“23andMe is a rare woman owned startup doing something innocent and fun”

BRCA results are fun Jane? Really?

PGx plavix results are innocent? Really?

The only one innocent here is you. And naive to boot.

Woman Power! Yeah! Sexist……

When one of those founders talks about doping up her kid with Benadry, I hardly think she is innocent…. http://thegenesherpa.blogspot.com/2008/10/dtc-says-your-baby-genomeit-fun_3040.html

This kind of tone is a real turnoff. 23andMe is a rare woman owned startup doing something innocent and fun. These women are not Halliburton.

“. From the very beginning 23andMe had disease risks, carrier status, ancestry, and drug responses. That was the best of the available research, but explicitly marked the whole time as “not diagnostic grade”. ”

Steve, you are dead wrong.

A. They did not have drug response testing until last year
B. They did not have BRCA testing until Feb of 2009
C. They did not have the majority of carrier testing either.

I am beginning to see your worry, just not your embellishment of the facts. The facts are this

1. 23andMe are testing for medical grade conditions NOW
2. 23andMe et.al. are using CLIA labs NOW
3. DTCG are using clinically validated genetic markers for medical grade disease NOW.
4. The PGx chip approved by FDA is a medical device not an LDT

Dude, the writing is on the wall.

again, your hyperbole does you an injustice.

Nowhere did I say I support the FDA approach to this whole situation. I was just explaining what I saw, which is that the FDA needed a way to get the ball rolling in a serious way. And the ball is rolling. Was there another way? Probably. Maybe FDA pushed the ball off a cliff or in the wrong direction, but that remains to be seen. It is still very early in the process, and all your whining about foregone conclusions is premature.

Navi and 23 and probably others have been involved in closed door discussions with the FDA and NIH well before last week, and those discussions will continue. Risk based regulation of some sort appears to be on the horizon. The risks that a DTC test might impart, and the consequences if that risk is realized need to be defined. Where it is unclear that a defined risk truly exists, or what the magnitude or consequences of the risk are, it may be necessary to provide some provisional classification and ensure that ongoing studies to establish the level of risk are carried out. If companies really want to do research and contribute to science they will put their money where their mouth is and follow through. Better yet, there may in fact be NIH funding available for such work.

Whether you approve of the FDA approach or not, the “poor wittle industwy” (give me a break)is in need of some regulation. Even the industry acknowledges this. But even if the companies disagree with regulation, I don’t believe that effective rulemaking necessarily needs to meet with 100% consensus from those being regulated. The US govt has sold off many of the regulatory agencies to the industries in question, and I don’t personally (BP) find that to be particularly effective (Enron).

with rspect to DTC genetic testing,

Claims should not be misleading.

Potential harms and the risks of such harms when known should be disclosed. The risk data is largely still in the research phase (perhaps not with navi’s tests) – so treat risk disclosure the way we do in a research protocol.

Limitations of the risk estimates (not diagnostic, not precise in most cases, may exclude disease risks due to other known or known factors, highly subject to change, may be based on studies of ethnic groups other than yours) need to be made absolutely clear . Preferably pre-sale, if I was a customer.

I am not defending the FDA approach. But, long run, I think thoughtful regulation will help the industry and not hurt it. Last week’s congressional hearing did not demonstrate much in the way of thoughtful regulation, but the FDA meeting was much more encouraging, and the whole thing was the beginning and not the end of the story.

“So: in other words, there was no law passed. No public debate. Not even a changing of personnel at the agency. Just a top down directive from the administration to ramp up diagnostics regulation. And not just for startups, but for all clinical labs, including nonprofits, hospitals, and academic medical centers”.

No public debate?

In November 2008 the US conducted a presidential election and the Republican administration’s lax regulatory record was one of the issues. As Republican Sen. Lindsay Graham said recently on another occasion: “Elections have consequences.” Considering the necessary work to reverse decades of market-fundumentalist anti-regulatory erosion of public protections, our concerns here are a small part of the wider debate.

Would the general public (if it cares) favor increased diagnostics regulation?
I assume that industry lobbyists and PR agents are already working to influence policy outcomes.
Who is working on behalf of the citizenry at large?
To which stakeholders is the US executive branch responsive in this controversy?

[You're both losers - ed]