Sunday, November 18, 2007

Who Needs Institutional Review Boards?

From Wired Magazine, a quote from Anne Wojcicki regarding her Gene Journal and risk calculator

"A lot of this is unknown. It's totally experimental," Wojcicki told me a few weeks before the science board meeting. "No one has looked at all eight diabetes markers together. They've all been identified individually, but they don't know exactly how they work together. So we've tried to make that clear."

To crunch these numbers and determine one person's risk factor, 23andMe has opted to multiply the risks together. But a competing school of thought argues for adding the risk from SNP to SNP. The two approaches can result in wildly different tallies.

Welcome to the first Google driven experiment in genetics, paid for by the customers......

Unfortunately that poor author from the NYT demonstrated her clear lack of that understanding. And she is a learned journalist, what's to happen to the layperson who has never had any education in genetics/science? Well, I guess you have to break a few eggs to make an omelet....... Primum Non Nocere....oh wait, I forgot, Anne isn't a physician...

The picture here is that of the Tuskegee syphilis study. A horrible experiment carried out on unwitting subjects that sparked the founding of Institutional Review Boards. IRBs were formed to protect research subjects. Why could Dr George Church only get a select few for his first personal genome project? The IRB deemed laypeople unable to give informed consent. How did they end around the IRB?

23andME "Genetics By Businesswomen"
The Mission? Mission Statement
23andMe's mission is to be the world's trusted source of personal genetic information
The Sherpa Says: Keep evading laws, it's the best way to gain my trust.


Eric said...

Morning Steve, great points. Do you have a link to your point about Church's study lacking patients due to informed consent?

I think these companies are ripe for a smackdown from the FDA soon.

It was very telling that deCODEme has placed a limit on certain US states (CA included), stating that residents cannot use the "risk calculators" of the service. Seems like they feel there are some state laws that prevent that type of diagnosis? I'm not an MD so maybe you know better.

Anyway...I'm off to see how I can get signed up for Church's PGP, hopefully I am qualified to give informed consent. ;)

Steve Murphy MD said...

The stuff from Dr Church comes from a conversation I had with him, Jason Bobe, one of my CGCs, and another geneticist. You make some great points. In your other comments I find something that is disturbing. These companies don't test for all SNPs that are scientifically valid. Why should the public have to shop for several "genome services" to cover their whole genome? Also risk calculators are used in the diagnosis or risk stratification for heart disease. This IS the practice of medicine. I soon see Reed Tuckson, Francis Collins and the rest of the US gov dig into these services.....
If you are in Philly Eric, why don't you try the Delaware Personalized Medicine project?

Anonymous said...

will you be adding Helix Health of Connecticut to your poll?

Steve Murphy MD said...

Doctors get sued all the time. What's news there?
(although we have never been..... knock on wood)