Last week Pixels & Pills’ editor Briana Campbell had the pleasure of sitting down for a Skype chat (so the quality is a little lower than our normal, professional videos) with Dr. Darshan Kulkarni (@FDALawyers) of the Kulkarni Law Firm in Philadelphia. And while the questions answered in the conversation don’t constitute legal advice and should not be constructed as such, we were very happy to get the thoughts of a lawyer on the recent FDA draft guidance. And to have him address some questions that you all had put forth on Twitter.

Further information on some of the things Darshan touches on can be found in the following sources:

The Park Doctrine

Par Pharmaceutical versus the FDA

FDA’s Cease and Desist to Triple Flu Defense

One more time, Jonathan Richman’s handy flow chart

He also mentioned to us, after we’d turend the camera off, that the FDA uses draft guidance as a way to express their thoughts on certain issues without the rigor of regulations. There is much draft guidance out there that never becomes finalized. To us, this means that we should take the guidance for what it is – all we are getting on emerging electronic/social media platforms at this time. And maybe ever.

Do you have questions for Dr. Kulkarni? Thoughts on this conversation? Leave them in the comments and we’ll continue the discourse.

by DJ Edgerton (@wiltonbound)

The question seems almost nonsensical at first – your Twitter followers may be really outstanding people, but they’re not organic chemists or researchers. And your Facebook fans, while devoted, probably do not, generally speaking, know how to move a new drug through the FDA approval process.

Just the same, it’s a mistake to discount your social audiences as a source for insight and innovation. In fact, a wide range of category-leading companies do just that. While social media is not as planned or controlled as a focus group, there’s potential in polling the audience when it comes to research and development – and along the way you can even benefit the very people you’re polling.

Doing it right requires a three-step plan:

Understand what you want to accomplish. In this regard, social media is no different than traditional R&D research: Don’t ask existing or potential customers anything without a clear purpose behind “the ask.” What do you want to accomplish? Are you looking for feedback on a service (such as when consumers call into the customer care center) or improvement on a product or direction for a new advertising campaign? What about new products: Are you exploring the potential for one or looking at whether your customers have a need for a product that you have not thought of?

A solid roadmap will have goals covering what you hope to accomplish and clear indications of which social channels are – and are not – appropriate. Need to demo a product? You Tube makes sense. On the other hand, Twitter may be a better fit for simple questions requiring quick feedback. And tools like custom Facebook apps offer ways to bring customers and fans into the content creation process.

Be relevant in your questions and rigorous in your data collection. A solid roadmap lays out needs and expectations, but even the best plans can go astray if your research questions don’t balance your needs with the realities of social media, which often boil down to: Don’t be boring.

Tweets sending people to a 50-question survey or requests that Facebook followers sit through six sample commercials in search of the one they like best are unlikely to go anywhere. Instead, keep things short, clear and – most importantly – be ready to monitor and take feedback from the conversations that grow out of your public questions. They can be the source of tremendous insight.

Crunch the data and don’t leave the audience in the dark. One of the unique aspects of social media is that a lot of silos get knocked down – people have a great (and sometimes unreasonable) desire to peek behind the corporate curtain and know what’s going on. This is a powerful force and can jump-start your social-driven research – people love to be treated like insiders, and promising to give them a first peek at a new innovation, a new campaign or even just a slight change in how your company does something will motivate participation in your research.

The key is: You have to deliver on your promise. If you tell participants you’re working on a new way to talk about an established product and want their input, give them a peek before it’s rolled out to the public. Not doing so is bad form in the social landscape; promising to do it and then not delivering is an even bigger faux pas.

Whether it’s a one-drug boutique company or a global powerhouse, research and development is a constant part of pharma’s product and service lifecycles. While social media isn’t a substitute for formalized marketing research, it can be a powerful, low-cost augmentation to the toolbox.

by Krissy Goelz (@krisgoelz)

Recently, we were asked what we thought about how Google+ could affect healthcare, by someone who had read an Xconomy post on the same question.

So, does this newest, mega-hyped social network have the potential to really transform the industry? As you’ve seen with our many point/counterpoint articles, we like to pick up an issue and look at it from all different sides. And certainly this question has a few possible answers. Let’s look at them.

“Yes! Google+ is already transforming healthcare.”

Like the rest of Google+, it’s getting there, just maybe a little more slowly than we expected. As one piece of evidence, just look at this list (curated by Ed Bennett of the University of Maryland Medical Center) of hospitals on Google+. (You probably know Ed from his encyclopedic and invaluable Hospital Social Network List.) It’s not huge, but it’s a sign. Hospitals realize that they need to find new ways of communicating and advertising in order to survive in an ever more competitive. They haven’t historically been known for being cutting-edge in social media, so you could argue that their presence on Google+ is a sign that it’s gaining mainstream acceptance.

The main way in which Google+ could change healthcare, or any industry, is in its revolutionizing the concept of sharing. Thanks to Google+, sharing is no longer an all-or-nothing proposition. And that, friends, is what will change the game. You don’t want everyone you know to be privy to your health history – you want that information available only to a very select group of people, who can only do very select types of things with your data. A year ago, social networking didn’t offer that ability. Today, thanks to Google+, it’s not only feasible, but extant.

“No! Google+ won’t have much effect on healthcare at all.”

On the other hand, it’s not likely, the skeptics say, that Google+ could transform an industry when it can barely transform itself into a social network. This is mostly a reaction borne of the disappointment people feel. The network arrived like a cannon blast, but has since fallen to more like kazoo-level excitement. Some pessimists say it’s never going to rise above that level. A social network does need a good structure, but it also needs the user-supplied content to succeed. Without that, it’s just a skeleton. So with people not using Google+… well, if it falls in the forest, will anyone care?

“Maybe? Google+ could matter to healthcare… or it could not.”

The potential effect of Google+ on healthcare depends upon the long-term health of Google+. Thus far, reports of its death, like Mark Twain’s, have been greatly exaggerated. Don’t forget that Facebook didn’t come out of nowhere; it’s just that when anything hits its tipping point, it seems to. Perhaps Google+ will come to nothing, and then, obviously, it won’t change healthcare. But what if its biggest rival, Facebook, does put a foot wrong, and Google+ seizes the opportunity? Then, it may change our social networking, our relation to friends and family, and, certainly, it could also change our healthcare.

Bottom line? It’s too soon to know… but it might not be Google+ who does it.

I can’t in good conscience be as optimistic as Rich Whalley and Steve Dickman, the authors ofthe original post that brought up this topic. They seem to believe pretty wholeheartedly that Google+ is changing the healthcare game. But while the geeks (and I count myself among them) were all thrilled about Google+, in the months since its launch, it’s fallen fallow – and I don’t know for sure if it can come back.

However, what does intrigue me was something our friend Jon Richman had to say recently about the new Facebook Timeline – and, in particular, the new ability to add “health and wellness” updates. Here’s a bit of what he had to say:

They even suggest a few to get you started (“Broke a Bone”, “Had a Surgery”, “Overcame an Illness”). However, you can put in anything you want here. One of the big reasons why people don’t share health information publicly, including Facebook, is because they don’t see others doing it. It’s not the norm. Well, sharing your location wasn’t the norm a few years ago, but people started doing it via “checkins” and now it’s pretty common among a large percentage of people. The question is whether this will extend to sharing health information.

My prediction is that it will. Not today or tomorrow, but in the near future. The tipping point will be when people start noticing some benefit for sharing this information. There really isn’t much incentive now. However, if you knew that you’d get better care by sharing this information, you probably would.

That, to me, is the crux of the matter. When we can use social networks to help patients help themselves faster and better than they could be cared for otherwise – that’s the transformation, the tipping point, the revolution.

So what do you think? Is Google+ going to revolutionize healthcare? Is Facebook? Do social networks have this capability at all? And if they do, what will patients use it for – what will that killer-app functionality be?

by Russ Ward (@russcward)

Browse through the business press, and you won’t have to search long before you find articles about pharma, patents and a whole lot of drama. From a patient perspective, what’s the big deal?

The issue: Within the next few years, multiple pharma companies are set to lose their exclusive production rights to some of the world’s most popular drugs and medications. This “patent cliff,” along with recent changes in Washington, means big changes in pharma patents – and that means big changes for patients.

If you’re in pharmaceutical marketing, you know all this – but patients don’t. And smart pharma marketers are looking at ways to bring them up to speed on this inside-the-industry issue.

Why do patents matter to patients?

Patents mean breakthrough drugs. Patients hear lots of advocacy messages from critics about the high cost of name-brand pharmaceuticals, but how often do they hear the other side: That patent protection means a company with a breakthrough drug has many years to offer its product exclusively, recouping the hundreds of millions (or sometimes billions) of dollars that can go into R&D? It’s no stretch to think that if patent protections weren’t in place, many of today’s most innovative pharmaceutical products might not be brought to market.

As an example of how exclusive drugs and their patents can impact a company, look at Merck. The company is struggling with the loss of patents, with two big expirations that contributed to a 2010 sales decline of 41 percent. Pfizer is watching closely: In 2010 sales of Lipitor alone accounted for more than $10 billion of the pharma giant’s annual income. When the company got a 10-month extension on Lipitor’s patent in the European Union, the Financial Times reported it had the potential to earn the company an extra $770 million.

Expiring patents can mean big discounts for consumers, but also create a marketing opportunity for the expiring brand. Pharma products that were sold for years on features and benefits often face a thrashing when generic competition opens up — an IMS Institute for Healthcare Informatics report states that more than 80 percent of a brand’s prescription volume is replaced by generics within six months of patent loss. That’s because most drugs are sold purely on features and benefits, with late-to-the-game brand marketing trying to keep consumers with the patented product only late in the life cycle. That’s a mistake, and pharma marketers should explore whole-lifecycle brand reinforcement that makes generics have to work harder for customers.

From diversification to purchasing competitors, pharma companies have a range of business tools for facing the threat of expiring blockbuster-drug patents. It’s time they added more strategic, life-cycle branding and consumer education to the toolkit.

The Defining Moments series looks back at the biggest events of 2010 to see what we can learn from them here at P&P, to work better in our calling, in 2011 and beyond.

Where were you on Wednesday, October 13, 2010?

I’m willing to bet that, at least at one point during the day, you were staring at a television screen, watching a tall, narrow metal cylinder on a long chain, from which, at long intervals, men in sunglasses periodically emerged.

Thirty-three men, trapped half a mile underground in a caved-in mine in Chile for 69 days, were the center of attention for the world: millions of people watched online and on television, while every one of them was brought out, rescued safely and brought back above ground to their families.

They were essentially buried alive for more than two months. Just the thought of that is enough to make your skin crawl, and to start a feeling of panic building in your gut. But these men didn’t panic. They didn’t lose it. They didn’t do nothing. They didn’t stay stuck.

They followed schedules of sleeping and waking. They kept themselves clean and neat. They set dining and living etiquette rules. They prayed. They built a desk from a vehicle hood where they could write. They recorded videos. They ran miles every day.

Even in the most hopeless, stuck, terrifyingly claustrophobic conditions, you can’t just throw in the towel. Well: you can, certainly. But you can also NOT. And in so doing, you can succeed.

Think about the things that frustrate you the most – make you feel like you’re stuck. At work, it’s probable that you’re waiting for things outside your control. Your project is being held up waiting for approvals. The product you work on is getting hung up by regulatory issues. The budget has been cut because of the economy.

You could take those restrictions and give up – or, you could look them in the face… and then look around them. There are many things you can’t change or improve, no matter how much you may want to, or how right you are. Nonetheless, that doesn’t mean you can’t change or improve anything.

Stop staring at the problem that’s keeping you stuck and look around it to see what you can do.

You can’t change the mind of the FDA, you can’t find a million dollars in a filing cabinet, and you can’t turn a legal and regulatory review into a Siskel-and-Ebert thumbs up. (If you can? Give me a call!)

But that doesn’t mean you can’t take any action. You can develop plans for what to do, depending on each of a variety of different responses from the FDA. You can look at lower-cost ways to still get the same goal accomplished. You can realize that your review team are a bunch of human beings who are all working toward the same goal. And you can remember that if 33 everyday guys can become the living definition of defying their circumstances and refusing to give up, things like that are the least that you can do.

Here at Pixels & Pills, we’re always trying to push the conversation about health and pharma in the digital space harder and farther along. Which is why we were intrigued when Shwen Gee let us know about The Social Health Un-Conference (SXSH), taking place September 19^th, right before ePatient Connections.

Aside from the impressive speaker list – with a kickoff keynote from Todd Park and keynote presentations from Ed Bennett, Sarah Krug, Lawrence Sherman, Jane Sarasohn Kahn, Garth Holsinger – and the great people leading and speaking at the unconference, SXSH has a mission that we can really get behind.

From the website:

SXSH hopes to facilitate and inspire conversations that are already taking place amongst the entire healthcare spectrum on social media platforms in order to help motivate us to solve problems across healthcare in new and innovative ways; ultimately bringing better care to patients.

As followers of Pixels & Pills are well aware, we are in a time of great change in the pharma and health industries. And there is some amazing opportunity for innovation. We want not only to keep the dialogue open, but to help it along as much as we can.  Let’s leverage the power of these technologies and communities and see if we can make that change happen just a little bit faster.

If you’re interested in attending The Social Health Un-Conference, please visit their website. To register (it’s filling up fast!), please visit SXSH on Eventbrite.

by Briana Campbell (@MsMatchGirl)

The talk, for a long while now, has been about Facebook’s change of guidelines, no longer allowing pharmaceutical companies to turn off comments on their Facebook walls. Yesterday, D-Day arrived.

Over on Dose of Digital, Jonathan Richman, was keeping a “deathwatch” vigil over pages that were apt to be removed. On Friday, the Washington Post did a nice piece of reporting, covering the reasons for and against (the comments, though perhaps not informative, are certainly entertaining), and Facebook’s reasoning behind the changes. As quoted: Andrew Noyes, manager of public policy communications for Facebook, said in an e-mail, “We think these changes will help encourage an authentic dialogue on pages.”

Over on Impactiviti Blog, Steve Woodruff posed this question: Does Pharma (a company and/or brand) really have anything uniquely valuable to offer on social media platforms? And he asks for us to leave our comments at the bottom of this post (where there is a pretty robust and very interesting discussion happening).

It’s a question we’ve been debating for a long time now, on Pixels and Pills, even last week posting a Point/Counterpoint, where two of our own took to two sides of the issue of whether is was time to give up on social media for Rx information or whether pharma companies and docs should stick it out and ride the wave.

Regulations are tight in pharma and healthcare. This is something that we are well aware of. But does this mean that pharma needs to keep its head in the sand, constantly going with the status quo? Never pushing forward?

In my opinion, no. Facebook, Twitter, Quora and blogs on a company’s own site, these are all great tools for providing information and engaging with interested people. Will there be some jerks out there, leaving comments you don’t agree with, or mentioning off-labels uses? Sure. It’s likely. But these comments can be moderated. They can be deleted. Facebook has native tools in place to filter certain words and phrases, which can be very helpful in moderation and in managing the community. A great community manager can soothe an upset commenter, engage the happy ones and provide information, content and resources to keep everyone talking. Pharma companies/brands on Facebook have long had the luxury of simply turning off the comments on their walls, as opposed to dealing with what might happen if they were to leave them on.

Let’s face it, people turn to social media platforms like Facebook to engage, to share – with brands, with people of the same interests, with people with the same problems. They look to social media platforms for community. By not allowing comments for so long, pharma companies have been able to navigate the waters of social media, while avoiding the “troubles” that may arise given true dialogue.

Facebook is a place for engagement. As a social media professional, I don’t understand, personally, why anyone – brand, company, person – would approach a social media platform (of any kind) if not to engage with their users, their friends and, heck, even their enemies. Lack of direction from the FDA has a lot of companies running scared, but does that mean that they truly need to cut and run?

by Briana Campbell (@MsMatchGirl)

There has been a lot of talk, over the past few months, over Facebook’s changing commenting policies and the pharma industry. Our friend Jonathan Richman clears things up nicely on Dose of Digital, so we won’t bother going into too much detail here. Basically, though, Facebook has changed its policy regarding comments on a gage. Wherein, in the past, a pharma brand could request to have comments disabled on their brand’s page, the policy has changed to allow only pages that are dedicated solely to a prescription drug to have the option to disable commenting.

Since pharma itself is such a highly regulated industry, this change has caused a problem for brands trying to engage (where their users/patients/communities are) but still control what is put on the wall of the page. What’s the problem, you may ask, in users posting what they think about a pharma brand/drug/product on the wall of a page?

It’s not so innocuous as it seems. The pharma industry, as those who are regular readers know and can relate to, is a highly regulated industry. There are a ton of rules. And a drug can only claim to be and do what the FDA has said it is OK to claim it is and can do. With open comments, companies run the risk of the general public suggesting uses that the drug is not approved for or making accusation against the company or even sharing unsupported (yet enthusiastically positive) praise. And much to the dismay of nearly everyone in this space, the FDA has not offered clear any guidance on the subject of health care and pharma social media.

There are ways (and were more when there was the simple option of disabling wall comments) to get around the touchy points and stay on the good side of the FDA when a pharma company has a Facebook presence. They include great community management (We’re talking someone monitoring and moderating twenty-four/seven) to using a spokesperson whose page would need less stringent regulation, but would still need a large amount of management, moderation and an eagle eye. Facebook has some filters in place for pages – where, for instance, a brand can set a list of words to block and checked before the comment will be approved – but the spammers and malicious commentators who want to get around them will do so. And easily.

Last week we heard about a new product, a Facebook “monitoring and moderation tool,” called PharmaWall, whose features (from their website) include:

We are curious if anyone has had a chance to play around with the live demo or implemented this product on your own pharma Facebook page yet. What do you think? Is this the tool you’ve been looking for? Will it make your role as a page administrator any easier?

And hey, if you think it’s still all too complicated, there’s always traditional advertising…

by Jon Fisher (@jmfisher)

Summer days used to mean scraped knees from wiping out on a bicycle or not heeding a lifeguard’s warning about no running around the swimming pool. These days? My fear of getting scraped is no longer from a reckless streak or summer sports; Like others sharing personal and health information online, I’ve become wary of data scraping.

The market for personal data about Internet users is large and growing. Professional scrapers track people’s activities; harvest that information, and then sell the details about their behavior and personal interests – usually without people even knowing it is happening. Data brokers have traditionally scoured public records for information, but social networks are becoming the new public records.

Recently, the online forum PatientsLikeMe noticed suspicious activity on one of its message boards. Sure enough, a member began scraping patient data, violating the site’s terms of service in the process.

On forums such as PatientsLikeMe, where people discuss experiences with AIDS, Multiple Sclerosis, depression, post-traumatic stress disorder, cancer, and other medical conditions, there is an expectation of privacy and being able to share freely. Behind the safety of anonymity, people willingly share details of their disease and treatment or read about other patient’s similar experiences in a quest for knowledge or alternative approaches.

Some members use a pseudonym on online message boards, but that’s proven to offer little protection in ensuring privacy. In the case of one PatientsLikeMe participant, his fictitious identity linked to his blog, which contains his real name.

We’ve grown comfortable participating in online communities, but the ‘net should come with a Miranda warning:  Everything you write can and will be used against you. PatientsLikeMe does sell data about its users, but the data it sells has no names attached. However, technology is available that matches people’s real names to the pseudonyms they use on blogs, Twitter and other social networks. Once medical records are electronic, the chances of even more personal information becoming available increases.

There are a few things you can do to make it difficult for others to use your information without permission:

*Most browsers have sophisticated privacy features. Upgrade to the most current version for maximum protection and consider browsing in “privacy mode” or incognito mode.”

*Monitor privacy settings on sites such as Facebook and Twitter and choose the strictest setting.

* Check for privacy policy updates on sites you visit regularly. While the site may have protections in place, your data may also be tracked via third-party entities as well. Check and delete all cookies on a regular basis, and block third-party cookies.

Some may say it’s paranoia to be worried about how your data will be used, but when it comes to online activity, having a healthy dose of paranoia is critical for protecting privacy.

by Krissy Goelz (@krisgoelz)

We’re not the first ones to tell you that Facebook is changing its commenting policy for pharma pages. Lots of our compatriots have done that in recent days. For a particularly great summary, check out Jonathan Richman’s Dose of Digital: he’s got the full story.

No, we’re not the first. But we ARE going to say something that nobody else has pointed out yet:

This is going to force pharma into the next stage of social media.

Facebook’s changen is exactly what the industry needs. No company was going to go too far out on a limb on its own, and we all know that long-promised guidance from the FDA wasn’t going to materialize. We should have known that the only force that would make things happen would need to be external – not pharma and not regulatory – and it would need to be big.

And what external force is bigger in social media than Facebook?

So far we’ve been treated delicately – special – and Facebook was very, very smart to do so. To co-opt a great metaphor that John Mack used, they were the lifeguard letting the scared kid keep his swimmies. All the other kids had grown up and moved past that stage, but pharma still needed that extra security, that extra feeling of safety, in order to sidle in and get the feel of things.

But now Facebook knows that we’re hooked, and because of that, it can push us to change. It’s a hot summer and we aren’t about to stop splashing around in the pool with all the other kids. It’s time to grow up. We can’t be the only ones with swimmies anymore.

So with apologies to Madame de Pompadour for misquoting her: after this, the deluge.

Facebook is telling us we’ve got to play by everybody else’s rules. We’re either going to have to hold our breath and jump in, or go play by ourselves and get left out.  And I don’t think pharma can stand being left out.

It will be too big of a leap for a few, just as some kids never did get up the nerve to climb up on the diving board. But most of us will figure it out.

Just like most kids, we probably wouldn’t have given up our swimmies of our own accord. It’s pretty rare to voluntarily give up your feeling of security. Sometimes the person in charge of the place has to tell you that you’ve got to grow up if you want to stay.

So well played, Facebook. Starting August 15, the Facebook experience for pharma is going to be exactly the same as for for every other brand. No more swimmies.