After reading a bunch of Twitter buzz and a few blog posts, I wanted to weigh in with my opinion on the most recent hot topic relating to pharma, social media, and the FDA. As you all know, the FDA recently had hearings about the use of social media by pharma companies. A number of people  have pointed out that patients were very much under-represented at the hearings (John Mack did the math). Only 5 of the 60 or so speakers were those you could classify as “patient advocates” whether they were patients themselves or speaking on behalf of patient groups. As many have noted since the hearings, this number is probably too low. I agree…sort of.

First off, there’s a reason why patient participation was low. Your “average” patient certainly wouldn’t have known about the hearings. They weren’t talked about on the evening news and by the time they might have found out through some blog or industry journal (if they even read them), the registration period would have long since closed. Perhaps there were many more patients or patient advocacy groups that would have liked to have given their opinion. Of course, they still can, as public comments are open until February (all the info you need to do so is here). It’s unclear if any patients have actually taken the time to do this. However, you can probably bet that your “average” patient isn’t going to be the one who writes comments to the FDA. By “average,” I mean your parents, your friends, not patient bloggers or advocacy group leaders. This is fine. There’s nothing wrong with these leaders being the only patients who submit comments. I love the fact that these leaders exist and really, truly speak on behalf of the groups they lead…nothing in it for them, no ego, just trying to do what’s right for the group. Names like Manny Hernandez (TuDiabetes) and Gilles Frydman (ACOR) come to mind as two great examples.

What’s my point? Where am I going with this?

Well, a lot has been made recently on many blogs and Twitter that the hearings, and by extension, the guidelines that come from these hearings will be completely devoid of any feedback or consideration of patients, who will be the ones really impacted by the final decision. I’ll quote one very representative view (which ironically includes a quote from me), which comes from my friend, John Mack in a recent post (quote in italics):

At the November, 2009, BDI Forum in New York City (“Healthcare Social Communications Leadership Forum Breakfast”), a question from the audience to a panel I was part of got to the core of the value of pharma to online patient communities. The question was “Should pharma be in discussion forums or lists frequented by patients? Do we need an industry consensus where we shouldn’t go?”

My colleague on the panel, Jonathan Richman (@jonmrich) noted that some consumer advocates speaking at the recent FDA public hearing said that under no circumstances should pharmaceutical companies be allowed to engage consumers in discussions on social networks. Jonathan thought that was too extreme. He suggested a few examples where such discussions could bring some value to the online patient community. He said there is data to suggest that patients/consumers would value the discussion if done the right way.

The problem is the TOTAL LACK OF PATIENT REPRESENTATION in this discussion! We’ve heard opinions of agencies and seen data from studies sponsored by agencies, but what are the views of real patients who have been using social media for years? [italics add, bold and caps his]

You can go to John’s blog to see my response, as it’s not really important for my point today. Let’s be clear. I agree that patients should have a voice and that the FDA should want their opinions.

Here’s where it gets controversial: patient feedback in the guideline development process is not at all necessary. The guidelines, whatever they are, will have very little impact on patients.

Now, before you alert the authorities, let me explain. First, to be sure, I don’t want pharma to turn social media into a free for all of advertising. I was pretty clear about that in my testimony for the FDA (download my presentation for “Question 3″). While I said that pharma should be able to participate, I was also pretty restrictive on how they should be allowed to do this. One of these restrictions was that pharma shouldn’t be allowed to just jump into conversations unsolicited. Rather, they can (and should) get involved in discussions where there is a question about one of their brands or some misinformation about one of their brands. Wouldn’t this be seen as a positive versus a negative if done appropriately? On the other hand, trying to sell a product shouldn’t be allowed or encouraged. For example, when someone says, “does anyone know which treatment is best for depression?”  I don’t want to see 25 pharma companies come out of nowhere and give the details on why their product is the best. That is, I don’t want pharma to have unfettered authority and access to do whatever they want online in social media or any other place.

Back to patient feedback on the guidelines. I’ve read a few great patient posts on this (here and here are couple of them). It seems to me that these patients are pretty much in agreement with me. Many say that they don’t want pharma involved at all in social media (which seems like an unlikely outcome). Others Iv’e read seem open to some involvement. Now, here’s why the guidelines will have no impact on patients.

Social media is just that: social. No one is in charge. No one has a higher rank than anyone else. It’s democracy in action. Yes, there are people who are more influential than others and can drive the community in one direction or another, but in the end, the people, whether they be patients or buyers of computers or new mothers, decide what happens in the community. They decide what’s credible, who they listen to, who gets “air time,” and, most important, who succeeds and who fails. Those with more influence aren’t the new members of the community (as pharma companies would be). They are long established members who people learned to trust for a number of reasons. That’s how social media works.

So, picture this: guidelines come out and pharma is allowed to do whatever they want in social media. Does this mean that they actually can? Say a pharma companies joins Tu Diabetes, for example, and inserts itself into a conversation about a particular treatment. If the community doesn’t want them there, that’s it. The show is over for the pharma company. People will ignore them, block them, report them, flag them, and everything else you do to people you don’t want in your community. The community polices itself. That which is not valuable or valued is ignored and rejected. That which is useful and beneficial rises to the top. Which direction do you think the average pharma company would find itself heading in these communities?

This is why I say that patient feedback into the guidelines isn’t necessary. All the guidelines do is give a guide to what is legal and what’s not. They don’t give a guide as to what’s effective and what’s not. A pharma company trying to insert itself into a conversation where it is not welcome will never be effective regardless of what’s actually legal.

In fact, in the end, patients have the most influence on the guidelines. Far beyond any pharma company or agency or government official, the end user, the patient, decides what’s effective, what influences them, and what’s meaningful. Patients don’t care about guidelines. They care about the quality of the discussion and the support they get from others. Do you think they’re going to let pharma companies get in the way of that?

Granted, some patient groups might prefer to nip this in the bud right now by banning pharma straight away from these discussions and avoid the trouble of policing it later. That’s not realistic though. So, in lieu of that, patients should be speaking with their actions in social media and not with their feedback to some set of government guidelines (which may never come). Sure, patients should absolutely submit their feedback to FDA, but they can have far more impact in social media with their actions. There are hundreds of examples from other industries of consumers destroying a company’s social media efforts when they find it useless, insulting, or just plain annoying. Why would patients behave any differently?

If pharma companies come to social media with the same promotional tactics that they use on TV and print, they will fail miserably. Who will see to it that they fail? Not the FDA. Not some set of guidelines. Patients will.

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