Ouch – In this case however, the probing does not involve physical contact. Instead, I am referring to the actions of both the FDA and the House Energy and Commerce Committee. These two separate groups have responded (finally) to the growing existence and marketing of personal genetic testing kits. Some have been available over the Internet for about a year and one in particular, a kit sold by Pathway Genomics, was slated for distribution through some big name pharmacies. (well, big box drug stores is really what Walgreen and CVS are – don’t you think?)
The FDA requested information on these kits at about the same time which, thank goodness, got the attention of the company big wigs who decided to wait before putting the products on their shelves.
The tests, which are saliva tests, cost about 20 to 30 dollars to purchase, but the actual diagnostics and results could cost an additional 80 to 250 according to an article written by J Corbett Dooren in the WSJ.
The tests might supply a person with information on genetic risk for disease, on passing on diseases through procreation (you know the whole blue eye, brown eye recessive gene thing!) and possibly, information on which type of disease a person has – in order for tailored medications to be prescribed. That last one is definitely one you would ask your oncologist to order and review – it isn’t the best do it yourself idea you might have! I believe I did a blog post on this new form of tailored treatment – but it is far from mainstream and no provider is going to tailor your treatment based on a home test.
Otherwise, there are genetic counselors for family planning and for goodness sakes; your risk for disease is almost always based on environment and your interaction with it. When the President’s Cancer Panel report came out recently both within the text and in publicly aired discussions among experts , it was said that 1 percent of disease is solely based on genes. It is almost always a multifactorial disease process. No matter what test you take or what kind of faith you want to put into it – taking care of yourself through healthful eating and near daily exercise is the MOST effective way to prevent disease (along with protective factors, like not smoking, avoiding pollution, wearing sunscreen etc). Is it a 100% guarantee against any disease – NO – but the thing is, the side effects – sore muscles from time to time and angst at passing over cupcakes and chips most days – well , that ain’t NOTHING compared to the side effects associated with pills, fad diets, supplements and the like.
The FDA is reviewing these products to verify accuracy and to make sure that the marketing by the companies is accurate. The house panel is rightfully concerned about the data. The Health Insurance Portability and Accountability Act, usually referred to as HIPAA, became law in order to protect the medical records of persons and I imagine the government is concerned with personal identity and the un chartered waters of DNA collection as well as the protection of health information.
3 comments:
I agree with your finally. Those in the business of genetics and public health have been trying for a long time to get the FDA and CMS (which runs Medicare, which ultimately runs insurance reimbursement practices)to address the problems of genetic tests available directly to consumers (known as dtc). Thanks for your blog. You can see more on this at my blog,
Whoops, blew the html codes for my blog. Locate the genetizen blog at www.geneforum.org
thanks Marie - the link still doesn't seem to be working, I will copy and paste to see - and surely this isn't the ONLY time we agree... and you are right - where CMS leads the others follow and that is not always a good thing...
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