FDA Warns Consumers about Unapproved Genetic Testing
The Human Genome Project (HGP) had its roots in the early 1900s, with the genetic mapping of the fruit fly, drosophila melanogaster, whose short lifecycle and large number of offspring made it a favorite for genetic research. (It also helped that 75% of disease-causing genes in humans are also found in the fruit fly.)
Starting in 1990, however, international collaboration focused on mapping all human genes, collectively known as the human “genome.” The project was considered complete in 2003, with the identification of just over 20,000 human genes.
Since 2003, this new information has allowed genetic research and genetic counseling to blossom. It has also produced the new industry of “over-the-counter” genetic testing. With just a small sample of genetic material, obtained either through saliva or urine, any number of companies are happy to sell you a “genetically-based” prediction of your response to a variety of medications. There’s just one problem: the tests are not necessarily accurate.
While genetically tailor-made treatments for various conditions are currently in the research phase, and perhaps we will one day be able to find out all sorts of important information about our health for just $19.99 including shipping and handling, the US Food and Drug Administration (FDA) warns that that day has not yet arrived.
The FDA recently published an alert to consumers and clinicians that many of the claims made by genetic laboratories have not been reviewed by the FDA, and may not be backed up the clinical evidence. The FDA warns of the “inappropriate treatment decisions and potentially serious health consequences” for people who rely on these tests. They recommend that no one change their medication based on a genetic test they took themselves.
The FDA also announced that they are investigating developers who are selling genetic tests using misleading advertising, and requests that anyone who has a problem with any laboratory test files a report via Medwatch, the FDA’s Safety Information and Adverse Event Reporting Program.
At Tower Lodge Care Center, in Wall, NJ, we embrace innovation, but do not fall prey to fashionable trends. We provide healthcare for our residents the old-fashioned way: with clinically-proven programs, nutritionally-sound and delicious meals, and compassionate care from our specially trained caregivers and therapists.
Check our reviews on senioradvisor.com, wellness.com, and caring.com to see why we are the best choice for your loved one.
Better yet, contact us, at 732-681-1400, or by clicking here to schedule a tour.
Leave a Comment