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How many times have we 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, 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 about national trials or www.clinicaltrialssearch.org/colorado_clinical_trials.html to find out about local Colorado trials.
How many of us consider that individuals participating 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. Years ago, my brother with advanced leukemia participated in numerous investigational drug trials.
How often do we wonder what happens to those who enter the trials only to realize that they are in the "placebo" group – those not receiving the trial drug or treatment? Those who read reports about their co-participants' improving health while their health continues to decline? Without individuals willing to play roulette with their lives, the FDA and drug companies would be without participants, then what?
One company in particular, Osiris Therapeutics, is in the third stage of a clinical trial for a stem cell treatment for Crohn's Disease, a debilitating intestinal ailment. The three groups in the study received full strength stem cells, half-strength stem cells and the third the placebo. Most approval protocols guarantee patients taking the placebo access to the real drug after the study ends. In this case Osiris did not have to confirm which patients received the various treatments nor did the company guarantee drug access for those who risked their lives to participate in the trial.
If you were a participant in this study, how would you feel with a promising treatment for your disease being within hands reach -- yet inaccessible? I can't even begin to sense the feeling of frustration by these individuals.
Thankfully something is being done to support the issue of clinical research and those desperately seeking solutions. Summer 2008, U.S. Senator Sam Brownback of Kansas (Rep) and Diane Watson of California (Dem) introduced a bill HR6270 (www.opencongress.org/bill) called the Access, Compassion, Care and Ethics for Seriously Ill Patients Act. If passed this act would allow availability of investigational drugs and treatments to seriously ill patients who have exhausted all other treatment options and release from suits and liabilities by the drug manufacturers willing to allow drug access. Certainly we all rely on the FDA to approve and monitor drug safety. However individuals who have exhausted all other options should be given the choice to access promising investigational drugs that just might improve their quality of life. Please give your support to this bill. None of us know today our health prognosis of tomorrow and we may be in need of access to investigational drug treatments.
Copyright 2011 Pamela D. Wilson, All Rights Reserved
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