Drug safety affects all of us

via Today in Science History:
"It is not enough that you should understand about applied science in order that your work may increase man's blessings. Concern for man himself and his fate must always form the chief interest of all technical endeavours... in order that the creations of our minds shall be a blessing and not a curse to mankind. Never forget this in the midst of your diagrams and equations." Albert Einstein Address to students of the California Institute of Technology, Pasadena, California (16 Feb 1931). In New York Times (17 Feb 1931), p. 6

via ALLIANCE FOR HUMAN RESEARCH PROTECTION:

 

The Alliance for Human Research Protection (AHRP) is a national network of lay people and professionals dedicated to advancing responsible and ethical medical research practices, to minimizing the risks associated with such endeavors and to ensuring that the human rights, dignity and welfare of human subjects are protected www.ahrp.org

Advancing Honest and Ethical Medical Research 

Vital drug safety information should never be hidden as a “trade secret.”  Drug manufacturers who obtain a public license to market their drugs should have to provide access to vital safety information.

After much debate, an important public safety program begun in 2010 by the European Medicines Agency (EMA) provided access to physicians and the public to the data from clinical trials that drug manufacturers used to gain marketing approval for their new prescription medicines in Europe.

The program was hailed by American, and European researchers--indeed by researchers around the world--as a major step towards improving drug safety.

Prior to the EMA disclosure program, the only way access to clinical trial data was gained was through lawsuits.

But by the time any legal action had been taken against a drug manufacturer for failure to disclose serious adverse effects, the companies had amassed their mega-profits, but thousands of patients suffered serious harm. That scenario cannot be tolerated.

AbbVie is the manufacturer of Humira, the number one selling medication in the world with projected sales of $10 billion in 2013; and InterMune, manufactures the pulmonary-fibrosis drug Esbriet that has recently been approved in Europe at a cost of over $40,000 per year.

These two companies have filed a lawsuit against the EMA in an effort to block access to vital safety information about the serious risks the companies know that these drugs pose.

Their motive is simple and self-serving: they are attempting to protect their profits by concealing their products' hazards. 

They are demonstrating that they have no regard for the safety of those who consume their drugs--their only concern is for their profits.

Please sign the petition--drug safety affects all of us.

Link to petition: http://www.change.org/petitions/richard-gonzalez-of-abbvie-and-daniel-welch-of-intermune-drop-your-legal-action-blocking-access-to-ema-clinical-trial-data

The petition calls upon AbbVie and InterMune to drop their European Union lawsuit and release all patient level data on Humira, Esbriet and their other products.

 Copies of the petition have been sent 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.

Sign the petition and pass on the request to your colleagues, as I have.

With very little effort, you may help move mountains!

Vera Sharav

cartoon Roger Schillerstrom Drug Discovery and Development 2008