Lifestyle Magazine

“Side Effects” the Movie That Inspired This Post on Human Drug Testing

By Lisaorchard @lisaorchard1

Hello Everyone! I hope all is well with you! I’m taking a break from discussing teen issues today and talking about a movie I saw. I went to see “Side Effects” a couple of weeks ago. It was a great movie with an awesome twist toward the end. I enjoyed it and the movie started me thinking about the new drugs that deal with psychological issues that are available on the market today.

Now, I’ve never taken a drug for depression or anxiety so I have no first-hand knowledge of what some of these drugs can do. But this movie raised some concerns for me. I asked the question, how do we know what the side effects of these drugs are? How do we test for them?

So, of course, I did some research and this is what I found:  A new drug has to go through three phases of testing before it is considered safe for the market and all drugs have to be approved by the FDA.

Phase One: This is where the drug is tested on animals. After the company does this type of testing they must fill out a “New Drug Application.”  This application is then reviewed by the FDA and a local Institutional Review Board. If the application is approved, the review board (made up of scientists and non-scientists in hospitals and research institutions) moves forward and sets up a clinical trial protocol. This protocol describes the type of people who can participate in the human testing of the drug.  The people tested in this stage are healthy humans and they are paid for their participation. The emphasis in this stage is safety. Researchers are looking for any negative effects the drug has on healthy individuals. If no major health concerns appear they move on to Phase Two. The number of participants for this phase range from twenty to eighty people.

Phase Two: This is the phase where they test the effectiveness of a drug while still keeping an eye on safety. They want to see if the drug actually works on the conditions or diseases it’s designed to help. The number of participants for this phase range between a few dozen to about three hundred.  If there is evidence that there is a positive effect from the drug the researchers move on to Phase Three.

Phase Three:  In this phase they gather more information on effectiveness and safety; testing the drug on different populations and different dosages. They also combine the test drug with other medications to see if there’s any negative reaction. The number of people tested in this phase range from several hundred to three thousand.

After this phase the sponsor of the new drug must fill out a New Drug Application. This is the formal step needed to seek approval from the FDA to market any drug in the United States.  If approved that Clinical Trials are set up and these trials are what take so long. They can take several years to complete. For more information on the New Drug Review Process please click this link.  http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm

It takes several years for a drug to appear on the market. As I researched this I grew concerned.  Who are these companies testing the drugs on?

Since these companies are paying individuals to be human guinea pigs there isn’t any criteria to become a test subject. Therefore, I concluded that the test subjects are usually the poor or uneducated or young people who need the money, like college students.

What happens when drug testing goes horribly wrong? As parents we need to teach our young people to value their health and not take it for granted. I know that drug testing is essential and I don’t fault modern medicine for finding new cures, but testing a new drug can be very dangerous for the volunteers. The risks are too great in my opinion. So, what are we to do?

I have an answer.

:)
But you knew I would didn’t you?  Where can we find human volunteers? My answer is why don’t we look for volunteers in our prison system? We’ve got a number of individuals who are either serving life sentences or on death row. They would be benefiting society and drug companies wouldn’t have to pay them. Maybe that would also bring the cost of the drugs down, which could ultimately bring down insurance rates for health insurance. Hmmm….makes you think doesn’t it?

One may argue that prisoners don’t fit the criteria of a healthy individual. Well…that is a point but my response to this arguement is…most prisoners eat better than our poor and uneducated. Sadly…they are probably healthier than many of our current volunteers.

Is it considered cruel and unusual punishment? I think not…because it is on a volunteer basis. In my opinion, doctors would be able to monitor the subjects in a controlled environment, which would make monitoring the side effects of the drug easier and more accurate.

:)
This would protect our college bound youngsters, the poor, and uneducated who have done nothing against society.

What do you think? I know this sounds a little extreme…but then you’d have to see the movie to understand my concerns.  I’d love to hear your thoughts on my opinions.

:)
Do you think this would be feasible?

***I want to thank www.fda.gov for some of the information provided in this post.


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