The FDA is looking at the consumer-direct sales of gene tests right now. Walgreens had planned to start selling them in stores but pulled back when the FDA raised questions about whether this needed to be an FDA-approved product. Other companies selling online tests also are in talks with the FDA, which came into this late. Now everyone’s trying to sort out what needs to be approved and what does not in the gene-testing business.

In this important story from The New York Times, you will read about the great expectations experts and elected officials had the day the decoding of the full human genome was announced. You will read how none of that promise has yet been delivered in the form of clinical treatments yet. Based on estimates at the time, these clinical treatments should have been appearing already.

Unlike a lot of other people who see testing one’s own genes as a consumer “right” for medical purposes, I think consumers/patients need to get this information with the assistance of trained health professionals who can tell them what the test results may mean.

As this story shows, whatever the gene report may say, its predictive powers fall woefully short. Why make yourself crazy over a risk which can change over time?

It made sense. Know your genes. You can plot a course to reduce risk. Know your genes. You will know where your ancestors really came from. How cool is that?

That is why there was so much buy-in for this before there was proof it could work. Common sense told us this should work.

So far, in scientific terms, knowing your genetic risk is not turning out to be a path to prevention—and most certainly not a sure path to prevention.

Except for fixed characteristics—eye color or height, for example—the rest of your genes are interacting with their environment. That environment includes your body and the world in which you live and work. This is a much more complicated risk dance, perhaps, than any of us understood at the time of the discovery. Genes mutate. Genetic risks often don’t turn into the disease as some expected.

This does not mean decoding the genome will not deliver better treatments in the future.

It does mean that the future is further off than scientists thought when the genetic code was cracked.

Do read the full story by Nicholas Wade. It is worth your time.

The New York Times

…”“Genomics is a way to do science, not medicine,” said Harold Varmus, president of the Memorial Sloan-Kettering Cancer Center in New York, who in July will become the director of the National Cancer Institute.”

Source: New York Times, June 13, 2010