User talk:Callisone10/sandbox
Hey there! so edited small things throughout the page. I didn't want to make the edits on you sandbox because I know it's hard to undo all the edits. Your facts were great and so was the organization. My only comment would be refrain from using "unfortunately" "also" and other transitional words. They make it sound essay like and it seems like you are bluntly trying to form the opinion of the reader. Gotta be more sneaky! I hope this is helpful. Good luck!
Contraceptive Trials in Puerto Rico[edit]
In 1955 a series of drug trials for the combined oral contraceptives were conducted in Puerto Rico. These trials were used to test the safety of the pill for use in the United States. [1] The scientists who conducted the trial were Gregory Pincus and John Rock.
American Testing Surrounding the Puerto Rico Trials[edit]
The first human trial of the female oral contraceptive was conducted in Massachusetts on a test group of 50 women. The series of tests were labelled fertility study to avoid state legal interruption of the trial. This trial was conducted by Gregory Pincus and John Rock. [2][3] Based on their findings, Pincus and Rock decided that the pill was ready for national consumption in the United States. With the approval of the Food and Drug Administration, the drug could be released in the U.S., This approval could not be granted, however, without a larger number of trial participants. In order to appease the FDA, a larger clinical trial was undertaken by Pincus and Rock in Puerto Rico. The test pill was developed by the pharmaceutical company, G. D. Searle & Company. [4]
In 1957, after the trials in Puerto Rico, the drug was approved for us in the U.S. as a treatment for severe menstrual side-effects. The drug was approved as an female oral contraceptive, the first in the U.S., in May 1960. [5] G.D. Searle and Company, which created the original pill for the trials, continued to produce the approved drug.
Drug[edit]
The drug used in the initial trials in Puerto Rico was known as Enovid. The drug was a combination of estrogen and progesterone, the same hormones used in modern combined female oral contraceptive pills.
Dosage[edit]
The amount of hormones in the test drug were a much higher dose that in the modern oral contraceptive pill. The initial dose in the pill was 10 milligrams, and was dropped to 5 milligrams after severe side effects, such as massive blood clots, emerged. [6]
Subjects[edit]
The women who volunteered as subjects for the trial were Puerto Rican women searching for an effective method of birth control. Many were not fluent in English and were illiterate. The lack of western education in the volunteers was believed to be a good indicator of whether the pill was viable for world-wide use.[4] There were a list of requirements for the women who wished to volunteer. They had to be under the age of 40, have a minimum of two children, be fertile, and be in good health. The women also had to agree to give birth should they get pregnant during the trial. [7]
Side Effects[edit]
Side Effects of this high dose pill were similar to that of modern day oral contraceptives, but amplified due to the larger dose of hormones. These side effects included nausea, bloating, weight gain, depression, loss of libido, severe mood changes, etc. Doctors did include patients in details of the study.
Blood clotting was a common problem with women participating in the trial. Blot clots are currently viewed as the most likely cause of death of the women who died during the drug trials. Tt took over a decade for official recognition that there was a link between blood clotting and the use of the drug, leading to multiple deaths within the trial itself.[8]
Deaths[edit]
Three deaths occurred among patients during these trials. At the time of occurrence these deaths were not reported in the U.S. to be linked to the trials. Despite strong circumstantial evidence that the pill was causing these unexpected deaths, it was not reported. Those conducting the trial considered the deaths to be merely coincidental.
Controversy[edit]
After the drug came into the American public, controversy over the ethical standards of the trial in Puerto Rico arose. Language barriers inhibited the Puerto Rican women from gaining access to answers about side effects and risks of participating. Autopsies were never conducted on the bodies of the women that died during the trial, causing worry that doctors overlooked serious issues in order to quickly gain access to sales in the U.S. [9]
The women were informed that they were being given a pill, free of charge, to prevent potential pregnancy. They were not fully informed that this was a clinical trial, or of the risks involved. [10]
There is a widely accepted understanding that "The Pill" at its current dosage is still a drug which poses a health threat to women. [11]
References[edit]
- ^ http://jhmas.oxfordjournals.org/content/57/2/117.full.pdf/
- ^ http://www.time.com/time/magazine/article/0,9171,1983970,00.html
- ^ http://www.pbs.org/wgbh/amex/pill/timeline/timeline2.html
- ^ a b http://www.pbs.org/wgbh/amex/pill/peopleevents/e_puertorico.html
- ^ http://www.nytimes.com/2010/10/26/health/26first.html
- ^ http://americanhistory.si.edu/collections/search/object/nmah_1147476
- ^ http://www.plannedparenthood.org/files/PPFA/PPFA_IB_Pill_Ann_051010.pdf
- ^ http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SelectionsFromFDLIUpdateSeriesonFDAHistory/ucm092009.htm
- ^ http://www.thebatt.com/2.8485/anger-over-puerto-rico-s-pill-test-lingers-1.1205789
- ^ http://www.pbs.org/wgbh/amex/pill/peopleevents/e_puertorico.html
- ^ B, Seaman, The Doctor's Case Against the Pill: 25th Anniversary (Alameda, CA.: Hunter House, 1995).