Is Access to Investigational Drugs a Privilege or a Right?
Is access to investigational drugs through clinical trials a privilege or a consumer or patient right?
How many times have you heard the statement “no risk, no gain”? For thousands of individuals with life threatening diseases this statement has become a daily motto. These individuals, the “lab rats” of today, as they volunteer to help promote advanced drug technologies.
But at what cost and what benefit? At present there are thousands of ongoing clinical trials in the United States. One only needs to visit www.clinicaltrials.gov to learn more.
Who Participates in Clinical Trials
How many of you consider that individuals who participate in clinical trials often do so from a sense of personal desperation? They have been diagnosed with cancer, Alzheimer’s disease, leukemia or another chronic, progressive and life threatening disease with little hope of a cure.
Years ago, my brother with advanced leukemia participated in numerous investigational drug studies and clinical trials. None were able to prolong his life.
Another friend diagnosed with cancer participated in clinical trials to advance genetic studies for persons with similar health concerns. The trials did not prolong her life but she felt a duty to do something that might benefit others.
Being in the Placebo Group
How often do you wonder about the disappointing experience of individuals who enter trials only to realize that they are in the “placebo” group – those not receiving the trial drug or treatment? They continue to participate but see their health continue to decline.
Without individuals willing to play roulette with their lives, the FDA and drug companies would be without participants, then what? And what about the fact that more men are enrolled in clinical trials, skewing the results toward men versus women?
Thankfully action was taken to support the issue of clinical research and consumers desperately seeking solutions. In 2010, the Compassionate Access Act was passed. More information about all acts before government vote is available at www.opencongress.org.
The 2010 Compassionate Access Act permits investigational drugs and devices to be made available if certain requirements are met, giving immunity to manufacturers, distributors, administrators, sponsors or physicians.
Copyright 2012, 2013 Pamela D. Wilson. All Rights Reserved