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Shel Holtz
Communicating at the Intersection of Business and Technology
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Blogging in a regulated environment

03/06/08 | 10 Comments | Blogging in a regulated environment

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  • 1.This is great, Shel. Funny thing: I had this VERY SAME conversation with a colleague a few days ago. We couldn't understand WHY some people within corporations felt that the CEO could never blog. "Oh, what if he says the wrong thing?" I wonder if they muzzle the guy when he leaves the office each day or is otherwise not in the presence of handlers. Sheesh.

    Donna Papacosta | March 2008 | Toronto

  • 2.the issue that is alluding you is as simple as the wonderful advice about not violating the regulations.

    The regulations are a smoke screen, a crutch for opponents of blogging to use because they don't see the reward of blogging being greater than the risk of it.

    I believe they see too little to gain, period. Candor, relationships, feedback, save it for the other guys, we'll jump in after they break their toes on a couple of lawsuits.

    Wait my friend, perhaps there is a way out of this. What if they were to blog or "participate" in other places like http://www.understandingcancer.tv or www.realsavvymoms.com, http://www.thehealthcarescoop.com, OH should I stop now.

    Go my friends in free speech albeit, regulated for reasons of public protection, trial lawyers, and shareholders.

    Go find those places where those you which to share information with are chatting. Listen, learn, and share that with the lawyers, the regulators, the corner office holders. If you share the right stuff, they will come.

    Albert Maruggi | March 2008 | St. Paul

  • 3.Hey, Shel.

    Been terribly lax in keeping up with blogs and podcasts. I'm still on episode 304 of FIR...but catching up!

    Thought I'd start on your blog from the most current and work my way back slowly while keeping current.

    On this particular issue, I think the issue is more complex than just "we're in a regulated industry." There certainly is that fear that "we can't venture down that road because of fears of running afoul of regulations", but I agree with you on that particular issue as well as some other fears...don't divulge anything that you wouldn't divulge in any other medium, don't behave in a way the crosses code of conduct, and always remember you are a representative of the company in all you do and say on and off the job.

    However, nothing in life is ever that black and white. Running behind those fears, I'm sure, are also concerns about the ability to keep up the content, inability to get approvals from legal on the establishment of the blog to begin with let alone the content that goes into it, getting IT and procurement to see the business merit and make the purchase of the platform (understanding you can always host your blog externally). Inidividuals within a company might also be afraid to champion the initiative for fear of being branded as someone who's always chasing the bright shiny object. You get my point. Answer for one obstacle and you get a line of others standing ready to prevent a company from taking the leap.

    I think the best advice I can give for anyone considering a blog for the company is to have a very specific initiative in mind, tied clearly to business goals, with at least some credible plan for measurement of success, have an editorial calendar and commitments for content in place, and show how you plan to enforce keeping the blog focused on the intended topic. It should be justified in the same way you would justify an ad campaign, direct mail campaign, newsletter, or any other communications vehicle.

    Just some thoughts...

    michael clendenin

    michael clendenin | March 2008

  • 4.Well done, Shel!

    I've done a good amount of biotech & pharma consulting in my time and have always been frustrated with that cop-out. It's not the medium that should be feared - it's the individuals.

    This is the same fear they had some 15 or more years ago about email. But they're all using email today, aren't they?

    I think where there's a little uncertainty is when they have a public forum - say a blog - where readers can comment. In my experience, they're scared of what may happen as a result of the comments - say, Mr. Smith from Indiana notes that he used a medication off-label, and then another reader looks at that, tries it himself and there's a negative outcome. They're concerned that by creating a forum where potentially misleading information can reside, they're going to open themselves up to all kinds of lawsuits and regulatory backlash.

    Do you (a) buy this argument and (b) see any way around it?

    Scott Monty | March 2008 | Greater Boston, MA

  • 5.Hi, Scott.

    First, the blog is an opportunity to tell Mr. Smith from Indiana that it is, in fact, an off-label indication. Second, it's important to know that the pharmaceutical company can't market this, but any doctor can prescribe any drug for anything they want, regardless of FDA approvals. If a doctor prescribed the drug to Mr. Smith, the fact that he says so on the pharmaceutical blog is neither here nor there. But ultimately, if the policy on the blog states that non-approved indications are one of the factors that will keep the company from clearing a comment from the moderation queue, Mr. Smith's statement never sees the light of day anyway.

    Ultimately, the phone company isn't held liable for the conversations people have on the phone (such as plotting murders and drug deals). Conversations people who are not representatives of the company have in the comment section of a blog post should be treated the same. Whether that passes muster with the courts -- or regulatory bodies -- is something that remains to be seen. But, like I say, the easiest way around it to to include in the policy regarding comments that won't be cleared are those that address off-label indications.

    Shel Holtz | March 2008 | Las Vegas, NV

  • 6.The real issue is lack of trust. This lack of trust by management is a result partly of a general fear culture in pharma, but also to give it some credence the up-side of social media is perceived in the industry as small (at best) whereas the down-side is known to be an abyss.

    It staggers me each time I speak with an IP professional how easy it is to lose a patent (either being granted one or have one upheld in a challenge). Loose lips really do sink IP. Regularly. And without intellectual property rights novel pharma as we know it can't exist. So this is important. It's particularly critical in R&D;, which the area in which I work.

    Young people joining the industry have absolutely no idea of these things. I've seen new recruits share profoundly confidential information on open internal systems because they had no comprehension of the impact of the information. Senior management then reason - if they put that on the intranet how can we possibly trust these people in a public forum.

    The answer to this is course is a combination of education and better information security - but why bother with the expense of this when the benefits are perceived to be small and the costs notable? Management truly doesn't get it at all and so the risk/benefit equation is completely stuck on risk.

    Mark | March 2008 | Europe

  • 7.Let me second Mark's observation that the real issue is trust. Executives have to (a) have guidelines, and (b) learn to trust employees. One way to ease into blogging is to start internally only. When we trust employees, all sorts of good things happen. With a little preparation, the costs are low and the benefits to organizational climate and productivity can be significant.

    Dan Smith | March 2008 | Hawaii

  • 8.I'll go one further, Dan and Mark. Companies functioning in these environments need to have processes dedicated to educating employees about their obligations and responsibilities; they also need to understand consequences. Perhaps it's part of the new-hire orientation. But it's ridiculous to assert that employees can't engage in social media -- the company cannot reap the benefit -- because our employees don't know what impacts their actions can have. If they don't know, it's the company's failing, not the employees'. It's like sending soldiers into combat without training.

    Shel Holtz | March 2008 | Las Vegas, NV

  • 9.I love how you look so much alike your caricature, I know "duh" it is you! But it was just so amusing I had to comment.

    JJ | March 2008

  • 10.JJ, I used a service called Iconizeme.com, which uses a photo to create the image. You pick the artist you like best. Pretty cheap, too; around $50, as I recall.

    Shel Holtz | March 2008 | Jackson, MS

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