Thursday, November 28, 2013

update: there has been aclass action lawsuit filed against 23andme, kind of piggybacking on the fda action. as a happy 23andme customer, I want to opt out and object,if I can find counsel. This blog by richard epstein
explains the basis for my objections. I read epstein's "takings", liked it, and once had the pleasure of riding in an elevator with him.
https://docs.google.com/file/d/0B0zYPQn3U6APbjhyMUxvN2ZtVEU/edit text of the suit

Ted Frank at http://en.wikipedia.org/wiki/Center_for_Class_Action_Fairness does objections to class actions, but his agenda is different than mine, so I need to keep googling to try to find somebody working on this stuff.
maybe the guy in michigan can't remember the name right now ran for governor, geoffrey fieger. http://www.fiegerlaw.com/home.php

Contact us:800.292.5865
Mark Ankcorn is the lawyer doing the suit. http://www.markankcorn.com/

"We'd love to hear your story, too, so please be in touch."

previous blog entry starts here:
The FDA has banned new sales by 23andme.com. Boingboing. Slashdot.
I got my dna read by 23andme a couple of years ago to find out which genetic marker my immigrant Stewart ancestor had. In the process I learned some useful things about my health as well as geneology. I am 2.4% neanderthal, and don't have the gene to be able to smell armpit sweat. These are not a big deal, but for some people the genetic data can be lifesaving, which is what 23andme was founded to do. The test was a gift to me from my brother, who is one of the other two people who have that Stewart direct male line.

The FDA kills on average 100,000 people a year in the United States by delaying medical innovation.
When these new drugs are kept off the US market for years, this also slows down their getting to other countries, so the death toll is far in excess of 100,000. Meanwhile that's more domestic deaths than from guns and car crashes. On the other hand dozens of lives are saved because occasionally the regulatory delays slow down or stop a product with unexpected dangers.

I work in the field of drug testing. I'm a lab rat,a human guinea pig. After new drugs pass animal tests, they are tested on people like me who get paid to participate in phase I clinical trials, before going on to be used with actual patients. Our job is 10% science, 90% just jumping through regulatory hoops.
It is both expensive and slow, and so for rare diseases which do not have a large enough market to justify the expense of the regulatory burden, research grinds to a halt.

I don't know if anyone is doing a letter-writing campaign or some other form of activism on behalf of 23andme and the other companies in this area. The company cannot do so itself because of the risk of further regulatory retaliation.

   This action by the FDA slows down progress towards the $1000 genome. By late 2013, we were supposed to be there. I want to be able to have my full genome read so that the drug testing I do for a living can produce better science, but the current costs are prohibitive for me.$1000 is a price point at which these tests would gain a wide enough market to bring on further economies of scale, but if the FDA is going to go around banning the sales of such products, this takes away much of the incentive to make the investments to get us there. The under $1000 genome would enable more genetic research into crops needed by third world countries to prolong the green revolution and help feed 7 billion people. It also allows for people with cancer to get their tumour's DNA read, which sometimes gives clues for treatment.Low cost DNA sequencing is also important to ecological preservation. These are the kind of things the FDA is intent on stopping.

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