Authors

Dov Fox is Professor of Law and the Director of the Center for Health Law Policy and Bioethics at the University of San Diego School of Law, where he has been named Herzog Endowed Scholar for exceptional scholarship and teaching. He also won BIOCOM's Life Science Catalyst Award for "significant contributions to human health through research, discovery, and entrepreneurship." His work has been featured in CNN, ABC, NPR, NBC, Reuter’s, Bloomberg, Slate, Daily Beast, Today Show, Boston Globe, and Washington Post. His latest book project, "Birth Rights and Wrongs," is forthcoming with Oxford University Press.

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.

Parenthood Bill for Known Donors in California

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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?

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End the Ban on Blood Donation by Gay Men

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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

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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?

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Fox on DNA Forensic Error and the Execution of Innocents

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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… 

Big Data and Pharmacovigilance, Part II

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By Dov Fox

Yesterday, I wrote about Ryan Abbott‘s new article that proposes to use health information exchanges to improve the collection of data about the safety of approved drugs. Today, I want to address his recommendation that the government pay private parties to help the Food and Drug Administration conduct post-market drug surveillance.

The article argues that health information exchanges will make far more data available for observational research, but the current drug regulatory system is not structured in a way that would allow it to use the information effectively. This is because pharmaceutical companies have powerful incentives to emphasize data favorable to their products. (The FDA’s own research is dwarfed by comparison to what industry does and could do, while insurance companies and academics have weaker incentives to investigate.)

So Abbott suggests encouraging private parties to submit evidence that an approved drug is ineffective or unsafe. Under his proposal, if the FDA determines the evidence warrants a change to labeling or approval status, the submitting party would receive a financial prize. Its size would depend on how much the government saved by avoiding the costs of ineffective and unsafe medicines. Abbott suggests that the prize come from taxpayer dollars, unless it’s determined that the pharmaceutical acted negligently (or worse), in which case the company itself would be responsible for paying it.

It might make more sense to put the burden on pharmaceutical companies, even when they haven’t been negligent, given that it’s their products that are found to cause harm. Not only do they have the most opportunities to seek out problems early in testing and development; they are also the parties deriving the most financial benefit from medicine sales. Claims by pharmaceutical companies that they can’t operate with additional costs or regulation sound exaggerated, at least for many of those companies, given that the pharmaceutical industry has some of the highest profit margins of any business sector.

The bounty system nevertheless deserves serious consideration as an innovative proposal for harnessing market-based incentives to improve the regulatory surveillance of approved drugs. And it need not be restricted to health information exchanges. Abbott suggests applying this system to the way agencies deal with scientific questions generally. We might worry competitors might trump up data hostile to approved drugs. The provocative question that Abbott’s article invites us to ask is whether we are better off evaluating medicines under an inquisitorial system or an adversarial system.

Big Data and Pharmacovigilance, Part I

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By Dov Fox

So much new data are created every day that 90 percent of all data worldwide has emerged in just the last two years. This information revolution has the potential, argues Bill of Health guest blogger Ryan Abbott, to transform how we develop new drugs, set clinical practices, and finance health care. His interesting new article paints an alluring “vision of a drug regulatory system powered by big data”:

“When the Food and Drug Administration (FDA) approved the cholesterol-lowering drug simvastatin in 1991, it was based on pre-marketing controlled clinical studies that included a total of 2,423 patients. In 2011 alone, just in the United States, almost a hundred million prescriptions were written for the drug. Imagine the impact of being able to analyze data from every one of those patients to evaluate whether simvastatin is safe and effective.”

The surveillance of pharmaceuticals after they’ve gone to market will matter more and more, Abbott argues, as personalized medicines become more difficult – and perhaps less necessary – to regulate before they’re released. He proposes a new plan for the post-market regulatory system that relies on the health information exchanges (HIE) created by the HITECH and Affordable Care Acts. These exchanges are slated to amass a vast repository of data on individual patients. Their large size and inclusive nature will enable more accurate analyses in observational research, Abbott suggests, and in ways that minimize the bias and selectivity problems associated with current data sets.

There are at least three obstacles to the integration of these exchanges in drug regulation. First, HIEs will be expensive. While the federal government provided considerable funding to get these exchanges off the ground, Abbott recognizes that in order to remain viable, they will probably have to sustain themselves financially. Second, their meaningful impact on post-marketing surveillance will require consistent reporting standards and information-sharing mechanisms. Third are important patient concerns about the privacy of their personal health information. States are experimenting with different patient participation models to address privacy concerns. For example, Abbott notes that in some states HIEs are free to exchange information without patient consent, while in others patients can opt-out of information exchange altogether. Either is permitted by HIPAA, so long as the information is de-identified so it can’t be used to identify individual patients.

Abbott argues that it’s worth tackling such concerns that the adoption of HIEs pose for citizens, policy makers, health care providers, and the health care industry, so we don’t squander the opportunity to use health information exchanges to their full benefit. Public support for data collection isn’t enough. That data must be translated into a format that regulators can use—something I’ll address tomorrow in my next post on the subject.

Fox on “The Flawed Logic of Prenatal Discrimination”

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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

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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.