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:11/27/2015)... ... , ... A team of Swiss doctors has released a report on mesothelioma ... posted the findings on the website. Click here to read the details now. ... patients who were treated with chemotherapy followed by EPP surgery. Among the 106 patients ...
(Date:11/27/2015)... , ... November 27, 2015 , ... Lizzie’s Lice Pickers ... company is offering customers 10% off of their purchase of lice treatment product. In ... full price. According to a company spokesperson. “Finding lice is a sure way to ...
(Date:11/27/2015)... ... ... No.1 Herpes-only dating community in the world, revealed that over 50% of its members are ... people under the age of 50 – or 67% of the population - are infected ... HSV-1 infection . , "The data shocks us highly!" said Michelle Li, Co-Founder of ...
(Date:11/27/2015)... ... ... A simply groundbreaking television series, "Voices in America", which is hosted by Hollywood legend, ... that are presently affecting Americans. Dedicated to providing the world with a wide variety ... consumers focus on, one episode at a time. , In the latest installment ...
(Date:11/27/2015)... ... 2015 , ... CBD College is proud to announce that on ... accreditation to its Diagnostic Medical Sonography program. CBD College is honored to join this ... colleges and universities in the state of California make the cut. CBD College is ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... , Nov. 25, 2015  Amgen (NASDAQ: AMGN ... Application (BLA) with the United States ... 501, a biosimilar candidate to Humira ® (adalimumab). ... application submitted to the FDA and represents Amgen,s first ... Sean E. Harper , M.D., executive vice president of ...
(Date:11/25/2015)... , Nov. 25, 2015 AAIPharma ... planned investment of at least $15.8  Million to ... Wilmington, NC . The expansion will ... to meet the growing demands of the pharmaceutical ... site expansion will provide up to 40,000 ...
(Date:11/25/2015)... N.Y. , Nov. 25, 2015  Henry Schein, ... and services to office-based dental, medical and animal health ... (GNYDM) Meeting the Henry Schein ConnectDental® Pavilion , ... broadest array of open solutions designed to help any ... Click here for a schedule of experts ...
Breaking Medicine Technology: