Talk:Mestranol/noretynodrel

Adding to History

I plan on adding information regarding the creation of Enovid and its social effects. This is for a class project. Feel free to remove any irrelevant or incorrect information. --AsherSchroader24 (talk) 02:11, 29 November 2023 (UTC)

The making of Enovid / Controversy

I removed the following inaccurate, misleading, WP:NPOV-violating sections added by:
• 07:02, 7 December 2013 Samafo (talk | contribs) (Providing more information to the background of enovid, including its controversies)
• 08:00, 7 December 2013 Samafo (talk | contribs) (→‎Drug testing Enovid in Puerto Rico)

The making of Enovid
The first oral contraceptive pill to be placed on the market, Enovid was the product of Margaret Sanger’s vision to provide women a means to separate their sexuality from reproduction. Through her work as a nurse with immigrant wives in New York, Sanger saw frequent cases of women inducing botched abortions in order to avoid another unwanted pregnancy. Sanger then vowed to develop a pill that would give women more control over their body.

Sanger’s best known breakthrough occurred years later when she partnered with Gregory Pincus, a biologist, to develop an oral contraceptive pill. With the financial support of Katharine McCormick, the drug was approved by the Food and Drug Administration and sold in the US market.

Controversy
Margaret Sanger’s motives to developing the Pill
Though recognized as an iconic figure in women’s rights, skeptics of Margaret Sanger question her motives for developing the Pill. Sanger was commonly accused by opponents of having an eugenic agenda for the Pill with concerns over population control. The implementation of Planned Parenthood clinics in impoverished cities targeting minority women and teenagers along with the controversial drug testing in Puerto Rico only fueled these allegations.

Drug testing Enovid in Puerto Rico
Pincus first tested the contraceptive pill on a small number of 12 women in Boston in partnership with Dr. John Rock. To combat legal issues surrounding oral contraceptive study trials, Pincus and Rock disguised their studies under fertility research. As was acceptable at the time, the Boston trials were conducted on psychiatric patients with the consent of the relatives. Now, Pincus still needed to conduct a large-scale trial to garner FDA approval for the Pill.

With the Puerto Rican government’s support for population control, Pincus concluded that the 3rd world country was the ideal place to conduct their drug trials. Already having 67 contraceptive clinics in place serving a large constant number of Puerto Rican women, Pincus saw the opportunity to prove that if "poor, uneducated women of Puerto Rico could follow the Pill," then any woman could. The results of the trials in Puerto Rico concluded that the Pill was effective in keeping the women from getting pregnant.

The trials in Puerto Rico bring up sensitive issues in the making of the Pill. The women who participated in the studies were not completely informed in what exactly they were partaking in. The experimenters violated informed consent protocols leaving the subjects to think they were taking safe drugs. Counter to that assumption, the initial dosage the Pill contained was an unnecessarily high dose of 10 milligrams of progesterone and 0.15 milligrams of estrogen. This caused very uncomfortable side-effects in the women such as "nausea, bloating, weight gain and depression." Pincus and Rock ignored these side-effects and went ahead with proposing the Pill to the FDA.

Serious side-effects
Later when the Pill had been actively used in the US, more serious side-effects were reported, the most common being blood clots and strokes. The most serious cases resulted in death.

that cited (and went beyond and misinterpreted) some People & Events blurbs (by Asian Studies major Hilary Klotz?)^{web site credits} from the 2003 WGBH website that accompanied the ten-year-old American Experience documentary "The Pill" by English and Theatre major Chana Gazit.
Also, way too much about Margaret Sanger for this article. Sanger was an initial catalyst in bringing together Gregory Goodwin Pincus and Katharine McCormick, but had no involvement in the development of Enovid after that.
The development of the Pill is described at length in the History section of the Combined oral contraceptive pill article. Lynn4 (talk) 22:21, 7 December 2013 (UTC)

I appreciate you linking me to WP:NPOV and for pointing out the amount of Sanger’s content on this page. According to NPOV, I realize that the previous posts came off subjective and I will be more conscious to avoid including my own interpretations.
One topic that I see neglected in the history of the Pill, though, is its trials, particularly those done in Puerto Rico.
One proposal I would like to make is to add more content to this page concerning the experimentation conducted on Puerto Rican women. Wiki articles regarding Enovid only mention Puerto Rico, but not the method of experimentation.
The reason why I edited the page for Enovid over the page for the Combined oral contraceptive pill is that this topic directly relates to Enovid’s history opposed to all contraceptive pills. I would like to hear your feedback on this. Samafo (talk) 21:48, 8 December 2013 (UTC)

The History section of the Combined oral contraceptive pill article was written before this (currently stub-length) article about Enovid.
There is substantial overlap between the early development of the Pill and development of Enovid in particular, so large portions of "History" section of the COCP article could be duplicated here, along with some additional detail about the early Enovid clinical trials and later developments such as the introduction of Enovid-E 2.5 mg in 1964, etc.
We could also add a sentence like:

While foes of the birth control pill have alleged since the 1960s that the early clinical trials of Enovid were inadequate and unethical, historians have found that the trials met or exceeded prevailing standards of their time.

and possibly add an explanatory note about aspects of Enovid's development that were most ethically problematic, e.g.:

testing from late 1955 through 1956 by biologist Gregory Goodwin Pincus and endocrinologist Harry Freeman at the Worcester State Hospital in Worcester of Enovid in 7 psychotic women for 3 to 14 cycles (average 7 cycles) and of progesterone/methallenestril in 5 psychotic women for 3 to 16 cycles (average 7 cycles), with the consent of the relatives of the psychotic women but without anticipated benefit to the psychotic women. The purpose of this testing was to obtain longer-term detailed physiological data like that previously obtained on infertility patients of Harvard gynecologist John Rock at the Free Hospital for Women in Brookline who had volunteered to participate in trials where they took progesterone, or norethynodrel (Enovid), or norethindrone, or norethandrolone for 3 cycles.

The 2003 American Experience documentary film "The Pill" and its accompanying website are not the best sources for this article. As with many documentary films, "The Pill" has a point-of-view which is not neutral and can be misleading. The film and its accompanying website are tertiary sources, not good secondary sources which are preferred for Wikipedia articles (see WP:MEDRS).
Some good secondary sources on the development of Enovid include:

• Maisel, Albert Q. (1965). "The Years of Testing" in The Hormone Quest. New York: Random House. pp. 126–147.
• Vaughn, Paul (1970). "Goody's Daring Enterprise" in The Pill on Trial. New York: Coward-McCann, pp, 36–57.
• Reed, James (1978). "The Product Champion" in From Private Vice to Public Virtue: The Birth Control Movement and American Society since 1830. New York: Basic Books. ISBN 0-465-02582-X, pp. 346–366.
• McLaughlin, Loretta (1982) in "The Pill is Born" and "The Pill is Approved" in The Pill, John Rock and The Church: The Biography of a Revolution. Boston: Little, Brown. ISBN 0-316-56095-2, pp. 108–127, 128–145.
• Ramírez de Arellano, Annette B.; Seipp, Conrad (1983). "An Answer to the Quest?" in Colonialism, Catholicism, and Contraception: A History of Birth Control in Puerto Rico. Chapel Hill: University of North Carolina Press. ISBN 0-8078-1544-6, pp. 105–123.
• Asbell, Bernard (1995). "'All These Trials Soon Be Over'" and "A Race for the Pill" in The Pill: A Biography of the Drug that Changed the World. New York: Random House. ISBN 0-679-43555-7, pp. 141–155, 156–169.
• Watkins, Elizabeth Siegel (1998). "Genesis of the Pill" in On the Pill: A Social History of Oral Contraceptives 1950–1970. Baltimore: The Johns Hopkins University Press. ISBN 0-8018-5876-3, pp. 9–33.
• Marks, Lara (1998). "'A 'Cage' of Ovulating Females': The History of the Early Oral Contraceptive Trials" in de Chadarevia, Soraya; Kamminga (eds.) Molecularizing Biology and Medicine: New Practices and Alliances 1920s – 1970s. Amsterdam: Harwood Academic. ISBN 90-5702-293-1, pp. 221–247.
• Marks, Lara (1999). "Human Guinea Pigs? The History of the Early Oral Contraceptive Clinical Trials" History and Technology 15(4): 263–288.
• Marks, Lara (2001, 2010). "Preface" and "Human Guinea Pigs?" in Sexual Chemistry: A History of the Contraceptive Pill. New Haven: Yale University Press. ISBN 978-0-300-16791-7, pp. xiii–xxxi, 89–115.
• Tone, Andrea (2001). "Developing the Pill" in Devices & Desires: A History of Contraceptives in America. New York: Hill and Wang. ISBN 0-8090-3817-X, pp. 203–231.
• Junod, Suzanne White; Marks, Lara (April 2002). "Women's Trials: The Approval of the First Oral Contraceptive Pill in the United States and Great Britain" Journal of the History of Medicine and Allied Sciences 57(2): 117–160.
• Fields, Armond (2003). "The Pill" in Katharine Dexter McCormick: A Pioneer for Women's Rights. Westport, Conn.: Praeger. ISBN 0-275-98004-9, pp. 259–291.
• Junod, Suzanne White (2007). "Oral Contraceptives. Women Over 35 Who Smoke. A Case Study in Risk Management and Risk Communications, 1960–1989" in Tone, Andrea; Watkins, Elizabeth Siegel (eds.) Medicating Modern America: Prescription Drugs in History. New York: New York University Press. ISBN 978-0-8147-8300-9, pp. 97–130.
• Marsh, Margaret; Ronner, Wanda (2008). "The Fertility Doctor Meets the Pill" and "The Era of the Pill Begins" in The Fertility Doctor: John Rock and the Reproductive Revolution. Baltimore: The Johns Hopkins University Press. ISBN 978-0-8018-9001-7, pp. 130–175, 185–221.
• Speroff, Leon (2009)."The Clinical Trials in the Caribbean" and "June 23, 1960: The FDA Approves the Pill" in A Good Man: Gregory Goodwin Pincus. The Man, His Story, and the Birth Control Pill. Portland, Ore.: Arnica. ISBN 978-0-9801942-9-6, pp. 201–224, 225–231.

Some primary sources, like medical journal articles with details about the procedures and results of the clinical trials of Enovid could also be useful.

The Río Piedras district of San Juan, Puerto Rico containing the University of Puerto Rico School of Medicine was chosen as the site of the first contraceptive trial of Enovid (from a set of limited options) for many reasons.
Puerto Rico was poorer than the states in the United States, but was not a "3rd world country"—in 1960, Puerto Rican GDP per capita was half that of Mississippi, but higher than Ireland or Japan.^{List of countries by past and future GDP (nominal) per capita#World Bank, 1960–69}
Norethynodrel 10 mg was chosen because in Rock's Brookline trials, use of norethynodrel 5 mg had resulted in breakthrough bleeding.
In Rock's Brookline trials, the norethynodrel was found to contain 4 to 7 percent of the prodrug mestranol; purifying the norethynodrel to contain less than 1 percent mestranol resulted in breakthrough bleeding, so 2 percent (220 mcg mestranol—bioequivalent to 154 mcg of ethinyl estradiol) was chosen for the initial Puerto Rican contraceptive trial in 1956.
As part of their extensive efforts to address the higher than expected (much higher than previously seen in Massachusetts) incidence of side effects reported in the 1956 first Puerto Rican trial, Pincus and Rock tried lower amounts of mestranol (180 mcg, 150 mcg, 80 mcg). The lower amounts of mestranol showed the same incidence of side effects, except for a higher incidence of breakthrough bleeding with 80 mcg of mestranol, so the amount of mestranol in Enovid 10 mg was lowered to 150 mcg (bioequivalent to 105 mcg of ethinyl estradiol) in the 1957 FDA-approved version.
In 1958, contraceptive trials began using Enovid 5 mg (with 75 mcg of mestranol—bioequivalent to 52.5 mcg of ethinyl estradiol) which was approved by the FDA in 1961.
Lynn4 (talk) 21:01, 14 December 2013 (UTC)

Rewrite the Making?

From the notes above, it is clear that there is still some controversy about how Enovid was developed. Does anyone want to take another shot? I can gather information from web sources, but I am not an expert. I suspect some of the information on Combined oral contraceptive pill belongs here instead. --GoldCoastPrior (talk) 17:01, 21 September 2015 (UTC)

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Wiki Education assignment: The History of Sexuality

This article was the subject of a Wiki Education Foundation-supported course assignment, between 28 August 2023 and 8 December 2023. Further details are available on the course page. Student editor(s): AsherSchroader24 (article contribs).

— Assignment last updated by AsherSchroader24 (talk) 04:29, 28 November 2023 (UTC)