FDA to Fertility Doctor: Stop Marketing 3-Parent Baby Technique

The doctor behind the technology that helped birth one of the world’s first 3-parent babies has been told by the FDA that he must stop marketing the experimental procedure.

According to the agency, John Zhang, a New York fertility doctor who helped a Jordanian couple give birth to a baby boy in 2016, had promised the FDA his companies wouldn’t use the technology in the U.S. without the agency’s permission, but they continued to promote it.

The procedure is not approved in the U.S., so a team of American doctors headed by Zhang traveled to Mexico (where the technique is not illegal) to help the Jordanian couple conceive.

According to a medical journal, the procedure occurred at Zhang’s clinic, but the embryo itself was taken to Mexico, where it was implanted. Zhang is under fire by the FDA for skirting the rules by traveling outside of the country to conduct the procedure. The regulatory body says the doctor may not modify embryos and ship them overseas again. [1] [2]

Paul Knoepfler, professor of cell biology at the University of California at Davis, said:

“It does seem like they’re pretty serious about this.” [2]

Zhang’s New Hope Fertility Clinic boasts on its website that it achieved the “first live birth” using the technology. The FDA took exception to that claim, as well others on the site, including a reference to “the first proven treatment for certain genetic disorders.” [1]

Leigh Turner, associate professor of bioethics at the University of Minnesota, said:

“The letter to me is like a shot across the bow. This seems like an area where you’d want to do careful cautious incremental research and not race into the clinic making strong marketing claims.” [2]

The FDA requested that Zhang address the violations immediately.

The experimental technique at the center of the controversy involves removing some of the mother’s DNA from an egg, and leaving the defective DNA behind. The healthy DNA gets inserted into a donor’s egg, which is then fertilized. That way, the baby inherits DNA from both parents as well as the egg donor, though the DNA contribution from the egg donor is very small. [1]

Source: The Guardian

The baby’s mother carries DNA that could have resulted in the child being born with a severe neurological disorder called Leigh syndrome that usually kills within a few years of birth.

In 2016, a panel of U.S. government advisers said in a report that it is ethical to start testing the procedure in pregnancy, but the first studies must follow stringent safety steps. Women at high risk of passing on a severe disease must be included in the research, and only male embryos may be implanted at first, to ensure the edits won’t be passed down to future generations.

Last year, Britain’s fertility regulator gave approval for the “cautious use” of techniques to create 3-parent babies, saying it would start accepting applications from fertility clinics that wish to become licensed to perform the procedure.

The child born with the help of Zhang’s clinic was not the first baby born to 3 parents. In the 1990’s, some children were born using a different technique, and are reportedly doing well.

Sources:

[1] The Washington Post

[2] BuzzFeed

The Guardian

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About Julie Fidler:
	Julie Fidler is a freelance writer, legal blogger, and the author of Adventures in Holy Matrimony: For Better or the Absolute Worst. She lives in Pennsylvania with her husband and two ridiculously spoiled cats. She occasionally pontificates on her blog.

Stem Cells: Not Only Embryonic?

The following article was written by my good friend, Dr. Richard DeAndrea, MD, ND. As a holistic physician who advocates a progressive approach to medicine, Dr. DeAndrea is the medical advisor to the American Naturopathic Medical Association, the Physician’s Committee for Responsible Medicine, and Earth Save International. His work places him at the forefront of the exciting advances described below.

It has always been the dream of doctors to cure and reverse disease. Now, through the use of stem cells, this dream is a reality. Cellular medicine is a revolutionary paradigm shift that is exciting for many and challenging for those invested in the “big pharma” model as the cure for “dis-ease.” Healing at the cellular level is the next generation of medicine that will leave the “cure” word behind.

Stem cells are helping us move from limited, synthetic therapies that have limited use and objectionable side effects to unlimited, organic regeneration that heals. They are used today to combat leukemia, heal traumatic brain injury, fix degenerated joints and sports injuries, and even replace the role of Botox in reversing the fine lines of aging. These procedures are happening right now in the United States, and none of the cells used are from an embryo or aborted tissue.

Where Do Stem Cells Come From?

Some people are skeptical of stem cell technology because of concerns with stem cells of fetal origin. It is, however, not legal to harvest cells from aborted fetuses and it’s not necessary. Stem cells are abundant in the bodies of adults. There are, on average, up to 65 million active stem cells in your bloodstream at any given time. These are called Mesenchyme stem cells and they rebuild and replace old cells.

Since the time of the ancient Greek physician Paracelsus, it has been known that cells can replace and renew themselves. Doctors such as the Nobel-nominated Dr. Neihanz—widely considered the Godfather of stem cell therapy—led the charge in pioneering this work during the early 1930s. In 1956, human stem cells were isolated; in 1967, the first stem cell was cloned. Since then, a technology known as autologous stem cell therapy was developed to take stem cells from your blood, grow them in large numbers, and use them to heal you.

Stem Cells: The Future of Medicine

As technology progresses, your own stem cells will be used to regenerate your system. This will put an end to chronic “dis-ease” and organ failure. Researchers at the University of Edenbrough generated a kidney using stem cells in a dog. The kidney is fully functional and the dog does not need dialysis. In fact, in our children’s lifetime, procedures like dialysis will be a memory. Stem cells are the hope for a new lease on life.

A Scientific First: Lab-Grown Eggs Produce Healthy Mice

The birth of baby mice made from eggs grown in a lab has sparked an ethical debate over whether the technique should ever be offered for humans by fertility clinics.

The experiment is a step up (or down, depending on how you look at it) from creating human organs from stem cells, which scientists at the University of Edinburgh successfully did for the first time in 2014.

Scientists created early-stage mouse eggs via 2 different experiments, 1 using stem cells, and 1 using skin cells from a mouse’s tail. These eggs were nurtured in the lab until they matured to the point that they could be fertilized by mouse sperm. [1]

Hundreds of embryos were made and implanted in female mice, leading to the birth of nearly a dozen healthy mouse pups. [2]

It will be many years before the procedure can be used in humans, but already researchers are looking to improve the process and make it safe enough to treat infertility, a problem affecting 1 in 6 couples.

Technologically speaking, it may someday be possible for fertility clinics to make viable eggs from the skin cells of an infertile woman.

The Experiments

According to Katsuhiko Hayashi at Japan’s Kyushu University, he and his colleagues first created some of the eggs from embryonic stem cells, and later from the skin tissue.

Out of 300 eggs, only 11 pregnancies ended in normal births. That’s just 3% of the embryos. [1]

Before the same process can be used to create human eggs and, later, human babies, scientists will have to overcome 2 major hurdles: the high failure rate, and potential risks to the young. [2]

When the team tested the artificial eggs made from stem cells, they found unusual patterns of gene expression in many of them, which suggests they did not develop the same way as normal eggs. Yet, more than 75% of the eggs made in the lab had the correct number of chromosomes. [1]

Creating mouse eggs in a petri dish is complicated work, and the team had to use ovary cells that support egg growth, Hayashi said. Originally, the scientists had reprogrammed stem cells to produce primordial germ cells, which give rise to eggs. However, they had to implant those cells into mice to finish developing into eggs in the ovary.

It’s not known how support cells in ovaries stimulate egg development. It may require something made by support cells or physical contact with them in order to fully mature.

Since scientists are not yet able to reproduce the supporting cells in a lab, so they need to get them from embryos. That could be another hurdle when trying to replicate the experiment in humans.

The (Far Off) Future

Azim Surani, a stem cell scientist at the Gurdon Institute at Cambridge University, who was not involved in the latest work, explained that it’s never too early to consider how this might be used to impregnate human females. [2]

He said:

“Ethically, this issue has yet to be discussed fully by scientists and society. This indeed is the right time to start a debate and involve the wider public in these discussions, long before, and in case, the procedure becomes feasible in humans.”

Some researchers warn that taking a crack at recreating a human embryo in the lab is a sure-fire way to omit important factors that have yet to be understood. Each lab-based manipulation introduces possible abnormalities, which make it a challenge to determine what factors are playing a crucial role. [1]

The report appears online in the October 17 edition of the journal Nature.

Yes, it will be years before lab-made eggs can be implanted in humans, but this takes humanity another step closer to creating “designer babies,” and the science behind this frightening prospect is developing rapidly.

In early 2016, scientists in Britain were cleared to start editing the genes of human embryos. Right now, the experiment is for the purpose of research. In the future, however, it could be used to create humans with certain genetic advantages over people born into the world with the help of nothing but nature.

And, just last month, scientists announced that the world’s first 3-parent baby was born in April.

Sources:

[1] Science Magazine (Featured image source)

[2] The Guardian

[3] Business Insider

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About Julie Fidler:
	Julie Fidler is a freelance writer, legal blogger, and the author of Adventures in Holy Matrimony: For Better or the Absolute Worst. She lives in Pennsylvania with her husband and two ridiculously spoiled cats. She occasionally pontificates on her blog.