ePharma Summit Recap

Thanks to all the presenters who braved "Snowmaggedon" to present at this year's ePharma Summit in Pennsylvania.

There were a lot of interesting presentations including some highlights from @skypen on his recent FDA interview with DDMAC's Dr. Jean-Ah Kang.

Of particular interest to me, since we are actively involved in developing guidelines and training, was the presentation from Mel Halkyard, who discussed the process she manages at Eli Lilly to implement social media guidelines and practices.

When talking about her learnings from the process, which is almost complete, Mel highlighted several themes:

• 1. K.I.S.S. (Keep It Simple, Stupid). When talking about personnel guidelines, it is important that everyone understands what is needed and required.
• 2. It's important to ensure that your social media guidelines are in sync with the rest of the personnel policies and procedures you already have in place.
• 3. It s a good idea to assign ownership so that there is a clear decision tree, and decisions can be made when needed. Ideally, a single point of contact, possibly a Social Media Czar, or an Interdisciplinary Social Media Steering Committee. Also needed is the sponsorship of senior leadership; preferably from someone who also sees the value proposition.

It's important to bear in mind during this process that it is a living document. Because of the rapidly changing communications landscape and the tools that go along with it, new situations will develop which may require that your guidelines change.

When using social media in particular, it's necessary to distinguish between the blurry lines of personal and corporate communications and to make it clear for staff what is acceptable from the company's perspective. Once you have your guidelines in place, it is then necessary to educate staff on the most productive uses and implementation of social media.

Does your company offer social media training or do you have guidelines or policies in place?

Originally published on Full Spectrum Blog Feb 17th 2010

Crowdsourcing for a Cause

I just read an excellent article about crowdsourcing health care solutions by Eliot Van Buskirk atWired. The article, titled "Harvard-Based Crowdsource Project Seeks New Diabetes Answers," describes in great detail a new initiative to crowd source diabetes information with an end goal of curing Type I diabetes. (Almost 2.4 million people in the US suffer from Type I diabetes.) "Using federal stimulus funding from the National Institutes of Health, Harvard Catalyst has teamed up with InnoCentive to explore whether open innovation and crowd-sourcing can spark new directions, collaborations and research in the healthcare community."

Congratulations to the National Institutes of Health for funding this and to Harvard's medical research department for developing this crowdsourced medical initiative sure to help those with Type I diabetes.

What's particularly interesting about the first phase of this project is the goal of ideation. The project's initial objective is not to identify a specific cure, but to start with the basic premises that there are questions or criteria that may not have been considered before now.

The study is awarding prizes ranging from $2,500 to $10,000 to anyone from experts to informed people who contribute the best answers. Should this be successful, it will continue with a new model for preliminary medical ideation and join a fine list of sites like patientslikeme.com and curetogether.com that are crowd sourcing medical innovations. Every day, the benefits the collective holds becomes clearer in everything from medical ideation to proxy clinical trials. (For a sound discussion of the merits of crowd sourcing, please see the following "How the Netflix Prize Was Won," also by Eliot Van Buskirk)

As this NIH-funded Harvard project moves forward with a potential second phase in crowdsourcing diabetes Type I treatment results, how great would it be for the project to talk to some of the sites who are already active in this area on a more clinical basis?

Originally published on Full Spectrum Blog Feb 16 2010

The FDA Spends $72 million to Speed Up Detection of Monitored Product Problems

As reported by CQ Healthbeat News, the FDA has awarded a contract to speed up the detection of product hazards. In a nutshell, the FDA awards $72 million over five years to Harvard Pilgrim Health Care Inc to develop a scaled down version of the Sentinel System. The system meets the requirements of a 2007 law intended to strengthen FDA drug safety oversight.

Forget for a moment the Orwellian program name "the Sentinel System", it's great to see the FDA moving up the timeline in their desire to learn sooner about Adverse Events. However, I find it surprising that they stopped three quarters of the way and didn't go right to the source.

With all of the technology available to be on the bleeding edge of potential Adverse Events (AEs) being discussed by e-patients, the FDA has decided to spend $72 million on examining historical data. For the historians among you, my definition of historical is anything that is not a part of today's conversation.

Now I'm all for data analysis and recognize the importance of this analysis in predicting future trends and being able to highlight the potential for Adverse Events. I further recognize that it is likely the FDA will now be in a position to encounter Adverse Events slightly ahead of where they are now.

However, would it not be much more helpful for the FDA to be in a position to interact directly with the patient and with their explicit permission to learn about potential AEs maybe even before they are reported to HCPs or even submitted for Insurance reimbursement?

The FDA does such a great job relying on crowdsourcing for outreach and dissemination and even data visualization of their recall information. Why does the FDA not recognize the value this same crowd sourcing brings in post market surveillance?

Isn't it time that the FDA truly gets on the cutting edge of these Adverse Events and out in front of where patients go to doctors or file medical insurance claims.

Social Media allows us to conduct post-market surveillance in a real-time setting. We can spot potential problems at the initial mention where individuals are discussing product issues with friends and peers. Was the FDA not listening at its own most recent Part 15 hearing? There were a number of presenters talking about the tools that exists today to discover in real time, that's up to the nanosecond, people who might be experiencing an Adverse Event or just recently experienced one.

For pre and post-market surveillance the crowd of e-patients is ready to assist the FDA in their gargantuan task of protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products, medical devices, our nation's food supply, cosmetics, dietary supplements, and products that give off radiation.

Do you know any Digital or Social Media monitoring vendors that would like to demonstrate the power of these tools in post market surveillance?

Orginally published on Full Spectrum Blog Jan 21 2010