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Walgreens Changed Their Minds on Selling Home Genomic Test Due to FDA Inquiry – What Is The Big Deal?

Posted May 13 2010 12:12am

Pathway Genomics and a few others have been doing this on the web for a while now and you will have consumers getting confused thinking that the over the counter price is a bargain, well they still have to register online and go through the normal processes, with the only difference being they don’t have to wait for the image mail to bring the kit!

If someone has not noticed, we are an aging society here in the US and those over 65 of age are not going to jump on this anytime too soon either.  I do agree there needs to be interaction with their physician to help interpret and understand what the results mean, and for that matter more doctors could learn a bit more about it as well.  For a good point of reference, it helps to read about what the first participants who had their genome sequenced had to say:

Here’s a couple of statements from Steven Pinkerton:

“The two biggest pieces of news I got about my disease risks were a 12.6 percent chance of getting prostate cancer before I turn 80 compared with the average risk for white men of 17.8 percent, and a 26.8 percent chance of getting Type 2 diabetes compared with the average risk of 21.9 percent. Most of the other outcomes involved even smaller departures from the norm. For a blessedly average person like me, it is completely unclear what to do with these odds. A one-in-four chance of developing diabetes should make any prudent person watch his weight and other risk factors. But then so should a one-in-five chance.”

I also have genes that are nothing to brag about (like average memory performance and lower efficiency at learning from errors), ones whose meanings are a bit baffling (like a gene that gives me “typical odds” for having red hair, which I don’t have), and ones whose predictions are flat-out wrong (like a high risk of baldness ).

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CVS is in the market too with genomics in a little different way and have their program going and their plan is for analysis with a “genetic benefits management company” called Generation Health.  Their plan is much more to worry about if you ask me as it could restrict patient access to certain drugs too as this begins to fall under areas of “health insurance” compensation as they want to manage testing costs for payors.  Pay attention here:

“Genetic Benefits Manager” is the CVS program venturing in this area – be aware.

CVS Caremark Launching Collaborating with Generation Health To Launch Program to Predict Patient Response for a Dozen Drugs With Genetic Testing

Again, I don’t understand the fuss over the kit being available over the counter versus sending off for it on the web and again I don’t see people breaking the doors down to get one as we other more important issues with getting medications we need now and ensuring patients can afford them.  It sounds like time for a little collaboration at the FDA on this topic and a thorough look at the CVS plan too while they are at it.  As patients we will of course be aware of anything that could stand to restrict access and lead to further analysis for risk management purposes, but worrying about having the box available for over the counter purchase here to me looks like the whole issue has turned into a “wild good chase” for now.  BD 

Walgreen Co. reversed a decision to carry genetic test kits in its stores after the U.S. Food and Drug Administration began looking into the supplier.
The drugstore chain, based in Deerfield, Ill., had planned to begin stocking its shelves Friday with the Pathway Genomics home test kit, which the manufacturer claimed could provide information on the risks of getting conditions such as Alzheimer's and heart disease, and also examine the likelihood of passing on health problems to children.

The product claims to assess the risk of dozens of health conditions, but some scientists and physicians had expressed concerns. Earlier this week, the National Society of Genetic Counselors issued a statement saying that receiving genetic information without input from a doctor "increases the chance for misunderstanding or misinterpretation of results."

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