genomeboy.com

In an effort to stop DNA testing on state campuses, a bill was introduced in the California legislature last week that would prevent the University of California system from:

“making an unsolicited request to an enrolled or prospective student of that segment for a DNA sample for the purpose of genetic testing.” It would also require that the universities report how much they are spending on such tests; the schools would then have their funding reduced by that amount.

Keep moving those goalposts, boys and girls. We may not be able to legislate morality, but ignorance is clearly within our grasp.

(hat tip: Dan Vorhaus)

Dr. Alberto Gutierrez—the FDA’s director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health—talks to NEWSWEEK about the personal genomics crackdown:

So the problem is that the companies are testing for genetic variants that might affect the way consumers make medical decisions?
That’s correct … If you’re making a claim about [a genetic variant that affects the metabolism of the anticoagulant drug] warfarin, and somebody decides based on the result they get that they want to change their dosing, that is a fairly risky decision. That could affect their health. If they’re not feeling well on their current dose and the drug is expensive, we don’t know what they would do.

Last time I checked, one could not buy warfarin over-the-counter. Oh well, I guess there’s still no way we could ever know what they would do. Fortunately the NIH would never support a website where anyone could input her own genotype data to evaluate her own warfarin dosing.

***

What Knome sells is more of a service than a device. It’s basically a software program that explains genetic data that consumers can have generated elsewhere. Can you explain to me why it requires pre-market clearance?
Software is a medical device, and they’re making medical claims. They’re taking results and making medical claims that come out of those results.

Gosh, I sure hope WebMD, mayoclinic.com, yourdiagnosis.com, medhelp.org, medicinenet.com, healthcaremagic.com, emedicine, MedicineNet, and healthline.com have pre-market clearance.  And fortunately the NIH would never support software blah blah blah…

UPDATE: In contrast to my screed, the Genomics Law Report offers a more balanced, detailed and sober analysis. 

“So, Mr. Public Genome, why aren’t you on Facebook already?”

“Oh, I don’t know. Just because.”

Cystic fibrosis screening in the real world:

Dr. Highsmith agrees that one “extremely good aspect” of CF newborn screening programs is that when an affected baby is identified and brought to a CF center, “you certainly get clinical improvement.” However, he asks, “What happens when you find carriers?…what is the cost of that strategy from both a medical and a parental stress viewpoint?”

Am I to understand that one of the complaints against newborn screening for CF is the “unintended consequence” of finding carriers? Hoo boy.

The awesome Susan Orlean on mules (subscription):

The mule’s commitment to survival is interesting in a Darwinian context, because mules–the hybrid result of mating a male donkey with a female horse–have an uneven number of chromosomes and are therefore sterile. Every mule, then, is sui generis; it leaves no legacy beyond itself, no radiating gene pool to mark its visit to this world…Even the sheer persistence of the breed seems a stroke of genius. Since a horse and a donkey rarely mate on their own, mules are essentially man-made. It has been a successful invention–in fact, mules are probably the most successful and enduring animal hybrid, with beefalo coming in a distant second.

You can’t make this stuff up.

Elsewhere in this volume she talks about creationism, saying she “didn’t believe in the theory that human beings — thinking, loving beings — originated from fish that sprouted legs and crawled out of the sea” or from “monkeys who eventually swung down from the trees.”

From the HIPAA, SHMIPAA files:

A new survey of medical-school deans finds that unprofessional conduct on blogs and social-networking sites is common among medical students. Although med students fully understand patient-confidentiality laws and are indoctrinated in the high ethical standards to which their white-coated profession is held, many of them still use Facebook, YouTube, Twitter, Flickr and other sites to depict and discuss lewd behavior and sexual misconduct, make discriminatory statements and discuss patient cases in violation of confidentiality laws, according to the survey, which was published this week in the Journal of the American Medical Association.

I’ve always maintained that what happens between two consenting species is nobody’s business, as long as they’re happy.