Drug testing procedures

Illustration by Douglas Fuchs
Illustration by Douglas Fuchs
Illustration by Douglas Fuchs
Illustration by Douglas Fuchs

Rachael WojciechowskiContributing Columnist

Recently there has been a surge of anti-vaccination advocates in the U.S. with many of them stating the reason for their concern is a mistrust for their doctors and the actual drugs themselves. While this may sound a bit paranoid, much of their logic is based on a mistrust of doctors or at least the medications they prescribe, which I wholeheartedly agree with, simply because the FDA is a cesspool of testing procedure failures.

The FDA is currently re-evaluating their procedure for accelerated drug testing, even though the current procedure is already faster than the European Union’s method and was just approved in 1992. The proposition being considered would allow drugs to be approved on the basis of “proof-of-concept,” meaning if the drug actually works, it will be placed on the market. These drugs would only begin late-stage testing after its release, legally making users clinical trial participants for the drug companies who dislike spending large amounts of money during the approval process.

According to the August 2014 edition of the Health Affairs Journal, there has already been a dramatic increase in the amount of recalls and black box warnings, such as Vioxx and Baycol, since 1992 with the rate of recall increasing by more than 5 percent. This is most likely due to the approval of an accelerated drug testing policy and the inability to use effective test subjects as stated by two cancer researchers, Marlene Cimons, Josh Getlin, and Thomas H. Maugh II.

These failures within the FDA have allowed a percentage of drugs on the market to be released though they should be considered as highly experimental. The patients receiving them unknowing become guinea pigs for informal drug trials. Personally, I have dealt with the side effects of Depo Provera, the birth control shot, all the while being told by my ill- informed doctors that they stand by the drug.

I experienced side effects of depression, weight gain of more than 40 pounds in two months, cramps that merited 10 times the normal dosage of Naproxen, periods longer than two months, and constant sharp pains from my abdomen. After thoroughly researching the drug, I also discovered it could also make me infertile and give me cancer. All with the blessings of four doctors who trust almost any drug put out by the FDA.

Depo Provera is a birth control shot that is known for being effective for three months and suppressing menstrual cycles completely. However, it is also known for its six columns of side effects ranging from increased risk of STDs, loss of bone mineral density and causing tissue clots the size of golf balls. This drug has had a very long history of rejections but the main reason was its ability to cause endometrial cancer in Rhesus monkeys and increase the rate of breast cancer in beagles. This was the first time endometrial cancer had ever been recorded in Rhesus monkeys.

This drug was finally approved in 1992, the same year the drug approval procedures were changed, even with heavy opposition from women’s health organizations and the Advisory Committee on Obstetrics and Gynecology. It is considered so dangerous to a woman’s reproductive system that many surrogacy groups will not allow women to take the drug at all in their lifetime.

The most disheartening thing about this drug’s approval is the fact that it is heavily exported as a form of population control by the U.S. and Canada to the Southern Hemisphere and is one of the most used birth controls in lower income households in the U.S., Canada, and the UK. This is reflective of the drug’s initial clinical trials starting in 1967 where over 14,000 women were illegally tested without their knowledge or consent by the Grady Institute in Atlanta, Georgia.

Half of the women were poor, African American women who had no idea of the fact that they were being injected with something that would destroy their reproductive systems with cancer or infertility. Several women actually died as a result of this and none of these deaths were ever reported to the FDA during the drug’s approval process. The clinical trials were so sloppy that over 13,000 women never showed up for their follow ups, but the FDA still saw fit to pass this abomination and completely silence the voices of those innocent women who died as a result of testing.

The FDA is willing to keep this drug on the market with no black box warnings or recalls in sight and constantly approve more drugs like it. The only chance of preventing this is to repeal the accelerated drug testing procedures and to implement the use of better test subjects to keep these experimental drugs out of pharmacies. For the meantime, thorough research is required for any drugs prescribed to you to assure that you in turn do not become the participant of a clinical trial.

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