U.S. regulators on Friday warned a New York fertility doctor to stop marketing an experimental procedure that uses DNA from three people -- a mother, a father and an egg donor -- to avoid certain genetic diseases.

The doctor, John Zhang, used the technique to help a Jordanian couple have a baby boy last year.

According to the Food and Drug Administration, Zhang said his companies wouldn't use the technology in the U.S. again without permission, yet they continue to promote it.

The procedure is not approved in the U.S., and Congress has barred the FDA from even reviewing proposals to conduct such experiments.

A receptionist at Zhang's New Hope Fertility Clinic in New York said late Friday that no one was available to comment. Zhang heads the clinic and a related company, Darwin Life Inc.

New Hope's website touts having achieved the "first live birth" using this technology, along with other advanced fertility treatments it offers. The FDA's letter to Zhang cites several other marketing claims, including a reference to "the first proven treatment for certain genetic disorders."

The birth of the boy was disclosed last September. The mother carries DNA that could have given her child Leigh syndrome, a severe neurological disorder that usually kills within a few years of birth.

"This mitochondrial disease is usually a very devastating situation for the babies and the family," Zhang told CBS News at the time.

"This is the very first time at least in human reproduction that the offspring are produced with three parties one sperm and different parts of two eggs," Zhang said. "So this is very revolutionary."

The experimental technique involves removing some of the mother's DNA from an egg, and leaving the disease-causing DNA behind. The healthy DNA gets slipped into a donor's egg, which is then fertilized. As a result, the baby inherits DNA from both parents and the egg donor -- producing what's been called "three-parent babies" -- though the DNA contribution from the egg donor is very small.

"If you look at the amount of DNA, it's almost like it's 2.001 parents rather than three. But it's DNA from three different people," CBS News medical contributor Dr. David Agus explained.

People carry DNA in two places, the nucleus of the cell and in structures called mitochondria, which lie outside the nucleus. The technique is designed to transfer only DNA of the nucleus to the donor egg.

A medical journal report on the case said the procedure was done at the New York clinic and the embryo was taken to Mexico, where it was implanted. The procedure isn't illegal in Mexico.

Last year, a report from a panel of U.S. government advisers said it is ethical to begin testing this approach in pregnancy as long as the first studies follow strict safety steps. The studies must include women at high risk of passing on a severe disease and, at first, implant only male embryos, so the alterations wouldn't pass to future generations.

The FDA had requested the report, though the law against such experiments remains in force.

British regulators last year approved "cautious use" of the technique, and this year issued its first license to use it.

The child born last year through Zhang's clinic is not the first to inherit DNA from three people. In the 1990s, some children were born after researchers used a different technique. But federal regulators intervened, and the field's interest now has passed to the new approach.

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New York doctor told to stop marketing 3-person IVF technique - CBS News

It appears, by all accounts, to be a momentous scientific achievement and possibly a turning point in human evolution. In a study released last week, scientists at Oregon Health and Science University confirmed they were able to modify genes in viable human embryos, proving the potential to permanently alter the makeup of a genetic line.

In this case, that meant replacing and repairing a mutated gene that causes a common and deadly heart disorder. But the possibilities heralded by gene-editing technology are endless, the scenarios as divided as they are bold. In some visions, it leads to a population of designer babies or consumer eugenics. Others imagine a utopia of scientific advancement where humans live free of disease, and devastating conditions are eradicated for the betterment of humanity. What direction the technology will take is the topic of much debate.

The big thing which is making the scientific and ethics community get excited, and on the other hand a little bit hot and bothered, is its a mechanism to change genes for multiple generations, says Dr. Alice Virani, a genetic counsellor and director of ethics at British Columbias Provincial Health Services Authority. There are two ways to look at it, the more realistic ramifications and the sci-fi, if-this-was-out-of-control ramifications.

Opinion: Gene editing is not about designer babies

The team at the Oregon universitys Center for Embryonic Cell and Gene Therapy used technology called CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, to repair or edit the gene carrying the heart disorder, seemingly with greater success than previous attempts by scientists in China.

News of the research has been anxiously anticipated by many in the field, both for what it means for the potential eradication of a disease such as hypertrophic cardiomyopathy and for the fundamental questions it raises about human reproduction, health and society.

When the study was leaked days before its publication in the journal Nature, its lead scientist, Dr. Shoukhrat Mitalipov, attributed the release to likely a combination of hot words: CRISPR, gene-editing, and designer babies.

The study and its combination of hot words didnt disappoint.

The New York Times hailed the milestone in research, while The New York Post cried BABE NEW WORLD and described an amazing and slightly terrifying breakthrough. A headline on Vox declared simply, This Is Huge.

Even actor Ashton Kutcher tweeted enthusiastically about the scientific breakthrough, writing: Scientists successfully used CRISPR to fix a mutation that causes disease. This is why I wanted to be a geneticist!

The tweet ignited among his followers the same range of responses that are always so keenly tied to the issue of changing human genes, from hope that devastating conditions such as muscular dystrophy will be eradicated, to fear about the unknown consequences of playing God.

Dr. Timothy Caulfield, a Canada Research Chair in Health Law and Policy and professor at the University of Alberta, says the polarized and dramatic response he has seen in recent days reminds him of early reaction to stem-cell science, where, he says, It was either going to be cloned armies, or we were going to eradicate all disease.

In fact, neither has turned out to be the case, and so it may be with gene editing as well.

We need to be cautious not to hype the benefits and be cautious not to hype the ethical concerns, he says. There are real issues on both sides of the debate but lets make sure our discourse is evidence-formed.

He described the new research as a genuinely exciting area, and said the potential of CRISPR which is used not only in human genetics, but also has potentially revolutionary applications for agriculture, animals, plants and food has introduced both exciting possibilities and reasons for deep policy reflection.

Erika Kleiderman, a lawyer and academic whose work focuses on gene-editing technologies, stem-cell research and regenerative medicine at the Centre of Genomics and Policy at McGill University, says the Oregon teams research is exciting because it confirms the ability of CRISPR technology to repair genetic mutations, and establishes the basic safety of the technique in a research context. And while she said people often go straight to thinking about the potential for manipulating genes to create so-called designer babies, a concept that is cool but also quite frightening, the medical implications could be equally staggering, and are far more likely.

For example, something like Huntington disease, she says. Being able to prevent that or treat that one day, in my opinion, would be a fantastic leap for our scientific knowledge and medical advancement. That being said, people will raise the eugenics argument. Is that a possibility? Yes. Are we close to that? I dont think so.

Canada has strict laws around genetic modification and editing, and altering genes in a way that could be passed on to future generations is a criminal offence under the Assisted Human Reproduction Act, punishable with fines up to $500,000 or 10 years in prison.

But as the technology takes a large step forward, Ms. Kleiderman and Dr. Caulfield and are among a group of Canadian scientists and academics calling for less regulation around genetic science and research in Canada, not more.

Both were involved in the creation of an editorial published in the journal Regenerative Medicine in January calling for new consideration of the issues and ethics involved in gene editing, and a revision of Canadian legal policy.

A criminal ban is a suboptimal policy tool for science as it is inflexible, stifles public debate, and hinders responsiveness to the evolving nature of science and societal attitudes, the editorial read. It was signed by seven other experts and ethicists, and came out of a think tank on the future of human gene editing in Canada held at McGill last summer.

Dr. Caulfield says legal prohibition of certain genetic research doesnt make sense when we dont yet know or understand where the science is going, or what the benefits or harms could be. Instead, he says he believes in regulation in problematic areas, while allowing for studies and trials. He says that some of the slippery slope scenarios people fear such as using genetic modification for human enhancement and to achieve superficial traits such as height remain distant possibilities given the complexity of the science.

That is not to say there are not risks or issues to be addressed as the technology continues to evolve. Ms. Kleiderman says that includes consideration of the potential risk to future generations, the safety of the technology and other irrevocable, if unintended, consequences, although she says those risks are not unique to gene modification but true of all technologies.

When it comes to CRISPR, one of the areas it would be most beneficial is with the treatment of prevention of disease which I think most people would be in agreement with, she says. Of course, we need to be mindful of doing not-so-positive things with it, like going down the enhancement route.

She said other potential issues, such as the preservation of human diversity and individuality, the welfare of children born from this technology and the potential for creating new forms of inequality, discrimination or societal conflict, all require significant consideration and research.

There is time. Although the technology is moving quickly, there is still a long way before gene editing is used in clinical human trials. Even after that, Dr. Virani says for the foreseeable future the technology will most likely be used by a small group of people in specific scenarios related to the prevention of serious genetic disease.

Im not saying we shouldnt be concerned about those potential issues, but sometimes we make that leap too quickly, she said. We dont necessarily [think] that the most likely scenario is that couples will use this technology on a very limited basis if they know their child may potentially have a devastating genetic condition. Thats not something that suddenly everyone is going to start to do. I think theres sometimes that leap to, Oh, we can create designer babies, but I think were very much in the lessening-burden-of-disease phase rather than the designer-baby phase, though thats where peoples minds go.

Dr. Virani said one of her own concerns is the possibility of off-target effects, where changing a gene unexpectedly alters something else in the genome. Other concerns are more social reality than science fiction, including that the technology and the ability to prevent disease may only be available to those who can pay for it. Eradicating a horrible disease is one thing. Eradicating it only for families who can afford it is another.

So is it going to look like just the wealthy are going to be able to afford this type of technology? she asks. Thats very problematic in my eyes from an ethics point of view, and thinking about fairness in society. If only poor people get Huntington disease, then the lobby to support Huntington disease research is greatly diminished. Its kind of like a two-fold negative effect.

On Thursday, the American Journal of Human Genetics ran a policy statement signed by 11 organizations from around the world, including the Canadian Association of Genetic Counsellors, urging a cautious but pro-active approach as the science moves forward. The statement includes an agreement that gene editing should not yet be performed in embryos carried on to human pregnancy. (The embryos used in the Oregon research were created only for the research, and were not developed further.) It also outlines a number of criteria that should be met before clinical trials take place, and supports public funding for the research. The U.S. government does not allow federal funding for genetic research on embryos. The Oregon research was funded by the university.

We dont want it to go speeding ahead, said Kelly Ormond, the lead author of the policy statement and a genetics professor at Stanford University in California. We want people to be very transparent about whats happening and we want things to undergo good ethics review, and for society to actually be engaged in these dialogues now while this research is just starting to happen.

She said she believes its important to be pro-active in talking and thinking about the issues related to the technology, and starting a broader conversation of how gene editing should and will be used.

We can all agree that that world [of eugenics and designer babies] doesnt feel very comfortable, and I think most of us dont want to go there, she said. So we need to find ways to prevent that from happening.

Follow Jana G. Pruden on Twitter: @jana_pruden

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Modification of genes in human embryos could mark turning point in human evolution - The Globe and Mail

It isnt a surprise to anyone whos been even casually following the development of reproductive technology indeed, many of us have been preparing for this moment since the movie Gattaca was released 20 years ago but last week made it official: We can now edit the genetic material of embryos.

Researchers took a sperm cell and removed a gene mutation which causes a particular type of heart defect, and then watched what happens when that sperm cell united with a genetically normal egg cell. The result was that, in 42 of 58 attempts, the resulting embryo simply used the mothers (healthy) copy of the gene to fill in the gap.

Thats a 72 percent success rate in blocking the genetic abnormality. In sexual production, the defective gene is passed on about 50 percent of the time.

But as the movie Gattaca so brilliantly demonstrated two decades ago, there are numerous, profound ethical questions when such a practice is normalized.

The first ethical question, of course, is about the moral status and treatment of the embryo.

There are important ethical questions to ask about the creation of a fellow living member of the species Homo sapiens in a laboratory in the first place (procreation that is disconnected from the fruitful sexual union of woman and man) and these questions become even more grave when embryos are made and then discarded like so much trash.

If other contexts, the medical community is obviously not permitted to do experiments on research subjects in which the subjects receive no possible benefit and are simply abandoned to die. If we took embryos seriously as the fellow human beings they are, we would do more than shrug (or perhaps not even take notice) when each of the 58 embryos used in the study cited above are simply discarded as medical waste.

But the ethical issues become even more profound when we think about ways in which gene editing is likely to be used in the future.

Sure, few have objections to increasing the chances embryos are without disease, but what counts as a disease is a notoriously slippery and controversial topic. Do disabled people, for instance, have a disease? Or do they simply have a different way of being in the world?

Is Down syndrome a disease? Maybe. But people with Down syndrome actually report being happier than those without it. Are blindness and dwarfism diseases? Maybe. But hopeful parents who happen to have these conditions sometimes want to select embryos for implantation with whom they can share their rich-though-different experience of the world with their children.

There is even debate about whether having red hair is a kind of disease. After all, such hair is the result of mutation of the MC1R protein, and that mutation is associated with increased chances of Parkinsons and melanoma.

Is there a line-drawing moral difference between editing out a genetic mutation which causes a heart defect, and editing out a genetic mutation which causes red hair?

If not, and we approve gene editing for future children, we are in for a wild ride of gene editing directed not only at avoiding disease, but at genetic enhancementsometimes referred to as designer babies.

Dont believe me? Think well somehow find a way to draw a hard line against using this new reproductive technology in ways which prohibit enhancement?

Think again. We are already using established reproductive technology to design our own children. For years now, weve seen hopeful parents pay obscene amounts of money to egg donors who are attractive, athletic and have sufficiently high SAT scores. Fertility clinics have drop-down menus on their websites which allow one to choose from egg donor profiles which have the desired traits.

Especially given the reproductive autonomy our culture gives parents today, there is very little reason to think gene-editing for disease wont also lead to gene-editing for enhancement.

It is a cultural problem that Pope Francis has appropriately called out as the medicine of desires. More common in affluent countries, the pope said it involves the pursuit of physical perfection which leads to the marginalizing and discarding of those who are not seen as efficient.

What will the medicine of desires do with gene-editing? It doesnt take a genius to figure it out. Gattaca predicted that a culture with this technology will refer to people not genetically-edited for the best traits as invalid, and their births derisively dismissed as religious.

In that dystopian world, procreation as a result of sex could only be the result of irresponsibility or vulgar superstition. In our world, the director of the Center for Law and Biosciences at Stanford writes books titled The End of Sex and the Future of Human Reproduction, hailing such a world as a wonderful development.

Some are less than impressed with these kinds of predictions. Art Caplan, head of bioethics at NYC, says that they fill him with amusement, and claims the technology for genetic enhancement is so far away that it is a question, not for us, but for our grandchildren.

RELATED: Gene editing: Gateway to Promised Land, or Pandoras Box?

But even if Caplan is right about the time it will take for the technology to arrive, the time to resist the culture which will lead to a dystopian reproductive future is now.

Now is the time to challenge the ableist assumptions built into our uncritical sprint toward development of this technology. Now is the time to challenge the idea that children are things to be created and manipulated in a laboratory rather than welcomed as gifts with an unconditional value that does not come from the will and desire of the parents.

Now is the time to challenge a throw-away culture which selects and rewards those who are productive and efficient, while discarding those who are not.

If we wait for our grandchildren to do so, it will be too late.

Charles C. Camosy is Associate Professor of Theological and Social Ethics at Fordham University.

Link:
We need to resist brave new world of 'Gattaca' before it's too late - Crux: Covering all things Catholic

This article first appeared on the Cato Institute site.

The BBC headline blares, " Sperm count drop 'could make humans extinct.

The story is based on a new systematic review and meta-regression analysis of recent trends in both sperm concentration and total sperm count.

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The study, published in Human Reproduction Update , reports "a significant decline in sperm counts...between 1973 and 2011, driven by a 5060 percent decline among men unselected by fertility from North America, Europe, Australia and New Zealand."

By "unselected," the authors basically mean young men who are screened for military service or college who are unlikely to be aware of their fertility status. (For example, the Danish military subjects its recruits to a compulsory medical examination that apparently includes measuring their sperm count and testes sizes.)

The meta-analysis encompassed the results of 185 studies involving 42,935 men from 50 countries on six continents who provided semen samples from 1973 to 2011. The researchers claim that their analysis tried to take into account confounding factors that lower sperm counts, including obesity, smoking, alcohol use, and stress.

They report that sperm counts among unselected men living in rich developed countries fell from 99 million spermatozoa per milliliter in 1973 to 47 million per milliliter in 2011. Total sperm counts fell from 337.5 million to 137.5 milliona decline of nearly 60 percent.

Men dressed in sperm outfits working for condom maker Durex, show condom samples during a campaign in Seoul on June 24, 2008 to mark the first sale of its products in South Korea. JUNG YEON-JE/AFP/Getty

On the other hand, the researchers found no decline in sperm counts among men living in South America, Asia, or Africa.

This not the first time a spermapocalypse has been declared. The claim was first made in 1992 article by Scandinavian researchers, who reported there had been a decline of nearly 50 percent in 50 years.

Ever ready to fan the flames of panic, the publicists at Greenpeace quickly initiated a clever campaign of advertisements declaring, "You're not half the man your father was."

As the researchers acknowledge, their study tells us nothing about what caused the declines it identifies. Nevertheless, they speculate that it could be result of endocrine disruption from lifestyle changes and exposures to pesticides and synthetic chemicals.

Endocrine disruption is the particular focus of one of the researchers, Shanna Swan, who teaches environmental medicine and public health at the Icahn School of Medicine at Mount Sinai. This study will doubtlessly be cited in grant proposals for more funding for research on the toxicologically questionable endocrine disruption paradigm.

So the extinction of humanity due to falling sperm counts near at hand?

Perhaps not.

In a 2013 comprehensive review of 35 sperm quality studies published after 1992, New York-Presbyterian Hospital/Weill Cornell Medical College fertility specialist Harry Fisch and a colleague looked into the trend data on sperm counts.

The researchers reported that eight studies involving a total of 18,109 men suggest a decline in semen quality; 21 studies encompassing 112,386 men show either no change or an increase in semen quality; and six studies involving 26,007 men show ambiguous or conflicting results.

The upshot, Fisch says, is that "allegations for a worldwide decline in semen parameter values have not withstood scientific scrutiny." Asked if he stood by those findings, he replies, "Absolutely."

Fisch suggests that despite their efforts to consider confounding effects, the researchers may have failed to adequately take into account the more or less reversible effects on sperm production associated with rising obesity, marijuana use, sedentary lifestyles, and testicular temperature.

Given that the World Health Organization finds that 15 million sperm per milliliter is considered normal and adequate for fertilization, headlines suggesting the imminent extinction of humanity seem a bit overwrought.

Ronald Bailey is a science correspondent at Reason magazine and author of The End of Doom (July 2015).

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Does a Declining Sperm Count Spell the End of Humanity? - Newsweek