The 55th anniversary of the birth of the first oral contraceptive Enovid
July 01, 2015 Source: Emerson
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Earlier this year, Carl Gerasi, an honorary chemistry professor at Stanford University, known as the father of contraceptives, died of a cancer complication in San Francisco. For the controversial topic of contraceptives, he wrote in his autobiography, "The contraceptives are right and wrong": "Oral contraceptives are born at the best possible time and mature at the worst."
The first oral contraceptive, Enovid, was born after World War II. At this time, the chemical revolution swept the world. As the new drug and new therapies continue to flourish, pharmaceutical companies, the medical community, the media, and the public see the promise of new inventions and discoveries.
At that time, the population explosion caused resources to be exhausted, and gender differences brought unfair treatment to women. These problems, which were originally subordinated to sociology, began to be hoped for medical solutions. And the contraceptive pill just happened to overcome the obstacles at this time.
Birth control pills start from hormone synthesis
Research on oral contraceptives is not new. German scientist Adolf Bunnant obtained estrogen and other hormones from thousands of liters of urine and determined the structure of estradiol. In 1939, he was awarded the Nobel Prize for this achievement.
However, at that time, no one realized that it could rely on estradiol for contraception. In the future, many pharmaceutical companies tried to directly make estrogen that can be taken for contraception, but it was either not effective or had too many side effects. Therefore, if the US FDA only approves estrogen for the treatment of adverse diseases caused by menopause in women, contraception does not become an approved indication.
Later, it was discovered that estrogen alone cannot be contraceptive, and contraception requires a key hormone, which is often referred to as progesterone.
As early as the beginning of the 20th century, the Austrian endocrinologist Ludwig Habland discovered through experiments on rabbits that progesterone progesterone secreted by the female corpus luteum can inhibit ovulation. He pointed out in the paper that progesterone progesterone may be There is potential contraception. However, if the progesterone progesterone is really effective, it must be injected in large quantities every day. This method does not have practical application at that time.
At that time, progesterone was only extracted from animals and it was very expensive. The price was as high as 1,000 US dollars and 1 gram. In the 1940s, the market for progesterone was mainly in the world-class horse breeding. Breeders allowed horses to give birth to eugenics by injecting progesterone into horses.
In 1943, American scientist Ruther Marco discovered an alternative source: yam. Mexico has a wild yam that provides a large amount of progesterone, which makes mass production of cheap contraceptives a display. As a chemist, Marco knew that the market had a large demand for hormones. After seeing this business opportunity, in 1944, he came to Mexico to form a new tex company to mass produce progesterone and other hormones, and the price was reduced to 50 US dollars / Gram. This led to the hormone industry in Mexico, and the yam produced in Mexico became an important raw material for hormone synthesis.
After the end of World War II, the US pharmaceutical industry developed rapidly. At this time, Carl Gerasi joined New tex and came to Mexico City to start research work that affected his life. The Jewish scientist from Austria is not a newcomer to the research. Before coming to Xintex, he worked on a famous health care product manufacturer such as the new group, he developed one of the earliest antihistamines - pyridine. And applied for a patent.
Karl Gerasi, who came with a halo, adjusted the research ideas of progesterone in Xintex and found that progesterone is effective for contraception, but it is not stable. Therefore, Karl Gerasi decided to develop an analog of progesterone to improve the effectiveness and reliability of this drug. Under his leadership, in just three years, the research team succeeded in using diosgenin as a raw material. The process synthesizes norethisterone. This is a progesterone analogue, but unlike progesterone, it is still very effective by oral administration and eventually became one of the first components of oral contraceptives.
Carl Gerasi's contribution made Newtex a great profit in the progesterone trade, and the company was satisfied with being a raw material drug company, only engaged in the trade of hormone production and sales, and did not realize the future of oral contraceptives. market.
When the female local tyrant meets the poor scientist
At this time, the drug company was not interested in contraceptives. It was actually a feminist. In 1950, Margaret Sanger, founder of the American Family Planning Association, began to pay attention to contraception. She was just inherited more than 600. Ten thousand dollars of female rich.
In 1950, Sanger met the scientist Gregory Pincus at a banquet and suggested that he study the subject of hormonal contraception and apply for a grant for him. Soon, Pincus started research with his student, Zhang Minjue, a graduate from Tsinghua University. They used the results of Jerashi to prove that progesterone has a good inhibitory effect on female ovulation.
In 1953, Sangra came to another feminist gold master, Catherine McMick, to jointly fund the research of Pincus. With the support of the gold master, Pincus invited another medical expert, Brooke, who graduated from Harvard. Participate in research.
At this time, Hill Pharmaceuticals is developing a drug to treat women's menopausal-related diseases. They are interested in the Pincus study and decided to fund them. Hill Pharmaceuticals knows the pros and cons of contraceptives. However, hormones can help women with various symptoms after menopause. Start with this indication and let new drugs get listed as soon as possible.
Through previous research, Pincus and his team recognized that the synergistic effects of estrogen and progesterone can achieve optimal contraceptive effects. The synthesis of estrogen is relatively easy. On the basis of previous studies, the team of Pincus quickly selected ethinyl estradiol. For progesterone, according to Jerashi's research, Hill Pharmaceuticals quickly synthesized norethisterone. The combination of the two was made into Enovid, which has a high steroid hormone content and is very effective in animal experiments.
Radical clinical trials
In 1956, the company conducted related clinical trials in Puerto Rico. In order to achieve the best results, Pincus and his team chose 10 mg of Enovid for trial use.
The results, as he expected - did not have an unexpected pregnancy. But the scientist who hosted the Puerto Rican trial on the scene, Adriatic Ray, warned Pingkas that 17% of the subjects had symptoms such as dizziness, headache, stomach pain and vomiting. It is believed that the 10 mg dose of Enovid may cause too many side effects and is difficult to be widely accepted.
Pincus did not accept the warning from Adris Ray. He insists that the studies conducted in Boston did not show such serious side effects, and complaints from Puerto Rico may be just psychological problems. In addition, side effects such as nausea have been identified as side effects of oral contraceptives, but these are only a small price compared to the benefits of effective contraception.
Even the death of three subjects during the trial did not attract the attention of Pincus. All he was concerned with was how to make the test data more beautiful, how to dispel the FDA's doubts about oral contraceptives, and pass the approval as soon as possible.
In 1959, Hill submitted an Enovid listing application for contraception to the FDA. Despite the pressure on public opinion, the FDA gave a release signal on May 9, 1960: "The approval of drugs should only be related to their safety and should not involve moral factors."
Double test of science and morality
The advent of oral contraceptives has caused a great impact on traditional social ethics. In 1958, the Holy See announced that the use of estrogen to treat menopausal-related diseases does not contradict the teachings. This convinced the researchers that the pope could also accept the promotion of contraceptives. But what worries the church is that contraception can make people more indulgent.
Out of this concern, in 1968, the Pope preached "The Life of Man" and explicitly opposed the use of birth control pills. Until the 21st century, the Holy See did not express its support for contraceptives.
Rock, who is involved in Enovid's clinical research, is also a devout Catholic who believes that a good sex life is an important factor in the health of a marriage. He was involved in the filming of the contraceptive pill, and his point was that contraceptives and women's natural physiological cycles are consistent, so the use of contraceptives and safe-term contraception is not guilty. Before the church was convinced, Rock actually became the image spokesperson for contraceptives in the 1960s.
Before the ethical test, Enovid also faced a severe scientific test. About 1.2 million American women enthusiastically embraced this drug that allowed them to control their own fertility. But not long after, reports of side effects frequently appeared. These side effects are no longer the relatively less important nausea and obesity that occurs during clinical trials. It may be a fatal thrombus, emphysema, or stroke.
By 1962, Hill had collected 132 cases of thrombosis in Enovid users, 11 of which resulted in death. But Hill has always denied that these cases are related to oral contraceptives. Until 1969, the publication of the journalist Barbara Seaman on the safety of oral contraceptives, "Doctor Interviews - Contraceptives," made the side effects of contraceptives widely noticed.
A series of parliamentary hearings and FDA expert panel investigations have shown that the main cause of these serious side effects is the high dose of estrogen in each generation of compound oral contraceptives represented by Enovid. Therefore, many new generations of oral contraceptives have been adjusted in the future to avoid serious adverse reactions.
Because Enovid has been approved for many new indications, such as polycystic ovary syndrome, endometriosis, anemia, acne, and even used to treat bulimia. Therefore, it was not until the late 1980s that Enovid exited the market as the first generation of contraceptives.
postscript:
The advent of contraceptives has dramatically changed the concept of sexual life and female roles in Western countries. However, scientists involved in contraceptive research may not always be honored.
Enovid's serious adverse reactions have made Fincas, Rock and Zhang Minjue, who really brought contraceptives to market, fail to win any honors.
Carl Gerasi became a harbinger of honor. In 1969, Jerashi published a public policy article on the possible global impact of contraceptive research in the United States; in 1970, another article he published mentioned The feasibility of developing male oral contraceptives. Active social activities enabled Gerasi to receive the National Science Award, the highest award for scientific and technological achievement in the United States, in 1973 for her contribution to new contraceptives.
Because of his academic achievements in the field of contraceptives, Gerasi received a lot of shares in the company, and he was very profitable after the contraceptives were sold. However, this did not help him get the coveted Nobel Prize.
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