DIY home screening

[PathJet]

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direct to consumer genetic testing for primary care decision making

wave of the future?

👎mad:

http://pathtalk.org/archives/39

http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aBpFp6D4Q9BE

 

[LADoc00]

would have zero impact on pathology, even if it becomes the standard.

Im a big fan of all direct to consumer medical care, gatekeepers are in essence Socialism. Set the people free.

 

[yaah]

That is a niche market perfectly designed for the paranoid consumer. The problem for primary care docs is that people are going to start coming into their offices convinced they have a certain disease. So many associations between markers and disease are really suspect and/or based on TINY studies with questionable methods and conclusions, yet it's treated as gospel because it was published. It says in the article that the SNPs are associated with a 1.8 fold increased risk of atrial fib. So? That means nothing.

This is all such crap but it is going to become more and more popular as trial lawyers take over the world. Everything, including getting a genetic disease, is going to have to be someone else's fault.

But more power to these people if they can get the sheep to buy into their questionable methods and pay them to tell whether there is a possibly slightly increased risk of a moderately rare disease.

 

[GreatPumpkin]

Hehe, just wait till that paranoid crowd starts getting their full body MRIs and CT screenings. The negative biopsies will shoot out the roof. At least this crowd will probably have insurance.

 

[docbiohazard]

There is a company out there that is marketing an assay based upon sampling a patient's lymphocytes and culturing them in a chemically defined media while varying different nutrient concentrations, purporting that if said mitogen stimulated lymphocytes grow better / worse with different nutrient additions, this somehow has a meaningful relationship to a patient's health.

The whole enterprise struck me as fishy, unless there are a lot of studies out there linking the behavior of mitogen-stimulated cultured lymphocytes and their division to the actual overall well being of the patient they came from... the testing is expensive and not covered by most insurance.

How all this gets past the FDA / CLIA, I have no idea...

BH

 

[PathJet]

That is a niche market perfectly designed for the paranoid consumer. The problem for primary care docs is that people are going to start coming into their offices convinced they have a certain disease. So many associations between markers and disease are really suspect and/or based on TINY studies with questionable methods and conclusions, yet it's treated as gospel because it was published. It says in the article that the SNPs are associated with a 1.8 fold increased risk of atrial fib. So? That means nothing. " by yaah



not an article its a blog but there isnt much difference nowadays

the company says a 1.8 fold increased risk-this is an important point

so what!!!--- exactly what does this mean? especially when the SNP studies were done on such a narrow population without an interpretation what does this mean -i think this sort of loose risk assessment in diagnostic testing will proliferate with these type of direct to consumer genomic studies


but the "sheep" as you call them make up both the physicians and patients served by the average pathology practice who will eventually turn to a pathologist for an interpretation-not everyone including you even knows about such tests-until you read the blog- much less the limitations of the test or the interpretation of the tests and eventually if we ignore their presence in the market it will be the same consequences as a primary care physician ignoring the presence of a new therapeutic which was directly marketed to consumers -the patients ask for the drug/therapy by name and if they dont get what they want shop around --etc

therefore i disagree with LADOC that this has no impact on pathology more and more the most adept morphologists and leaders in the field who dictate what is the standard of care gear their studies and recommendations based on this push for personalized medicine --

warfarin sensitivity is one example

ancillary molecular and genetic studies for leukemias/lymphomas, breast prognostic profiling, MSH/MLH markers in colon cancer ----just the beginning

 

[yaah]

The whole enterprise struck me as fishy, unless there are a lot of studies out there linking the behavior of mitogen-stimulated cultured lymphocytes and their division to the actual overall well being of the patient they came from... the testing is expensive and not covered by most insurance.

How all this gets past the FDA / CLIA, I have no idea...

BH

It probably doesn't have to get past CLIA because it's not regulated or covered by insurance. They are probably full of disclaimers that results should not be used for healthcare decisionmaking, etc (in small print, of course). But I am not totally sure. It's probably similar to how "natural" remedies etc aren't FDA regulated.

Given the rampant proliferation of schemes to convince people to improve their health through various "natural" and holistic remedies, this is a natural offshoot. To many people, anecdotal evidence is much more powerful than scientific evidence, because everything in scientific evidence has to be a conspiracy (through big pharma, the govt, etc) whereas holistic "cures" are the beacon of reason in the wilderness.

 

[yaah]

but the "sheep" as you call them make up both the physicians and patients served by the average pathology practice who will eventually turn to a pathologist for an interpretation-not everyone including you even knows about such tests-until you read the blog- much less the limitations of the test or the interpretation of the tests and eventually if we ignore their presence in the market it will be the same consequences as a primary care physician ignoring the presence of a new therapeutic which was directly marketed to consumers -the patients ask for the drug/therapy by name and if they dont get what they want shop around --etc

There are all kinds of tests currently done by pathology that have very little clinical relevance, especially in many of the contexts they are ordered in. And many personalized and molecular tests are becoming standard of care (like the FV Leiden mutation analysis being done even without any real consideration of traditional coag studies). It is and will remain the job of pathologists to interpret diagnostic tests. It is usually not up to us to make the decision of whether the test has significant clinical relevance, although obviously we should not put too much of our own work behind tests that we do not feel are that warranted. We don't need to jump to provide unnecessary tests at the expense of important, necessary ones. There will always be a market for the questionable ones.

I don't really think it's about ignoring their existence so much as holding a healthy skepticism about their value. As I said, any large pathology lab is going to provide a test that is ordered a lot. We have tests here that are sendouts, and when the volume of sendouts increases significantly, the lab moves to get their own in house version.

While it is the responsibility of every physician to respond to clients/patients and provide care that they need, it is also under the responsibilities of a physician to ensure that they don't order things unnecessarily or that will cause more harm than good.