Testing+on+Volunteers-+Amber

__**Testing on Volunteers**__ by Amber Frost Tesing on volunteers has proven to be a controversial issue for several reasons. One of the more obvious is the drastic risk that comes with testing an experimental drug or procedure. Drugs are often recalled and prodcution is sometimes halted due to adverse effects experienced by test volunteers.

One such example of this is the clinical study performed by the company Amgen. In a hope to help cure their Parkinson's disease, five volunteers agreed to allow the company to test a new drug on them. The trial would be conducted as a double blind trial, which is a trial where half of the volunteers are given a placebo (a sugar pill) and half are given the actual drug, and neither the doctors or the patients know who recieved which. This is done to eliminate bias from both the pateints and the doctors. The placebo is often effective in improving patients conditions because they simply believe it s working. This kind of influence would be harmful if it were reflected in a negative way. Amgen gave three volunteers the drug GDNF, a chemical substance that would hopefully create an icrease in dopamine fibers in the brain. The drug proved to be sucessful, and in one subject even created a 500 % increase in dopamine fibers in the brain. Amgen then preceded to conduct a phase II study, with 34 volunteers. Again, half the volunteers were given a placebo. All patients responded well to the second trial, however treatment came to a screeching halt, when Amgen claimed patients who recieved the drug were developing brain lesions. however, it has been argued that Amgen only stop treatment because it was in their best financial interest; not the best interest of the volunteers. Now the volunteers who were recovering, are slipping back into the paralyzing grip of Parkinson's Disease. In a desperate attempt to continue treatment, several are suing Amgen and saying they want the drug again, even if it causees brain lesions. This kind of complicated situtation represents one of the many reasons testing on volunteers can be so murky.

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In America, there are certain guidelines that must be legally adhered to when a medicinal company is attempting to get a drug on the market. There are three phases of clinical testing. that must be completed. However, trying to find the required number of volunteers for these trials is nearly impossible. A company called SOMO reports that, "More than half of all clinical trials are outsourced by pharmaceutical companies to subcontractors," (Controversial practices...) An article published by SOMO states that performing, "clinical trials on people in low wage countries poses serious risks. The trial subjects are often vulnerable in terms of poverty, education and illiteracy." (Controversial practices...) This opens up the questions of just how voluntary these "volunteers" really are.

http://www.drugs.com/fda-approval-process.html

http://somo.nl/news-en/controversial-practices-in-outsourcing-of-clinical-trials