MedWatcher Social: Online Listening for Adverse Events
In just the past week, we have seen a flurry of news about FDA-approved acid reflux drugs and possible associations with increased heart attack risk. Media and regulatory attention demand that manufacturers find innovative solutions for monitoring and managing messaging about their products.
Epidemico offers a post-market surveillance solution, MedWatcher, a suite of tools aimed to help industry better understand patient experience, and navigate adverse event reporting. MedWatcher Social (MWS) is a GxP-validated social media monitoring platform, offering assurance that MedWatcher complies with strict regulatory standards and practices.
5 of the top 12 pharmaceutical companies already use MWS for post-market surveillance and signal management.
Try the demo and check out our new video for more information:
Epidemico, great work. I thought this was another app we needed to develop but you have already done it! Can we enlist your help on an important project that is time sensitive? The comment period is until July 1st:
Ask FDA to adapt Form 3500B so it is appropriate for dental fillings and dental devices, for which patients get no information (such as brand name, model number, serial number or any info on composition of materials or written informed consent), and many of the questions are not appropriate (in some cases it is lifetime bioaccumulation rather than a particular filling being place or drilled out that causes onset of symptoms)? There is also no mention made of dental devices as an example in the instructions.
This is important, because new peer reviewed research in PubMed 2011-2015 finds harm from dental amalgam for boys with certain gene types, so the findings of amalgam safety from the Children’s Amalgam Trial have been retracted by the toxicologists on the research team (see James S Woods et al). Numerous other studies find associations between amalgam and inflammatory chronic diseases in association with gene types that do not methylate or clear toxins well (for a summary article, see Homme et al 2014). Amalgam’s harm is well known internationally, where is it banned in 5 nations and increasingly restricted in others.
The FDA has overridden its own Scientific Advisory Panels on the harm vs. safety of dental amalgam in 2006 and 2010, and ignored testimony of ill and injured patients, biologic dentist associations such as IAOMT, and expert medical and research scientists at hearings in Washington and around the country in 2010-2011. They have archived all of these materials on the FDA website so they are hard to find.
There was a concerted effort to submit FDA reports in the old DENS system, about 900 were submitted through 1993. These were ignored. An unknown number were submitted 1993-2003. About a hundred were submitted since 2004; patient and dental groups unfortunately stopped recommending their use as they were discounted or ignored, and the instructions are inappropriate, confusing and hard to follow for dental devices.
It would also be helpful to have online listening for adverse events regarding mercury and dental amalgam via Facebook and blogs. While Twitter is ideal for many diseases, a significant number of people with mercury toxicity are older and not familiar with Twitter, and some find it confusing given cognitive as well as health impacts from mercury toxicity. Many people lose the ability to work, and face large uncovered dental and medical costs, since there is no patient protection or medical necessity in dental plans, and they deny appeals for coverage because the FDA still says it is “safe,” while requiring manufacturers to warn dentists, but no warnings to be provided from dentists to patients.
I look forward to hearing from you soon.