Category: Dov Fox

Dov Fox on the FDA’s ruling on 23andMe

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Dov Fox has a new piece up at the Huffington Post on the 23andMe controversy: “Genetic Testing Needs a Nudge.” From the article:

Mail-away genetic testing promises to revolutionize the way that people learn about and manage their health. Already half a million Americans have sent their saliva to find out their risk of genetic disease — no doctors needed.

Splashed across TV sets nationwide this past summer was 23andMe’s invitation to discover “hundreds of things about your health,” including that you “might have an increased risk of heart disease, arthritis, [or] gallstones.”

Since the company’s inception in 2007, the government had allowed it to market and sell its at-home genetic tests free of regulation. For $99 and the click of a mouse, 23andMe promised a “first step in prevention” to “mitigate[e] serious diseases.”

But this winter, the Food and Drug Administration issued a letter forbidding sales of the test to diagnose health conditions unless there is evidence that it works for that purpose. Shortly after 23andMe announced that it had “suspended” all sales of its “health-related genetic tests to comply” with the FDA directive, consumers brought aclass action lawsuit against the company, alleging that it “falsely and misleadingly advertises” the genetic test “as providing ‘health reports on 240+ conditions'” in the absence of “analytical or clinical validation.”

The 23andMe controversy illustrates a stalemate over the role of direct-to-consumer genetic testing in American health care.

You can read the full piece here.

Can you be taxed for selling your eggs?

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By Dov Fox

Those who deal in alternative ways of making families use euphemisms that obscure the market mechanisms at work when individuals ‘‘donate’’ their eggs or sperm, couples ‘‘contribute’’ their embryos, surrogates ‘‘offer’’ their wombs, and orphans are ‘‘matched’’ to adoptive parents. Make no mistake, family formation is big business. The question of first impression before a San Diego Tax Court judge is whether that business is taxable.

Nichelle Perez, like almost 17,000 other women every year in the U.S. alone, received payment (in her case $20,000) for providing her eggs to the infertile through an invasive and risky process of ‘‘superovulation.’’ When the IRS sought to tax that payment as business earnings from self-employment, Perez objected that it ought to be exempted, lest she ‘‘be[] penalized for doing something good for another person.”

Should the sale of eggs that have grown inside a woman’s body be taxed like property that’s subject to a long-term capital gain? Or does the pain and suffering that the transaction involves make it more like a settlement from a personal-injury lawsuit? Does the answer turn on the legal (or moral) status of human eggs? Or on whether the conditions under which a woman agrees to their extraction are meaningfully ‘‘voluntary’’?

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

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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.”

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Dov Fox on Roe v. Wade

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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.

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Dov Fox on screening sperm donors’ DNA

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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”

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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

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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”

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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?

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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?

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Dov Fox on the Future of Genetic Privacy

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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.