Fda Approved Drugs: Do Risks Outweigh Benefits?

Topics: Pharmacology, Pharmaceutical industry, Food and Drug Administration Pages: 8 (3005 words) Published: February 22, 2013
FDA Approved Drugs: Do risks outweigh benefits?
Among all of the ailments that are a part of everyday life there is a necessity for remedies from big too small. But in the end are the potential risks and hazards of these medicines worth the questionable outcome. This is the question you must ask yourself, for yourself and your family. “A drug is removed from the market when its risks outweigh its benefits. A drug is usually taken off the market because of safety issues with the drug that cannot be corrected, such as when it is discovered that the drug can cause serious side effects that were not known at the time of approval. However, completely removing a unique product from the market could be very dangerous to people who depend on the drug. So, decisions to remove products from the market are made very carefully, especially if people would be in danger without the product.”

I personally find the statement made above rather scary, that such leisure seems to be taken on behalf of the safety of the people prescribed to certain drugs. It would seem reasonable that an extreme amount of precautions and steps would be taken on behalf of a drug that could potentially enhance or create new problems among the consumer. We see it all the time in ads or on television the commercial for a drug that might be able to stop your headache but the list of after effects are extreme and vast. As well as drugs that were first prescribed 10 years ago with many people using it that now causes a wide variety of sickness not only for the host but in some cases the children of that person. In going over the review process it does appear that there is a rigorous process in which these drugs are tested and approved, yet one thing it cannot review is the effects of the drug after years of use. So no matter how many tests are done unless they do a study for a long period of time there are many unforeseen factors that play into the chemicals reacting with a body. In this paper I will be going over the review process in which the drugs are released or not released and two sample medicines in which was released with many bad outcomes. In no way am I stating that the technological advances in medicine are not outstanding and some very effective and beneficial, merely that it is in all of our best interests to not be hasty for a cure that could potentially take our way of life as well as life in-in of itself.
In going over the review process something’s may seem bullet pointed and rhetorical but I assure you it is necessary and effective in understanding how certain drugs are allowed in the market. The base of the whole process is what is called the “investigative new drug application,” (IND). Most pharmaceutical companies go to the (FDA) food and drug administration for advice before even releasing the IND so that when the companies and corporations seeking to produce this will not be getting a product that’s shot down before it gets started. When these research institutions and sponsors get a hold of the idea or product they must prove to the food and drug administration and the institutional review board (IRB) a reason why this drug should be pushed forward into testing. Working in conjunction with the FDA in regards to medicine is the IRB, they control what type of people should be tested, the dosage, length of time of trial and make sure the patients understand the risks and what they are about to partake in. Phase one testing on humans usually consists of 20 to 80 people and if the outcome is not “too harmful” they move on to phase 2 to determine the effectiveness of this drug. Phase 2 is between 12 to 300 people and test subjects with diseases are analyzed against people taking a placebo or “fake” drug to determine its effectiveness on the certain drug. In some cases drugs created for a certain disease may not work yet on another they are very effective. This just comes to show how unpredictable medicine can be. After...
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