On July 25th, 40 years ago, Louise Brown was born in Oldham, northwestern England – the first child to be perceived by in vitro fertilization, that is, through artificial insemination outside the body of the woman. It was a medical breakthrough and caused a big move. Gynecologist Patrick Steptoe and reproductive doctor Robert Edwards, who had made the miracle possible with his team, were celebrated.
Of course, such a complicated medical procedure does not fall from heaven. Every scientific advancement is based on research, and the Edwards and Steptoe team worked on breakthrough at Oldham Clinic and Cambridge University for almost ten years. Every clinical research needs volunteers. And there was a lot in this case. Very many women who had to endure a lot ̵
Later, Martin Johnson and Kay Elder, former Edward and Steptoe co-workers, reviewed their records from 1969 to 1978. During the nine years before Louise Brown's birth, the Stepto's team had carried 475 egg pickup and transferred 112 embryos back to the womb. A total of 282 women participated in the program.
Two children were born, one of them is Louise, another born in early 1979. The number makes it clear how much the researchers fell in the dark: the procedure was very experimental and subjects almost had no chance of having a child.
"Consent to Enlightenment"
That alone does not mean that the study was unethical. Basically, the standards for medical ethics allow studies that do not treat patients, but only the development of new methods. "But then the demands on the doctor's responsibility are particularly high," says Heiner Fangerau, Head of the Institute of History, Theory and Ethics in Medicine at the University of Düsseldorf.
In particular, the subjects must be informed in detail about the project and agree to participate. "Informed consent" is what is called. This is stated in the Helsinki Declaration by the World Medical Association, probably the most well-known ethical guideline for human research. «The statement summarizes the norms discussed for a long time before its first publication in 1964. It was published in general. I think it is unthinkable that in major research institutions nothing was known about it, "says Fangerau," for me, the issue of enlightenment in this context is the crucial point. " For exactly here, there are differences.
Lesley Brown – Louise's mother – was incredibly unaware. Her book, "Our Miracle is Louise," said she was unaware that no child was ever thought outside the womb She had only imagined that there are already hundreds of IVF children. Grace MacDonald, mother of the other child, knew that the process had not been successful yet, but she had never talked to either Steptoe or Edwards about how many times it had been tried. She was only fixed if this was an opportunity for her to have a child, she said in an interview with Johnson and Elder.
"Informed consent" can not be said in both cases. "Behind the word enlightenment is the idea to lead from understanding of immaturity to maturity. You need to make it clear to people that they are participating in a research project, not a therapy. And in 282 test subjects, one can not speak of a healing attempt, "said Fangerau.
" Therapeutic Misunderstanding "is the term used when people do not understand the difference between clinical research and therapy." The term was coined in the 80's. However, the perception that many people in need or hope participate in studies were discussed a lot earlier, "said Fangerau. Not only Lesley Brown and Grace MacDonald seem to have met this phenomenon in the IVF research program.
" Was it difficult subjects? "Johnson asked a former nurse from Steptoe's team as part of his research on Oldham's clinical notes. "No," the answer says, "they were all so excited to be here and glad we tried to help them." It also sounds like therapeutic misunderstanding.
"Many gynecologists refer their patients to us and we are having trouble dealing with the number of volunteers," Edwards wrote in a letter to the Ford Fund Richard Mahoney, which oc also suggested that doctors hoped their patients would be helped in Oldham.
The treatment was not entirely without risk
In an interview with Johnson, John Webster, then a gynecologist in the team, Steptoe reminds patients: "I think that little was said, except that it was An experimental project was and (…) that there were no successes. It was as you know, it only risks. "This suggests that information was given but not for education. There is no indication that patients are said to be one in hundreds.
The treatment was not without risk. Preparations for intake received the subjects in almost all cases hormone therapy to stimulate the ovaries. Egg pickup through laparoscopy is a minor surgical procedure. In addition, there was a risk that the fetus would not develop properly.
All women treated by Steptoe and Edwards had to approve amniocentes and pregnancy in pregnancy if deviations were noted.
Be clear to the women what they were involved in
When the story of IVF is told, it is usually a story about Lesley and Peter Brown's happiness when they held their daughter Louise in their arms. And it is the story of the researchers who have helped all the difficulties to stick to their vision and make IVF a success. The intentions of Edwards and Steptoe were certainly good – they wanted to develop new medical procedures to help people. You have also thought of ethics, Edwards has written about it in different publications. But suspicion is obvious that it is in a hurry in the implementation. In current heat, they may even have overestimated the chances of recovery themselves.
In the end it turned out that IVF is now an established method. But you did not know then. 280 women have paved the way for IVF by undergoing medical interventions because they hoped to become pregnant. There was little chance for them – the method had never worked before. These women are also part of IVF's history.
Created: 25/07/2018, 17:50