Week 5 Assignment 2.1 Submission
The Public Needs to Know-Revised Version
November 10, 2013
As you're reading this, you can probably think of a few people you know personally that have battled cancer or are battling it right now. Do you ever think about the drugs that it takes to keep them healthy or how their produced? It's a long process, but it is most certainly worth the wait. These drugs save lives.
Approximately 7.6 million people die from cancer each year and most of these deaths can be prevented. Drugs like Herceptin(breast cancer) and Methotrexate(lung cancer) are tested to prevent deaths that can be avoided all ...view middle of the document...
It takes about twelve years for a new drug to go from the laboratory to the pharmacy shelf. “Only one in 1000 of the compounds that enter laboratory testing will ever make it to the human testing.” said by Drugs.com. Before an application can be made to the U.S. Food and Drug Administration, a drug typically undergoes around three years of testing. If the FDA gives the green light to “investigate”, the drug will go through three different phases. Phase one can use twenty to eighty healthy volunteers to make sure the drug is safe. This takes approximately one year. The second phase employs one hundred to three hundred people to test the drugs effectiveness. This takes about two years. The third phase involves one thousand to three thousand patients in hospitals and clinics who are monitored often to determine the effectiveness and determine if there are any side effects. This phase can take up to three years. After these three phases the company submits an application to the FDA, which is around 100,000 pages. This can take up to two and a half years. After the final approval, the drug becomes available for physicians to subscribe to patients. While the drug has been approved, it is still being watched closely. Any adverse reactions are reported. It is obvious the drug testing process it lengthy.
When it comes to testing a drug for cancer patients, most drugs that are being developed start from studying the biology of cancer cells. Most researchers start off by comparing genetics(DNA) and cellular processes of cancer cells to healthy cells. This allows researchers to identify important steps in the cancer development process and allows them to potentially alter this by using a drug. Once potential drugs are identified, they are tested in human tumor cells to see if they can stop the growth of cancer cells. The drug is next tested in animals to be sure that it is effective. The drugs can be tested on two or more different species of animals. Testing on animals helps researchers identify how the drug affects the body, what dosages can be used and the side effects the drug could potentially cause. This is the effective way to test drugs.
Since some drugs are tested on animals to make sure they are effective and safe, this can be considered an economic issue. If animals are being tested on and it is not certain that the drugs will not hurt them, then this can be a problem. Some animals might not react well to the drugs, which can cause health issues and even death. This would lead to too many animals being affected by drug testing. Drugs are tested on the animals before patients to insure no humans will risk their lives, but this process can...