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Developing New Drugs Essay

1507 words - 7 pages

The Business of Developing New DrugsThe Business of Developing New Drugs for Cancer
Larry Cephas
Strayer University
Developing new drugs for cancer and or any other medical purpose is a tedious, complex, expensive process. The process in developing new drugs involves numerous stages of trial and error. According to Mahajan and Gupta (2010) on average it can cost anywhere from US$ 802million to US$ 1billion dollars to successfully develop and market new drugs and, that process can take up to 12years with on average of only 8% of them ever hitting the market. From the beginning of civilization, people have been concerned regarding the quality and safety of medicines, which I do not fault ...view middle of the document...

The next step is applying for an Investigational New Drug Application (IND). If the Food and Drug Administration (FDA) approves the IND within thirty days, the IND becomes affective giving pharmaceutical companies the green light to start testing the potential new drugs on humans. Once steps one-four have been accomplished we move to the fifth step which is the clinical trials. Here there are three phases that must take place and be successful. In Phase1 the drug is given to approximately 20-80 healthy volunteers to be studied to see if there is any potential toxicity in the people. Once this process is successful after one year we move on to Phase II. Phase II trials the drug is than given to 100-300 volunteers with the disease so that they can study and determined the drug effectiveness, and Phase II can take up too two years to be completed before moving on to Phase III. After Phase 1 and II are successfully completed Phase III can begin were now 1,000-5,000 volunteers with the disease that are in hospitals and clinics are given the drug. Here doctors monitor closely to determine the effects of the drug and if any the side effects, and Phase III will determine if the drug is safe and ready. After all the clinical phases have been completed successfully the pharmaceutical company than can proceed with the next step in the development process which is filing a New Drug Application (NDA) with the FDA. If all important information is presented to the FDA by the pharmaceutical company verifying the effectiveness and safety of the drug than it moves to the final stage, releasing it to doctors to prescribe to patients (California Biomedical Research Association).
Economic Issues People with Cancer Face
The economic burden of cancer can be compounded by high out of pocket expenses for prescription drugs, medical devices and supplies, and expenses related to co-insurance. Due to the bad economy and the high cost in drugs needed to treat cancer and sometimes the long term treatment needed bankruptcy is one issue people with cancer face. People who are diagnosed with cancer are more than two-and-half more times likely to declare bankruptcy than those without cancer. A study done by Dr. Scott Ramsey revealed that between 1995 and 2009 there were 197,840 people in Western Washington diagnosed with cancer and of those diagnosed with cancer 4,408 (2.2 percent) filed for bankruptcy after being diagnosed, and of the ones not diagnosed with cancer 2,291 ( 1.1 percent) filed bankruptcy (Forbes, 2013). People diagnosed with cancer are also faced with employment and financial issues. A history of cancer can have a significant impact on employment which may also affect the ability to obtain and retain health benefits and life insurance. Now, financial difficulties may arise because, some cancer survivors health limitations may cause a reduction in their work schedule. The employment, insurance, and other issues are not necessarily limited to the cancer patient...

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