Experimental drug therapy is something that has been apart of life, really ever since the beginning of time. Every culture has their history of medicine. For the Egyptians their extensive knowledge about the human anatomy from their mummification treatments gave them a great understanding of the body. They had a range of remedies, from using thyme as a pain reliever to using camphor for epilepsy. In Greece they used the stars for guides to how individual people will respond to different treatments. Today, at least in the US, the history and regulation of experimental drug therapy lies closely with that of the FDA’s (Food and Drug Administration) history.
The FDA was created as a way to protect consumers from the potential dangers in drugs and food. The FDA can trace its roots through Charles M. Wetherill of the Department of Agriculture who did studies on food, soils, and fertilizers. FDA got its start under the 1906 Pure Foods and Drug Act which prohibited interstate commerce in contaminated and misbranded food and drugs. In the 1930s FDA was given its current name and really started enforcing the regulation of food and drugs. In 1938, President Roosevelt signed the Federal Food, Drugs, and Cosmetic Act. This act gave new meaning for safe consumer goods and made it so that drug manufacturers had to provide scientific proof that their drugs and products were safe before they were allowed on the market.
President Kennedy signed the Drug Amendments of 1962, which stated that drug effectiveness had to be established prior to marketing or else it would not be truly safe. This required drug firms to send the adverse affects reports to the FDA. Also, any advertising in medical journals had to provide the doctor with all the possible risks and benefits.
The laws that were made in the past have shaped where we are today. These laws are beneficial to consumers, because they can have more assurance about taking a drug. But there are also problems with the laws. They often require so much time for an experimental drug to be tested that a lot of people are hurt because they have no way of accessing it.
By Stacie Guinn
Sources:
Fowler, R. (2007) Egytian Medical Treatments. Retrieved from http://egyptian-history.suite101.com/article.cfm/egyptian_medical_treatments
Jansen, W. (1981). The Story Behind the Labels. Retrieved from http://www.fda.gov/AboutFDA/WhatWeDo/History/Overviews/ucm056044.htm
There are many good things about the FDA. I think it is important to have truth in advertising and that drugs should be tested for safety. I just wish it didn't take so long to approve some treatments. I hope that with the new national health care they will take a look at this whole process.
I agree, that the FDA needs to work quick at approving many of the new drug out there. They also need to run many tests to prove they are safe for use. Look at the Swine flu shot, I don't understand how you are going to put an injection out for pick to get if you have not run clinically tests to see how safe it is. Running tests does not mean give out mass shot to the public and then see what side effects arise. How is that safe???
You have to consider the downside to this also. If there is a quick path without doing everything needed to be as safe as possible then the there may be a way for a company to help speed the process along through some type of impropriety.
At least under the current methods everyone has to go through basically the same process. Even so you still have drug companies not presenting complete information on their studies and the FDA is understaffed and can’t verify everything they are given. Consider the anti-inflammatory drug Celebrex. It was approved under this type of process, and when people started dying from its use it was discovered this had shown up in the testing but hadn’t been submitted to the FDA.
Everyone knows that most diseases are related to stress in one’s environment.
Good natural Cannabis is well known to help relieve stress, resulting in less disease! It would at least be easy to get volunteers for a trial!