FDA investigates fertilization of “three” embryos

Dennis Thompson
Health Day Reporter

Tuesday, February 25, 2014 (HealthDay News)-US Food and Drug Administration hearing was controversial on Tuesday Fertilization Technology that uses the DNA of three people (two women and one man) for the purpose of prevention Hereditary Genetic disease.

This technique involves unfertilized eggs or “oocytes” from two women. A portion of each egg is combined to remove the hereditary genetic disorder contained in the DNA of one woman and the resulting healthy egg is fertilized with male sperm.

FDA 2 days Hearing It is intended to provide a forum for discussing how this technology will be tested in humans. Clinical trial..

However, the debate is expected to turn to an ethic that manipulates human genetics to produce something “perfect.” Baby..

Dr. Michel Hackaby Lewis, a faculty member at the Johns Hopkins Berman Institute for Life Ethics and the Center for Genetics and Public Policy in Washington, DC, said:

According to Lewis, gene tinkering reverberates over time, so this procedure can have unintended health consequences for both newborns and future generations.

In addition, she said, the technology raises the annoyance of parental rights and family structure.

“Using technology in this new way really challenges our notion of what it means to be a parent and what it means to be a family,” says Lewis.

The· Hearing Inspired by the work of Shoukhrat Mitalipov, a quasi-scientist at Oregon Health & Science University (OHSU).

Mitalipov Fertilization A technology that produces five healthy monkeys and seeks FDA approval to initiate a human trial in women with defective genes that can pass on serious illness to children. ..

He is attending a hearing on Monday to explain the process he described Associated Press As “gene modification” instead of “gene modification”.

“We want to replace these mutated genes that are inherently pathogenic to humans,” said Mitalipov. AP.. “We’re returning them to normal, so I don’t understand why you oppose it.”

This procedure aims to prevent disease caused by defects in the DNA of the mother’s mitochondria, a small structure that produces the energy that powers individual cells.

During reproduction, the embryo inherits almost all maternal mitochondria present in the egg. This means that according to the OHSU website, all gene mutations present in mitochondria are passed from mother to child.

About one in 5,000 children in the United States inherits a genetic disorder from their mother’s mitochondrial DNA.These illnesses can lead to widespread health problems Blindness, Organ failure, Epilepsy, cancer And Diabetes mellitus, OHSU pointed out.

New technology seeks to avoid this by using eggs from healthy female donors that contain undamaged mitochondria. The nuclear DNA of the future mother will be transplanted into the donated egg and replaced with the donor’s nuclear DNA.

Result: A child who inherits the mother’s nuclear DNA. This includes most of the inherited traits of a person, but also the healthy mitochondrial DNA of the donor.The child may have the mother’s eye color and height, but there is no risk of inheriting Genetic disease From mitochondria.

Tampering with such genes raises concerns among many bioethicists. In a letter to the FDA, the Nonprofit Genetics and Social Center stated that “more than 40 countries, including the most highly developed biomedical sector, have adopted policies on human germline alteration. All of these prohibit it. “”

“This new global policy consensus has been endorsed by major international biomedical and bioethics organizations and councils,” the letter continued. “We believe it is unconscientious for the United States to unilaterally cross this bright technological and policy boundary that has been observed internationally for decades.”

The Center’s letter also questioned how useful the new procedure would be.

“We sympathize with women who place great importance on genetically associating their children, but keep in mind that the number of women who are candidates for the technology in question is very small.” The letter states. “About 1 in 5,000 to 10,000 people suffers from mitochondrial disease, Mitochondrial disease It is caused only by mutations in mitochondrial DNA. “

Lewis said the FDA must first determine the safety of these procedures and how to ensure their safety during human experimentation.

Beyond that, agencies need to consider ways to track children born from this process, resulting in unintended consequences (eg new). Birth defects She said she could detect what originated from genetic manipulation.


Men and women may have equal fertility problems.
See answer

“There was no registry to follow these kids created using In vitro fertilization And other artificial technologies, so perhaps that’s something to think about in the future, “Lewis said.

This process also raises many social concerns about parental rights and consent.

“It’s important to emphasize what the consent form looks like, so it’s very clear what the potential future rights of all the different people are,” she said. “As experience shows, this kind of problem is IVF First discovered. “

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Source: Michelle Huckaby Lewis, MD, JD, Faculty, Johns Hopkins Berman Institute of Bioethics and the Genetics and Public Policy Center, Washington, DC, Associated PressOregon Health & Science University Website; Genetics and Social Center, Letter, February 18, 2014

FDA investigates fertilization of “three” embryos

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