Friday, March 12, 2010

The FDA, 2c19 and the ACC

Did anyone see the FDA issuance of the better warning that as many as 14% of patients will not benefit from Plavix/Clopidogrel?

Did anyone see the cold shower being poured on by the press and the cardiologists?

Christopher Cannon Assoc. Prof at Harvard says:
The ACC will need to develop protocols, "Thus a real conundrum"

He then says "I expect mass confusion in response to this FDA warning"

Well Chris, It's not as if we haven't been shouting from the rooftops about this for over a year now.......

"The test costs about 500 USD according to Courtney Harper PhD, Director of the FDAs division of chemistry and toxicology devices. But cost isn't the only issue."

Which BTW is false 23andME is cheaper......But wait, isn't that medicine?

"The time to get a result varies. It may be a few hours to a day or two, or other labs may take a few weeks"

This is absolutely true. It takes me 3 weeks for a test from Quest. I am certain that there has to be some lab to do it quicker.......

BUT, the FDA has only approved AmpliChip for this testing.....

This sounds to me like the FDA needs to approve some kits and PDQ with the ACC meeting coming up like,

My guess

1. The ACC will address and release its prelim algorithm

2. The ACC conference will have even further data regarding this released.

3. The last step is to FDA in some kits to do this test, quicker and more standardized.

We need a company that can direct us to

So the question, why all the cold water on this killer app? Well, because it is getting lumped in with DTC genomics, which is feeling a backlash from hype and failed promises. Or trying to play medicine.
As well as a flat disregard for medicine. So when the press and the healthcare providers are against you, you can feel it.

But this is what I have been frustrated about all along. I saw this coming. Doctors blowing off PGx thinking it is SNPChip Hype. Journalists pouncing on overpromising and intellectually dishonest DTC Genomics companies.....

This is why I was so mad about the blimp.

When something really awesome comes around, people are burned out from Open Bars......

The Sherpa Says: Let's really do this. Genomics and PGx IS medicine. Let's say it proud, Let's ay it loud. Quit screwing around to avoid regs. Let's how the world how we can use this to help mankind!

2 comments: said...

I think you are correct to draw attention to personalized medicine as the future of how we practice.

I personally am not aware of alternatives to Plavix that have been shown to restore better cardiac outcomes to non-metabolizers (sorry that's convoluted).

We don't have any data to show that increasing the dose of Plavix in "non-responders" enhances clinical outcomes. There are papers showing improvements in in-vitro platelet function, but not in clinical outcomes.

We don't have a paper showing that using a different antiplatelet agent is more effective in people with Plavix polymorphisms.

So FDA is kind of throwing us under the bus. So sure, I think we need to tailor our treatments to the individual, but I also think we should base that on evidence.

We went through this in clinical oncology a few years ago with the arrival of gene microarray studies. Since cancer is a genetic disease, it followed that you should be able to tailor the chemotherapy cocktail based on the pattern of gene expression. First paper was 2001 in lymphoma. It appears there are different categories of large-cell lymphoma based on gene profile, but we treat them all the same.

In other words, it's a lot easier to designate a resistance phenotype, but tougher to determine how best to circumvent that clinically.

Thanks again for a thoughtful post; I hope to see more from this great blog.

Michael Benjamin, M.D.

Steve Murphy MD said...

Dr Benjamin,
I completely agree with you. This is really a tricky situation with which we approach evidence based medicine.

I will be in a meeting with Issam Zineh next Monday and we will debate precisely these problems and issues. I look forward to hearing about what the ACC's take is regarding this as well.

I also anticipate MedCo's results.
Here is what I have been doing.

I genotype my patient's 2C19. And then classify if they are an EM/UM/IM/PM

If they are a PM I tell them that there is some data regarding poor outcomes with Plavix and the genotype. I call the cardiologist. I suggest that we may try Effient.

I document all of this and let the patient know we are flying by the cutting edge here. I am forthright with this.

This is true for many things we do in medicine. Smoking cessation etc. The only catch is the increased risk of bleeding. Which I also address.

What to do with UM/IM/EM well, that is a different animal altogether.

I agree that we need more science here. But I also agree with the science that exists regarding increased second events.

This is similar to PSA, but riskier......

Discuss alternatives and risks. Then decide, with the patient sharing decision making.

That my friend is what personalized medicine is all about.

We will get there. Slowly.

Take Care.