The GAO Gets Genetic

I didn't want my title to be so clever as to prevent you from reading, but my post is about the genetic tests that are marketed to YOU in magazines, Internet ads and on the TV. I have already told you that they are not ready for prime time and that the biggest concern from some experts and certainly from me, is that people will rely on the test results over common sense and family history. This view is vindicated in a very recent General Accounting Office report. I really think that you should read the whole thing. It is a 33 page pdf document that can be accessed here.

The GAO investigated several genetic tests and the companies that make them in 2006. They found them to be unreliable. They also found that the companies made disease predictions that were not medically valid. Since then, new tests have been developed and placed on the market. Some companies suggest that they have the support of experts. Very recently big chain drug stores agreed NOT to sell these new tests. The field of human genetics is a remarkable and valid science. Please do not take my strong distaste for the direct to consumer marketing of retail tests to be a judgment against the science. It is not. Genetic testing and counseling has been in place for many years and for a number of diseases it is VERY accurate.

The tests that are currently available for YOU to buy and use at home with a saliva DNA test are NOT scientifically valid, useful., accurate, legitimate or endorsed by the leading genetic experts. In fact, the GAO report has some charming quotes from some of them. Let us see, one person described them as "complete garbage." Another expert used the word "horrifying" and still others noted my most pressing concern which is that people might get a test result that demotivates them to make healthy lifestyle decisions.

Some of the companies try to sell supplements as well. They say the pills will prevent certain diseases. This is an illegal statement. The claims are fraudulent. The advertising tactics explained in the report are despicable. I would NEVER purchase these 300 to 1000 dollar kits.

It just gets crazier. Some of the people in the "sting" operation actually had the diseases that they were tested for and told that their risk for getting that particular disease was low. The GAO sent the same DNA sample to different companies and got completely different results on the same diseases for the same person. Companies offered consultation but rarely did more than regurgitate the results. People were told to talk to their doctors, but I gotta tell ya, the average doctor doesn't know what to do with these results either. That is NOT a reflection on the doctor but on the tests.

I write this blog in order to help people make decisions on things to do and not to do in order to increase their chances of a long, quality, active, limited diseased life. The best that any of us can do is know what has happened to people both with similar genes as ours (our family) and with similar lifestyles (people who smoke for example, or don't exercise or do exercise, etc). If you want a valid prediction of what will happen to YOU - that is where to look for answers and place your bets.

This sentiment is stated quite directly in the report. One expert suggested that people send in the DNA sample, the 500 dollars, complete the family history profile and then through out the DNA results and go from there!

Please read the report - a government agency doing something to protect the consumer from fraud. It is a good thing. (btw, the GAO report is not a clinical study or rigorous research, but it is informative)

When Probing is a Good Thing

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.