Thursday, April 29, 2010

2C19, Navigenics and Clinical Reality.

Ok,

I would like to welcome Navigenics to the world of Clinical Utility. Just yesterday they announced their pharmacogenomics panel available to both consumers and physicians. It is about time!

However, the problem I see is threefold:

1. Where is the price of the test? Anything more than 200 won't work.

2. Is there a change in the terms of service, which allows me as the doctor to use it?

3. Will insurance pay for it?

Let's say that this is not intended for the doctor but instead just for the patient/consumer. Which Navigenics has agreed NOT To Do, At least in NY.

What exactly do you expect the consumer to do with this information?? Stop Plavix? Don't you Dare!

Write themselves a prescription? Ummmmm, OK.

Oh No, these tests are specifically for medical use.

Disagree? Merely the information itself is important? What good is information without ability to act on it? maybe you should ask Cassandra?

There are multiple companies out there offering PGX testing in one form or another. This makes the following questions of utmost importance

1. Which SNPs are tested?
2. Can you really trust a genetic counselor to give you advice on medications? How many have they prescribed? No offense, just reality.
3. Will the laboratory results and work in a clinical setting, integrated with clinical care?

Just because you're a great product backed by venture capital, with with analytical validity and the plan to get to market doesn't mean you will succeed in the market. Why? Most consumers still trust genetic testing decisions to be made by the doctors.

How do I know this? I'm the doctor. I am licensed to give clinical advice.

The Sherpa says: Why these DTC companies try to cut out the doctor is beyond me.

8 comments:

Dan said...

You go from saying Navigenics has agreed not to cut out the doctor in NY to still lambasting the DTC sphere for wanting to cut out the doctor. They are offering a service. They would like doctors to buy into it. You are a rare breed of doctors heavily invested in personalized medicine and the potential promise of genetics. Their mission is necessary and they consistently seek to educate doctors and get them on board with their services. Sure there are weaknesses that you correctly (sometimes) point out but it has to start somewhere. Time to acknowledge when you are wrong at times... I may sound like a Navi rep or something but that can't be further from the truth fyi. Just a frequent genetic blogger reader

Andrew Y said...

Navigenics isn't trying to cut out "the doctor." They are trying to seize intellectual property and distribution contracts in the most expedient means possible ---means which include a complete disregard for the actual medical application and provision of the genetic tests themselves.

Companies like Navigenics are not even the same people as their original founders. The incoherence of companies like Navigenics has now their core advantage in their new function as which intellectual property prospectors who seek to extract a rent from the work of others because they had already "established reasonable grounds to initiate an ongoing discussion."

If a company like Navigenics were coherent, then that "ongoing discussion" would be short and obvious ---if not non-existant--- and as you and I know quite well: one cannot extract billables nor settlements from such a reasonable relationship.

Steve Murphy MD said...

@Dan,
Company Rep? Like Pharma Rep?

Anyways, if NY didn't force them to use MDs to order tests, they wouldn't. This company used to joke

"Teaching doctors genetics isn't hard.......it's impossible"

So, I say yes, finally doing something clinically useful, congrats......but you need the clinician to make it useful.....DUH.

Keith Grimaldi said...

Ha - Mussolini was better "It's not hard to govern the Italians, it's just a waste of time" Sub in doctors and teach genetics...

Ryan said...

Question: Navigenics has CLIA approval, but they still go DTC. Given this CLIA approval, they can go through doctors - why aren't they?

Anonymous said...

oh - just checked out your link for "most consumers still trust genetic testing decisions made by their doctors." You cite one person's take on this as "most people"? Not to mention, there are really two options here after acknowledging the potential increases in suicide rates, as your link suggests:

(1) mandate a company offer genetic counseling with DTC testing
(2) disallow DTC testing w/o physician approval prior.

I am for the first, as I believe it a right to be able to make decisions for ourselves and not have people do that for us. But, this is a difference in ideology and fundamental philosophy. Some believe we should be "protected" from our ignorance as consumers.

-Ryan

Steve Murphy MD said...

@Ryan,
Why aren't they going through doctors?

1. Their parent company P&G is trying to get them to.

2. The doctors see most of these tests as not worth the time or energy to use

3. That link was just to say, that it is something noted. Burrill's report is pretty crystal clear on that consumer trust.

Steve Murphy MD said...

@Keith,

Yeah, Mussolini. Nice comparison.