DTC APOE4 testing suspended (Reiner)

According to a news item in Nature,  Smart Genetics has apparently stopped providing DTC tests for APOE4, a SNP associated with increased risk of Alzheimer's disease.  The issue is based on the specifics of the license: Smart Genetics sublicensed the rights from Athena Diagnostics who originally licensed the rights from Duke University and Alan Roses, who discovered the linkage in the early 1990's.  What is particularly interesting from the neuroethics point of view is the specifics of the dispute.  From the Nature news item:

Roses and Duke argue that Athena's licence covers APOE testing only in people who already have symptoms of dementia.

"The test was never intended to be used for wholesale screening of non-cognitively impaired individuals," adds Alan Herosian, director of corporate alliances for Duke University. He says he has contacted Athena many times in recent months to press this point.

Roses and Duke are to be applauded in enforcing this point, as their are substantial ethical implications of knowing about increased risk for developing AD in the absence of any meaningful treatment.

Comments

[Adam Kolber]

Very interesting. While the article is clear enough about the intellectual property issue, the article is not entirely clear on why the Duke/Roses are enforcing their property interest. Is it purely because they have ethical concerns or is there also a financial reason?

And how serious of an ethical concern is this? We can certainly warn people in advance that there may be no treatment for a particular illness for which they are being tested. Maybe they'll choose to fund research into their future ailment for the next twenty years. Maybe they will quite prudently adjust their spending and retirement plans.

[Peter Reiner]

Not only might they alter their spending and retirement plans, but data demonstrates that they will also load up on long-term care insurance (Zick et al., Health Affairs, 2:483-490, 2005). According to Annas & Roche (Bioethics 22:ii–iv, 2008), this is why long-term care insurance was excluded from the Genetic Information Nondiscrimination Act (GINA) because, "permitting individuals to get predictive genetic testing, like APOE testing, and then letting them use that information to decide whether to purchase long-term care insurance without disclosing the results, could put the insurers out of business."

[Rick Berg]

Witholding the APOE test from the market appears to me to be unethical.

Consider my personal situation. My father and all of his full siblings had Alzheimer's or Parkinsons. Two had Alzheimer's (one deceased) and one Parkinsons (deceased). Therefore, a high level of concern is already present. A positive result for APOE-4 would help me make possibly critical choices in avoidance strategies (diet, excercize, light alcohol consumption, etc.) while avoidance may still be possible. I do not want to wait until it is used to confirm a diagnosis. That is much to late!

Also, is there a legel reason (FDA regulations, etc.) why a licensed physician cannot order this test done without a dementia diagnosis? If there is, it would appear to be not only unethical but possibly useless. Could a full genomic scan could be ordered which would presumbably include APOE-4 status?