The launch of a new medication can be a very exciting event.  It can renew hope for a better future and provide proof of the billions spent on research every year.  It can also stimulate a lot of interesting conversation.

Or not.  We’ve learned from you that not every new medication warrants your attention and discussion.  What’s fascinating is learning which ones do and which ones don’t, and why.  We saw a recent example of this on PatientsLikeMe:

(In this chart, the medications are called “A” and “B” so, as we continue to observe and research dialogue about these medications, we will not have influenced you in any way.)

This chart shows the volume of conversation about two new medications that were approved by the FDA to treat the same disease.  We studied the time immediately following FDA approval of each new medication to see whether or not patients were talking about them.  Since the drugs were approved at different points in time, we simply shifted them onto a single timeline for head-to-head comparison.

What a difference!  In the first month following FDA approval, you discussed Drug A 67 times but Drug B only 25 times.  Three months later, the difference grew to 402 discussions about Drug A to only 42 discussions about Drug B.

What caused this difference, and why is it so pronounced?  Let’s get the obvious stuff out of the way:

• There was no major event or change on PatientsLikeMe during this time.
• The number of patients on PatientsLikeMe was approximately the same when both new medications were approved.
• PatientsLikeMe was not influencing conversation on either new medication.
• Neither medication was available for use before month 3, long after the two lines in the chart had separated.
• Similarly, the companies that developed these new medications did not begin their marketing efforts before month 3.

What this leaves is the new medications themselves.  There must be something different between Drug A and Drug B – could be side effects, could be efficacy, could be something else entirely – that drove the volume of conversation about Drug A only.  PatientsLikeMe will study this in greater detail to understand and illuminate the factors behind this phenomenon.

Why?  Because researchers need to know what you value in new medications.  By listening to your unmet needs, researchers can develop solutions to unsolved problems caused by your disease.  Wouldn’t that get you talking?

This is just another example among many of how you are selflessly giving back and helping advance medicine on PatientsLikeMe.

2010 was a strong year for business development at PatientsLikeMe.  Our goal was – and continues to be – to align patients’ needs with industry interests in order to maximize interaction between the two.  Here are a few of our successes and challenges over the year.

Successes

1.  New Partnerships, New Communities

In the first quarter of 2010, PatientsLikeMe launched two communities with corporate partners.  UCB helped us develop our Epilepsy Community, while Novartis partnered with us to create our Transplants Community.  Both communities have grown to more than 3,000 patient members and are now the largest of their kind in the world.

As with all of our partnerships, we made sure the focus is on the patient experience.   For example, what are your perceptions about the medications you take?  How do you see these treatments impacting your quality of life?  Getting quantifiable data on such questions can help our partners understand how they can help patients like you improve your health outcomes.

2.  Enhanced Services for Partners

When we create products and services for our corporate partners, it’s with a single objective:  to amplify the patient voice.  As a result, healthcare companies who wish to improve health outcomes have the information to improve their products and services accordingly.  In 2010, PatientsLikeMe further heightened the voice of patients by enhancing two existing products.

PatientsLikeMeListen^TM and PatientsLikeMeLandscape^TM

These complementary services help measure both the frequency and sentiment of treatment discussions in our community forums.  In 2010, we added functionality that allows our partners to see a longitudinal comparative view of patient sentiment (using  PatientsLikeMeListen^TM) as well as identify discussion topics that are rising within a forum (using PatientsLikeMeLandscape^TM ).  Both products help to elevate patient concerns and bring their importance and relevance to life for industry partners.

Challenges

As a for-profit health company that enables data sharing by patients, we knew we’d face our share of challenges.  2010 was no different.  Many groups, including patients, nonprofits, government and industry, had valid concerns about working with PatientsLikeMe because of our Openness Philosophy.

1.  Guidance on Industry Interaction with Social Media

One of the main (and valid) concerns our industry partners express is that the Food and Drug Administration has yet to deliver clear guidelines on how to interact with social media.  Dipping their collective toes into the social media wave pool is perceived as risky because the FDA levies severe penalties for companies attempting to directly sell to patients.

PatientsLikeMe has taken a leadership role in addressing this concern by further developing our PatientsLikeMeLeaders^TM service. After investigating all privacy and regulatory conditions, PatientsLikeMe has created a fully compliant solution for direct industry-patient feedback in an online forum that we moderate.  Now you as patients will be heard directly by those making decisions on what treatments are developed and how they are introduced, while our partners can learn what patients like you want and need – without fear of non-compliance.

2.  Being Open About the Data Scraping Incident

In May 2010, we discovered that a major media monitoring company had created a patient account and automatically downloaded forum posts in order to add data to their sentiment analysis client service.  Not only is that a violation of our User Agreement (“You may not use any robot, spider, scraper, or other automated means to access the Site or content or services provided on the Site for any purposes.”), but it reduces the trust patients have with our site.

We dealt with this challenge openly by disclosing our discovery of this “data scraping incident” the day it occurred.  We sent a message informing all patient members, and about 200 patient members left the site as a result.  In October 2010, The Wall Street Journal included PatientsLikeMe in its special series on the benefits and risks of sharing health information online, with the practice of data scraping highlighted as a risk to patients.  We welcomed this article coverage and continue to engage with other leaders in this ongoing discussion.

Since our PatientsLikeMeListen^TM product measures sentiment of discussions in our forums, we reminded our members about this similar service.  We will continue to inform and educate our members about how we conduct business so there are no surprises.

Summary

In 2010, we continued to grow our patient communities and further confirmed that the success of our business lies in aligning patient and industry interests.  In fact, we have recently been cited by the Board of Innovation as one of 10 Business Models That Rocked in 2010.

Because of the sensitivity of sharing health data online, however, we remain upfront, open and transparent about our business practices so that patients like you can be informed participants in your health, medical research and the development of effective treatments.  Happy 2011!

This week on our blog, we’ve been highlighting how patients like you are putting their experiences in context.  With the launch of InstantMe and some of the design updates you read about, you can see we’re listening to your call for more functionality that lets you understand how your condition affects the whole you.

Patient Reported Outcomes (PRO) questionnaires are a great tool to illuminate the physical, mental, and social dimensions of your overall health. In fact, PROs are increasingly used in clinical trials, and in December 2009 the FDA approved the use of PROs to support product claims. Best of all, PROs are free of clinical interpretation, which empowers you, the patient, to have your voice heard in the real world.

PatientsLikeMe is an unparalleled platform for electronic PROs, which have a few advantages over traditional pen-and-paper ones, such as:

• Patients are more likely to share and share truthfully using electronic interfaces;
• Researchers have real-time access to the data;
• Electronic PROs enable alerts for specific concerns (such as adverse side effects), ensuring better safety for all patients (1).

Early on in our partnership, our colleagues at the biopharmaceutical company UCB proposed a longitudinal PRO survey: members of our Epilepsy Community would have access to surveys that reveal the effect of their condition on everyday life over distinct periods. That’s right — you could see your progress over time! Together with UCB,  we decided to take the concept of an electronic PRO one step further: not only would you be able better understand your own experience with epilepsy, but you would also be able to put it in context. When you complete a PRO survey, you’ll see that you can compare your results to the larger Epilepsy Community!

Figure 1

Figure 2

Such commitment to patient health reveals two interesting things about UCB: First, patients really do come first; and secondly, UCB is committed to understanding how their products work in the real world, and not just in clinical trials. It is not easy to take a leadership position in an innovative arena such as this, and we are proud to partner with such a company.

As of today, members of our Epilepsy Community have completed more than 1,300 PRO surveys. By the end of 2010, many of you will have contributed to the largest patient-led study ever in epilepsy.

Are you in on what our communities already know?  Share…and then compare. If you understand your condition in the broader context, you’ll be a PRO too.

1. Dupont et al. “Use of Tablet Personal Computers for Sensitive Patient-Reported Information.”  Journal of Supportive Oncology. Volume 7, Number 3. May/June 2009.

Engaging in social media presents a number of uncertainties to pharmaceutical companies. In a world where much of the medical dialog has moved online, these uncertainties have emerged due to absent or unclear guidelines from the Federal Drug Administration (FDA), privacy and regulatory concerns about engaging directly with patients, and the potential for significant consequences.

When I recently spoke before the FDA, we highlighted how our pharmaceutical partners are taking a leadership role by navigating through these issues. In so doing, our partners are learning about real world experiences of patients and how to meet their adverse event reporting responsibilities in the PatientsLikeMe Epilepsy, Organ Transplant and Multiple Sclerosis communities.

“…as the FDA contemplates the Internet and social media as an emerging source of drug safety data, it is essential to consider what characteristics distinguish a social media site as being capable of contributing to drug safety in a meaningful, computable and quantifiable manner.”

Meaningful, computable and quantifiable are three words that underscore all that we do at PatientsLikeMe. This includes the creation of our patient safety program. Early on, we approached patient safety proactively with a pilot program in our Multiple Sclerosis Community. Launched in 2009, this program allows patients to voluntarily report adverse events that funnel to the FDA’s MedWatch system. Our system automatically pulls relevant data from the patient’s existing profile into an FDA 3500 form, dramatically reducing form completion time.

Going beyond that in areas where we work deeply with our pharma clients, we developed an integrated and comprehensive drug safety reporting platform that monitors patient data and free-text for potential adverse events. This data is then medically curated into standard MedDRA terminology and submitted electronically to meet regulatory timelines and reporting criteria. Of note, PatientsLikeMe is the only online health data platform in social media that has passed multiple drug safety compliance audits.

The reality today is that patients are sharing their real-life experiences with post-marketed drugs online. By using structured data collection tools within the PatientsLikeMe platform overseen by a drug safety professional, industry partners can improve patient safety.

This is about more than just compliance, though. We believe it’s about leadership – patients and pharma working together in new ways. Listening – to understand the positive and negative patient experience – is the right step in developing a trusted relationship. And this trust-based relationship is the only foundation upon which to build your social media strategy.

As 2009 comes to an end, we want to take this opportunity to thank all of our members, partners and general fans for another great year.   Here’s a recap of some of the exciting happenings at PatientsLikeMe these past 12 months.  Wishing you all a Happy New Year!

Community Milestones
This year, the 15+ disease communities at PatientsLikeMe became an online home to more than 50,000 members.   The fibromyalgia community was expanded this past fall to include patients with chronic fatigue syndrome, and we announced a new community scheduled to launch early next year for people with epilepsy.  In addition to celebrating our communities’ awareness days and months within the site and right here on the blog (including Fibromyalgia Awareness Day, MS and PD Awareness Months, National HIV Testing Day and World AIDS Day), many of our members also participated on PatientsLikeMe teams in walk/run efforts to raise awareness and money in the name of their disease.  Congrats to the 40+ teams walking at events to support non-profit organizations like ALS Association, National MS Society, NAMI, Parkinson’s Alliance, APDA, and the MS Society of Canada. The real-time sharing and learning happening on PatientsLikeMe was also highlighted in the report series called The Patient Voice (starting with inpatient therapy for people with Mood conditions).  Check out highlights from all these programs on these videos from the Fibromyalgia, Parkinson’s, Multiple Sclerosis and Mood communities.

Many of our members have also become fans of PatientsLikeMe on Facebook.  Here are a few quotes posted to our Facebook page in ’09:

“I find this site so beneficial in looking for the tools to cope with the disease. People post research and real-life patient experiences of current trials and treatments. Hope is a major focus of PLM and I encourage others to join. We are strong in numbers and we have a voice.”

“PLM is a wonderful way to express what and how to live with this disease. It has changed my life for the better, have met wonderful individuals and we have shared, cried and grown by reaching out and expressing from our hearts, have made wonderful friends and have learned so much.”

Research Updates
If you haven’t checked out our research page or subscribed to Google Scholar alerts (92 articles referred to us in 2009!), here’s what you’ve been missing…

This year our ever-growing research team continued their analysis of the real-world data being shared by patients like you.  Awarded the inaugural JMIR award at Medicine 2.0, the PatientsLikeMe research team published pieces on compulsive gambling in patients with Parkinson’s disease in Movement Disorders, expanding the gold standard rating scale in advanced ALS in European Journal of Neurology, and “The power of social networking in medicine” in the highly respected journal Nature Biotechnology.

Throughout the year, the team has also shared insights via videos (like this series on the history of ALS or a recap of a study on the antidepressant Amitriptyline) and various presentations (such as an overview of our work at the at Eurordis AGM in Athens and updates on our lithium study at the International ALS/MND Symposium).  In addition to working on the development of our new communities, the team took additional steps to incorporate genetics into the PatientsLikeMe platform.  By participating in new partner studies (such as 23andMe and NEALS) and utilizing new product upgrades, including the launch of the Genetic Search Engine, patients are learning more about their condition and coming closer to answering the question:  “Given my status, what is the best outcome I can expect to achieve, and how do I get there?”

Keep your eyes out for more to come in 2010 as our R&D team rolls out more insights and outcomes measurements (like the Quality of Life scale in HIV), more improvements to the PatientsLikeMe platform, and cutting edge research in the peer-reviewed scientific literature.

The Business Side
As Ben said in a recent blog post, “we can’t have a business without you [the patient] and our communities can’t exist to help patients without a business.”  Throughout the year, the PatientsLikeMe executive team traveled around the world to present to industry partners, researchers, healthcare professionals and government leaders about the power of real-world patient data-sharing.  Here are some highlights from ’09:

• Partnerships: Earlier 2009, PatientsLikeMe announced partnerships with biopharma leader UCB to launch an epilepsy community next year and personal genomics company 23andMe to help people with Parkinson’s.

• Government: Piloted in our MS community this year, PatientsLikeMe members now have the ability to voluntarily report adverse events directly to the FDA; in fact, Jamie recently presented about adverse event reporting at an open FDA hearing on the “Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.”  PatientsLikeMe was also one of the collaborating organizations responsible for writing the Declaration of Health Data Rights and launching HealthDataRights.org this past June.  Finally, Jamie testified before the National Committee for Health and Vital Statistics, and gave an exciting rapid-fire presentation on the future of medicine at the Gov 2.0 Summit.

• Innovation: As a leader in Health 2.0, PatientsLikeMe executives are often asked to speak at various industry events.  Check out photos of Ben speaking at The National Summit and stay tuned for videos from Jamie’s presentation at TEDMED and David’s presentation at Bil:Pil.  You can also tune in to our live event tweets on the PatientsLikeMe Twitter account in 2010.

• Media Highlights: PatientLikeMe members, data and executives were also featured in media mentions throughout 2009, including WIRED, Forbes, U.S. News & World Report, Fox Business Live, Newsweek, New York Times, as well as Seed magazine, Nature Biotechnology and Neurology Today.

Happy New Year!
- The PatientsLikeMe Team

Every so often, we sit down to try and make our business objectives clearer to our patient communities.  Why?  Well, we can’t have a business without you and our communities can’t exist to help patients without a business.

This often results in our Privacy Policy and User Agreement being updated to help clarify our goals and objectives.  One of our company’s core values is transparency, which means we never want to surprise you.  Our site wouldn’t be what it is today if we didn’t honor the trust you put in us.  Because of that trust and our values, we want you to understand what our Privacy Policy means for you and make sure it clearly states what we’re doing with your information as a business.

So, what has changed about our Privacy Policy?  Well, the short answer is not much – but if you haven’t read it in a while, it will read differently (and hopefully much clearer).  As you know, we talk very openly about how we encourage our paying customers to partner with our patients (check out our Read This! section) to better serve your needs. The latest changes to the Privacy Policy reflect what we have always intended to do as a business, which we’ve hopefully expressed to you.  In this latest revision, we try to make it clearer by providing examples of what different parts of the policy means.  We give specific examples of real world cases of where and when your data is used and/or sold.

For example, over the last year we have expanded our efforts into understanding drug safety in the real world.  This started with the Treatment Evaluations – letting you tell us (and our customers) what is good and what is bad about the treatments you are taking.  Next, we piloted (in our MS community) the ability to voluntarily report adverse events directly to the FDA through PatientsLikeMe.  Lastly, in conjunction with UCB, we are expanding our efforts to measure drug safety in the Epilepsy community.  All of these initiatives are building to a better understanding of how treatments work in the real world – one of our goals here at PatientsLikeMe.

As we’ve said through our site from the start – you control your information and you “may enter as much or as little information as they like.” We just added “and should not enter any information they feel uncomfortable sharing.”  This is common sense on any website, but for new members we wanted to make it clearer.   The bottom line – the more you share about your real identity online (whether its on PatientsLikeMe or other Internet sites), the better the chance that someone could identify you.

If you haven’t see our Read This! section, please do.  It’ll help give you a sense of what we believe the risks and benefits are to sharing information.  Openness is at the core of who we are as a company (see our Openness Philosophy).  Your openness is improving patients’ lives, accelerating research and helping improve medical care.   Thank you for that.  If you have any questions or comments, you know where to find us!

Last month, PatientsLikeMe announced our partnership with biopharma leader, UCB, to launch a new community for people with epilepsy.  Below is an interview with UCB’s Vice President of Clinical Research, Peter Verdru, MD.  David S. Williams III, head of PatientsLikeMe business development, recently spoke with Peter about the forthcoming epilepsy community, adverse event reporting, and the partnership in general.

***

	(David) UCB is known as The Epilepsy Company.  What’s your goal in partnering with PatientsLikeMe to create a new community for people with epilepsy?
	(Peter) As patient-centric companies, UCB and PatientsLikeMe are both committed to advancing research and improving the lives of people with life-changing conditions.  UCB has a long-term commitment to the epilepsy community – so a partnership with an organization like PatientsLikeMe seemed only natural. Our goal with this partnership is to provide this community to patients with epilepsy to help them manage their disease. Additionally, the community will generate patient-reported outcomes that may help UCB better understand how patients live with epilepsy and help advance epilepsy care. We anticipate patient-reported outcomes data across treatment groups for seizure severity, number of seizures, symptoms, adverse events, health-related quality of life, and co-morbidities, among other things. Using this knowledge for our future clinical research programs would be a logical next step, leading to an even better understanding of what future treatments could offer or what type of patients would gain additional benefit.
	(David) This partnership is said to give patients a voice in advancing research.  How so?
	(Peter) This community will give patients the tools they need to measure their own outcomes. Participants will record their real-time, day-to-day progress in controlling their seizures and achieving their treatment goals, and share that with the community to help other patients, caregivers, researchers and industry learn more about the disease. Tracking their disease over the long-term may help patients and physicians work together to evaluate the impact of their treatment. Eventually, clinical research programs might also benefit from the long-term data these patients are sharing.
	(David) Through the partnership, both companies will be working to design and deploy a system that allows for adverse event reporting to the FDA.  Why?
	(Peter) UCB has an ethical and legal responsibility to report adverse events associated with our drugs. If adverse events for any UCB drugs are mentioned on the site, UCB is required to report these directly to the U.S. Food and Drug Administration (FDA). Therefore, we are working to develop and deploy a solution that will allow us to assess and process potential adverse events, report them to the FDA, and capture them in the UCB safety database.
	(David) What’s the most exciting part of this initiative for UCB?
	(Peter) We’re excited to be taking a leadership role in the pharmaceutical industry to create a community that will give patients a forum for showing their treatment outcomes. Patients are really the experts about how epilepsy impacts their lives. UCB is focused on bringing new treatments to patients with severe diseases like epilepsy. We sincerely believe this unique partnership will bring real value to the large community of patients, families and caregivers
	(David) Thanks Peter!

PatientsLikeMe is proud to announce a pilot program in our multiple sclerosis community which helps patients submit treatment-related adverse events directly to the The U.S. Food and Drug Administration (FDA) through our site.

“Adverse events” are severe side effects or events that occur as a result of using a medication, medical product or device.  Understanding when these events occur helps the FDA better regulate the pharmaceutical and medical product industries to protect consumer safety and bring safer, more effective products to market.

We are excited about this pilot as it marks the first time ever that an online patient community has helped its members identify and report adverse events.  We recently submitted our first batch of reports to the FDA’s MedWatch system.

Patients like you are becoming more and more influential in their treatment decisions. No longer are you simply consumers of pharmaceuticals and medical products, you are customers.  In this emerging world, you have become better educated about your treatment options, the risk and benefits of different treatments, and your overall quality of health.  Now you have the opportunity to tell the FDA if you’ve had an adverse event.

Welcome to the new world.