The white elephant in the room: the FDA hearing and DTC

friendship

friendship

The FDA hearing on social media took place almost a month ago already and a lof of ink (or pixel for that matter) has flown since on what was presented. I vividly encourage you to dig through the sources on Fabio Gratton‘s excellent #fdasm site to paint your own picture of the content.

In my simplistic view, however, I would classify the presentations on proposed guidance at the hearing into three categories:

1. Enable direct to consumer advertising (DTC) via social media- by allowing links to fair balance and safety information (“one-click rule”)

2. Improve patient safety – via social media AE reporting (MedWatch icons) and correction of gross misinformation

3. Enable collaborative content creation- define a transparency framework for content created in collaboration with patients online (3 Cs proposal)

Yet, after having gone through most of the great content from the hearing as well as through reactions afterwards, I much regretted the little amount of e-patient input. Only 9% of the speakers at the hearing (accoring to John Mack’s great analysis) were consumer advocates.

Why was this? Did patients not care about improving access to better information and enabling informed health choices? Did they not want to help define pharma’s role in their choices?

I came across this discussion initiated by Lisa Emrich, one of my favorite MS bloggers and an incredibly sharp thinker. Lisa popped the question on FDA, social media and pharma to her MS community on health central. She gathered no less than 43 comments within hours! A lively discussion on the value of DTC, to say the least. This is one of the rare patient discussions I witnessed about the hearing, so I invite all of you to read it with great intrerest. I also decided to analyze it in greater detail for you. Below you thus see a tag cloud attempting to capture  this insightful discussion. As you can see, it was driven by a debate on information vs. advertisement and the pharmaceutical companies’s role in providing it:

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Patients are saying they need good drug information to make informed health choices – not more mechanisms to enable pharma drug advertisement. Unfortunately, they perceived the FDA hearing to be mainly about applying DTC regulations to the context of social media.  Maybe, this was the reason for the absence of most prominent e-patients? Maybe, there was a big white elephant in the room during that hearing- called DTC advertisement?

Patients have been turned off by years of abusive DTC TV ads and despise the idea of it leaking into their social media haven. And I have to agree: Social media is not compatible with DTC! In my opinion, DTC  is not the right framework to define and regulate patient/pharma interactions in social media. There are three reason’s why I believe this:

1. Social media is Global, DTC is local!

Social media information travels across national borders. Its most definite limit is language, not geography, though patients frequently translate US information to make it accessible in languages were information is scarce. DTC is banned in most countries around the world, except US, Canada and New Zealand – so how is any DTC guidance ever going to be applicable to social media? How can you create guidance that is adapted to the global nature of social media?

2. Social media marketing is pull, DTC is push!

This post by ClikZ took the words right out of my mouth:

Social marketing isn’t about pushing ads at target consumers, even if you know where to find them. It’s about listening to what they’re saying.

Social marketing isn’t about shouting a made-up claim that your product is great. It’s about respectfully asking their opinion and observing how they tell their friends and peers about why they love or hate your product.

Social marketing isn’t about getting your message to a ton of people (reach). In fact, it’s better if only those people who wanted the information could find it, when they wanted it.

Social marketing isn’t about how often you beat people with your ads (frequency). It’s about allowing them to find your information in the words they choose to use when they search.

3. Social media believes in empowering patients, DTC does not!

Donna R. Cryer from DC patient summed this up brilliantly: I’m not as afraid of health social media because I believe in the intelligence, passion, persistence and generosity of my fellow patients (and I still believe in doctors). FDA has a strong role in ensuring that information by regulated entities (under their control or influence) is accurate and meaningful …  Pharmaceutical companies and other regulated entities should listen more than talk and only interact to provide value to patients, as defined by patients.

I believe patient involvement around the hearing was quiet low, because the questions asked did not resonate with patient advocates. Patients do not want to figure out how to apply DTC to social media. Yet, I also believe that this is throwing out the baby with the bath water. The FDA hearing was a much needed catalyst to get important changes going in redefining the pharma/patient relationship and more importantly in building new bridges for patient empowerment. It was the first time the FDA acknowledged that patient generated content on social media was special and needed its own set of regulations.

I thus would like to encourage patients to speak up and participate in the commentary that the FDA is gathering until February (Please also click here to participate in John Mack’s survey on the matter).

Please seize this important opportunity to define the relationship you would like to have with pharma: if you do not want DTC applied to social media speak up! Don’t let an elephant cheat you out of an important opportunity to get heard!

If you do not care about DTC, think about improving AE reporting and enabling collaborative content creation. In my eyes, these will be the real advances in terms of social media guidance, because they will allow you to get access to better information and to make safer health choices.

11 Comments on "The white elephant in the room: the FDA hearing and DTC"

  1. Wendy Blackburn 8 December 2009 at 5 h 02 min ·

    Nice post Silja. I agree we could all have benefited from more patients being a part of the discussion at the hearing. I definitely hope more representatives of the patient communities will provide their thoughts in the form of written commentary to FDA as you suggest.

    You have a good point about patients perhaps being “turned off” by the context of the hearing … by applying the DTC framework to social media. Unforunately it is the DTC framework here in the U.S. that allows pharma companies to “promote” to (or even proactively talk to) consumers at all. I think the bigger question is, where is the line drawn betwen communication and promotion? Right now, DTC regulation is all we have to go by, and DTC for offline communications at that … so we’ve been trying to retrofit regulations for years, and it’s clearly not working.

    Thanks for keeping the conversation going!

  2. jilske 8 December 2009 at 10 h 27 min ·

    I think DTC is both a blessing and a curse. On one hand I’m sure companies would love the opportunity to do it, on the other hand everything they do can be misinterpreted as DTC – even if it is an answer to somebody’s question (consider that pulled not pushed?).
    I know it very simply put, but it is something that stands in the way of deliverying information. Non-pharmaceutical companies can do it. But the reason why social media works is because it exposes exactly when companies are in it for their own gain and are considered impersonal. You can simply opt out if you’re not interested?

  3. Gilles Frydman 8 December 2009 at 16 h 25 min ·

    Last week, at the Partnering for Cures meeting in NY, I asked Joshua Sharfstein of the FDA, if they planned to rectify the lack of patient representation at the FDA hearings about Social Media. His response was pretty clear: “Yes!”

    We will do what we have to do, but will make sure that the voices of the patients are heard before Feb 2010. We may even start an active campaign on ACOR to make sure that thousands of individuals have the ability to voice their opinion about this very important matter.

    DTC is not the biggest concern for cancer patients, but their role in social media and how they will interact in the future with pharmas in the various types of online communities are. And both clinical trial evaluation and post-marketing surveillance are real issues in cancer online communities.

    In any case the vast difference between social media where the individuals are the content and broadcast where they used to be static recipients of DTC parallel the difference between Participatory Medicine and the old, broken paradigm of the Industrial Age Medicine.

  4. Greg Rust 8 December 2009 at 19 h 35 min ·

    Excellent post followed by very healthy discussions. I think the reason epatients didnt show up for the FDA hearing is probably one from “who needs it”. Thats the beauty of social. All these communities regarding conditions and disease have been created by a patient(s) and have been able to grow organically with the purest of reasons–so each could share and be heard. Perhaps their attitude is “Why wait until pharma and the FDA figure it out?”.
    Perhaps we should ask them to craft our path for us. Of course, tha would mean the industry would have to stop and listen. Is it ready for that??

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