FDA, Novartis and Facebook

Whether or not FDA releases formal guidelines on social media anytime soon, it is clear that they are monitoring what their pharma constituents are doing. The good news is that today there is much more to monitor among the CDER crowd. The bad news is that FDA’s DDMAC continues to focus on minutiae. Remember those 14 warning letters in March 2009 referring to sponsored links.

The latest missive to emanate from the hallowed halls of “The Agency” was sent to Novartis, which is quite a progressive company when it comes to social media. The FDA letter cites Novartis’ dissemination of content using a Facebook Share widget on Tasigna’s branded site. Tasigna, obviously a Novartis drug,  is indicated for certain leukemia patients (Ph + CML).  The letter states: “The shared content is misleading because it makes representations about the efficacy of Tasigna but fails to communicate any risk information associated with the use of this drug. In addition, the shared content inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products.”

Many of my colleagues in the agency business got right on this case and did a thorough job of dissecting the issues.  Among them was Jonathan Richman of Bridge Worldwide and the amazing Dose of Digital blog who released a Digital Alert that covered all the bases and recommended solutions. Jonathan was correct in pointing out that DDMAC was not going after social media at all –  they were still harping on the fair balance issue (the content, not the medium). He wrote, “The FDA argues that the content in these META tags should include fair balance (risks, side effects, warnings, etc.) since they had the drug name and indication. The FDA did not have an issue with Facebook sharing in of itself, but rather the content that the site generates automatically, which cannot be changed by the user.”

Another good take on the brouhaha comes from Wendy Blackburn of InTouch Solutions who publishes ePharma Rx. First read FDA WidgetGate: Implications and Recommendations and then Pharma Social Media Live and Learn.

Mayo Clinic Center for Social Media

Much happening as it relates to social health and medicine (not socialized, just social). Mayo Clinic recently announced the formation of  its own Center for Social Media. The mission is to speed adoption of social tools that lead to better health behaviors and outcomes, both internally within the Mayo system and externally across the country and globe.  No hospital system or institution has done more to harness the possibilities of social than Mayo. They post a range of high quality video content on YouTube (a must-see is the video of the elderly couple playing the piano in the Mayo atrium, which went viral and now boasts over 7 million views); they have nearly 66 K followers on Twitter; their Facebook page has 23 K fans.  Plus they have a News blog, a podcast blog and a Sharing blog where patients, relatives and employees can write about their experiences. And let’s not forget their amazing – and free – repository of medical, disease and treatment information for consumers: MayoClinic.org.

So Mayo has quite a bit of experience to share. Services they plan to offer through the Center for Social Media include social media training for healthcare employees, consulting and coaching for healthcare organizations, conferences and events, and resources like guidelines and toolkits.

Much of the credit for Mayo’s success in this sphere goes to the unstoppable Lee Aase, who is the Manager of Syndication and Social Media for Mayo Clinic and is among the new Center’s leaders. By day Lee runs the Mayo social operations and by night he is the august Chancellor of Social Media University Global (SMUG), a free online higher education institution that provides practical, hands-on training in social media for lifelong learners. I had the pleasure of appearing on a panel with Lee last November at Northwestern during Kellogg’s annual Healthcare Conference. I had heard of Lee and knew of his rock star status within social media circles but had no idea what a nice person he’d turn out to be. Warm, approachable, engaged. And how could you not like someone who starts a social media talk with Martin Luther and the theses? BTW, Lee has 35 of his own.

One of my favorite physician bloggers, Bryan Vartabedian (@Doctor_V) of 33 Charts, wrote a good blog post about what Mayo’s move represents. I particularly liked his point that “health care social media isn’t owned by marketing.” Right on. Its utility goes so far beyond marketing and advertising and public relations. It is about education, research, care delivery, improved outcomes.

Finally kudos to the upper echelons at Mayo for supporting social media. Others take note.

Mobile health is now

I love mobile technology and the possibilities it holds for health, both on the patient/caregiver side and physician/HCP side.  I’ll be writing more on the topic over the coming weeks and months (and hopefully I’ll actually stick to my new resolution to blog at least once a week ), but here are a few data points to set the stage:

• Nearly 2/3 of U.S. physicians use a smartphone  for medical or clinical purposes according to both Google and Manhattan Research
• 95% of physicians who use handheld devices/smartphones download applications to access medical information (SDI Research)
• Wireless adoption within healthcare has grown over 60% in the past year (ABI Research)
• The global market for handheld mobile devices in healthcare is forecast to grow to $8.8 billion in 2010, with patient monitoring devices accounting for about 2/3 of the total (Kalorama Research)

In short, the intersection between medicine/health and mobile is happening now.  Two of the best sources of information I have found to keep up on the trends are  Fierce Mobile Healthcare (the business side) and iMedicalApps (the clinical side).  Fierce Mobile is part of the Fierce empire (Fierce Biotech, Fierce Healthcare, Fierce Biotech, Fierce Bunny – oh maybe that one is in development) and provides a solid round-up of news in the space. iMedicalApps is a physician-led site where practicing doctors provide commentary and reviews of mobile medical technology and applications.  For people interested in understanding what is really valuable to a physician (vs. what agencies tell you is valuable), then the site is a must.

There are also conferences galore where you can explore the topic.  One that looks promising is the mHealth Summit in Washington, D.C. in November.  I have no real insight on it but it appears to have top-quality speakers and  is well-priced (tickets below $500). I am beyond sick of attending $2000 conferences which are also funded by high-paying sponsors. Typically the content is so basic that I leave having learned nothing new, at least from the formal meeting.

Mobile health seems to hold so much promise that in late June  the venerable World Economic Forum convened its own mHealth Summit in San Diego. Paul Jacobs, CEO and Chairman of Qualcomm, and Chair, World Economic Forum Global Agenda Council on the Future of Mobile Communications wrote, “With nearly 5 billion mobile phones in use, there is an unprecedented opportunity to leverage humanity’s most pervasive global platform to transform the health care sector and empower people to take charge of their own health. By helping to shape future policy and encourage innovation in this critical area, we can make a real contribution to human health, all over the world.” You can watch video of the conference and download proceedings.

Just last week (July 26 and 27) the FDA and FCC held a public meeting to initiate inter-departmental dialogue and coordination on the topic. With mobile health, the regulatory lines begin to blur. To their credit, the agencies are attempting to define the issues that they’ll need to address as the sector takes off.

So if you thought mobile health was the future, guess again.  Mobile health is now.

Data for All

After all the time, money and paper spent on HIPAA, we are now discovering that many patients actually don’t want to hide their data, they want to share it openly. Why? Because they believe it may lead to more effective therapies in their lifetime.  PatientsLikeMe (PLM), a well-known social network for patients with chronic or fatal diseases, was one of the first companies to promote the idea of public access data. In 2008, after learning that a small clinical study in Italy suggested that lithium might postpone the progression of ALS (commonly referred to as Lou Gehrig’s disease),  PLM encouraged those taking the drug to track their regimen and its effects using tools created for them by PLM programmers. Those participating discovered that lithium was not the panacea they had hoped – the drug had neither positive nor negative effects on their ALS.  While this was not a scientifically orchestrated study funded by pharma, overseen by a KOL principal investigator, and run by a Top 5 CRO,  its findings were later validated by such a study published last month (May 2010) in Lancet Neurology. It showed that lithium did nothing to slow the course  of ALS.

While this type of qualitative/directional research will not replace double-blind, placebo trials, it does show the benefits of data collection and aggregation freom the real world of patients. We all know that trials are based on proscribed audiences, not everyday people. So it is important to have the data from the real world in addition to that of the “ideal patient” world.

The MIT Technology Review wrote a story about this.  They spoke to Mark Roberts, a physician and professor of Health Policy and Management at the University of Pittsburgh, who offered this assessment: “The beauty of observational trials is that you can see how an intervention works in the real world.  For example, many trials eliminate patients with secondary ailments, such as renal failure or chronic obstructive pulmonary disorder.  All my patients have those things, so how do I know it works in people I see?” Exactly!

Similarly, the patient-driven social network TuDiabetes launched TuAnalyze, an application that lets those with diabetes track, share and compare their data. Members of the community choose how much information (if any) to share about their hemoglobin A1c levels. The program was developed in collaboration with Children’s Hospital Boston with funding from a CDC grant.

So the open data movement is on. Let’s see where things go over the next year.

Health Care Costs 101

OK, this is not really social or digital in nature, but it’s important. The California HealthCare Foundation has put together Health Care Costs 101, an overview of the latest (2008) national health care spending trends. Why 2008? Because that is the latest available data from the U.S. Department of Health and Human Services and Centers for Medicare and Medicaid Serves (CMS) Office of the Actuary. Thank you to CHCF for putting together this impressive report.  I am a huge fan of the organization – they publish iHealthBeat (a website and free daily newsletter about technology and healthcare) and have supported Amy Tenderich’s  Diabetes Mine Design Challenge for the past few years.

There are so many interesting statistics I don’t know where to start.  Here are a few highlights:

• In 2008  healthcare spending was $2.3 trillion = 16.2% of GDP = $7,681 per person
• How is the money spent? Not what you’d expect given all the hoopla about pharma in the press. Only 10% goes toward Rx drugs. The lion’s share goes to Hospitals (31%) followed by Physician and Clinical Services (21%).
• Who pays for all of this? Public sources via federal, state and local governments (Medicare, Medicaid, Medical, etc) account for 47%.  Private sources (private insurance, fee-for-service, etc) contribute 53%.
• Prescription drug spending grew 3.2%, an all-time low, and the smallest increase of any major health care goods and services category.
• With the implementation of Medicare’s Part D drug coverage in 2006, a larger share of drug spending is now being paid for by the public sector.  In 2005, government paid for 28% while in 2008 that share rose to 37%.
• Medicare’s share rose dramatically (from 2% in 2005 to 22% in 2008) as it absorbed drug spending once paid out-of-pocket, by private insurance, or by Medicaid (on behalf of those eligible for both Medicaid and Medicare programs).

Definitely review Health Care Costs 101 – CHCF has made the data so easy to digest. Plus,  there are great charts and graphs you can show in your own presentations!