Author Archive | Nita Farahany

Judge Brody Rejects NFL Settlement Agreement

I’ve been following with fascination the overwhelming evidence about brain injuries caused by football. On the one hand, I believe in individual autonomy. On the other hand, I’m not really a fan of football. But I also don’t favor paternalistic policies that limit individuals from undertaking calculated risks. And yet, what about undisclosed risks?

All of that and more is at issue in the complaint brought by over 4,500 former football players who sued the National Football League for damages arising from their injuries. The complaints were consolidated before U.S. District Judge Anita Brody in Philadelphia. The players claim that the NFL was negligent in failing to inform players of the link between repeated traumatic head impacts and long-term brain injuries, including early onset Alzheimer’s and dementia. They claim the NFL knew about these neurological impairments as early as the 1970s and didn’t take any steps to redress these issues until 1994.

On Tuesday, Judge Brody took the unusual step of a issuing a preliminary rejection of the “$760 million over a period of 20 years” reached between the players and the NFL, asking for more detailed financial information, and stating that:

“Judicial review must be exacting and thorough. The task is demanding because the adversariness of litigation is often lost after the agreement to settle….

…I am primarily concerned that not all Retired NFL Football Players who ultimately receive a Qualifying Diagnosis or their related claimants will be paid. The Settlement fixes the size of the Monetary Award Fund. It also fixes the Monetary Award level for each Qualifying Diagnosis, subject to a variety of offsets. In various hypothetical scenarios, the Monetary Award Fund may lack the necessary funds to pay Monetary Awards for Qualifying Diagnoses. … it is difficult to see how the Monetary Award Fund would have […]

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Our commentary on why the FDA should allow 23andMe to proceed

For those of you who have been following FDA actions against the consumer genomics company 23andMe (see my prior posts here and here), you may enjoy the commentary that Robert Green (geneticist at Harvard) and I published in Nature today.

We argue that it’s an open question whether FDA has jurisdiction over the health-related interpretations that 23andMe and other consumer genomic testing companies provide. And even if they do, that the precautionary approach the FDA adopts is unwarranted here. Early empirical data that shows little harm and significant benefits to consumers. Moreover, we believe that FDA’s regulatory approach puts it in even greater tension with the First Amendment. An excerpt from the article below:

“The FDA cannot reasonably regulate all such indirect information as medical devices. Moreover, as the court cases of Sorrell v. IMS Health (2011) and United States v. Caronia (2012) demonstrate, doing so could put FDA regulations in greater tension with the First Amendment of the US Constitution, which protects the rights of individuals to receive information, and of ‘commercial speech’1. Given this backdrop, the agency should avoid restricting consumer genomic testing unless faced with empirical evidence of harm.”

Read the rest of the commentary here.

 

 

 

 

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Class Action Suit Filed Against 23andMe

Well that didn’t take very long.

Five days after the FDA issued a cease and desist letter to 23andme, San Diego resident Lisa Casey has has filed a class action law suit, and she is seeking to represent the “ten or hundreds of thousands” of others across America who paid for the product and were “harmed” because of the “false and misleading claims” about the tests’ ability to provide health information to individuals since 23andMe hasn’t “validated” its interpretive claims with the FDA.

There’s a silver lining here. 23andMe just might decide to litigate whether FDA has jurisdiction over direct-to-consumer genetic testing, and whether the FDA has overreached by classifying their “test kit” as a medical device.

Read more about it here, and here.

 

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FDA Overreach and 23andMe

According to the FDA, a soiled plastic cup is a medical device subject to its jurisdiction. In its seemingly infinite expanse, the FDA has issued a cease and desist letter to 23andMe stating:

The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).

“This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. For example, your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.”

What’s the “PGS” process? Sign up on 23andMe’s website, pay the fee, and soon thereafter receive your “test kit” in the mail.  The “kit” is a small  plastic tube that you spit into, seal, and then send back to 23andMe. Using a panel of probes, 23andMe detects single nucleotide polymorphisms […]

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Ilya’s Sensationalized “Designer Babies”

I hate to be disagreeable (especially since I’m new here, and all) but I take serious issue with Ilya’s gloss on “Designer Babies.” I find so many parts of his post problematic that I hardly know where to begin. [The conflating of self-enhancement with offspring enhancement? His seeming endorsement of state-sponsored control of reproduction? The distributive justice claim?]. To be fair, I am against prohibitions against genetically modifying babies (see my debates on IQ2Al-Jazeera, and On Point, with Tom Ashbrook). But a responsible bioethical discussion should begin with the scientific facts:

The largest study ever of genetic contributions to childhood intelligence, published earlier this year, found that only around twenty to forty percent or so of variation in childhood IQ can be explained by genetic factors. That’s far less than many believed, and far less than necessary for the deterministic “Designer Babies” Ilya hypothesizes. Even if we did a throwback to old-school genetic determinism, we are nowhere close to having a decent understanding of the actual genes involved, (let alone the gene-gene, gene-environment, and epigenetic variations to name a few) in the complex behavior called “intelligence.” Moreover, there are so many safety impediments to the genetic modification of complex behavioral traits in human, that for the foreseeable (and distant) future, engineering ourselves (let alone our offspring) for intelligence is just science fiction.

And yet, we are on the cusp of FDA trials for doing real genetic engineering of offspring—using mitochondrial DNA transfer (which leaves the nucleus of the egg or embryo untouched–where  nearly 100% of the coding traits are–including any genes related to intelligence). Mitochondrial transfer could prevent the needless suffering of thousands of children a year. But if we sensationalize science about “designer babies,” we will never approve this truly […]

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Bias in the Northern District of Georgia?

On Sunday, the Atlanta Journal of Constitution published a front-page story: Workers Who Cry Foul Seldom Get a Day in Court. The story focuses on an empirical study on summary dismissal of employment discrimination claims brought in the Northern District of Georgia in 2011 and 2012. That study reveals that it is “nearly impossible to get trial in an employment discrimination case” in the Northern District of Georgia. [The study was commissioned by the law firm of Barrett and Farahany in Atlanta, GA, and authored by Tanya McAdams and Amanda Farahany (full disclosure: my sister)]. The Northern District of Georgia (and Atlanta, in particular) appears to be an outlier, in that “70 percent of cases brought under Title VII of the Civil Rights Act of 1964 are dismissed before trial [nationwide],” while in the Northern District of Georgia, “judges toss more than 80 percent of all cases.” In Atlanta, they toss 94% of employment discrimination claims. In 2011 and 2012, 100% percent of racial harassment cases and all but one sexual harassment case were dismissed. By comparison, when the firm compared the results from the Northern District of Alabama (also within the 11th Circuit, and also a state with no state laws concerning employment discrimination (like Georgia)), they found that 66% instead of 80% of employment discrimination claims were dismissed in full.

How should we interpret these results? Could the Northern District of Georgia be facing far more frivolous suits than other jurisdictions? Perhaps, although it’s hard to believe that’s a complete answer. I, for one, would like to know how these results compare to summary dismissal of other types of claims in the same jurisdiction. Assuming that the rate of summary dismissal for employment discrimination claims differs from dismissal of other civil claims, should we infer some […]

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Eavesdropping on the Brain

Everyone has been so distracted by the government shutdown and before that, Edward Snowden and the NSA, that you probably missed the first real-time study of eavesdropping on the brain that was just published.

Before you get too excited, you should realize that the particular technique described in this paper is unlikely to spawn a large-scale government brain-monitoring program. First, it’s invasive (you have to cut out a piece of the skull, implant electrodes, and then wirelessly monitor brain activity). Second, the researchers recorded quantitative thought rather than more complex thought. What is remarkable about this study is that the researchers recorded real-time brain activity while subjects engaged in real-life activities, rather than in an artificial lab environment. The researchers found that lab math looks like real world quantitative thought in the brain. This means that the biggest indictment of neuroscience—“real-world tasks aren’t the same as lab tasks”—may be wrong. That’s why Joseph Parvizi, senior author of the study said, “We’re now able to eavesdrop on the brain in real life.” Move on, NSA. This is so much better than scouring e-mails.

I’m new here, so you don’t know whether to take me seriously. I’m quite serious. Consider this – one of my favorite neuroscientists, Jack Gallant, is building a brain-mind map. In one of his extraordinary studies, he showed subjects YouTube videos while monitoring their brain activity using a technique called functional magnetic resonance imaging (fMRI). He then built a computer algorithm “dictionary” of the brain (this brain activity corresponds to this image in the YouTube video, and so forth). Using his brain/mind/dictionary, he showed the subject new YouTube video clips that the computer didn’t get to “see” and the computer had to “guess” what the subjects were seeing. The results are really […]

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Hello Conspiracy!

Hello Conspiracy! I am truly delighted to be joining you as the newest Conspirator, and thank Eugene for the invitation and warm welcome. I’ll be blogging primarily about issues at the intersection of law and the biosciences, including developments in neuroscience, philosophy of biology, and bioethics and the law. Occasionally, I’ll be posting about seemingly random but truly amazing breakthroughs in the biosciences. For those of you who don’t know me, I’m a Professor of Law and Philosophy, and a Professor of Genome Sciences and Policy at Duke. I’m also one of the co-founders of a new peer-reviewed journal, The Journal of Law and the Biosciences (a collaborative effort between Duke University, Stanford University, Harvard University and Oxford University Press). As a member of the Presidential Commission for the Study of Bioethical Issues (our esteemed staff is now back at work), and the most recent recipient of the Paul M. Bator award from the Federalist Society, I’m also a bit of an enigma. You can also find me on Twitter @NitaFarahany where you’ll get daily morsels of science. And if you followed the Law and Biosciences Digest, please join me here from now on, instead. I look forward to engaging with my fellow co-conspirators, and with all of you, our excellent readers! […]

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