Wednesday, September 29, 2010

breaking away from the superficial and the transient - p2


FDA, are three letters that can make most pharmaceutical companies cringe.

Capable of regulating all food and drug industries in the U.S., the FDA is a government funded agency that "protects and promotes American's health."

For the purpose of this blog, we'll focus on just the drug part and the role the FDA plays in getting a drug to the market. Drugs that are currently sitting in pharmacies have all been FDA approved. They have survived hundreds of tests and made clear their worth to the health of the American people. 

But drug approval is not always so black and white. There are certainly grey areas filled with ethical dilemmas and questionable issues. And the FDA is the sole regulator in deciding where the lines are drawn.

If you've ever wondered how a drug gets approval for market sale, you've come to the right place. I have wondered it myself. Looking into market approval, the most important aspect is for a drug to be consumer safe. The drug is put through a number of clinical trials to tests its effectiveness and find most if not all possible side effects resulting from the drug. The more that is known about a drug the better the likelihood of chemists perfecting it. And if you've ever read articles on drug approval you would see how vital clinical trial results are to securing support from the FDA. 

However, as I read through articles describing the clinical trials of drugs like Ceravix for HPV and PXL4032 for melanoma cancer I've found very questionable results. The drug trials produced numerous unexplained diseases and complications for trial patients. More specifically the articles raised serious issues regarding the FDA's cancer trial designs. 

In Central Valley, California, two cousins developed almost identical forms of melanoma skin cancer. One cousin entered the drug trial lottery and showed success under the use of PXL4032, while the other cousin entered the chemotherapy treatment that became fatal. These boys however were not given the opportunity to chose their trials. Had they been given that option, both boys would be alive and well today instead of just one. Due to FDA drug trial regulations requirement of a control test group, a needless fatality occurred. This poses serious questions for the FDA and their drug trial policies. The more articles I come across the more faults I find in patient drug trials. Although drug trials are typically for patients with no other alternative, it is not meant to shorten the lives of those who are hoping for a treatment or cure. And yet I keep coming across tags similar to: development of cancerous cells, abnormal heart rates, herpes infection, liver disease, and so on. 

And of all the articles I have sifted through, I haven't found one that openly questions the credibility, reliability, and overal integrity of the Food and Drug Administration. From the looks of it, the FDA is playing God. Their decision is the only one that matters, and although their main goal is to "protect and promote American health" the real question is: How competent is the FDA?

We need to tear away the layers of all the shiny new drugs that are currently saving lives, and look deeper into all the lives it did take because at one point it was prematurely tested on patients, or because the FDA's stupid requirement of a control group that cost the life a boy in Central Valley, California. 

Is the FDA of substance, or are they just this superficial government agency used to make it look like the U.S. has drugs under control? 


I'm going to find out.

-J

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