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Tag Archives: compassionate use

Compassionate Use: Fix What Is Broken

arthurcaplanby Kelly McBride Folkers and Arthur L. Caplan, Division of Medical Ethics, NYU School of Medicine

 

Over the past decade, cancer research and treatment has advanced well beyond what scientists thought possible. The rhetoric around cancer certainly has changed, and breaking its fearful grip on patients and their loved ones seems more within reach than ever. Vice President Joe Biden’s chairmanship of the cancer “moonshot” project is just one example of our society’s hopefulness that we can, once and for all, beat cancer.

 

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A Primer on Compassionate Use

fdaby Kelly McBride Folkers and Lisa Kearns

 

Expanded access, or “compassionate use,” allows patients and their physicians to request from pharmaceutical medical products (drugs, devices, biologics) that have not yet been approved by the U.S. Food and Drug Administration (FDA). There are several steps you and your doctor must take to get access to an unapproved medication, according to the FDA’s Expanded Access Program.

 

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Compassionate Use

RichardPlotkinby Richard Plotkin

 


 

Intro by Jonathan Agin, Section Editor Childhood Cancer Awareness & Advocacy

The childhood cancer world is filled with all kinds of journeys and fights.  Children diagnosed with cancer fight on a daily basis for survival.  Some are fortunate enough to have viable treatment options.  Even still, those treatments do not always provide a “cure.”  And then there are those who, on top of fighting against the underlying diagnosis, are faced with other incremental and peripheral battles that are direct outgrowths of the cancer and the treatments used to provide the “cure”.

The following is the story of how one of those very battles evolved.  It is the story of strange bedfellows who ultimately grew to respect one another significantly.  The story reads more like a work of fiction than the true to life reality that unfolded and has brought the community to this point of reevaluation of the policies and procedures of expanded access, or as it’s more commonly referred to, compassionate use.  In the end, the efforts of the author, Richard Plotkin, numerous other advocates and one unlikely “hero” successfully saved the life of a boy who was almost certainly going to die within days.  The twists and turns provide for a roller coaster ride of life and death.  Thankfully, this has kick-started high-level conversations with the goal of reforming the manner in which dying children receive experimental drugs.

There are always struggles within the childhood cancer community.  Fighting to obtain a drug that means the difference between life and death should not be one of those struggles.


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