Comments on: 23andMe and the FDA clearance

By: Brandon Keim

Brandon Keim — Fri, 03 Aug 2012 16:30:34 +0000

It’s easy to see genomic data regulation in romantic narrative terms — The plucky little guys who want to be free! The big, bad institutions who want to control them! — and it’s also a trap. Interpreting genomic information in a medically useful way is very, very complicated. It’s easy to do badly — and people may make life-altering decisions based on bad information.

Gene-testing companies already have a track record of offering tests unsupported by unsupported by clinical evidence, such as CYP450 testing to determine antidepressant dosage. A let-the-market-regulate-itself, buyer-beware approach isn’t any more desirable than it would be for new drugs.

By: Stephen

Stephen — Thu, 02 Aug 2012 15:50:50 +0000

So long as personal genomics interfaces are primitive, the FDA won’t worry that any implicit medical advice is unwarranted. But making a “slicker app” is not intellectually neutral — it carries with it a claim that the data are meaningful to people without the background to understand the primitive version. For genes of drastic effect there’s little difficulty. But relative risk estimates are fraught with (and cannot be separated from) interpretive vagaries. There will always be a category of scores which are only global probabilities and aren’t strong data about individuals. The specific way a “slicker app” presents these carries a value judgment that the FDA might deem an aspect of doctor-patient relations.

By: Razib Khan

Razib Khan — Wed, 01 Aug 2012 16:13:46 +0000

#3, i’m not. my point is that better app design doesn’t require FDA approval. that will come if there is money in the area (or, if nerds take sufficient interest re: open source).

By: John

John — Wed, 01 Aug 2012 15:18:25 +0000

I wouldn’t underestimate the need for slicker interfaces. What we have now is not up to the task, and would certainly lighten the burden in terms of educating general public/physicians methinks.

By: Stephen

Stephen — Tue, 31 Jul 2012 17:46:52 +0000

The only clean approach is that the people who get/sell the data and the people who advise about its meaning should be separately licensed, if licensed at all, and separately priced. Because I buy SNP chip results from one firm should not obligate me to buy that firm’s advice. The reason for this is simple conflict of interest, in that the data seller makes an implicit statement about the data’s importance. It’s not in their interest to be clear about how few SNPs are truly useful. The buyer is already free to take the data to any interpreter, including those with purely educational, not financial, motives, of course. Yet the FDA needs to avoid sanctioning any particular, implicit medical importance attached to the sale of raw data.

By: Rhwawn

Rhwawn — Tue, 31 Jul 2012 14:59:07 +0000

From their announcement:

> We are confident that our initial application to the FDA is complete and comprehensive. Being the first in the industry to announce we are actively working toward FDA clearance of our direct-to-consumer service demonstrates our commitment to make personal genetics an integral part of routine healthcare without sacrificing people’s right to access information about themselves. Our goal is to remain the world’s trusted source of genetic information — not just for people with a doctor’s order, but for everyone regardless of why or how they choose to learn about their DNA. DNA is fascinating, but it’s even more fascinating when it’s about you.

And the frontrunner in industry X begins to raise barriers to competition by working with regulators… This is not something to celebrate.

(As Peter Thiel said, Paypal’s so valuable because with all the post-9/11 regulation, it’d be next to impossible to start another one.)