Sign the RxISK Drug Safety Petition

Richard Gonzalez of AbbVie, and Daniel Welch of InterMune: Drop your legal action blocking access to EMA clinical trial data

Let us see Drug Data! Drug hazards are not “trade secrets”!

Drug companies maximize the sales of new drugs by hyping their benefits while downplaying significant risks. In 2010 the European Medicines Agency began releasing patient-level data from the clinical trials used to approve new medicines in Europe – a development hailed by American, and European researchers and researchers around the world as a major step towards drug safety.

This process has been shut down by a lawsuit taken by two American corporations – AbbVie, makers of Humira, the number one selling medication in the world with projected sales of $10 billion in 2013; and InterMune, whose pulmonary-fibrosis drug Esbriet has recently been approved in Europe at a cost of over $40,000 per year.

AbbVie and InterMune have filed suit to deny access to the data from their trials on the benefits and harms of these drugs, claiming these vital facts are “trade secrets” whose release would harm their profits. Their action has led to the shutdown of the entire public-access program, leaving millions of patients worldwide, and their doctors, in the dark.

We call on AbbVie and InterMune to drop their European Union lawsuit and release all patient level data on Humira, Esbriet and their other products. Vital data on drug safety should never be hidden as a “trade secret.” By copying this petition to President Barack Obama and members of his Cabinet we call on them to ensure that meaningful public access to clinical trial data becomes the policy of the FDA and is written into any international trade agreements governing the sale of prescription drugs and devices.

Copies to:
President Barack Obama;
Margaret Hamburg, M.D., Commissioner, Food & Drug Administration;
Secretary General Ban Ki Moon, United Nations;
World Health Organization Director Dr Margaret Chan.

To:
Richard Gonzalez, c/o Gregory Miley, Group Head, External Communications, AbbVie
Daniel Welch, c/o Jim Goff, VP Corporate Communications

Please drop your legal action blocking access to EMA clinical trial data.

Sincerely,
[Your name]

[signature]

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