Drug Development and Toxicology - Essay Example

Drug Development and Toxicology Introduction Drug development is a gamble; one that involves spending billions of dollars and close to a decade before one can finally say that he has developed a drug that can actually cure a certain disease. Before a drug enters the market, it must undergo different processes that confirm it is fit for use on the patients for whom its developers purposed (Machin & Green, 2007). Preclinical research and clinical trials are required to either approve or reject the use of such drugs in the market. Some drugs fail to gain approval, and do not enter the market at all, while others are withdrawn from the market after a certain period of usage. Others are approved for use but they work under certain conditions and for specific conditions only. This essay presents the reasons as to why drugs fail to gain clinical approval, current issues on the same and any approved action for the failed approval. Reasons for Failed Drug Approval during Clinic Trials The Food and Drug Administration (FDA) reports that most of the drugs reported to it do not come with sufficient information. The FDA says that drug developing companies need to submit information on the compounds that are used to manufacture the drug, uses of the drug and its effects among other important data. It reports that if companies submitted this kind of information, the drug approval process would be much quicker than the current 8 years that are required. Consequently, it would increase the number of drugs that are clinically approved to enter the market without any restrictions (Friedhoff, 2009). In the end, this will help save a lot of money as well as patients who die in between the approval period. One common reason for the failed approvals is that drug development companies fail to indicate the optimal dosage that a patient should use so as to minimize the listed drug effects as well as any dangers associated with taking the drug. When undergoing the approval process, such a drug will be disqualified as the clinics conducting the trials have no way of knowing the appropriate dosage. FDA also noted that the populations that are sampled during drug development are very different from the population that is meant to use the drug (Zanders, 2011). When clinical trials are being conducted and such an error is noted, the drug is disqualified as having been developed for a different population from the one that its safety tests were conducted on. When clinic trials are being conducted, it is very important that a drug undergoing the trial has a high end point; that is the survival and response rate to the drug from the patients who will use it. Failure to reach the set end point will result in a drug been disqualified from entering the market. Clinical trials are conducted in 4 steps. The first phase involves using healthy volunteers to determine the safety of the drug in question. Human clinic trials are needed to prove that the drugs are safe for human use. This will involve testing for the effects of drugs on a person’s fertility, immune system, respiratory system and the reproductive system. If the compounds in a drug prove to have negative effects on these systems, it is disqualified without further trial tests (Chin & Lee, 2008). The second phase entails testing the safety of the drugs on a small number of patients and checking to confirm whether or not it evolves positive effects. During the third phase, the drug is tested on a larger group of patients to determine its safety and efficiency in healing the fore mentioned disease. The final phase will involve drugs that have passed the previous phases. The drugs are let out to the market and their efficiency observed. Its long term effects are checked and if they turn out negative, the usage of the drug is discontinued immediately (Bairu, 2012). For example, Alatrofloxacin was withdrawn from the US in 2006 after it was realized that the drug caused serious liver injury which eventually resulted to liver damage and eventually death of the patients using it. An example of a drug that has undergone these phase is Avastin which was developed for the sole purpose of treating glioblastoma multiforme which is a recently emerged brain cancer. When the drug was tested on a small number of patients, it was observed that their tumors shrank to much smaller sizes. The diseases also stalled for several months and the patients could continue with their lives normally. This was accredited to reduced blood supply to the tumors that were noticeably cancerous (Devettere, 2009). However, when the drug was tested on a large number of patients, it was realized that their survival rates were equal to those patients who had previously been given Placebo. For this reason, the usage of the drug was discontinued for it was proven that it was not more effective than those already present in the market. The use of propoxyphene was discontinued after doctors realized that it increased risks of heart attacks as well as strokes. Difemerine, on the other hand, worked in such a way that it affected multiple body organs. The drug caused multi-organ toxicities and its use was discontinued in 1986. Emerging Issues Many people in the medical field have complained that the clinical procedures involved in drug approval are too complicated and take a lot of time. They claim that this time wasted could lead to several deaths which could otherwise be reduced or prevented by the drug. Consequently, costs related to clinical trials can be shortened by taking less time to complete the trials. This has led to claims that something needs to be done to shorten the duration taken to complete the clinic trial procedures (Tang & Tu, 2013). Actions that will help to improve Clinical Trials The world today demands more trials that can pinpoint all safety concerns that arise with a newly developed drug. With the advancement of technology, it is possible for the several trials to be conducted simultaneously over a large number of countries across the world. This will help reduce the time that was traditionally taken during trials as the testing was done in one place after another; not simultaneously but continuously. Incurring one-time costs is also much cheaper than incurring various costs that are all aimed at arriving at the same goal. Drug development companies are urged to provide all the necessary information that is required by the clinics conducting the approval trials. By so doing, the clinics do not have to struggle to find out details such as the target population relating to the drug in question (Brody, 2011). In conclusion, it is important that drug trials and approval be quickened. Modernization has brought along many diseases that are related to today’s lifestyles as well as technology that can help in developing appropriate cures for these diseases. Slow clinic trials are a hindrance to these forms of development due to the phases involved and the unfulfilled roles of the drug developing companies. With faster and more cost effective clinical trials, it is possible to save on drug approval as well as reducing the number of deaths that are associated with modern diseases such as cancer and heart diseases. Works Cited Top of Form FRIEDHOFF, L. T. (2009). New drugs: an insider's guide to the FDA's new drug approval process, for scientists, investors, and patients. New York, Pharmaceutical Special Projects Group. Bottom of Form Top of Form DEVETTERE, R. J. (2009). Practical Decision Making in Health Care Ethics Cases and Concepts. Washington, Georgetown University Press. http://public.eblib.com/EBLPublic/PublicView.do?ptiID=547791. Bottom of Form INSTITUTE OF MEDICINE (U.S.). (2000). Dietary reference intakes: applications in dietary assessment : a report of the Subcommittee on Interpretation and Uses of Dietary Reference Intakes and Upper Reference Levels of Nutrients, and the standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Washington, D.C., National Academy Press. Top of Form ZANDERS, E. D. (2011). The science and business of drug discovery: demystifying the jargon. New York, Springer. Bottom of Form Top of Form (2006). Imaging in drug discovery and early clinical trials. Boston, Birkhauser. Bottom of Form Top of Form MACHIN, D., DAY, S., & GREEN, S. (2007). Textbook of Clinical Trials. Chichester, John Wiley & Sons. http://public.eblib.com/EBLPublic/PublicView.do?ptiID=284435. Bottom of Form Top of Form BORCHARDT, R. T. (2004). Pharmaceutical profiling in drug discovery for lead selection. Arlington, VA, AAPS Press. Bottom of Form Top of Form BRODY, T. (2011). Clinical Trials Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Burlington, Elsevier Science. http://public.eblib.com/EBLPublic/PublicView.do?ptiID=802460. Bottom of Form Top of Form CHIN, R. Y., & LEE, B. Y. (2008). Principles and practice of clinical trial medicine. London, Academic. http://www.myilibrary.com?id=176238. Bottom of Form Top of Form BRODY, T. (2011). Clinical Trials Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Burlington, Elsevier Science. http://public.eblib.com/EBLPublic/PublicView.do?ptiID=802460. Bottom of Form Top of Form TANG, W., & TU, X. M. (2013). Modern clinical trial analysis. Bottom of Form Top of Form BAIRU, M. (2012). Global clinical trials playbook: management and implementation when resources are limited. San Diego, Academic Press. Bottom of Form Read More