Thursday, March 18, 2010
Here is the G-d's honest truth. Not all SNP/DTCG companies are bad. What do I mean by bad?
Not all SNP/DTCG companies misrepresented that which is not medically useful as medically useful.
I look at Pathway and Counsyl for example. Fast followers looking to say what they do and mean what they say.
Some of these DTCG tests could be clinically relevant and useful. The problem I have, is that there is no point at which I can say, "Hey I just want the clinically relevant stuff!" No ear wax please.
I need that as a clinician. If I want a huge panel of say CYP450 tests, where do I go? there are some labs that do this and charge and arm and a leg. One company, who I used charged the patient thousands of dollars because insurance wouldn't pick it up.
That cannot ever happen again.
With the addition of these tests with some clinical value, there must be a value add of inexpensive and RAPID TAT (Turn Around time)
A classic example is my last post. Provided these tests become validated clinically, in a patient who can't give me her Gail risk information (tough not to, but it could be a real case) I would use that other panel
The same is true for BRCA founder mutations. Provided you won't drop it in some google database that they get served up mastectomy ads, some patients are afraid of needles and that is a barrier.
There are some very good things here. These good things are getting drowned out by some very bad things.
We can work together if you are willing to bend.
Keith Grimaldi said it best on his blog
"The lack of really effective clinical utility and the existence of commercial interests increases the confusion though. It’s hard to sell something that is interesting, “fun”(?), quite expensive, but not actually that useful to the majority right now. Hard to sell means sometimes over the top marketing."
What medicine cannot tolerate is Over the Top Marketing. It leads to inaccurate statements. This is something extremely forbidden in certain states. In fact, some states don't allow advertising to patients at all, or there laws are so strict you couldn't say anything than
"Dr Murphy, accepting new patients, take insurance"
Why is this? It is to prevent false claims and promises. Doctors can't make money back guarantees. They can't make statements which are not based on fact in advertising. A lot of companies in a rush to get out young science and feed the hype cycle for grants and whatever have been all too guilty of this hype.
So when I get a comment from one of my readers who says (paraphrased)
"Hey all this bashing you do on DTCG is making us in the science end of the SNP reseach look bad"
It prompted me to say, hey, I wouldn't have to throw so much cold water on it if it weren't being hyped so much by DTCG.......
So I guess my point is simple.
Hey DTCG, your opportunity is to leverage your amazing platforms to launch medical services, TO and WITH physicians.
Keep the nonmedical exactly that, NONMEDICAL
Keep the Medical EXACTLY that, MEDICAL
People can benefit by knowing their 2D6/2C19/2C9/VKORC1.
But there are some hurdles to be overcome
1. How can I trust your results?
You have started by enlisting or creating CLIA certified labs, that is a good start. Maybe FDA cert would be nice. Not needed, but nice. There currently is only AmpliChip that is FDA approved....Would like others.
2. How can I know your interpretation is correct?
By using board certified molecular pathologists, I can get a comfortable feel for the fact that the results have been vetted by your specialist. This is muy importante!
3. How can I integrate the results into my EMR/PHR/etc.?
This is going to be super important. How can I save these results linked to patient care? Sure, some would pull paper and put it in the chart, others would prefer a pull in and link. You have to think how to do this.
4. What if the interpretation changes?
Will you take responsibility to contact Either the ordering physician or patient when a result changed? This will be important as we learn more about the nature of these genetic changes.
Doctor's rely on these 4 things from most labs that they use. The depend on these services to be provided professionally and accurately.
These 4 things are EXTREMELY hard to do. But NEED to be done if you really want to be a part of the medical community. But even if you don't, I think your customers deserve this sort of validation and service. Don't you?
Take the jump, create a medical arm. Work with us.
The Sherpa Says: This is what is needed. Medicinally used DTCG that is "Allowed" to be of clinical use. A new Terms of Service, just for doctors, with a validation process that is transparent. And a Marketing process which is truthful.