Analysis of Medical Drugs

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Overview

"The value of research depends upon the integrity of study results. One of the ethical justifications for research involving human subjects is the social value of advancing scientific understanding and promoting human welfare by improving health care. But if a research study is so methodologically flawed that little or no reliable information will result, it is unethical to put subjects at risk or even to inconvenience them through participation in such a study."¹
Human subjects used to test newer drugs is a neccessity. Progressive testing can only show so much, and testing on animal subjects, no matter how close a biological relation, can not for see all possible effects of the new substance on an actual human. However, as the above states, these methods of study must be worth while to risk potential harm to others.


What the study means

The retrospective study is a means for new drugs to be tested in controled environments to test effectivness of the drug on specific medical conditions. Before these tests, the drug is used upon animals to make sure many harmful effects are detected before such research is done. These tests can be done in a variety of ways. One of the most common is called the "double-blind" test. In this test, a volunteer is giving something that the subject believes is the new drug. The administer and the researcher observing results also do not know if what the subject has taken is the actual drug or not. In this way, there are no bias or false results given as the researcher takes note on the effectivness of whatever was taken. This could be the drug itself, or a simple placibo. Other ways include surveys given to the subject days or even weeks after the medicine is given. These surveys are created with specific guidelines and rules to follow. These tests could take some time to complete, and it is in the best interest of the company making the new drug to finish quickly, as all during the test the new medicine is already patented, and is slowly losing time to when any generic company can use and create the drug.

Failures, it happens

Yes, sorry, failures happen. Even through studies and surveys, some drugs get past and get to the market without full knowledge of the problems it could cause. Most problems that occur because of these drugs end up being long term or not easily seen problems. Even so, the FDA is very quick on getting these off the shelves, but most of the time damage is already done. Those that are harmed by the drugs normally get large settlements from the drug manufacturer, which means it is in the drug companies best interest to put a lot of time into studies. However, like stated above, since the patent time ticks away during testing, the companies have to balance the loss of profit and the success of testing to try their best to get the most out of the new product. Many internet sites take interest in listing those hazardous drugs, so that the general population knows about it. One such site, Brayton and Purcell legal site³, lists many of such drugs. This list is updated when newer drugs are recalled, and not only list the drug name and manufacturer, but also the problems it causes. Most recent additions include Celebres and Vioxx.


Glory of success

Success is more worth while. A drug success is allowed to stay on the market for the full time, increasing profits. Success is more often then failures, but with all the regulations on testing and making, it is expected. Many companies take pride in their work, and proudly talk about their successful drug. One drug that has some current attention is AMORYN². Listed on this site is the percentage of patients that got quick results, and good results from use of the drug. Success is talked about and boasted, while failures tend to get pushed into corners and never talked about. Just like the real world.


Printouts

When a drug finishes testing and gets into the market, the company publishes the testing results for those that wish to know more about the drug. These can get collected on vaious sites to give the general public the information that they should look over before asking about prescriptions, though many don't. These reports include the various volunteer testing, and the surveys taken. The MHRA⁴ has a large listing of such information. For those interested, I suggest looking up some of the newer drugs on the market, or even some you are taking to see all the information that the companies must actually get in order to put that drug on the market.


Hypothesis, the other testing

The other testing going on is on a hypothesis. Several solutions to medical problems are only based on observation or known effects that some substances cause. These are then formed into a hypothesis, basically a guess, trying to see if this substance is actually useful. Most of the time, the companies go ahead and patent the formula, to deter others from taking the credit while testing is going on, in order to test the substance. The hypothesis could be correct, resulting in a new drug and ultimatly, new sources of revenue for the company in question. Other times, however, it could be wrong. One such hypothesis proven to be untrue was reported in ScienceDaily⁵. This hypothesis is that Selenium, a natural element, can be used against cardiovascular disease due to its antioxidant properties. However, studies have shown it to be unsuccessful, and that the element does not help in combating the disease or against cancer, another hypothesis made about Selenium. Had this testing bee faulty, incomplete, or just plain skipped, it could have been years before the truth would come out about it. As with the top quote, when doing testing a company must make sure to follow some ethics on how well to test.



References:

¹ http://www.hhs.gov/ohrp/irb/irb_chapter4.htm
² http://amoryn.com/help_success.html
³ http://www.braytonlaw.com/practiceareas/medicaldrugs.htm
⁴ http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&nodeId=742
⁵ http://www.sciencedaily.com/releases/2006/04/060426000738.htm