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!

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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.

Click on an image in the mosaic below to learn more about that person and to follow them on Twitter.

[If you are not following me on Twitter, why not? Find me @pharmaguy. If you are following me and your clickable image is not included in the following mosaic, I am sorry. I did delete some generic images from the list and the software I used may not have produced an all-inclusive mosaic.]

Get your twitter mosaic here.