FDA hearing on social media- The first hole in the wall?

Written by Silja on 9 November 2009 in guidance & regulations - 8 Comments

Exactly 20 years ago today, one of the most horrific monuments of the cold war came down: the Berlin wall.

I remember strolling through East and West Berlin some days after the fall and hearing a reporter say: “Everyone who is not dead, is walking the streets of Berlin right now.” And it surely felt this way: alive and animated by feelings of solidarity and common purpose every street corner seemed plunged into incredibly effervescent discussions about democracy vs. dictatorship, capitalism vs. communism and choice vs. responsibility. These were the most free, passionate and constructive discussions I ever witnessed, led by the people that had brought about the most radical peaceful change in human history.

I also remember another scene from the fall of the Berlin wall: I went into a supermarket and saw a woman weeping in front of the abundantly filled shelves. She was overwhelmed by choice. In Eastern Germany, she would have only one detergent, one kind of soap, one type of canned soup to chose from. She would not be able to buy bananas, coffee or oranges. She would take her Wednesday afternoons off to queue for her groceries and when it was her turn, she would buy whatever she could find on the shelves.

The woman was weeping, because now she could buy everything whenever she wanted. Yet every single purchase had become an ordeal – how do you chose the “best detergent“ amongst 30? By its price? Its efficacy? The way it makes your clothes smell? This poor lady had to go through a complete purchasing process for EVERY single product on her list. Even worse, she had to learn about a gazillion other products that she had never heard about and decide whether they could be of value and importance to her and her family.

In the early days after the reunification, and still sometimes today, we have lively discussion in Germany about whether or not choice is good. Whether more information and more choice does not create more inequality, more costs and more hardship on the people that have to deal with it?

I traveled to the US this past week and had the chance to participate in a panel discussion around the upcoming FDA hearing on social media at the excellent eye for pharma 4th e-communications and online marketing conference. It dawned on me that a lot of the discussions around this hearing came back to the topic above: choice. How much and which type of information does a patient need to make informed health choices? How good is the information patients find on the internet? And if we do give them access to more information, how do we make sure that they are educated enough to make the correct choices?

These are all very important questions that will be very difficult to answer. Yet I also believe that the mere fact that we are now having these discussions with regulatory authorities will lead to important changes.

istock_000003756941largeAbove you see a picture of a piece of the Berlin wall. The writing says:  “This is where the first hole in the Berlin wall was created in 1989.”

For me, this picture is a perfect metaphor for the curent discussion around patient information and empowerment. Let me try to explain to you why:

Social media cannot be owned by pharma: Listening to some of the discussion over in the US, I sometimes get the  impression that “we” (the FDA and the industry) can decide what information “they“, patients and caregivers, will have access to. This is completely illusionary. Patients will have the discussions they need via social media and the Internet whether we want to or not. And just like in Eastern Germany 20 years ago, once the discussions start there is no turning back. And we should not try to stop it either, we all should have the freedom to inform ourselves however we choose.

Social media cannot be regulated away: Social media is the supermarket where I met the woman in Berlin. We cannot close it tomorrow, because we think that there is too much (mis-)information or because we think the choice is too hard on people. Just like the lady in the supermarket, patients today have to learn how to become empowered health consumers. And they will learn, even if it is difficult, but it will take time. We need to make sure that the information patients find in this social media supermarket is of good quality and safe. So we need guidelines and best practices on what good information should look like and have a sound system to report Adverse Events, allowing us to make our drugs safer.

Social media is not compatible with DTC: As the FDA hearing nears, we should stop and take a long critical look at ourselves: are we wasting time and energy trying to force-fit a broken process onto a disruptive new value system? Is figuring out the technicalities about how to cramp a 586-character-long fair balance statement into a 140-character-tweet really going to help patients? Patients do not want “branded tweets” nor do they need “product banner ads” across their favorite social media site. They want someone qualified to talk to, they want guidance so that they can make the best choices for their health. Information about available prescription drugs is a very important part of this choice. How can we ensure that we will be able to deliver this information to patients responsibly and with care?

In my honest opinion, too much focus has been put on the current DTC rules, and not enough on patient needs. Maybe this explains the low participation of consumer advocates in the hearing- they do not see how this hearing is going to help them? We need to steer away from the “direct to consumer” model to an “engaging with patients” mindset. We need to teach patients how to make good choices, explain them how our products work and how they could be of value to them. We need to help them make the choices less overwhelming without manipulating them.

For me, the FDA hearing is an effort to chisel the first tiny holes into the archaic wall that was put up for patient protection and now hinders patient empowerment. The effervescent conversation that I experience varound these topics remind me of the energy and excitement in Berlin after the fall of the wall. We are discussing choices, question systems and evaluate health care in completely new ways.

Much like the lady weeping in the supermarket, we have come to terms with the aftermath of the social media revolution we are confronted with. Choice is neither good nor bad. It just is. Hindering choice is artificially restricting freedom and progress. It will not be easy to educate hundreds of millions of health care consumers on how to deal with the information they now have available at their fingertips. It will even be painful and scary at times and it will take a long time. Yet it is inevitable and we, as an industry, have to take responsibility for the changes to come.

8 Comments on "FDA hearing on social media- The first hole in the wall?"

  1. Ellen Hoenig 9 November 2009 at 15 h 39 min ·

    Great to finally meet you!
    Great post— I fully agree that the power of the patient is unleashed and will never or should be “controlled’, and there is the need for a changing mindset to that of ‘engaging with patients’ and putting them in the center of decision making process. …so that they can begin to play a greater and participative role in their own treatment choices and health…
    To me, this IS the scary new DTC model (or DWC Direct with consumer) that must emerge and be about engaging ‘with’ ‘each’ patient—providing education, value and meaning–so that people/patients have the right info at the right time…So, I’m not sure that is has to always be an ‘either or’ –can it be an ‘and’? As you point out, consumers need and want to find out about new prescription options etc. So engaging must take into account all touch points, unbranded and educational, and branded and educational …and social media is fast becoming the way in which patients et all are learning and engaging…importantly, social media must also become part of the full view from awareness and diagnosis to action… across touchpoints and interactions with their doctor and payor, and integrated with other branded and unbranded efforts…Hopefully, we’re starting that process! Ellen

  2. Blogaceutics 9 November 2009 at 18 h 25 min ·

    A very appropiate metaphor. I especially like this: ‘from the “direct to consumer” model to an “engaging with patients” mindset’.

    Silja, while reading this nice post I couldn’t avoid thinking of the well-known Pink Floyd’s song ‘Another brick in the wall’:

    We don’t need no education
    We dont need no thought control
    No dark sarcasm in the classroom
    Teachers leave them kids alone
    Hey! Teachers! Leave them kids alone!
    All in all it’s just another brick in the wall.
    All in all you’re just another brick in the wall.

    You could substitute ‘kids’ by ‘pats’.


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