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Social media as a tool for improving drug safety is now an old idea (“old” in the world of social media means more than a year ago).  We have seen several sites, mainly patient oriented that deal now with drug safety.  See such sites as www.patientslikeme.com and www.adverseevents.com.  One also sees AEs collected on “old” social media sites like Facebook and LinkedIn.

What these sites seem to be doing is collecting AEs from consumers, patients and healthcare professionals.  There are forums, groups, chats, blogs, discussion groups in which all sorts of things are seen including advice from one patient to another (rarely from a healthcare professional to a patient for all the usual reasons: liability, hard to know a patient and what to do from a short paragraph on a social media site etc.), lamentations, fury at the drug companies/doctors/hospitals/insurance companies but not so much with nurses or pharmacists.

In other words these sites seem to be a very useful forum for venting and exchanging ideas, anger and possible solutions.

The question that folks are only now starting to ask is whether there is a good way, using social media, to collect meaningful medical and scientific information from which sound, evidence-based advice can be given.  If the answer to this is yes, then social media will be providing more than just an outlet to vent spleen but perhaps a mechanism to cure spleen (sorry for stretching the cliché).

A very interesting proposal has just come out of Brussels from an organization known as the “Innovative Medicines Institute”.  This is a public – private venture funded by the European Union (EU) and the pharmaceutical industry in Europe via their trade organization (European Federation of Pharmaceutical Industries and Associations (EFPIA)).  The EU and EFPIA have each contributed € 1 billion ($1.3 billion).   From their website (https://www.imi.europa.eu/content/mission):

“With a €2 billion euro budget, IMI supports collaborative research projects and builds networks of industrial and academic experts in Europe that will boost innovation in healthcare. Acting as a neutral third party in creating innovative partnerships, IMI aims to build a more collaborative ecosystem for pharmaceutical research and development (R&D).”

On July 9, 2013 the IMI announced a new initiative-the WEBAE Project (Web Adverse Events):

Tapping into social media to monitor drug safety

“Recent years have seen an explosion in the use of social media, applications (‘apps’) and online platforms that allow people to share news and information and connect with one another in unprecedented ways. At the same time, legislation requires the relevant authorities to monitor the safety of medicines by gathering information on adverse drug reactions (ADR) experienced by patients. Currently this takes place via official forms. Nevertheless, for a variety of reasons, many ADRs go unreported.

One of the main objectives of the proposed WEBAE (‘Web Adverse Events’) project is to develop tools to tap into the wealth of content that is openly available online to both detect ADRs, and provide patients with the most up-to-date drug safety information.”

The budget for this is approximately € 4.5 million ($6 million) and will run 3 years.  Full details are available at https://www.imi.europa.eu/sites/default/files/uploads/documents/9th_Call/Calll_9_Text.pdf

We’ll discuss them briefly here.

The ideas underlying this project include:

From industry, the participants in the project are Novartis, Janssen, AZ, Sanofi and UCB.  There are many other stakeholders: biotechnology companies, small & medium enterprises, regulators (EMA and member states), policy makers, government agencies, payers, academics, and non-profit organizations (e.g.: patient, disease advocacy and privacy groups). (Author’s note: Nobody from Facebook, Google, Microsoft etc?!).

The problems they wish to resolve include:

The major goal is to develop methodologies and data mining algorithms for social media content (forums, blogs, tweets, public posting, etc.) in order to find emerging, medical signals.  The system will be outside of and outside of the control of pharmaceutical companies. (Author’s comment: Oh my.  Does this mean that they don’t trust industry?).

A second goal is to try to develop applications for direct reporting of suspected ADRs to the health authorities electronically from social media via EudraVigilance (the EU safety database).

So far this is reasonable enough.

The deliverables, alas, are primarily rather soft and are, in fact, not really deliverables but rather are objectives and goals.  Some “hard” deliverables are in blue:

There are many potential issues to resolve not the least of which is language.  There are dozens of languages and dialects used in the EU.  If one throws in abbreviations and slang as well as incorrect, ungrammatical, misspelled words, well…..lol.

There is an aggressive three year plan with more detail.  Based on these plans, the primary outcomes seem to be the development of apps, databases and visualization interfaces (do you know what that is?).


This is a lovely and laudable idea in theory.  The practice looks very very messy.

There are too many stakeholders and they include some of the wrong ones and exclude some of the right ones.  As with any large and varied group of dozens (or more) players, usually a handful of people end up dominating the group and determining the outcome.  How the operational aspects of this will play out remain to be seen.

It’s not clear what “success” is.  Will success be simply uploading AEs from many languages into EudraVigilance (without viruses and malware)? Or will it be more subtle: eliminating cheaters, getting ADRs rather than just AEs, avoiding duplicate reports etc. etc.  In many situations like this, the lofty goals are rarely met but some minimal deliverables ultimately do get prepared and everyone will declare a victory.

Will they actually test it?  It seems they will since this will be an iterative procedure.  If the software developers have any say in the matter they will force the project to actually test the software using standard software life cycle development procedures.  That may not be easy.

What is that “registration/certification for prescribers” deliverable mean?  It is not explained but does not sound good on its face.

Don’t tackle they language issues till they figure out the science.

Lots of other issues in here make this whole project way too ambitious and over-arching.  What is needed is simplification.  Here’s my revised proposal:

This seems possible (perhaps) in three years with $6 million.

Undoubtedly my proposal will not be adopted.  Rather, a large project will occur with lots of meetings (in lovely venues no doubt), lots of talk, lots of delays, cost-overruns, a rethinking (18 months into the project) of the goals and on and on and on.  Some deliverables will be produced but the final outcome will be that another project, this time with more funding and more time, is needed to achieve these goals.

Hope I’m wrong but I doubt it.

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