The Business of Developing New Drugs for Cancer Patients
English 115
November 9, 2013
The Business of Developing New Drugs for Cancer Patients The author of this informative paper is a communication specialist writing about the Business of Developing New Drugs for cancer Patients. In this informative paper the author talks about four major issues: today’s economic situation, special needs (e.g., health) of the population being served, process, and benefits of the program. In this paper it is clear that today’s population have special needs and that there is a very intense process involved in developing new drugs for cancer patients.
Drug Discovery and Development
According to ASCO (American Society of Clinical Oncology) “The FDA does not develop or test drugs. Instead, pharmaceutical companies and other organizations, such as university medical centers and some government agencies (for example, the NCI) work to discover and test new drugs. The organization that develops a drug is called the sponsor. The sponsor conducts the research needed to provide the FDA with the necessary information to help them make decisions about drug approval.”
Depending on the type of cancer requiring new medication,the sponsor must start there research based on the cancer symptom’s. This would require the sponsor to brainstorm. According to (Roen, Glau, and Maid 2011) “when you brainstorm, you record on paper or on –screen the information you already know about the topic you are exploring. Once you have written down several possible topics or ideas or possible ways to focus your paper, you may have an easier time finding the one that seems most promising.”
The discovery of new cancer drugs happen in a variety of ways. (2011) such as Accidental discovery. This is where something happens to someone and a cure is found by process of elimination. There is testing plants, fungi, and animals. There is studying the biology of cancer cells. Understanding the chemical structure of a drug target where computers are used to simulate the interaction of a potential drug and its target, similar to fitting two puzzle pieces together. Clinical research: Testing in people. “Clinical trials are research studies involving volunteers that are designed to evaluate whether a new drug is safe, effective, and possibly better than the current (standard) treatment. There are usually three (sometimes four) consecutive phases of a clinical trial. Each successive phase involves a larger number of patients and provides more detail about the new drug's safety and effectiveness. Clinical trials frequently take years to complete and may involve thousands of patients.”(2011)
“Before new drugs are allowed to be taken by people, the sponsor must submit an Investigational New Drug (IND) application to the FDA. The IND contains the results of the preclinical (laboratory and animal) studies, plans for clinical (human) trials, and details about how the new drug is made. The FDA approves potential drugs for human testing if the preclinical research indicates the drug is likely to be safe and effective, if the proposed clinical trials are designed correctly, and if the drug can be made the same way every time.” (2011)
Economic issues and Benefits
Roxanne Nelson states in the Medscape Medical News “A number of innovative cancer treatments have recently entered clinical practice — some costing as much as $100,000 per year — but it has become apparent that many of these expensive new drugs offer uncertain benefits. Some add only a few weeks of survival at a cost of tens of thousands of dollars.” (A Cancer Journal for Clinicians 2008) The cost of new drugs and the uncertain benefits become economic issues as the person being treated cannot afford the cost of the new developed drug or it may provide treatment for a few weeks as a means of prolonging the end result of death. Because of the large price tag attached to many of the agents
