Yesterday, Walgreens canceled their plans to begin selling a home genetics testing kit later this week, based on a legal challenge by the FDA.
The testing kit, marketed by Pathway Genomics, requires individuals to send a saliva sample to the company for analysis. The sample is tested for genetic markers that may indicate an increased propensity for developing numerous medical conditions (including several cardiac conditions, such as heart attack and atrial fibrillation), as well as a handful of drug reactions (including side effects from statins). Further, the DNA sample is stored in the company's "DNA Lockbox," where it can be re-tested as more genetic markers are discovered.
Home genetic testing kits have been controversial from the beginning. They don't tell you whether you are going to get a medical condition, but merely whether your odds of getting it are increased. Because virtually everybody has genetic markers for one medical condition or another, experts worry that these testing kits will create unnecessary anxiety, and other problems caused by the lay public's poor understanding of genetic propensities. For example, according to the Washington Post, Hank Greely (director of Stanford University's Center for Law and the Biosciences) considers the sale of such kits "reckless.. . .Information is powerful, but misunderstood information can be powerfully bad."
And healthcare policy experts, of course, worry that do-it-yourself genetic screening will increase patients' requests for expensive medical testing. (In a different context such testing might be called "preventive medicine" - which, as we have seen, always increases the cost of healthcare.)
Whether the FDA actually has jurisdiction over home genetics testing is an open question, but in an effort to block the sale of this product, the agency sent a letter to Pathway Genomics which, essentially, directed the company to prove that its test does not need FDA approval. (Proving that something does not exist is often a difficult task, both philosophically and practically.) Successfully fulfilling this request (since even the Director of the FDA's office of in vitro diagnostics admits it is "difficult to clearly state which tests need FDA approval"), may take some time.
And in the meantime, Walgreen's intention to sell this product is on hold.
I personally would not consider doing broad genetic screening on myself. The results are too "shotgun" and too vague for my tastes, and are very unlikely to be actionable in any productive way. However, I find it disturbing that government agencies, backed by ubiquitous "experts" of this and that, are so quick to block individuals from purchasing with their own money products that (they believe) may help them manage their own health. In my opinion this goes beyond the mere paternalism expressed by Mr. Greely and other experts, and at least borders on big-brotherism.
This is certainly poses an interesting question. It doesn’t make much sense why someone would want such a test without the supervision and expertise of a doctor or other qualified health professional. It will be interesting to see how this plays out and what the FDA’s role will be going forward.
I took one of these tests just this week. Here’s why:
I have arrhythmia that doctors have not been remotely helpful with. I gave them a decade and my condition only worsened. After an extremely bad EKG I googled every cause for my symptoms. I learned that some families have a gene that blocks absorption of minerals. My grandfather had a pacemaker, so I think our family could be one of them. I started taking minerals and asking dr after dr about it. All agree the minerals have substantially helped my heart, but refuse to pursue the possibility that my family has such a gene. Instead I am given very dangerous drugs – WHY? Because pharmaceutical companies OWN the medical community.
My family is tiny & from a tiny country. Only 91 of us have been born since 1900, so it is easy to track what ails us. I researched everything we die from. Every disorder but smoking caused cancers could have been caused by mineral deficiencies.
I’m not a silly hypochondriac fool, as the people fighting this are trying to convince people to think. Doctors invest themselves too little. I’m simply counterbalancing that and have found a tool that can help. It is outrageous that the FDA is trying to stop sales. Obviously the pharmaceutical and insurance companies are behind it.
Who are the real fools?
While not medically trained, I’m educated & able to research to learn about my health issues. Insurance companies, our government, & drug companies tell us we’re “dumb” & like little children would be scared if we were able to do our own tests to learn the TRUTH. The proceedure has happened with every home test & home medical equipment released to us. Do your job FDA & let me take care of myself!