Toronto, Ontario — September 13, 2013 – RxISK.org, the first free, independent website for researching and reporting prescription drug side effects, has launched a drug safety petition asking two pharmaceutical giants to stop blocking the European Medicines Agency (EMA) from releasing prescription drug clinical trial data.
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.
“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 was launched in English and French last week and Italian, German, Chinese, Hindi, Punjabi, Urdu, Telegu, Spanish, Dutch, Swedish, Serbian, Yoruba, Russia, Welsh, Mayalayam, and Czech versions will be released over the next several days.
“Patients can’t be kept in the dark,” says Healy, who is hoping for 5,000 signatures to the petition. “These companies need to understand that patient safety data is not a trade secret.”
Click on the image to read the petition and sign.
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.
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’s free drug side effect reporting tool and use this data to help make medicines safer for all of us.
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