Fox interviewed on NPR about FDA’s Ban on Direct-to-Consumer Genetic Testing

Bill of Health Contributor Dov Fox was interviewed today on NPR’s “Marketplace” about the FDA’s decision to ban all sales of direct-to-consumer genetic testing by 23andMe.

23andMe provides information about genetic health risks to people who buy at-home “DNA spit kits.” The company seeks to inform consumers about their susceptibility to more than 250 diseases. But the FDA now says the company hasn’t proved the tests are accurate enough, and the agency is worried Americans are relying on the results instead of visiting their doctor. The FDA exercised its jurisdiction under the Food Drug & Cosmetic Act to regulate the DNA spit kits as a genetic device used in the diagnosis or treatment of disease.

“This field of personalized medicine is really in its infancy,” said Fox, “and its terrifically exciting what we might learn one day, but its just not there yet. 23andMe hasn’t shown that their reports about your health from your genes alone are all that useful. They’re just not accurate at this time in the way that the FDA requires.”

Critics say regulators are standing in the way of consumers having the convenience of obtaining information about their own health at a reasonable price point without an expensive trip to the doctor.  According to Fox, it’s a powerful argument that is often made by genetic testing companies such as 23andMe. The problem is the public’s understanding of genetics is very low. “These tests,” he argued, “come not only with limited accuracy, but also without the benefit of genetic counseling.”

Continue reading

Dov Fox on Roe v. Wade

In a new piece at the Huffington Post, Bill of Health Contributor Dov Fox explores “The Forgotten Holding of Roe v. Wade — that states have a valid reason to regulate reproductive conduct because of an interest in “potential life.”

That “the State may [legitimately] assert” that interest, Roe held, “as long as at leastpotential life is involved,” explains why the government may, as a constitutional matter, restrict stem cell research that destroys human embryos, for example, whether or not those frozen embryos might otherwise be brought to term. That the fetus “represents only thepotentiality of life,” on the other hand, and accordingly lacks any interests of its own under the Constitution, explains why states may not, as many have tried, accord the legal status of personhood to human life beginning at conception.

The potential-life holding helps to resolve these and many other disputes over embryo contracts, fetal pain, and sex selection, for example, as I show in a forthcoming article. Arecent lawsuit exemplifies the enduring significance of Roe‘s potential-life holding. The case marks the first-ever federal challenge to fetal protection laws that punish women for using drugs during pregnancy.

Continue reading

Dov Fox on screening sperm donors’ DNA

In “Company seeks to make sperm banks safer,” a recent article in the Boston Globe, Bill of Health blogger Dov Fox recently weighed in on new companies that propose to screen sperm donor DNA in an effort to reduce the chance that children conceived with donated sperm will have childhood genetic diseases:

Dov Fox, an assistant professor at the University of San Diego School of Law who studies bioethics, said it is unclear whether genomic understanding will evolve to allow testing such as GenePeeks offers to ever be informative for common diseases caused by a blend of genetic and environmental risk factors. And he, like others, worries that one day such technology will be extended to not just avoiding disease, but selecting the babies parents want. GenePeeks will not cross that line, Morriss said.

Read the full article here.

Dov Fox on the question of “designer babies”

Bill of Health blogger Dov Fox was quoted in the recent article “Genetic-testing patent raises concerns about ‘designer babies’.”

“‘Some people might say this is in some respects similar to dating websites to the extent you look for traits in somebody you want to have children with,’ said Dov Fox, a law professor at the University of San Diego. But the important question, he said, is whether the accuracy from the genetic testing, albeit imperfect, makes 23andMe’s service more troubling.”

View the full article here.

Fox on 23andMe’s Designer Baby Patent

Check out blogger Dov Fox‘s new op-ed over at HuffPo discussing 23andMe’s Designer Baby Patent.  Here’s a quick taste: 

Even if 23andMe doesn’t bring its donor selection technique to market, there’s still reason to resist granting such patents in the first place. Patents do more, after all, than incentive innovators to disclose their inventions to the public. When the government confers a patent for a particular invention, it implicitly approves of that invention as an object worthy of exclusive rights. A patent award sends the message that this is an invention whose development should be protected and promoted.

The utility standard in patent law requires that a patented invention be “socially beneficial.” That requirement once contained a morality condition that rendered ineligible for patent protection inventions whose sole use was deemed “injurious to the well-being, good policy, or sound morals of society.” But this morals dimension of patent law’s utility requirement has more recently fallen out of favor. The PTO expressly rejected the argument that “patents should not issue for [human] genes because the sequence of the human genome is at the core of what it means to be human,” and the Supreme Court declined even to consider such morality-based arguments in last summer’s gene patenting case of Myriad Genetics.

Congress should consider amending the patent law to appoint ethical representatives to the PTO. Its present staff, given their alternative professional backgrounds and competing professional responsibilities, cannot reasonably be expected to account for the relevant methodology and literature. But qualified experts could equip the PTO to enlarge the range of arguments that it draws upon to determine whether an invention serves social utility.

Dov Fox on Genetics and “The End of Family Secrets”

Bill of Health blogger Dov Fox was featured in a recent National Geographic article on genetics and genealogy.

Dov Fox, an assistant professor of law at the University of San Diego who specializes in genetic and bioethical issues, told me that it’s only a matter of time before genetic genealogy leads to lawsuits regarding fidelity, paternity, and inheritance. But it’s unclear, for now, how the law will handle those cases.

Here in the U.S., there aren’t any federal privacy statutes that would apply, Fox says. The U.S. Genetic Information Nondiscrimination Act (GINA), passed in 2008, says that health insurers and employers cannot use an individual’s genetic information to deny medical coverage or to make employment decisions. But genetic genealogy doesn’t have anything to do with medical risks. That means lawyers will have to get creative in how they present their cases.

“What happens often with advances in science and technology is that we try to shoehorn new advances into ill-fitting existing statutes,” Fox says. So genetic genealogy cases might hinge upon laws originally written for blackmail, libel, or even peeping Tom violations.

For more, read the full article here.

Does Individuality Save Eugenics?

By Dov Fox

So asks medical historian Nathaniel Comfort in today’s Scientific America, echoing Ross Douthat’s New York Times inquiry into Eugenics, Past and Future. Comfort and Douthat are skeptical of the view, articulated by an emerging class of academics, that individual parents should use reproductive technologies to select or enhance certain genetic traits in their children.

“Hitler gave eugenics a bad name,” is how I expressed this view in the first scholarly examination of that ideal, “but there is nothing objectionable as such about the eugenic ambition to produce people of a particular type.” Comfort illuminates two centuries of developments in the medicine, society, and culture of “eugenics.” But he offers little analysis of why individuality fails to “save” the new eugenics, beyond his two assertions, heard often in these debates, that it risks “unforeseeable consequences” and might “dissolve into a species of collective eugenics.” What more might be said in support of this second suggestion, that a political theory that privileges freedom, equality, and fairness cannot accommodate individual choice about offspring characteristics?

Continue reading

Dov Fox on the Future of Genetic Privacy

Bill of Health contributor Dov Fox has a new op-ed at the Huffington Post on “junk” DNA and the future of genetic privacy in the aftermath of the Supreme Court’s ruling, in Maryland v. King, that police may collect DNA from people under arrest. Fox argues,

The next great controversy over forensic DNA won’t have anything to do with whether police can test “junk” DNA from people whose identity they already know. It will be about whether police can look “more broadly” at the “other stuff” that genetic information can reveal from people who aren’t yet known to them. That our DNA could serve as an eyewitness has powerful implications, beyond individual privacy, for the pervasive role of race in the investigation of crime.

Read the full piece here.

Parenthood Bill for Known Donors in California

By Dov Fox

Naomi Cahn and June Carbone have a timely and thoughtful new op-ed in tomorrow’s L.A. Times that considers the evolving social and genetic dimensions of legal parenthood in the context of assisted reproduction. When many of the rules that govern sperm donation were enacted in the decade after Roe v. Wade, donors were presumed to be unknown to, and uninterested in knowing, the woman or resulting child. Today, however, donors are sometimes friends or lovers who want to assume a parenthood role at some point after the child is born, even if they didn’t think they would when they gave up their gametes to conceive him or her. How should the law approach such claims?

Continue reading

End the Ban on Blood Donation by Gay Men

By Dov Fox

86 members of the U.S. Congress have requested an end to the federal policy that prevents men who have had sex with men from giving blood. Advances in blood screening technology have discredited the medical justification for this exclusion. And our country’s current critical blood shortage makes it dangerous for public health.

The antidiscrimination objection is more complicated. The policy wasn’t born of illicit motivations and doesn’t seriously disadvantage gay men. That it doesn’t reflect bad intentions or effects, does not, however, vindicate the policy on equality grounds. The blanket exclusion, independent of individual risk levels, reflects a disparaging stereotype that gay men are sexually promiscuous or use illegal drugs, I argued in an op-ed last week. I have elsewhere called this objectionable social meaning the expressive dimension of donor deferral.

Secretary Sebelius should answer the congressional plea to end our exclusionary blood donation policy. In the meantime, those who already enjoy the opportunity to help save lives can serve the causes of public health and social equality by making an appointment to give today.

Fox discussed in The Atlantic article on Brain Imaging and the Right to Silence

A new article in The Atlantic, “Could the Government Get a Search Warrant for Your Thoughts?: Why remain silent if they can just read your mind?“, cites Bill of Health blogger Dov Fox’s research on brain imaging.

Last year, a Maryland man on trial for murdering his roommate tried to introduce results from an fMRI-based lie detection test to bolster his claim that the death was a suicide. The court ruled the test results inadmissible, noting that the “fMRI lie detection method of testing is not yet accepted in the scientific community.” In a decision last year to exclude fMRI lie detection test results submitted by a defendant in a different case, the Sixth Circuit was even more skeptical, writing that “there are concerns with not only whether fMRI lie detection of ‘real lies’ has been tested but whether it can be tested.”

So far, concerns regarding reliability have kept thought-inferring brain measurements out of U.S. (but not foreign) courtrooms. But is technology the only barrier? Or, if more mature, reliable brain scanning methods for detecting truthfulness and reading thoughts are developed in the future, could they be employed not only by defendants hoping to demonstrate innocence but also by prosecutors attempting to establish guilt? Could prosecutors armed with a search warrant compel an unwilling suspect to submit to brain scans aimed at exploring his or her innermost thoughts?

Continue reading

Fox on DNA Forensic Error and the Execution of Innocents

By Dov Fox

Willie Jerome Manning, a 44-year-old black man, is scheduled to die by lethal injection on Tuesday for the 1992 kidnapping and murder of white college students Jon Steckler and Tiffany Miller in Mississippi. No physical evidence has ever linked Manning to the crime. And the Justice Department has just come clean that the forensic science used to prosecute Manning was fundamentally flawed.

A jury convicted Manning almost 20 years ago based on three kinds of circumstantial evidence. First was the testimony of his cousin and a jailhouse informant who claimed that he confessed the crime to them. The cousin had accused two other men before Manning, however, and the informant has since recanted altogether. Second were Steckler’s jacket, ring, and CD player from his car that Manning was arrested for trying to sell. Manning told police from the beginning that he had acquired the stolen property from someone he didn’t know.

Critical to the prosecution’s case was the last piece of evidence against Manning: expert testimony by an FBI agent that African American hair fragments were found in Miller’s car. Not only did DNA and fingerprints found at the crime scene never incriminate Manning himself, however. Two days ago, the Justice Department notified Manning’s lawyer and the County District Attorney that “testimony containing erroneous statements regarding microscopic hair comparison analysis was used in this case.” Federal officials have yet to detail the precise errors involved, but made clear in their letter that the FBI’s forensic evidence was unsound not least because it “exceeded the limits of science” at the time.

Keep reading… 

Fox on “The Flawed Logic of Prenatal Discrimination”

Dov Fox has an interesting new piece up at HuffPo examining the constitutionality of the abortion restrictions just enacted  in North Dakota:

As the Supreme Court heard oral arguments this week in the same-sex marriage cases, North Dakota enacted three of the most restrictive abortion laws in the country. Two of them are unlike any ever considered by U.S. courts.

One bans abortion wholesale after a fetal heartbeat is “detectable” (as early as six weeks into a pregnancy), unless termination would save the woman’s life. The other law forbids any abortion that’s sought on the basis of fetal sex or genetic anomaly, even fatal ones.

Both laws should be struck down as unconstitutional. But the selective abortion ban presents new legal questions for supporters of reproductive rights. Indeed, the Supreme Court in Roe v. Wade declined to insist that a woman “is entitled to terminate her pregnancy . . . for whatever reason she alone chooses.”

 Keep reading…

Cyborg Bugs and Glow-in-the-Dark Cats

By Dov Fox

That’s what CNN called yesterday’s report with science writer Emily Anthes about her new book, Frankenstein’s Cat, which examines “genetically modified this, or cloned that,” as she put it, or “creatures that combine electronic bits and biological ones.” Wrestling with the ethics of such cases, Anthes explains, “reveals that we’re deeply conflicted about the role that animals play in our lives.” Yet she laments that this tension supplies no satisfying answers to underlying questions like “Is this unnatural?” and would “that make it wrong?”

Our confusion lies, I’ve suggested, in the failure of animal welfare discourse to capture the sense many of us share that animal “nature” has value apart from its happiness or well-being. If its welfare were all that mattered, then we shouldn’t be troubled by animals designed to experience less frustration living in the conditions for which they’re destined. Consider three examples of designer animals that are currently being developed: cows with stunted sentience, less apprehensive of going off to slaughter; chickens that lack nesting instincts, more satisfied to a life confined to laying eggs in a battery cage; and pigs without legs, better suited for a sedentary existence as ham and bacon in potentia.

The dominance of the animal welfare view obscures a reason to resist such creations: to preserve animal integrity. Cows should be able to fear danger, pigs to play in the mud, and chickens to peck about in the sand, according to this view, less because those capacities make the animals happy than because they are integral to an intrinsically valuable way of being. To deprive a cow of its responsiveness, or a pig of its limbs, or a chicken of its proclivity for pecking would, on this account, violate its essential “cowness” or “pigness” or “chickenness,” even if those animals were perfectly content in their designated roles.

For thoughts on why animal nature may indeed be worth preserving, and implications for conventional breeding (e.g., dogs for companionship, or horses for racing), and what all of this  means for designer children and embryonic stem cell research, check out the article.

Fox on Prenatal Genetic Testing

front-page story in today’s Sunday Boston Globe quotes Bill of Health blogger Dov Fox on whether the routine use of new prenatal blood testing could “‘bring a tendency to exclude rather than accommodate people whose abilities fail to meet [certain] demands'” of modern society or “‘exert[] social pressure on parents to terminate pregnancy for fear of criticism or reproach from people who regard the[ir] choice [to have a] child with a disability [] as negligent, or irresponsible.'”
If these non-invasive tests (which look at potentially unlimited amounts of fetal DNA) were able to provide genetic information for conditions beyond just sex and health, might we come to think in similar ways about children of “merely” average looks or normal height or ordinary intelligence? Dov explored this question and others in a talk that he gave as a 2006 summer fellow at the Petrie-Flom Center. His article is called Silver Spoons and Golden Genes.

Birth Control for Men?

By Dov Fox

We’re not talking vasectomies or condoms.

Medical Daily reports that the NIH has awarded a $4.7 million grant to come up with a “Pill” for men. Most previous attempts to develop such contraceptives used testosterone to reduce the number of sperm men produce. This one takes aim at its mobility instead, using a non-hormonal compound that promises fewer side effects, according to scientists. Clinical testing into its safety and efficacy, assuming the FDA grants permission, would take at least five to ten years before the agency could consider approving the drug for use.

The availability of male birth control would make it possible for men and women to share responsibility for contraception. Today, women alone shoulder the considerable physical and other burdens that come with the Pill. And only women enjoy the security that control of its use affords over the likelihood of unwanted pregnancy. Tomorrow, we could even things out a bit. That’d surely be a development worth embracing. Or would it? Sharing responsibility for contraception means leaving it to men to take the necessary measures to prevent the reproductive consequences that in our society fall far more heavily on women.

We might suppose that some such men, who have less at stake than their female partners, would be less vigilant about birth control and forget to take the pill. There is also evidence to suggest that other men might use greater control over conception for abusive purposes. A 2010 study found that 15% percent of respondents women ages 16-29 who sought care in several Northern California family planning clinics reported that their male partners had damaged condoms or otherwise sabotaged their birth control.*

Would birth control for men be cause for celebration, or concern? Would it revolutionize sexual equality, or change little at all?

*This “pregnancy coercion,” as the researchers call it, differs in respect of the gestation, abortion rights, and sex-differentiated social expectations involved from the reverse-gender cases that Glenn Cohen has analyzed in which courts “have imposed legal parenthood [] on fathers deceived into believing that their partners could not conceive” or under circumstances in which “conception took place without meaningful consent.”

The U.S. Should Cover the Cost of IVF (for Gays and Lesbians Too)

By Dov Fox

Glenn Cohen and I make the case in this morning’s Huffington Post:

This week the United Kingdom joined the ranks of countries like Canada, Israel, and Sweden that provide in vitro fertilization (IVF) treatment to citizens under a certain age (42 in the U.K.) who can’t have children without it. That includes gays and lesbians. When it comes to helping people form the families they long for, the United States is woefully behind. The U.S. has among the lowest rates of IVF usage of any developed country in the world, owing in part to boasting the highest cost for the procedure, on average $100,000 for each successful pregnancy.

Among the handful of states that require insurers to cover IVF, many carve out exclusions for same-sex couples and people who aren’t married. These singles, gays, and lesbians are sometimes called “dysfertile” as opposed to “infertile” to emphasize their social (rather than just biological) obstacles to reproduction. The U.S. should expand IVF coverage for the infertile, and include the dysfertile too.

The U.S. Supreme Court has held that the inability to reproduce qualifies as a health-impairing disability under the Americans with Disabilities Act. The commitment to universal health care that we renewed in President Obama’s health reform act invites us to understand the infertile and dysfertile alike as needing medicine to restore a capacity—for “[r]eproduction and the sexual dynamics surrounding it”—that is, in the words of the Supreme Court, “central to the life process itself.”

Continue reading

Caplan on “$10,000 to Abort?”

Art Caplan has a new column up discussing the surrogacy agreement gone awry (noted by Judy Daar below) in which a surrogate was offered $10K to abort the fetus upon discovery of abnormalities.  Take a look.

We’ve also had other discussions of this issue at Bill of Health, from Dov Fox’s recent post on abortion of disabled fetuses to Glenn Cohen’s post on Mitt Romney’s son’s abortion contract.

The ADA and Declining Down Syndrome Birthrates

[Posted on behalf of Dov Fox]

Having a child is hard work. It can be especially taxing—“physically, emotionally, and of course, financi[]ally, to bring a child with [disabilities] . . . into the world and raise it,” as commentators have noted in response to an earlier version of this piece that Chris Griffin and I wrote yesterday on Huffington Post. So it is not difficult for many of us to sympathize with the genetic parents who, CNN reported later in the day, offered their surrogate $10,000 to have an abortion when they learned “the baby would need several heart surgeries” and “ha[ve] only about a 25% chance of having a ‘normal life.’”

At the same time, doctors and authors justly celebrate the increasing willingness of those who decide that, for them, it makes sense to bring a pregnancy to term after getting a positive test for a condition like Down syndrome. These advocates explain the perceived shift in social norms by noting that the landmark Americans with Disabilities Act (ADA) provides legal protections to combat employment discrimination and enhance access to public accommodations. What they fail to appreciate is that these protections have not always brought with them the anticipated acceptance of having a child with disabilities.

A study we published in 2009 reveals a 25 percent decline in Down syndrome birthrates nationwide after the first President Bush signed the ADA into law. Controlling for variables from maternal age and marital status to prenatal testing and access to abortion, we found that about 15 fewer children per 100,000 were born with Down syndrome after the law was passed. So here’s the puzzle: Why would fewer children be brought into the world just as they are being afforded greater opportunities in life?

Continue reading