Toronto, Canada (PRWEB) September 13, 2013
In 2010, the EMA began releasing patient-level data from the clinical trials used to approve new medicines in Europe, but the program was shut down in 2013 due to legal action by AbbVie and InterMune.
(See European Court of Justice Interim decision C-389/13 P, EMA v. AbbVie, C-390/13 P, EMA v. InterMune U.K. and Others which puts a hold on the release of data by EMA.)
[For background on EMA, the legal suit "RxISK Seeks Reports from AbbVie Customers as part of campaign launched today by Dr. David Healy on PRWEB"]
"Patients and their doctors need access to the data provided to regulators for drug approval," says RxISK CEO Dr. David Healy. "This is a global problem because the same chemicals — often under different brands — are used around the world. Access to this data can help patients, their doctors, and researchers assess the benefits and risks of these medications."
The petition to InterMune and AbbVie has been launched in English, French, Italian, and Chinese. German, Hindi, Punjabi, Urdu, Telugu, Spanish, Dutch, Swedish, Serbian, Yoruba, Russia, Welsh, Malayalam, and Czech versions will be released over the next two weeks.
“This is the most important legal action in healthcare for a generation and could have profound long lasting negative effects on individual health and health costs. Patients can’t be kept in the dark,” says Healy. “We have had over 2,300 signatures covering 44 countries and people from all walks of life sign the petition so far.”
The posts in multiple languages together with links to the petition itself are available at RxISK.org.
RxISK — your megaphone to help change drug safety:
RxISK.org allows users to enter the name of a prescription drug and see the side effects that have been reported to the FDA since 2004, as well as to RxISK, for more than 35,000 drug names from 103 countries. The data is presented in tables, tag clouds, heat maps, and interactive graphs, showing what’s happening with other people taking the same drug around the world.
Users can then select the effect(s) they are experiencing and click on Report a Drug Side Effect to complete a report. They get a personalized RxISK Report linking their symptoms and meds, which they can take to their doctor or pharmacist to facilitate a better treatment conversation. This will also add their anonymized experience to the RxISK database so that others can benefit from this information.
About Data Based Medicine Americas Ltd:
RxISK.org is owned and operated by Data Based Medicine Americas Ltd. (DBM), based in Toronto, Canada. DBM's founders have international reputations in early drug-side-effect detection and risk mitigation, pharmacovigilance, and patient-centered care. Although drug side effects are known to be a leading cause of death and disability, less than 5% of serious drug side effects are reported. DBM’s mission is to capture this missing data directly from patients through RxISK.org’s free drug side effect reporting tool and use this data to help make medicines safer for all of us.
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