Thursday, August 27, 2009

JAMA not so surprising, DTC genomics neither.

Let's add fuel to this debate. Pharmacogenomic testing is CLEARLY a clinical laboratory test.
Seriously. In what world would this testing be used for anyting OTHER than the adjustment of medication?

You may be saying "But what about caffeine metabolism with CYP1A2?"

Ok, caffeine IS a drug, but it is available everywhere, so why shouldn't the people be allowed to have this test. Ok fair enough. But Theophylline is a drug which ALSO is covered by 1A2 and is NOT widely available.......

So here are my questions.

Should we regulate a test which COULD be used clinically?

What if there might be harm from using the test?

Should we regulate a test which has no purpose OTHER than clinical use which is being used for "Fun"?

What if there might be harm from improper interpretation and use of the test?

These are the questions which the government should ask itself. Why in the world is a BRCA test "for Fun"?

Why too is a CYP2C19 test which shows response to a medication and IS FDA approved in a certain type of kit not being regulated when it is a DTC test?

Does this make any sense to you?

So when one of these companies is playing on how they have CYP2C19 testing available in their "research" I wonder why in the hell, this non-IRB approved research is not considered clinical/medical???

Valid research like that in JAMA this week shows the real use of CYP2C19 testing in patients who are on Plavix.......


Tell me? Please. I am not the smartest guy on the planet, but you have gotta see what I see here.

There needs to be one of 2 things here. Either these DTC companies STOP offering clinical tests or they announce PLAINLY and Forcefully on their websites, marketing material, blogs, tweets, Blimps, Zeppelins, FU@k!ng cars, etc

"These tests SHOULD NEVER BE USED IN CONJUNCTION with medical care".

Otherwise, there needs to be a moratorium and analysis of what in the hell is going on here. I await the first lawsuit against the government for not protecting the public, because G-D knows the DTC people will run away and claim no responsibility in the harm caused by their deceptive marketing.

I am very disappointed that when the survey came out about the physicians inappropriately using these tests that the DTC companies didn't make public that the tests are NOT to be used for medical care.

What do you say?

The Sherpa Says: A little responsibility from a lady who wanted to dope up her child and her billionaire hubby would be nice to have don't you think?


Anonymous said...

You have a point, but the situation is a lot more complicated than you realize.

Setting DTC genomics aside for a moment, there are thousands of lab tests being ordered by physicians and reimbursed by insurance that have not been approved by the FDA. Myriad's test is one of them. Some of these have demonstrated clinical validity and utility; many don't.

So it may be fine and good for you to call for regulation of DTC genomics; but this would entail an entirely new set of regulations covering far more than just DTC companies.

Genentech's effort is only the latest; the late Sen. Ted Kennedy introduced the Laboratory Test Improvement Act in 2007 to do exactly what you propose, but it was never passed (and now will likely never be).

The resistance is likely to be due to limited resources (as is most often the case). Sydney Brenner was once asked what the next big important -omics would be and he answered, "Econ-omics."

Steve Murphy MD said...

Brenner is a genius