The FDA recently issued draft guidelines that impact how pharma can communicate in social media, but leaves many in the industry underwhelmed.

The guidance addresses only off-label information. It doesn’t cover on-label promotions, which means the industry can continue to communicate using this channel.

These guidelines provide instructions for pharma on addressing unsolicited off-label questions presented within a public arena, like a forum or chat room.

What industry can do:
If a question about off-label use is stated in a public arena (i.e., within a social media forum), the company may publicly provide a response. This response should:

1. Convey that the question pertains to an unapproved use of the product, noting the approved indication and safety information, and
2. Include the contact information for medical affairs, and
3. Only link to the product’s package insert. Links to promotional websites or third-party websites are prohibited.

Lastly, the firm should record the person requesting information and any follow-up questions from the requestor.

Industry agrees that these guidelines shouldn’t prevent companies from getting involved in social media. As long as they act in the spirit of the law, communicating in social media shouldn’t be inhibited by the lack of more specific additional guidelines.

She was given mere months to live.

Now, I’m sure you’re thinking, “How would I react if I or someone I love were given this sudden news?” and the answer in your mind might be to fold your cards and accept your destiny.

Did this stop my mother from living her life? Not a chance. She had deep roots in faith and religion and she never once complained, blamed God, or even her physician who missed her cancer six months prior. She never stopped fighting cancer. My mother didn’t live for just the six months given to her. She fought ovarian cancer for two entire years, always smiling and spending time with her children.

One could literally see the cancer eating away at her body. She physically was only a shell of the person she was when healthy. But I know that cancer never defeated my mother. It may have taken her body, but I know she was destined for greater things.

She inspires me regularly. There isn’t a day that goes by that I don’t hold a conversation with her, and I know she is listening. She has taught me what it means to be selfless, to cherish the life you’ve been given, and to help others in need.

That’s why I do what I do.

There is a parallel between Ralphie’s situation and the medical community. Some (not all) doctors and regulators believe that sharing medical knowledge and treatment information with patients is not in the best interest of the patient. At best, these physicians consider a patient’s personal medical research to be a waste of time. At worst, they think this information will be harmful to patients or reduce the stature of the medical professional.

But that’s where the parallels end. Unlike a BB gun, information and resources in the hands of patients can only help patients. Patients who research information and therapies may be told by their doctors “you’ll shoot your eye out,” but rest assured, the environment that fosters these interactions is slowly evolving.

The benefits of patient empowerment should challenge those in authority who currently do not value the patient role in medical care. Patients value physicians who work together with them in a partnership. The outcomes from these partnerships will eventually tilt the medical conversation so patients’ needs are better met.

And that leads to better outcomes for everyone involved.

From Compass, we wish you warm holiday gatherings, delicious Chinese turkeys, and for all of your holiday wishes to come true. See you in 2012!

Welcome to Social Media. The party is all your potential customers (or patients, in our case). The people at the party know each other, like or dislike each other, and are, in some way, connected with one another. And, of course, this party never ends.

The problem is nobody knows much about you. And you don’t know them—not really.

So when the big moment comes, what are you going to say? Are you going to walk in the front door and start shouting your brand’s benefits? Who exactly are you going to shout them at? After spending 10 minutes at the party, are you going to head home, feeling like you’ve checked the box?

Many brands do just that. They don’t grasp that to use social media effectively absolutely requires a commitment of time and energy to understand the community you are engaging with. Who are the popular kids (the influencers)? What are they interested in, what do they care about? Is there a good reason for them to care about your brand?

Let’s go back to the party. Grab a brew. Now, the first thing most brands think to do is to ask the Homecoming Queen to the Prom. In other words, we’ve identified a key influencer who is extremely popular and active in the community, and look, she’s standing right over there, and the brand would really love for that influencer to advocate for the brand.

OK, but why would the Homecoming Queen allow you to take her to the Prom? Is that fantasy, or reality? She’s very popular; you’re not. She has her reputation to protect. What’s in it for her?

That’s what you have to understand before you approach any influencer: what are they interested in? How do they feel about your brand? Is there something that you can do for them? What is it? You have to carefully engage with each influencer and try to find common ground. (A social media landscape analysis is a good start.)

Hopefully, you’ll find it—but there’s a lot more you can do. There’s a misperception that the most obvious influencers are the only targets of a social media engagement. Quite the contrary, usually we find that the biggest influencers are only willing to play ball with the brand up to a certain point—they are often too independent, they have their own agenda driving them, and they don’t want to be seen as working for your brand. That could diminish their credibility.

So it pays to find other voices in the community who are willing to advocate for your brand—the more, the merrier. These are patients who are already positively predisposed toward the brand, either from what they’ve heard from others, or from what they’ve experienced themselves (by participating in your clinical trial). Note that we’re not looking for patients who are neutral and then trying to “convince them” to advocate for the brand; we are looking for the ones who have already drank the cool-aid. They’re out there. By finding the real brand advocates, listening to them, providing them support and value as part of an ongoing relationship, your brand advocates will reciprocate by communicating the brand’s POV within their community.

These are all extremely valuable connections for the brand to establish. In the rare disease space patients tend to band together and rely heavily on each other for information and advice. Brands that participate and contribute value (beyond just the drug) through social media channels can reach and influence a relatively high percentage of their potential patients.

But it requires an ongoing investment in managing key relationships on an almost daily basis. Think Facebook, Twitter, LinkedIn. Nothing ever stops, and you want to be part of the conversation. Every community has its own personality and influencers, and new issues pop up every day. This is real-time learning that can help you evaluate how your brand overlaps with the needs of the community, and how to talk about (position) your brand to best fit with those unmet needs.

None of this can be done solely by “monitoring” and “observing” the community from afar. Personal relationships are an absolute necessity in order to gain trust, and yes, even friendship. Meeting patients in person (often at advocacy group meetings), listening to what people are dealing with as they attempt to manage their disease (only a small part of which is your brand), and being able to demonstrate that you understand the patient experience are all critically important if you hope to dance with the Homecoming Queen—or anyone else, for that matter.

At 35, while pregnant with my sister, my mom was diagnosed with Type 2 Diabetes. In the 25 years that followed my mom suffered from nearly every complication on the list. It started slowly, but eventually there was a seemingly constant onslaught of medical problems, including high blood pressure, foot infections, hypoglycemia, nerve damage, circulation issues, iron deficiency, eye complications, chronic UTIs, and kidney disease (to name a few). In the last two years of her life she was in and out of the hospital constantly. She’d been diagnosed with end-stage renal failure and continued to struggle with life-threatening wounds due to extreme numbness in her feet. She remained good-natured through it—and even liked to joke about the time she lost a shoe but didn’t realize she was barefoot until she had walked across a parking lot and got into the car with my dad.

My dad was (is) amazing. My mom didn’t want to have to be in the hospital for dialysis treatments so my dad learned how to administer peritoneal dialysis at home (which needed to be administered EVERY night—by my dad, the CARPENTER). He learned how to take care of her wounds—including all of the equipment needed to help stimulate her circulation. He ordered all of her medical supplies and equipment. He dealt with the medical supply companies when things didn’t work properly. He checked her vitals and blood sugar several times per day. He drove her to every appointment. He did all of her shopping. He did all of her cooking. Eventually, he fed and bathed her. He even made a crazy contraption out of wood that enabled him to take her and her wheelchair up and down the stairs—one stair at a time!—so that she could stay at home near the end and sleep in her own bed. (I remember it made a horribly loud noise as is lumbered from one stair to the next and I was always sure he was going to hurt himself.) I never saw anyone more determined.

My mom ultimately succumbed to her disease in 2007 at age 59. It’s hard to say what complication was really the culprit, as her body was so badly ravaged at the end. My dad was destroyed. Not only did he lose his soul mate, but he also felt like he lost his entire purpose in life and his reason for being. He’d spent the last two years caring for my mother 24/7. The concept of “free time” hadn’t existed in his world for over two years. But suddenly there were no medical appointments to fill up his week nor treatments to administer nor vitals to check. Other people were moving on with life but he had to figure out a new life. It was incredibly difficult (and that doesn’t begin to cover it). It took him over two years to find his “new normal”—and of course he still has moments of extreme emotion. In those moments, I just hug him and tell him how much I love him.

In the coming years, I would love to see us (Compass) and our clients do more for the caregivers—not only during the diagnosis and treatment stages, but also after they have lost their loved ones. At the end of life, one hopes that the patient moves on to a better place. But I can tell you from experience that the caregiver moves on to a far worse place. It’s a place filled with despair, guilt, sadness, and an overwhelming feeling of disorientation. I know that we can help them. The opportunity to play a part in that is why I do what I do.

There are two pictures—one of my mom and I at my wedding in 2006 (10 months before she passed) and the other is my dad with my sister at her wedding in 2011. I can see in his eyes that he’s thinking of my mom. I’ve come to know that look. ☺

That’s why I feel very close to Laura when I meet a patient who refuses to see their condition as a limitation or a handicap. Recently, at a patient advocacy group meeting where I was conducting focus groups, a young boy was asked to describe how his condition affected him. He was silent for a moment, and then he said cautiously: “Well…I suppose it might be better maybe not to have it.” That was as negative as he got, and his condition was not something to take lightly. He was so engaged in living, so focused on what he could do and what he was going to do, that his condition almost didn’t matter. My sister was the same way: a mix of optimism, practicality, and uncommon bravery. Laura never, ever talked about her medical problems, even when she was very sick, in the hospital, undergoing painful procedures, or on her deathbed. She talked about her friends, and about what she was doing, and she always wanted to know how I was doing.

Laura inspires me to do what I do.

A posting on the website of an online rare diseases group, which I’m a member, described the frustrations and despair of Antonieta, a Brazilian mother whose 33-year-old son has a rare disease known as Cerebrotendinous Xanthomatosis, or CTX. Since 1993, he had been treated with a medication that had changed manufacturers numerous times. The medication was now being offered for a price 10 times higher than what Antonieta was used to paying, and she could no longer afford the treatment that her son needed for survival. Antonieta, who had already pursued legal measures within her country to get help paying for the medicine (to no avail), had run out of options. She ended her post: “I don’t know what to do…”

The disease sounded familiar, so we at Compass researched it and tracked down the pharmaceutical company that is now in the process of filing an NDA for the drug. At that point, we sent an email to both Antonieta and the president of the company to put them in touch with one another.

That simple online introduction was all it took.

Antonieta thanked us very much for reaching out to her, and in 24 hours we got word from the pharmaceutical company that Antonieta will now be receiving the drug her son so desperately needs through the organization’s compassionate use program.

It was a great feeling knowing that one simple action could have such a profound impact on the lives of others. As a full-service patient marketing agency we understand the intricacies of marketing to patients—from message development and disease education to patient advocacy and support services. But it’s always rewarding to hear from patients directly to know that our contributions make such a difference.

Compass Healthcare Marketers will be holding our 5^th Annual Innovation Lab: Translating the Patient Experience into Commercial Success, to answer these essential questions. Join us for one day at San Francisco’s Cavallo Point lodge where rare disease industry professionals will come together to talk about the important role of the patient in their commercial planning, as well as address key topics in the orphan drug space.

This “closed-door” session—no media or regulatory agents—with leaders from several orphan drug companies and expert consultants will provide a safe and intimate environment in which we can have a very honest and productive dialogue about:

• The unique commercialization challenges in the rare disease and orphan drug space
• Pricing, reimbursement, and market access strategies for orphan drugs
• Social media’s unique and significant influence on the patient experience
• How to find, acquire, and inspire patients with rare diseases
• Case studies of orphan brands leveraging the patient experience for commercial success

Vew the complete agenda or register now to attend this exclusive, industry-only, “closed-door” event to learn more about understanding and leveraging the patient experience in the rare disease and orphan drug space.

After the workshop, we will also be hosting a wine tasting event featuring Cavallo Point’s extensive collection of Old World and New World wines.

We look forward to seeing you on the 20^th in San Francisco!

At that moment, though, something told me a deeper answer was in order. See, what my son really wanted to know was why I went to work instead of staying home and playing with him. He’s the only boy in the family (the poor kid has three sisters!) and he’s a Daddy’s Boy. He misses me terribly when I’m at work and I thought he deserved a better answer than any of the facile responses that passed through my head. He deserved an honest answer, one that might help him really understand why I do what I do. So I said, “I work for your Uncle Matt.”

My son didn’t know his Uncle Matt. In fact, Matt wasn’t even his Uncle. He was, however, one of my best friends, and he died last year after a long, brutal, and devastating battle with a rare disease called Huntington’s. Huntington’s is a genetic disorder that affects muscle coordination and, ultimately, leads to cognitive impairment, dementia, and inevitably death. Roughly 50% of children with affected parents will develop the disease. Unlike most Huntington’s suffers who become symptomatic in middle-age, Matt learned he had the disease in his early 20s. He faced it bravely, as I knew he would, but it ultimately claimed his life at the age of 36.

There are no effective therapies for Huntington’s beyond a few medications that can marginally—and briefly—improve quality of life, but I’m hopeful that with continued research and investment a cure may someday be found. In the meantime, I do what I do. I work to raise awareness of rare diseases like Huntington’s and to help those affected by them. I help bring patients together with those who can offer them potentially life-changing therapies. That’s something of which I’m tremendously proud and passionate. Even more than that, though, I’m proud to be associated with the folks here at Compass. Each of us has a similar story to tell and an equal level of passion and pride in the work we do.

But most of all I’m very proud that when I told my son, “Daddy helps people who are very sick find ways to get better,” the look on his face told me that he’s proud of his Daddy, too.

The sale of miracle cures, many of which had low success rates, was common in history. Before scientific advances, Pharma products and their sales were more about showmanship than actual success. If you projected your voice, dressed well, and made the most compelling claims, sales would soar.

Marketing of non-prescription medication, including pain relievers and allergy medicine, has been alive and well since medicine’s inception; however, it wasn’t until 1997 when the marketing of modern-day prescription medications to patients entered the equation. Prior to then, it was believed that the mass marketing of medicine was fruitless, since it was doctors who chose which medicines to prescribe; patients had virtually no say in their treatment. With that belief, marketing to medical professionals seemed to be the smartest route.

Marketing to healthcare professionals included detailing in doctor’s offices and hospitals, and placing ads in professional journals; an important part of these efforts was marketing to medical students.

Things changed drastically with the advent of the Internet and the introduction of e-marketing. Healthcare professionals now had a vast reservoir of information at their fingertips. But so did patients, and with this knowledge began an era of patient empowerment, with patients now taking a more active role in their healthcare.

The other day, while cruising the net, I came across this funny video about the Internet-spurred growth of pharmaceutical marketing, created by well-known pharmaceutical digital marketer Kevin Nalty.

The empowerment of patients was critical for marketing, especially for those suffering from rare diseases. Some diseases are so rare that many physicians are unaware they exist, let alone know how to accurately diagnose and treat them. So these patients have taken to the Web to find information about their disease and how to diagnose and treat it. They’ve also found the Web useful in connecting with others with similar experiences via social media. Before the internet, educating patients with a rare disease like NAGS deficiency would have been very difficult. And it simply would not have made sense to market to physicians who most likely would never encounter a patient with such a rare disease. But the Internet has brought people closer together than they’ve ever been, and opened doors that didn’t exist just several years ago.

And opening doors is just what Compass is here for. Compass knows that when patients understand their diagnosis, disease state, and treatments options, they are much more likely to engage in their own care. Compass focuses on empowering patients and their caregivers with rare diseases. By understanding their unique experience, pharma companies, healthcare professionals and other stakeholders in the rare disease community can provide greater support, which can lead to better outcomes. Whether through social media, mentor programs, conferences, and disease state awareness campaigns, or a myriad of other ways of engaging the community, Compass is determined to make a difference. And seeing how far pharmaceutical marketing and patient empowerment has come in just the last 15 years, being able to reach and positively impact the life of every patient with a rare disease doesn’t seem as unrealistic as it once did. It is now a very real possibility, and Compass is doing everything in our power to make it a reality.