Tuesday, March 16, 2010

The Argument Against DTC Genomics Marketing and such

Keith Grimaldi and Daniel MacArthur and Andrew Yates and I have a little bit of confusion. I think we are arguing over 2 different points.

First, Keith, Daniel and Drew need to go read a paper I authored entitled

"In Need of a Reality Check" published in the May 2009 Nature Biotech Journal.

I think many people have misunderstood our messages. So to be simple.

A. Keep the Medical, Well, Medical.

1. Medical Genetic tests that are to be used clinically should have clinical input
2. Medical Genetic tests should be regulated according to the laws of each state/country
3. DTC Genomic tests come in several flavors. The DTCG Medical tests should be Medical.

I have been championing this one for a LONG time. The arguments for this are pretty clear

1. Without clinical input, selling medical tests without an understanding of their use on a FIRST HAND basis is a bad business plan. Also, the risks of a non physician over marketing these tests as to be used for too many things or used before the science pans out could harm the consumer. Think OvaSure......

How? Via false advice and guidance, delivered not by a physician, but by a website.
Who takes accountability and liability for this? The answer no one. Thus, the chain of trust is broken and the patient is left no recourse.

2. Medical Genetic Tests should be regulated by the laws of the country/state/province of use.

Why? Well, if we don't agree to follow laws, we are lawless. How does being lawless benefit the consumer/patient? How does it build trust? It doesn't, thus, EVEN IF the laws are "stupid and outdated" those who break the law, break the trust required for such special testing and care.

3. Medicinally used genetic tests, whether DTCG or not, should be represented and treated as Medical Tests.

Why? This goes back again to quality control and tests. This also goes back to trust. If a patient is encouraged to use a medicinally used genetic test, they should have the confidence that it meets medical quality and that the lab follows that are required for medical tests.

Am I wrong? I challenge someone to give me 3 good reasons why these rules should not be followed. And they cannot use "We are slowing innovation" "It is inevitable" or "You are rent seeking doctors" Why? these are stupid arguments that you will need to prove beyond a shadow of a doubt. Why? When patient safety and trust is one the line, you better be DAMN sure of your stance.

B. The marketing of these current DTCG tests in not keeping medicinally used tests in the medical realm. They should immediately correct this course.

1. Marketing message confusion leads people to equate nonmedical tests as medical. This results in the customer/patient. relying on non-standard of care tests.

I use here the example of Dane Jasper an SV entrepreneur who said he could save "25 bucks" buy relying on 23andMe's CF test instead of going to a trained professional to have testing done.

2. Simply stating your tests are "nonmedical" does not make them "nonmedical" especially if they have a long history of being used medically.

May I skip getting licensed in a state if I say I do "nonmedical" medicine? May I give you coumadin "OTC" if it is to not be used to diagnose or treat a condition? No, I may not. Can someone OTHER than a pharmacist/doctor get access to medications? Not in the US.

They do this to avoid charlatanism and people putting other people at risk. In this case, the risk is a "nonmedical" diagnosis of CF carrier state, or a "nonmedical" misdiagnosis of no CF carrier state.

3. Marketing "NonMedical" Medical tests as cool and hip

A. Turns off doctors from using useful tools
B. Makes the valued noble profession of medicine appear, trivial, akin to Paris Hilton.

Please stop this now.

The Sherpa Says: This is too long to have in a post. I am drafting a paper on this subject now. But you first should read "In Need of A reality Check" in Nature Biotech.

9 comments:

Andrew Yates said...

Excellent. Yes, this is exactly it.

keith grimaldi said...

Steve, I replied to this on Daniels blog - maybe I've broken all the rules but it's to keep most of the stuff in one place

danejasper said...

My argument for using 23andme's screening for CF was simply that it was already done. Also, CF screening is precautionary, not mandatory.

We're Kaiser members, so there's no cost for tests, I just didn't see the point in duplicate testing for both my wife and myself when we'd already been tested for many things by 23andme.

-Dane Jasper

The DNAcowboy said...

I'll be curious to learn about your arguments as soon as full genome sequencing will be available for $100?

Steve Murphy MD said...

@danejasper

So you broke the terms of service from 23andMe when they said these tests were not to be used for medical diagnosis (say CF carrier) and used them as such? Then 23andMe insinuated it was OK to break that terms of service.

I can't blame you, you are not a geneticist.

Steve Murphy MD said...

@Keith,
I will no longer be continuing the string on Daniel's blog as it has nothing to do with HIS post.

Anonymous said...

Litmus test: substitute the word "scalpel" for the term "genetic test" - do-it-yourself recreational surgery is just that: loads of fun for all. But if I intend to remove my glioblastoma, perhaps a surgeon is a better choice.

Steve Murphy MD said...

@DNACowboy,

Let me get this straight. Your persona is cowboy? Wild West Shoot 'Em up? Sounds kinda dangerous.

My argument is the same. Some tests are useful medically and should be branded as such. Some are not and should be branded as not.

Don't conflate the medically useful tests with the nonmedically useful tests and make people think that the BOTH are medically useful.

Develop a service JUST FOR DOCTORS.

Same's true with the cheap ass genome. Last time I checked, you can't get 2 dollar penicillin without some medical intervention here in the US.

ernie said...

Very... Nicee... Blog.. I really appreciate it... Thanks..:-)