Direct-to-consumer advertising (DTC) has elevated some everyday conditions to diseases needing prescriptions but other prescription products have gone over-the-counter.
Claritin, one of the first drugs sold DTC along and its allergy drug cousins, Zyrtic and Benadryl, is now sold over-the-counter -- though Sudafed is now behind the counter thanks to its use in meth labs. And so are pregnancy tests and home tests for blood sugar, cholesterol and urinary tract infections.
And then there's Insight, the at-home DNA tests almost sold at Walgreen's last month.
San Diego-based Pathway Genomics Corporation planned to place the Insight Saliva Collection Kits in 6,000 Walgreen stores until the FDA said, "you're selling WHAT?" and it put its plans on hold. The $20 to $30 genetic testing kits -- essentially containers for saliva which customers mail in for analysis in Pathway's labs -- would predict someone's risk of diseases, chance of transmitting health problems to offspring and reaction to prescription drugs. The company which was incorporated in 2008 also markets ancestral DNA tests.
Insight was supposed to reveal risk for heart attack, venous thromboembolism, high blood pressure, leukemia, colon, lung, prostate and breast cancer and celiac, Crohn's, Huntington's, Parkinson's and Alzheimer's disease. It also could pinpoint risk for diabetes, obesity, polycystic kidney disease, multiple sclerosis, macular degeneration, psoriasis and more said the manufacturers, though their claims have since been disputed.
Of course DNA self-tests were already available online from companies like 23andMe and Navigenics. And DNA paternity tests have been sold at major drug stores by Sorenson Genomics and Identigene for over two years. But selling Insight over-the-counter would widen the window of DNA products sold with no pretence of a need for clinical geneticists, genetic counselors or other health professionals to interpret results for consumers.
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