by 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.
by Mark Lewis MD, CKN Social Media Editor
When I started my fellowship in medical oncology in 2009, there were 2 inalienable truths.
First, as we assessed the weaponry we could deploy against cancer, we identified only three angles of attack: surgery, radiation, and chemotherapy. The first two were, in essence, local therapies, effective only where the scalpel or the high-energy beam was directed respectively to excise or ionize a tumor. Chemo was different because it was systemic, diffusely delivered, and the exclusive armamentarium of the medical oncologist, whose expertise lay in administering chemicals to poison malignant cells while trying to limit collateral damage to the host’s normal tissues. If the cancer signified weeds in the garden, this was akin to dispensing pesticides artfully enough to preserve the good plants. But it was hard to avoid a black thumb. Wistfully we hoped for a more discriminating way to stymie the growth of the bad actors, envious of the targeted aim of our colleagues in surgical & radiation oncology.
A comment from Dr. Mark Lewis, CKN Social Media Editor
Participation in a clinical trial is, ideally, a two-way street. The patient potentially stands to gain therapeutic benefit while the researchers learn about the efficacy and toxicity of the intervention under study. This post on the New York Times Well blog highlights concern about a lack of transparency in reporting the outcomes of trials, even if they generated negative results or, to quote Susan Gubar, “adverse consequences.”
CKN understands how important it is for you to be connected with leading- edge Clinical Trials here in Canada.
We’d like to help you begin your search here:
Canadian Cancer Trials Group