of J&J, and only because it was "required by law" for all J&J employees to report any and all "adverse events" associated with use of J&J products. It mentioned that I would be under obligation to report anything I heard, even if on the internet, including contact information for the person stating the problem. Nothing about getting their permission to relay that information, which stuck out given the detailed, "legal" approach of the survey.

So, basically - agreeing to be a "troll"

POSTED BY: "Chris Braile" [Profile not available on site]
First, this may be part of the answer to FDA's first question about AER (Adverse Event Reporting). J&J seems to take it very seriously, although we cannot be sure this is true -- I cannot verify who the poster is or contact him/her to get verification. This illustrates the main problem with tracking AEs online: you often cannot identify the person making the report or the patient who suffered the AE (see FDA's question #4, above).

According to my survey on this (see here), 94% of respondents agree that "Usually, there is uncertainty regarding the true identity of the reporter" and 88% agree that "Usually, there is uncertainty regarding the true identity of the patient."

"Chris Braile" points out another problem: relaying personal information gathered on the Internet to a pharmaco by consumer agents may violate (or seem to violate) the privacy of the reporter. Chris seems to think it is sleazy to require him/her to do this (assuming there is any personal information to report).

It is not known whether the J&J contract with Chris says that reports should be made ONLY if there is knowledge of the four basic elements for submission of an individual case safety report (ie, identity of the reporter, identity of the patient, identity of the drug, and certainty of seriousness of the event). Yo9u cannot expect a consumer hired by BzzAgent to know if all the requirements are met. Therefore, J&J is asking these consumers to scoop up and report everything, which makes it necessary for J&J to sift through these "trolled" reports to find any that meet the requirements for reporting to the FDA. No wonder many pharmacos find this too daunting a task and give up on getting involved in social media. J&J may be an exception, also UCB (see "Finally, a Drug Company Embraces Social Media, AEs Included!").

Monday, September 21, 2009

My Twitter Followers: Thank You!

Thanks to all of the more than 3500 people who currently follow me on Twitter. If you follow me, tell me more about yourself. Take my "Getting to Know You Twitter Survey."

Find out more about my followers in the Sept Issue of Pharma Marketing News. See here.

If you are not following me on Twitter, why not? Find me @pharmaguy.

Pharma Influence Over 3rd-Party Conversations in Social Media

FDA announced a public hearing to be held on November 12-13, 2009. The agency is asking for public comments on "Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools" (see "Let's Respond to FDA's Questions Regarding Its Regulation of Social Media").

The FDA has asked 19 specific questions that it would like input on (see link above). To help get the discussion going, I've put all these questions in a survey (here), which I hope will help you formulate your own comments for submission to the FDA while seeing what others have to say.
In this post I'd like to start the discussion around FDA's first question: What parameters or criteria should be applied to determine when third-party communications occurring on the Internet and through social media technologies are subject to substantive influence by companies that market products related to the communication or discussion?

In the survey, I suggested a couple of parameters that I thought are relevant to this question:
  1. Marketer or agent paid for an ad on the page that is displayed based on the content of the page (eg, Google Adword on content sites)
  2. Marketer or agent paid for the content (eg, paid blogger or Tweeter to write about product)
Keep in mind, I included these choices in the survey ONLY as starting points. If you have any others, please let me know by including them in the comment section of the survey or comments to this post. I will then add them as additional parameters so that survey respondents can vote on them.

A related question is:  How should companies disclose their involvement or influence over discussions or material, particularly discussions or material on third-party sites?

A couple of options, include:
  • Disclosure is necessary only when content is paid for.
  • Disclosure should be prominently displayed alongside relevant content when possible
It's easy to determine when a marketer pays for an ad that runs alongside user-generated content on social network sites that accept advertising. According to common practice, such ads should be labeled "advertisement," as is the case with ads appearing on this blog page.

Of course, unethical sites may not include the notice and then it becomes a matter of interpretation whether the information is a paid ad or not, especially if it is worded and formatting in such a way as to look like content. This matter was discussed long ago in what seems like a galaxy far far away by the Internet Healthcare Coalition (no disbanded), which developed the eHealth Code of Ethics.

The second point -- paying someone to write content in a social media setting -- is definitely having "substantive" influence over the content. Not disclosing this fact is adding insult to injury. I am sure that this has happened in the past and may still be happening. Example can be found here: "Alli Ad Campaign Promises Honesty, But Does It Deliver?"

Although I can't prove it, I sense that there are paid agents of the pharmaceutical industry out there whose job it is to pose as consumers or patients on social network sites and post messages that essentially marketing messages.

It's nearly impossible for the FDA to regulate that sort of thing other than to provide guidelines that state any such messages from paid agents should include a disclosure notice that the person writing the message is an employee of a pharmaco or of an agency hired by a pharmaco.

No one will know for certain when such a guideline or regulation is violated, but if a violation is ever revealed -- by an investigative reporter, for example -- then the FDA could act. more importantly, however, every pharmaceutical company should have its own guidelines on such issues and make them PUBLICLY available, just like they do with their privacy policies.

How about this: FDA guidance should include a statement that says each pharmaco must have a SM policy that includes a notice of transparency...yadda, yadda, yadda [YOU CAN PROVIDE THE DETAILS in comments to the survey here: http://bit.ly/GgW14]

Related issues:
and

Sunday, September 20, 2009

Let's Respond to FDA's Questions Regarding Its Regulation of Social Media

On Friday, September 18, 2009, the FDA filed a notice to be published in the Federal Register on September 21, 2009 calling for a public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools:
Docket No. FDA-2009-N-0441, CDER 200994. Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing (Notice of public hearing; request for comments). Public Hearing on November 12, 2009 And November 13, 2009 Comments due February 28, 2010. (See "FDA Announces Public Hearing on Promotion of Drugs on Internet & via Social Media. This is NOT a Hoax!")
The FDA is requesting the public to submit comments to a series of specific questions, which are included in a new survey created by Pharma Marketing Network. Find the survey here.

This survey includes these main sections (pages):
  1. Introduction
  2. Questions About You (affiliation, support of industry, etc.)
  3. Issue 1: Accountability
    • What parameters or criteria should be applied to determine when third-party communications occurring on the Internet and through social media technologies are subject to substantive influence by companies that market products related to the communication or discussion?
    • In particular, when should third-party discussions be treated as being performed by, or on behalf of, the companies that market the product, as opposed to being performed independent of the influence of the companies marketing the products?
    • How should companies disclose their involvement or influence over discussions or material, particularly discussions or material on third-party sites?
    • Are there different considerations that should be weighed depending on the specific social media platform that is used or based on the intended audience? If so, what are these considerations?
    • With regard to the potential for company communications to be altered by third parties, what is the experience to date with respect to the unauthorized dissemination of modified product information (originally created by a company) by noncompany users of the Internet?
  4. Issue 2: Fulfilling Regulatory Requirements
    • How should product information be presented using various social media tools to ensure that the user has access to a balanced presentation of both risks and benefits of medical products?
    • Are there data to support conclusions about whether different types or formats of presentations have a positive or negative impact on the public health?
    • Are there proposed solutions that may help address regulatory concerns when using social media tools associated with space limitations or tools that allow for real-time communications to present product information?
    • How should companies address the potential volume of information shared on various social media sites with regard to real-time information that is continuously posted and regulatory requirements to submit promotional materials to FDA as applicable?
  5. Issue 3: Posting Corrective Information
    • The agency is interested in any data or research on how companies have approached these issues related to posting of corrective information.
    • Are there any parameters or criteria that could be used to determine the appropriateness of correcting misinformation and/or scope of information a company can provide when trying to correct misinformation on a Web site outside a company's control?
    • Should the parameters differentiate with regard to the prominence of the third-party site (i.e., readership), its intended audience (e.g., general public, health care professionals, patients), its intended purpose (e.g., personal diary, encyclopedia-type reference), and/or the author of the information on the site?
  6. Issue 4: Links
    • The agency is interested in any comments about the appropriateness of various techniques regarding the use of links (including between various social media tools) and data or research about whether or not users find these approaches to be misleading.
    • Should parameters be established for links to and from Web sites?
    • The agency is interested in any data or research concerning the frequency with which users actually click on different categories of links (e.g., banner ads, links within Web sites, sponsored links, organic search result links) to get additional information about products.
  7. Issue 5: Adverse Event Reporting
    • How are entities with postmarketing reporting responsibilities and other stakeholders using the Internet and social media tools with regard to monitoring adverse event information about their products?
    • How is adverse event information from these sources being received, reviewed, and processed?
    • What challenges are presented in handling adverse event information from these sources?
    • What uncertainties are there regarding what should be reported from these sources to meet FDA adverse event reporting obligations?
  8. Opt In Choice
  9. Thank You and Summary of Results
Many questions are pre-programmed with answers that you can select. As the survey progresses, other choices may be added to the list of answers. These additional choices will come from reviewing comments made to each question. It is important, therefore, that you include comments with any additional choices. Results of this survey may be summarized in Pharma Marketing News. After you complete the survey, you will be able to see a summary of responses, not including comments or other identifiable information about respondents. Your comments are confidential (anonymous) unless you specifically provide your contact information at the end of the survey and allow us to attribute comments to you personally. It is hoped that by participating in this survey you will learn more about the issues and use what you learn to submit an official comment to the FDA. Find the survey here.

Saturday, September 19, 2009

FDA Announces Public Hearing on Promotion of Drugs on Internet & via Social Media. This is NOT a Hoax!

On April 1, 2009, my "April Fool's" joke press release announcing that the FDA issued draft guidance for use of social media for Rx drug marketing created quite a stir among pharmaceutical industry pundits and executives (see "FDA Issues First-ever Draft Guidance on Pharma’s Use of Social Media!").

Later that month, I drafted a petition calling upon the FDA to convene a public hearing on the issue. The petition stated:
"...it is necessary for the FDA to convene a PUBLIC HEARING where ALL stakeholders can participate in a discussion of the issues and provide the FDA with a good understanding of the Internet as it exists today and tomorrow. That understanding and knowledge can then be the basis for issuing guidance that will allow the pharmaceutical industry to contribute to the conversation online" (see "FDA, Tear Down This Wall! A Draft Petition Calling for a Public Hearing").
Well, the FDA has now actually submitted a notice to the Federal Register (to be published Monday, September 21, 2009) calling for a public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools:
Docket No. FDA-2009-N-0441, CDER 200994. Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools; Notice of Public Hearing (Notice of public hearing; request for comments). [OFR PRE-PUB: PDF of notice] Public Hearing on November 12, 2009 And November 13, 2009 Comments due February 28, 2010

[FIND THE PDF VERSION OF THE NOTICE ATTACHED TO THIS POST.]

The pharmaceutical industry and readers of this blog have long supported such a hearing. See this Pharma Marketing News article:
"Developing Guidelines for Pharma's Use of the Internet & Social Media" (FREE!) to see the results of the survey "Should FDA Convene a Public Hearing on Use of Social Media by Pharma?"

Friday, September 18, 2009

An Example of Non-Transparency Over at FDA's Transparency Blog

As seen today at FDA's Transparency Blog using Firefox browser:


Except for the Helicopter, Pfizer Got This "Top Gun" MD at a Discounted Rate

According to a law suit filed by by Mark R. Westlock - who was a Pfizer sales rep from 1991 to 2007 - Dr. Neil S. Kaye, an assistant clinical professor of psychiatry at Jefferson Medical College, "was known to Pfizer sales representatives as a 'big gun'" (see "Pfizer Paid for Doc's Helicopter in Off-Label Geodon Push").

In his whistleblower law suit, which was part of the $2.3 billion Bextra settlement, Westlock claimed that Pfizer "conspired with Dr. Kaye as early as 2001 to begin a nationwide Geodon® promotional campaign at locations across the United States. In exchange for promoting Geodon® off-label, Defendant Dr. Kaye was paid up to $4,000 per day plus all his expenses. Defendant Dr. Kaye became such a frequent speaker that he used his own private helicopter to fly to various locations throughout the United States, all at Pfizer's expense." Dr. Kaye gave these presentations at clinics, hotels, restaurants, physician offices and mental health facilities all across the country.


I visited Dr. Kaye's Web site where he blatantly presents his "hired gun" contract, including prices, for the whole world to see (see here; click prices). Even Peter Rost, the notorious whislteblower and professional witness against pharma, does not display his price sheet.

On the left is what I imagine Dr. Kaye's contract with Pfizer looked like (click the image for an enlarged view).

I assume Dr. Kaye's speaker fees are equivalent to his per diem testimony in court fees. Usually, Dr. Kaye charges $5,000 per day to testify outside of Delaware. This does not include expenses like helicopters.

Although Westlock claims "the amounts of money being paid to Defendant Dr. Kaye were considerably more than Pfizer normally paid for such 'thought leader' presentations," it seems that Pfizer got a 20% discount off Dr. Kaye's $5,000 per diem fee.

However, Dr. Kaye's helicopter expenses probably exceeded the $1,000 saved on the per diem fee. I know that when I use my car to visit clients, I charge about $0.33 per mile or whatever the IRS allows for that expense. I wonder how much per helicopter mile Dr. Kaye charges? I'm sure it's a lot more than $0.33.

Hat Tip to Jim Edwards for turning me on to this.

Thursday, September 17, 2009

FDA Reads My Blog: Declares Latisse Web Site Misleading

On September 10, 2009, the FDA sent Allergan a notice that its Latisse Web site was misleading (see "FDA Says Allergan's Web Site for Eyelash Thickener Is Misleading"). The letter states:
"the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed the “FAQs” and “About Safety” pages of a consumer website and a “Launch display timeline” (timeline) (APC36ON09) for LatisseTM (bimatoprost ophthalmic solution) 0.03% (Latisse) submitted by Allergan, Inc. (Allergan) under cover of Form FDA-2253. These promotional materials are misleading because they omit and minimize risks associated with Latisse. Thus, the website and timeline misbrand Latisse in violation of the Federal Food, Drug, and Cosmetic Act..." [my emphasis]
Latisse is Allergan's product approved for hypotrichosis, a term dermatologists use to describe a condition of no hair growth. Allergan markets Latisse for increasing the growth of eyelashes.

In a previous post dated June 1, 2009 -- "Will Latisse Turn Brooke Shields' Blue Eyes Brown?" -- I noted that in the "About Safety" page of the Latisse web site, Allergan stated:
"Increased brown iris pigmentation has occurred when similar medications were instilled directly into the eye to treat elevated intraocular pressure/glaucoma. Although iris pigmentation was not reported in clinical studies with LATISSE™, patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent."
I commented: When Allergan says "similar medications," it really should have said "this medication" because Latisse is just another name for Lumigan, Allergan's anti-glacoma drug. Both are (bimatoprost ophthalmic solution) 0.03%.

FDA, in its letter to Allergan, said (click on image to enlarge and read):


Of course, I conclude from this that FDA reads Pharma Marketing Blog. Maybe it has also read my post about organic search "ads" (see "Are Organic Search Results Next on FDA's Chopping Block?").

Tuesday, September 15, 2009

New Poll Reveals that Cialis & Levitra Brand Marketers Need to Work Harder

You may be seeing a lot more Levitra and Cialis ads on TV these days than you do Viagra ads. That may be due to some free market research data that Pfizer got access to thanks to its trademark infringement case against Ayre Sachs, the retired Israeli army sergeant who parked his "erectile projectile" Viva Viagra missile in front of Pfizer's Manhattan headquarters (for background see "Warning to Buzz Marketers: 'Pfizer did not get the joke'"). Keep reading for the explanation.

As mentioned in a previous post (see "Viva Viagra Missile Guy Vows to Continue His Quixotic Fight Against Pfizer"), Mr. Sachs surveyed 400 people as evidence that the Viagra trademarks are not entitled to trademark protection because they have become so famous that they are now generic.

Sachs sent me data from his survey in a personal communication (see the chart below; stroke it with your mouse for an engorged view).


I won't comment on Sach's contention that this proves his point about the Viagra brand being so common it is generic. More relevant to me is that it proves that Cialis and Levitra advertising agencies need to work overtime to capture the share of mind that Viagra has among the public. Well, at least the public that Sachs surveyed, which consisted of "Gays, Lesbians, vegetarians and war opposing residents" in the neighborhood of Union Square, NYC.
"On 12/9/08 a missile with an ED drug name was driven through Manhattan and parked for a survey at the center of Union Square (see images) an area known for high concentration of Gays, Lesbians, vegetarians and war opposing residents," said Sachs in his communication to me. "Out of about 100 people polled on location with a missile detached from the truck and fully erected in the middle of the street only 4 have stated they hate it to the point they will switch to another drug and two of the four where female."
Sachs also sent me this photo taken in Union Square to prove his point. I imagine it was included in the communication he sent to Pfizer that was cited in the court papers:


I don't know, but maybe Pfizer was pissed that Sachs displayed a "Viva Cilais" missile instead of the "Viva Viagra" missile he used in front of Pfizer's headquarters.

Ayre sent me this comment/correction:
Please correct the following on your site: "Well, at least the public that Sachs surveyed, which consisted of "Gays, Lesbians, vegetarians and war opposing residents" in the neighborhood of Union Square, NYC."

This comment is true but is related for survey VR-4 which goes to show that even "Gays, Lesbians, vegetarians and war opposing residents" in the neighborhood of Union Square, NYC. who naturally will oppose such advertising platform - agreed nine out of ten that it is a fun idea (and that is why I brought the actual missile for them to view). The 413 people I sent you info about are the ones that where pulled with the questioner VR-1 around the city which makes your point about cialis and levitra even stronger.
Hope that clarifies things.

It's Advertising Awards Season Again! MM&M Beware of Being "Kanyed!"

Yes, awards' season is upon us -- even those of us in the pharma advertising and marketing business. One of the most prestigious awards in that category are the MM&M Awards. The MM&M Award Ceremony will be held on October 29, 2009 and I'm not invited, yet!

I've been to this event in the past (see "MM&M Award Winners Announced at Gala NY Event!") and thought how cool it would be if I were to join the winners on stage and be photographed along with them. Sort of like Woody Allen's Zelig character who was digitally inserted into historic newsreel footage.

But then I saw the following scene from rapper Kanye West's interruption of Taylor Swift's acceptance of her music video award.

The MM&M Award finalists have been chosen (see here) and Beyonce is NOT on the list! Will there be a "Kanye West" moment during the awards ceremony?

I hope that James Chase, Editor-in-Chief at MM&M, invites me back this year. Don't worry, James, I won't pull a "Kayner" and tell the audience who should really win an ad award!

Viva Viagra Missile Guy Vows to Continue His Quixotic Fight Against Pfizer

Ayre Sachs, the retired Israeli army sergeant who parked his "erectile projectile" Viva Viagra missile in front of Pfizer's Manhattan headquarters, is not going to go softly into the night after losing his trademark infringement case to Pfizer (see "Warning to Buzz Marketers: 'Pfizer did not get the joke.'"). That's Mr. Sachs in the photo below.


"The judge was clearly blinded by the sheer power of this global corporation," said Sachs, 49, who thought it was "more than just a little coincidence" that the ruling came exactly one year after his not-so-little stunt (see "Mission Aborted for Viagra Missile").

Mr. Sachs clearly is not blinded by Pfizer's power. He acted as his own attorney in the case and vows to continue to protest against Pfizer.

AOL conducted an online poll asking "Is the Viagra missile satire or trademark infringement?" More than 6,000 people responded so far. Sixty-six percent (66%) said it was "satire, and it's funny" whereas only 6% thought it violated Pfizer's Viva Viagra trademark (see screen shot on left; click for an enlarged view).

"I just wanted to say that this was not a marketing stunt," Sachs said in a personal communication to me. "It was a fun day out. However, had it been a marketing campaign it would have been a very successful one. Pfizer got a huge coverage around the world after only two days on the road and a law suit. Imagine what could it done if they would have really embraced it? " He based his opinion on the AOL poll results.

Sachs is most concerned that the judge refused to include his own survey results as evidence that the Viagra trademarks are not entitled to trademark protection because they have become so famous that they are now generic. The survey asked "what brand name they would use to describe an erectile dysfunction drug." The judgment described Sach's survey as an "ad hoc" survey of 100 people that was not created by a professional and that recruited respondents via Craigslist.

Sachs had this to say about that:

"The survey was NOT done by anything related to Craig List. It was done by law students who have either finished Law School and where awaiting the bar exam or a 2nd and 3rd year law students who presented people in public places with a questioner (sic) that proved that the public will use the name Viagra as a generic name to ED twice as much as they will use established generic names such as Kleenex for tissue paper and Escalator to moving stairs. I used Craig List to place a recruiting ad...that is all!"

Sachs claims that close to 400 people filled out his survey by hand!

"...so no one can say anything about the integrity of the survey in oppose to 'Professional' polling company where half to all the stuff are part time regular students or starving actors / out of home moms etc."

Any "professional" polling companies out there want to respond to Sachs' criticism of their staff's creds?

"I do not mind to lose fair and square," said Sachs. "I went out there knowing the risk having fun with that name on one of my missiles. I rejected three offers to drop the case from Pfizer knowing the risk - no problem. But I do not want to go down as an idiot who polled 100 people on Craig's list after all the work and efforts that went in to this survey. The Judge can just reject it as un admissible (sic) but not they he did it apparently not even reading it."

Speaking of unprofessional surveys, the AOL survey is also flawed in that it does not include the choice "Funny, satire (maybe), but definitely infringed trademark." That's how I would have voted.

P.S. Regarding the court's reference to exhibiting the "Viagra-branded missile at an adult entertainment exposition in New Jersey with a banner promoting its advertising services," Sachs remarked "Who are we kidding here? The adult industry is one of [Pfizer's] larger consumer group who uses Viagra for recreational purposes."

Hmmm...I wonder if Sachs has survey data to back up that claim?

Monday, September 14, 2009

FDA Approves Depressant Drug For The Annoyingly Cheerful

Maybe you've already seen this breaking news. It's new to me. I have to agree with Dr. Whey who was interviewed in this video news release.

Are Organic Search Results Next on FDA's Chopping Block?

In April, the FDA sent warning letters to several pharmaceutical companies citing paid search engine ads that it claimed violated FDA regulations (see "FDA's Actions Speak Louder than Its Words: On the Internet It's the Medium as Well as the Message!").

But what about organic -- ie, unpaid, "non-sponsored," natural -- search engine listings such as the following for Viagra (click on image for an enlarged view)? Are they next on FDA's chopping block?

That was a question posed by Julie Batten, e-marketing manager at Klick Communications (see "Search Marketing in the Pharma Industry").

"To date, organic listings haven't been considered promotional, and rightly so," said Batten.

Batten notes that pharma companies can determine the wording of organic listings by carefully crafting "meta" data (ie, TITLE and DESCRIPTION) within the header of HTML files that generate Web pages. Since "meta data isn't meant to be consumer-facing; it's meant to be [Search Engine] spider-facing," Batten argues that organic listing based on meta data "aren't within the jurisdiction of the regulating bodies to review and approve."

However, upon review of a few meta tags for Rx drug sites, I find that the wording seems to be crafted especially for consumers and not just for search engines. The following are some examples:

Viagra
  • Meta tag TITLE: “Erectile Dysfunction (ED) Treatment - VIAGRA ® (sildenafil citrate)”
  • Meta tag DESCR: “Learn about prescription VIAGRA ® (sildenafil citrate), an erectile dysfunction (ED) treatment option that may help your ED."
Sponsored ad (top) vs. organic listing (bottom):


Concerta (http://www.concerta.net)
  • Meta tag TITLE: “CONCERTA® - ADHD Medication to Treat ADHD Symptoms in Children and Adults”
  • Meta tag DESCR: “Learn about ADHD in Children and Adults, treatment options, and how CONCERTA� can help manage ADHD symptoms.”
Sponsored ad (top) vs. organic listing (bottom):


Latisse
  • Meta tag TITLE: “LATISSE® Home | LATISSE® — the first and only FDA-approved eyelash growth treatment”
  • Meta tag DESCR: “Grow your own natural lashes, LONGER, FULLER, DARKER. From the creators of BOTOX® Cosmetic.”
Sponsored ad (top) vs. organic listing (bottom)


In each case, the organic listing exactly matches the meta tags, which are clearly written with the searching consumer in mind. That is, each DESCR meta tag is actually a small direct-to-consumer (DTC) ad! However, none of these descriptions contains the fair balance (ie, side effect) information that FDA requires real-world DTC ads to include.

So, my question is: Will the FDA look upon organic search engine listings as direct-to-consumer ads because the meta tags are clearly written as ads, not merely descriptions of the landing page?

Thursday, September 10, 2009

Warning to Buzz Marketers: "Pfizer did not get the joke." Same for J&J?

A Long Island man infringed on Pfizer's trademark by towing a 20-foot replica missile with 'Viva Viagra' painted on its side through midtown Manhattan, eventually parking it in front of the drugmaker's 42nd Street headquarters, a federal judge ruled (see "'Viva Viagra' Missile Infringed on Pfizer Marks").

I commented on this story back in October, 2008 (see "The Erectile Projectile: A New Form of Outdoor Advertising") and suggested that:

You don't tug on Superman's cape
You don't spit into the wind
You don't pull the mask off the old Lone Ranger
And you don't mess around with Pfizer, da do da do...

But Arye Sachs -- the Long Island defendant in this trademark infringement case and the CFO ("Chief Fun Office") of JetAngel.com, the co-defendant business he owns -- insisted on tugging Pfizer's cape. Not only did he tug, he virtually told Pfizer to "go f**k yourself" or some other profanity. I'm just guessing that's what Sachs said based of this comment in the court decision: "Defendants' email closed with a profane remark directed at Pfizer."

That email message was delivered to Pfizer on September 14, 2008.

According to the judge's comments, the defendants not only parked the missile in front of Pfizer's headquarters, they also "exhibited the Viagra-branded missile at an adult entertainment exposition in New Jersey with a banner promoting its advertising services." Sorry I missed that!

In the September 14 email to Pfizer, the defendants also announced their intention to take the missile on a twelve-city tour where they would distribute condoms "bearing the images of the candidates for President of the United States." They also threatened to return to Pfizer headquarters with the missile, this time "featuring two female models 'riding' it and distributing condoms."

It seems this whole thing was the brainchild of the advertising agency AVI Media Group, which claims to be "a dynamic, innovative design/interactive media firm dedicated to providing powerful solutions." I only see one pharmaceutical company -- Johnson & Johnson -- listed in its portfolio of clients. I have no idea if J&J is a current client. But I don't think J&J, the mommy & baby company, needs a relationship with an ad agency that threatens pharma companies and engages in unwholesome buzz marketing activities.

Wednesday, September 09, 2009

WTF! Cease & Desist or Else ...

Friends of mine have been telling me that Pharma Marketing Blog posts are being reproduced on other sites without my permission. Worse still, the content is being modified in such a way as to hide the original source, which is me, John Mack.

One such site is here: http://bit.ly/YNaCX

What's my strategy for dealing with this? Well, I left this comment on the above site (edited for daytime viewing):
What the f**k is my content doing on your site without permission? Not only are you ripping me off, but you are changing the content to hide its source. Cease and desist or I'll have my lawyers cut off your balls!

John Mack
President
Virsci Corporation
Editor: Pharma Marketing Blog
There! That should do it!

What?! You don't think that is enough?

Ripping off content is practiced by many of us on the Internet. Come on, admit it. But most of us include a link back to the source at least and do not modify the content. I freely distribute my content via RSS and invite you to pick up my RSS feed and post it to your site. But please do not modify it and have the decency to link back to the original source.

Even sleazy sites like the one above provide some benefit to me when it rips off my content. The links within my posts to other posts I have made bring new readers back here to the original source. I can't complain about that.

So, thank you, all you content crooks out there! But, you will be hearing from my attorney!

Tuesday, September 08, 2009

Alli's New Marketing Strategy: Enhance Product Claims, Cast "Treatment Effects" as a Benefit!

Back in June, I noted that TBWA took over the alli -- GSK's OTC weight-loss product -- account. "This is one of the greatest marketing challenges today," said an industry executive, who added that Alli has to overcome diet-pill stigmas, a challenging economic climate and lazy human nature -- as well as a horrendous side effect (“Side Effects of TBWA Win Include Unpleasant Alli Account”).

Have you noticed that the new alli ads on TV and on the www.myalli.com web site have changed?

Specifically, there is no direct mention of the "horrendous side effect" (ie, anal leakage). In addition, product claims are enhanced.

The new ads feature testimonials from healthcare providers and consumers who are making product claims that go far beyond what is supported by the clinical trials that the FDA used to approve Xenical, the Rx version of alli. Yet the ads continue to emphasize that alli is the ONLY FDA-approved OTC weight loss product. Taken together, these messages suggest that the exaggerated claims have been approved by the FDA.


In one "real alli story" depicted on the myalli.com web site "Cheryl," a pharmacist, says "the thing I like about alli is it just blocks the fat in your body...and keeps the fat from being absorbed into your system." Sounds like Cheryl is claiming that alli blocks ALL fat from being absorbed, whereas alli actually prevents at most 25% of the fat from being absorbed. This fact is displayed in small type on the screen when Cheryl makes her "enhanced" product claim in the voice over. In another part of the ad -- when there is no text on the screen -- Cheryl the pharmacist repeats that "basically it just blocks the fat that you are eating." Clearly, if this ad were subject to the same FDA regulations as Rx ads are, the FDA would call GSK out on it.

Cheryl goes on to downplay the side effects and says that "you're not going to get the bad side effects that you do with some of the other drugs as far as the crankiness, the irritability, the inability to focus, the jitteriness." Cheryl does NOT mention alli's well-known anal leakage side effect (aka, "treatment effect"; see "Alli Newspeak: Oily Spotting is 'Treatment Effect'" and "alli Marketer Explains 'Treatment Effects'").

Cheryl claimed to have lost 25 lbs while taking alli. Not an unreasonable result. Melissa, in another testimonial, claims to have lost 75 lbs and Connie lost 57 lbs. Of course, these are NOT typical results as the small type on the screen points out (it's virtually impossible to read this type on the Web site versions). Typically, someone taking alli may lose about 1-2 lbs per week. It's doubtful that Melissa has been taking alli for 37 to 75 months!

Either Melissa was coached or knows more about alli's mechanism of action than does pharmacist Cheryl, because she was careful to say that alli "takes SOME of the fat that you eat out of your system."

In previous promotions, the anal leakage side effect was cast as an INCENTIVE to eat less fat (see a frame of such a video reproduced on left).

Melissa makes an indirect reference to this when she says "when they explain to you how alli works, you can kind of see what's going to happen if you eat way too much fat in one meal." You'll see anal leakage, that's what you'll see!

In fact, Jill -- in another testimonial -- said she experienced one "treatment effect" incident and she learned her lesson! By which she meant: don't eat so much fat!

This alli-induced "aversion therapy" reminds me of the book/movie Clockwork Orange where Alex is conditioned to throw up whenever he hears the music of Beethoven.

Melissa ended her testimonial by claiming that alli "improved her entire life!"

Jonathan Richman over at Dose of Digital Blog asked pharmaceutical marketers what they would do differently if there were no FDA or FTC rules (see What If There Were No Rules in Pharma Marketing?). One option he gave them in a poll was: make "Enhanced" Product Claims. Only a couple of respondents were honest enough to admit that they would do it (3% of the votes).

"I think everyone here knows that 'enhancing' your product claims isn't a winning strategy," said Richman. Obviously, GSK and TBWA do not concur. Alli is a great case study of what pharmaceutical companies would do if there were fewer or no FDA regulations to contend with - they would enhance the benefits and downplay the side effects.

Thursday, September 03, 2009

Marketing Team Players Should Pay Attention to the "e" in "Team": Ethics

By now, you've probably heard about Pfizer's settlement with the Department of Justice to pay a $2.3 billion fine (see "Pfizer To Pay $2.3 Billion For Fraudulent Marketing").

@pfizer_news, Pfizer's official Twitter account that keeps journalists and bloggers like me informed of Pfizer news, provided this announcement and link to a press release in response to $2.3 Billion settlement news:
Pfe Concludes Previously Disclosed Settlement Agreement With U.S. Department Of Justice http://tinyurl.com/nuzfv6
The news also revealed that even while Pfizer was in the midst of resolving allegations that it illegally marketed Neurontin, "executives and sales representatives throughout Pfizer’s ranks planned and executed schemes to illegally market not only Bextra but also Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, which treats nerve pain," according to a New York Times report (see "Pfizer Pays $2.3 Billion to Settle Marketing Case").

“The whole culture of Pfizer is driven by sales, and if you didn't sell drugs illegally, you were not seen as a team player,” said John Kopchinski, a former Pfizer sales representative whose complaint helped prompt the government’s Bextra case. Mr. Kopchinski's personal share of the Pfizer settlement is expected to exceed $50 million, says the NY Times article.

Frankly, I always had a difficult time being a "team player" because -- as the saying goes -- there is no "I" in "team."

Of course, the "no-I-in-team" argument is a crock! Everyone in the team wants to benefit personally from winning. For pharma sales reps, to win means to get a bonus. That's the one big reward that some of the "I's" in pharma sales & marketing teams receive.

Pfizer has to do a number of things besides paying $2.3 Billion -- an estimated 3 weeks of sales income -- to the government. It has to implement a corporate integrity agreement with HHS's OIG (see here).

That agreement includes, for example, a provision that "On or before March 31, 2010, Pfizer shall post in a prominent position on its website an easily accessible and readily searchable listing of all U.S.-based physicians, and Related Entities who or which received Payments directly or indirectly from Pfizer between July 1, 2009 and December 31, 2009 and the aggregate value of such Payments." (I have some issues with the implementation of such listings. More on that in a future Blog post.)

The corporate integrity agreement also specifies minimum requirements for Pfizer's written Code of Conduct (aka "Blue Book"; find it here) concerning reporting violations of federal law.

I wish that Pfizer and all other pharmaceutical companies would go further than what Uncle Sam requires in its Code of Conduct. A new corporate code of conduct provision should state the following:
"It is forbidden for any manager to motivate employees using the phrase 'There is no I in team.' Instead, managers should say, "Remember the E in team stands for Ethics. Everything we do should adhere to the highest ethical as well as legal standards of our industry."
Maybe Pfizer should require all its sales & marketing people not only to read a Code of Conduct, but also to attend a series of classes about ethics. I'd be happy to help lead at least one of those classes.

Wednesday, September 02, 2009

What Do Phone Sex, the Pittsburgh Symphony Orchestra, Amgen, & Psoriasis Have in Common?

The #pso hashtag in Twitter! Hashtags are used in the Twittersphere to allow you to follow all the Tweets about a specific topic. There are no rules for developing a hashtag; you just come up with one and announce it. Amgen announced yesterday it would use the #pso hashtag when it live-tweets about the Addressing Psoriasis(TM) Fashion Show today:
"Amgen tweeting tomorrow live from Addressing Psoriasis(TM) Fashion Show. Tim Gunn is hosting the event. Hope to see you here! #pso"
Get it? p, s, and o are the first three letters in the word "psoriasis."

Why is Amgen tweeting about this show? Here's why:
"Amgen and Wyeth announced the eight winners of the Addressing Psoriasis contest, which recognizes people with moderate to severe plaque psoriasis who have tried not to allow the condition to inhibit their personal style. The winners will help raise public awareness of the condition by walking the runway in the Addressing Psoriasis Fashion Show hosted by television host and fashion consultant, Tim Gunn ("Project Runway," and "Tim Gunn's Guide to Style"), on Sept. 2, 2009."
Unfortunately, the #pso hashtag is also being used by Phone Sex Operators according to @WendyBlackburn and for fans of the Pittsburgh Symphony Orchestra.

Here are a few other Tweets you'll find using the #pso hastag:
"Are you a veteran PSO, or someone looking to get into the business? We have openings fabulous low drama company with unsurpassed support!"

"Getting ready for PSO on-sale at noon. Scores of classical music fans, waving money in my face. Hope they're not too rowdy ... "
So, you'll have to wade through all these other PSO's to find out more about the Addressing Psoriasis Fashion Show. Or you can just follow @Amgen.

My advice to Amgen and all others who want to use Twitter hashtags: (1) do some research first, and (2) use a longer hashtag that is more likely to be unique. Of course, #psoriasis won't do. While it's easy to remember, nobody can spell the damn word!

Twitter's for the Dogs! ... and Other "Indirect Customers"

No, I'm not agreeing with Rich Meyer (@richmeyer) that Twitter is only good for PR. PR people may be the "dogs" in "dog and pony" shows, but they are not really dogs.

I'm wondering if Twitter can be used to inform dog owners about medications for their pets and how that may be regulated by the FDA.

Why do I wonder about this? For one thing, I see that Imran Haque, Director eBusiness Strategy and Inside Sales, Pfizer Animal Health, will be the last speaker at eyeforpharma's 4th Annual eCommunications & Online Marketing Summit in November, 2009. [I'll be a panel member at this conference and Pharma Marketing News is a Media Partner.]

Mr. Haque's topic: "Developing a digital strategy for direct and indirect customers"

Very interesting. My little cartoon shows what a hypothetical "Pfizer_Dogs" Tweet might look like directed to and received by an "indirect customer." I suppose FDA would think this Tweet violated its regulations, even if it's a dog-to-dog communication.

All seriousness aside (as comedian Steve Allen would say), I am curious about what Mr. Haque has to say on the subject. Perhaps he will be a guest on my planned Pharma Marketing Talk show scheduled for October 13. More on that later.

Tuesday, September 01, 2009

Twitter for Patient Support: Not as It Is, but as It Could Be

I am getting comments from several readers about my idea for pharmaceutical companies to use Twitter to notify patients about drug recalls, counterfeit drugs, or drug safety warnings (see "Twitter and Drug Safety: A Paramount Concern"). One of my Twitter colleagues commented:

"John read ur great patient ed/Twitter wrap-up. But since tweets appear on feeds w/o all the warnings, don't u think that's a violation?"

To which I responded with a quote from George Bernard Shaw: "Some men see things as they are and say why - I dream things that never were and say why not."

I've often been the first to bring pharma marketers to task when they push the envelope with regard to obeying regulations, especially when others are playing by the rules. But that doesn't mean I believe the rules are immutable.

For example, if a communications channel exists that clearly is very useful for getting critical information to patients, then the FDA rules may need to be changed so that the risks match the benefits of pharmacos using that channel for certain purposes. Twitter may be such a channel as I argued in my previous post.

This is also precisely the argument that some people have used against FDA's recent warning letters regarding branded search engine ads (see here); ie, the benefits of searchers finding FDA-approved information via Adwords offsets any risks because the ad does not include the fair balance information.

In the case of Adwords, however, I personally don't agree that the benefits outweigh the risks because the message is purely promotional and not educational or supportive of current patients. That is, the Adword is specifically designed to acquire new patients for the advertised drug, not to support patients already on the drug.

I would support new FDA guidelines for use of Twitter that would relax FDA fair balance regulations to allow pharma companies to use Twitter to send certain notifications to patients -- such as drug safety notices. What I am dreaming about is a Tweet that mentions a brand name drug while warning about some safety issue with a link to more information about that safety issue.

Note: Several people commented that Twitter does not have the reach among consumers to be used for DTC communications. That's not relevant to my idea, which is focused on CURRENT patients who are taking the Rx drug in question. These patients can be RECRUITED to follow the brand's Tweets on the drug.com site or via direct mail. Of course, patients can also sign up for email notices, but Tweets are much more viral -- current patients and their followers can retweet messages and help spread the word.

Would pharma companies do this even if FDA allowed it? As I said before, if patient safety comes first, then they should do it -- that's my dream and I'm sticking to it!

With "what could be" in mind, please take the following survey on how effective Twitter can be in carrying out patient support activities/communications:


What's Your Opinion About Branded Patient Support via Twitter?
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