Saturday, May 22, 2010

Thomas Goetz has the wrong debate. FDA doesn't intend to restrict.


I think everyone in this space has been way off base as to what the problem is with FDA and Congress wanting to investigate the DTC Genomics companies.

The whole mindset is wrong.

What I hear from this debate is "
It's my data, mine, mine, mine. Gimmee, Gimmee, you can't keep me from my data Big Brother!"


From Mr Goetz's Blog
"The controversy seems to have stirred the FDA to assert its authority – and that of physicians – over any and all medical metrics."

"To me, getting access to this information is a civil rights issue. It’s our data."

This is a straw man argument that has been set up to make regulating these companies seem unseemly and an invasion of privacy.


IT IS A DEAD WRONG ARGUMENT and I will not stand for it being perpetuated anymore.

This is not about getting access to your data.

Fine, you want a whole genome, go get it!

The FDA is not asking should people be able to go out and buy this.
It is asking several other questions.

1. Is Interpretation of biometric data considered medicine?

The answer here is certainly confusing. I think it rests solely with intent.

Do you intend to tell someone something about a disease they now have based on this biometric data that you analyzed?


If the answer is yes, that is viewed legally and medically as a diagnosis.
Which ultimately I think is medicine and falls under medical regulations.


2. Is DTCG analyzing biometric data and intending to give an interpretation of that data which indicates a disease a person has?


It depends on what you define disease as.

Most legal experts defer to the International Classification of Diseases


3. Should we regulate a system which has not given indication of their quality control if they are indeed intending to provide medical diagnosis?

4. Are these methods of obtaining human samples to derive biometric data for the intent of analyzing and providing information about disease considered medical devices?


This is precisely the argument and precisely what Congress and the FDA are trying to define.

So stop acting like a bunch of little kids running around because someone took your kool aid away!


If I hear another, "It's my data" whine again I will scream.

This is not about restricting access to biometric data.

Which by the way, some states do already.


Is an EKG biometric data? What about a cholesterol?

Probably, no one is stopping you from going out and buying a machine to obtain this data yourself.


But any doctor will tell you, it is the interpretation that can vary widely. As demonstrated by the multiple interpretations that Venter et.al complained about

What they are intending to do is to prevent a third party from having NO ONE to answer to when providing interpretation of that very SAME biometric data.


The Sherpa Says: Regulation here will most definitely not stifle innovation as bad as a consumer death or class action lawsuit or lack of trust from consumers because of the aforementioned.

13 comments:

Thomas G said...

It's my data.

Steve Murphy MD said...

@tomg
what is your data?

Alice Rathjen said...

Steve, clearly a persons raw genotype data belongs to them. Government regulation should be in the form of audits to entities that store personal raw genotype data requiring they prove authorized use (which the consumer should be able to revoke at any time).

The interpretation of that genotype data will undergo constant change.

I don't see how it's possible to regulate every interpretation of every SNP... by everyone, for everyone...world wide.

Alice

Steve Murphy MD said...

@Alice
Then why regulate at all Alice?Your snps, etc are yours. Paying to get at them is the right thing to do. As is paying to have them interpreted. Data can be useful. Agreed. But that's not why the FDA and Congress are investigating.

So stop arguing that it is.

Molecular Creativity said...

FDA should help document quality of testing and standards in the maturing DTC industry. People talk past one another in these discussions. My DNA is my data. I personally might decide I want a consult but value the option to get my raw data independent of additional costs that provides no value. Many consumers of DTC are not interested in disease but prevention. Biased perspective to only disease restricts others. Provocative and inflammatory comments are amusing but do not illuminate.

Molecular Creativity said...

"The nine most terrifying words in the English language are, "I'm from the government and I'm here to help." Ronald Reagan

Keith Grimaldi said...

Thomas G said...
It's my data.

I think he meant, go ahead, scream

Anonymous said...

"It's my scalpel!"

Go ahead, make the incision.

The socio-cultural phenomenon that this line of reasoning illustrates is that cognitive medical expertise is not just undervalued, not just considered optional, but generally regarded as an obstruction. People have always regarded compassion and empathy as more valuable than cognition, be it in medicine or politics, and as soon as the business model of medicine jettisoned compassion and empathy as enemies to the bottom line, the value of medicine, be it genetic or surgical, declined.

If you decide to buy a case of scalpels and set out to do some surgery, do you or anyone else have an interest in finding a surgeon, perhaps even a board-certified one, to give you a hand?

Anonymous said...

MDs want a monopoly. They'd outlaw home pregnancy tests.

Let markets decide this one. Until there's hard evidence that costs of freedom outweigh benefits. then let it ride.

Last thing we need right now is a "Chinese Great Firewall" mentality to the peoples' data.

Steve Murphy MD said...

@anonymous
Where do you get the idea that Doctor's want a monopoly on self absorbed humans without disease that bring in a huge list of SNP ills? Doctors don't even get paid for that. Besides even if they did, you couldn't pay me enough to deal with @anonymous and his SNP list....

Anonymous said...

Until there is firm evidence, not just anecdotal, that unregulated genomic testing is worse than regulated testing, then I say dont interfere.

Steve Murphy MD said...

@anonymous,
Yeah, sounds like what Goldman told Bush.
Smart.

The DNAcowboy said...

My dear US citizen friends! I love your debate.

Please come to France, my country, where our geneticists have invented the right of "not to be known", where our bioethic committee has regulated genetict testing in a way you cannot even order a test, and where if you do so, it costs a €15.000 fine and 1 year of jail. Yes, France. Revolution Day, we miss you ;-(

Glad you are still allowed to order a test in the US.

But frankly, you got F. Collins in your administration, an administration that clearly understands the perspectives and benefits of genomic medicine, but also who understands the challenges. Well, they want to talk about the challenges. What's wrong here?

At least there is a dialog.