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The Point Washington Update - February 27, 2014

In this edition of The Point:

Article #1

Excerpted from "FDA raises concerns about three-parent embryo procedure," USA Today, February 26, 2014 - In two days of hearings ending Wednesday, a federal committee proved quite skeptical about research that might help some patients birth healthy children — but might also open the door to human gene manipulation. The procedure being considered, called mitochondrial transfer, would mix the genes of two women in hopes of creating a healthy baby.

Although the panel, which advises the federal Food and Drug Administration, did not take a vote, many members questioned the ethics of the procedure, and whether the research into it is as far advanced as some supporters claim.

All people carry two sets of genes in every cell: the 20,000 genes in the cell's nucleus, which determine traits like height, eye color and intelligence; and the 37 genes in the mitochondria, which provide energy for each cell. The mitochondrial transfer procedure would combine the nuclear genes from the mother with the mitochondrial genes of a donor woman. When fertilized, it would lead to babies with genetic material from three "parents."

The procedure promises to help women who carry defective genes that can lead to devastating mitochondrial problems in children, including blindness, organ failure and stroke. It might eventually also help resolve some types of infertility.

The committee considered what scientists would need to do before they could try the technique in people, and whether it would be possible to design a clinical trial to answer the many outstanding questions about the procedure. David Prentice, a cell biologist and senior fellow for life sciences at the Family Research Council, a conservative advocacy group, told the panel he strongly objects to any mixing of genetic material.

"The individuals created are experiments," he said by phone after the meeting ended. "You're actually creating and destroying young human life which we object to. It just seems a very wrongheaded way to proceed."

Editor's Note: CMDA CEO Dr. David Stevens debated this issue with ethicist Arthur Caplan on the Fox and Friends national news program, cohosted with Elisabeth Hasselbeck on Thursday, February 27. Dr. Stevens noted the destruction of human embryos in the proposed procedure and non-destructive alternatives to pursuing the cure. He also highlighted the ethical issue of foisting genetic changes, with unknown consequences, on successive generations.

"Germ line manipulation is something that has been prohibited in science all over the world up until the present time," Dr. Stevens noted.

Dr. Caplan replied, "I understand the concern about where we might go. I'm going to worry about that when I get there."

Watch the video here

Commentary #1-A

CMDA CEO David Stevens, MD, MA (Ethics): “Dr. Caplan is not a scientist so maybe he doesn’t understand the grave dangers that germ line manipulation can cause. In some mice studies using ‘mitochondrial replacement therapy,’ there were decreased survival rates, developmental delays, fertility problems and behavioral changes in progeny. No one knows what will happen if it is tried in humans, but we do know that if problems occur, they will continue through every generation. We should be worrying about that now, not when ‘we get there.’ By then, it will be too late.

“As an ethicist, Dr. Caplan should be concerned that the scientists experimenting on the unborn can’t get informed consent from that child’s granddaughter before doing experiments that will affect her life. He should be concerned that two of the methods of replacing ooplasm require cannibalizing another human embryo causing their death.

“Forty-one years ago, the Supreme Court decided a child could be destroyed if a woman didn’t want it. The FDA is now deciding whether a woman has the right to construct the child she wants. That decision is based on a genetic mutation problem that only causes serious disease in 400 to 600 of the four million babies born each year. If women get this new right, how can society deny them exercising it to correct more serious problems like obesity, diabetes or heart disease, if this ability becomes available through germ line manipulation? Look at all the money society would save on healthcare! Wouldn’t people be happier?

“While the scientist is tinkering, why stop at just making members of that family tree skinny? Why not add making them all six-foot tall, blue eyed and athletic? Welcome to the brave new world of designer babies and two classes of humans, the enhanced and unenhanced.

“As a society, we should not cross the clear line in the sand prohibiting germ line manipulation. It’s science too dangerous to use.”

Commentary #1-B

Executive Director of The Tennessee Center for Bioethics & Culture D. Joy Riley, MD, MA: (from her testimony before the FDA, Feb. 25, 2014) – “It is remarkable to note that while more than 40 nations have prohibited germ line modification, we are contemplating stepping over that bright line. It is imperative that we reflect upon the words of philosopher George Santayana, who presciently wrote, ‘Those who cannot remember the past are condemned to repeat it.’ This applies in several ways.

“First of all, consider that this change is being evaluated by the ‘Cellular, Tissue and Gene Therapies’ Advisory Committee of the FDA. While this is your purview, it is not merely cells, tissues or genes which are being affected by this decision. No, it is human beings – human beings at their earliest stages – who are the subjects of this research. These are your and my children, grandchildren, nieces, nephews and cousins being considered here today. Their Petri dish appearance should not confuse us. They are very much human.

“Secondly, consider codes of international standing:

“The Declaration of Geneva proclaimed for physicians worldwide, ‘The health of my patient will be my first consideration.’

“The Declaration of Helsinki stated, ‘In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests.’

“In the Council of Europe’s Convention on Biomedicine and Human Rights, intervention on the human genome is countenanced ‘only if its aim is not to introduce any modification in the genome of any descendants.’

Finally, a major requirement of research on human subjects is that of fully informed consent by the human being whose life, health and posterity will be impacted by the proposed human experiment. This is not therapy for the ones undergoing experimentation. Their very formation is the experiment under consideration here. They are not able to give consent; neither are all their descendants who come after them able to give consent, yet the proposal is to experiment on all of them by virtue of altering their germ line for all time.

Article #2

Excerpted from, "Critics want to overturn the Religious Freedom Restoration Act, but that's going too far," by The Los Angeles Times editorial board, February 4, 2014, Copyright 2014, Los Angeles Times.)

Two decades ago, Congress overwhelmingly approved and President Clinton enthusiastically signed the Religious Freedom Restoration Act. But now that the 1993 law is being used to challenge the Obama administration's requirement that employer health plans include contraceptive services, some supporters of the law are having second thoughts, and several organizations want the Supreme Court to declare it unconstitutional. That would be a mistake.

Congress passed the Religious Freedom Restoration Act, which says the government may "substantially burden a person's exercise of religion" only if necessary to further a "compelling government interest" and only if the law in question is the "least restrictive means" of achieving that interest.

Next month the Supreme Court will hear arguments in two cases in which owners of for-profit businesses argue that the law allows them to disregard the contraceptive mandate because of their religious objections. We hope and expect that the court will reject their claim. The law refers to burdens on "a person's exercise of religion," not a corporation's, and the burden must be substantial. Providing insurance coverage for a woman who uses it to obtain contraceptives no more implicates an employer in her decision than does the payment of her salary, which can also be spent on birth control. Finally, ensuring that women have access to preventive healthcare is clearly a compelling interest.

Commentary #2

By Jonathan Imbody, CMA VP for Govt. Relations (Published Feb. 4, 2014 in The Los Angeles Times) – The Times rightly defends but wrongly interprets a federal law that forbids the government from imposing ‘substantial burdens’ on the exercise of religious convictions and requires federal officials to pursue the ‘least restrictive means’ of achieving any ‘compelling interest.’

The Times neglects 1st Amendment principles in defending the administration's attempts to force employers with conscientious objections to bow to the government's edict to provide controversial contraceptives and sterilization surgeries.

The government easily could avoid restricting religious freedom by directly supplying poor women with contraceptives, just as it does worldwide.

Just as the 1st Amendment protects the free speech of citizens and corporations such as The Times, it also protects the free exercise of religion by citizens and employers. When the administration attempts to force even elderly nuns to violate their religious convictions, clearly the government has trampled on sacred 1st Amendment ground.

Article #3

Excerpted from " Jim Crow laws for gays and lesbians?" column by Kirsten Powers, USA Today, Feb. 19, 2014) - What's the matter with Kansas? A bill protecting the religious freedom of businesses and individuals to refuse services to same-sex couples passed the state House of Representatives last week. It was blessedly killed in the state Senate on Tuesday.

Similar bills have cropped up in a half-dozen states in an effort to protect anti-gay religious believers against lawsuits. A florist in Washington state, a Colorado baker and a New Mexico photographer have been sued for refusing to serve gay couples getting married. They say to do so would be to "celebrate" nuptials at odds with their Christian faith.

It's probably news to most married people that their florist and caterer were celebrating their wedding union. Most people think they just hired a vendor to provide a service. It's not clear why some Christian vendors are so confused about their role here.

Whether Christians have the legal right to discriminate should be a moot point because Christianity doesn't prohibit serving a gay couple getting married. Jesus calls his followers to be servants to all. Nor does the Bible call service to another an affirmation.

Christians backing this bill are essentially arguing for homosexual Jim Crow laws.

Some claim it's because marriage is so sacred. But double standards abound. Christian bakers don't interrogate wedding clients to make sure their behavior comports with the Bible. If they did, they'd be out of business. [Pastor Andy] Stanley said, "Jesus taught that if a person is divorced and gets remarried, it's adultery. So if (Christians) don't have a problem doing business with people getting remarried, why refuse to do business with gays and lesbians."

Maybe they should just ask themselves, "What would Jesus do?" I think he'd bake the cake.

Commentary #3

CMA VP for Govt. Relations Jonathan Imbody – “The bill that Kirsten Powers' acerbic commentary rails against would simply prohibit coercing people into performing marriage ceremonies or providing adoption or business services that are ‘contrary to sincerely held religious beliefs’ ‘regarding sex or gender.’ Powers cites the Bible and several pastors to argue that Christians should love and serve everyone regardless of sexual preference, suggesting that unchristian bigots who decline to bake cakes for or take photos of same-sex weddings deserve no protection for contrary convictions.

“What Powers overlooks is that our 1st Amendment guarantees that even if your beliefs do not comport with the Bible, even if your conscience goes against the current of the culture, the government must not compel you to violate your convictions. Christians and non-Christians alike enjoy the same protection of conscience, a bedrock of our country's founding and an essential foundation for comity and tolerance today.

“Americans' historic commitment to conscience is so strong that we do not even force conscientious objectors to join the Army when the nation is at war. Nor do we force Catholic physicians to participate in the death penalty, or Jewish deli owners to serve pork barbecue, or commercial photographers who support animal rights to supply shots for fur coat ads.

“People may disagree as to whether or not a Christian is bound by biblical principles to participate in same-sex weddings. But legally speaking—and that's the focus of this fight—the government should not be determining the answer for us.

“Unfortunately, many proponents of same-sex marriage apparently do not feel it's enough to have gained the legal right to marry; now they want to compel everyone to participate in same-sex wedding ceremonies. How ironic it would be to turn a wedding won through a campaign for ‘equality and freedom’ into an event of subjection and coercion.”

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