Navigation Links
RxISK Drug Safety Petition Asks AbbVie and InterMune to Stop Blocking Access to Drug Clinical Trial Data

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 — your megaphone to help change drug safety: 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: 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’s free drug side effect reporting tool and use this data to help make medicines safer for all of us.

Media contact
David Carmichael
+1 (647) 799-3792

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related medicine news :

1.’s Dr. Healy Coming to Talk to U.S. Audiences About Deadly Prescription Drug Side Effects
2. RxISK Seeks Reports from AbbVie Customers as part of campaign launched today by Dr. David Healy
3. Job injuries among youth prompt calls for better safety standards
4. NYUCNs Dr. Laura Wagner: Study finds accreditation improves safety culture at nursing homes
5. Better Ways Needed to Track Drug Safety: Report
6. Only Half of Meds Taken by Kids Have Adequate Safety Info: Study
7. OSHAs Safety Tests Protect Workers at Little Cost: Study
8. Keep Food Safety in Mind This Memorial Day Weekend
9. Analysis will examine safety of in-hospital underwater births
10. ACP-New York State Chapter partnership results in patient safety organization recognition
11. SYNERGY HomeCare Offers Free Home Safety Assessments
Post Your Comments:
(Date:6/25/2016)... , ... June 25, 2016 , ... "With 30 hand-drawn ... specific project," said Christina Austin - CEO of Pixel Film Studios. , ProHand ... all within Final Cut Pro X . Simply select a ProHand generator and ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, Van ... Wellness at Work award to iHire in recognition of their exemplary accomplishments in worksite ... 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in Linthicum ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... awareness about the dangers associated with chronic pain and the benefits of holistic treatments, ... for individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with all areas ... , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a revolutionary adjunct ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... at the Clinical Decision Making in Emergency Medicine conference in Ponte Vedra Beach, ... journal articles published in Emergency Medicine Practice and Pediatric Emergency Medicine ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... Dublin ... of the " Global Markets for Spectroscopy Equipment" ... This report focuses on the global ... including its applications in various applications. The report deals ... three main industries: pharmaceutical and biotechnology, food and beverage, ...
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
(Date:6/23/2016)... 23, 2016  MedSource announced today that it ... software solution of choice.  This latest decision demonstrates ... to their clients by offering a state-of-the-art electronic ... establishes nowEDC as the EDC platform of choice ... clients.  "nowEDC has long been a preferred EDC ...
Breaking Medicine Technology: