There are two perspectives to examine and when I look at each side, I arrive at completely oppositional opinions. In other words, I'm disagreeing with myself. Lost yet?
23andMe is a company that will test our DNA and provide us with a vast array of information. One saliva sample and the test will produce a report including over 240 health conditions or traits. Unlocking our DNA potentially holds the keys to many breakthroughs. We may learn if we are at risk for developing a disease, researchers may find ways to interrupt the process or "repair" a mutated gene. And that's barely scratching the surface. And it's a gross oversimplification of a highly complex matter.
Yesterday, I learned that the FDA sent a Warning Letter to 23andMe directing them to stop the sale of their DNA kits pending receipt of specific information they were asked to provide. It wasn't long before discussions began on social media and my initial reaction to the announcement was completely in support of the FDA decision. It also wasn't long before a petition was drafted demanding the Obama administration overrule the FDA decision.
Having had the experience of genetic counseling before my own BRCA testing and having also experienced genetic counseling with my dear friend about a different mutation which causes a rare thyroid cancer, I understand the full ramifications of genetic testing. The key is to know what you will do with the information before the needle touches your skin for a blood draw or in the case of saliva testing, before the spit leaves your lips.
There was a rather robust discussion and I read through the articles written by a number of journalists. Matthew Herper, in his Forbes article, questions why 23andMe has not responded to the numerous requests made by the FDA. He supports our freedom to access our DNA data without the need for a middle man. I want to agree with him. However, I can't.
Many of us struggle to understand evidence based medicine when a disease is already diagnosed and being treated. Those of us who seek to facilitate this process as advocates try to break down the science so it can be understood by others who, hopefully, give that information the weight it deserves when making treatment choices. It's okay to go against the evidence (I'm speaking strictly to the lumpectomy/mastectomy debate) but not if we are doing it out of a sense of hysteria or to blanket ourselves with a false sense of security. Our reasons should be compelling. And compelling enough for me can be as simple as "I want them to match" as long as it's thought through. Thoroughly.
In the petition, it is stated that the "risks associated with services.... are understood by private consumers....." I respectfully disagree with that statement. Why? Those who are involved in the present conversation, discussion, debate in support of 23andMe are all science savvy. Unfortunately, that is not a true (or even close) representation of the majority of the population and it seems to me, the FDA is seeking to protect the rest of us.
Some of us are hand-wringers, some of us are complete hypochondriacs and some of us simply do not understand the ramifications or the significance of the information that may be gleaned from our DNA. If that is the target audience and 23andMe is all about providing individual data to any person who spits and sends along with their $99.00, I stand by my feelings. This information does not belong in some of our hands before we fully understand the overarching reach and the spider like impact some of this information may cause. If there is something identified for which there is no known cure or any preventative measures, which is 100% guaranteed to develop (Huntington's Disease jumps to my mind), is it ethical to simply provide a test without counseling a patient first? (That link is not going to work without a Medscape login)
I say no test without full understanding. Signing a disclosure when it comes to genetic testing does not constitute full understanding. It simply says, "I need to sign this in order to have the test processed." You know I'm right.
We struggle with decisions when we already have a disease diagnosis, now let's add the maybe element. If there are over 240 things being examined, how extensive is the information being provided. Am I being told the odds? Over what time period? Is this just a predisposition to something innocuous? Can it be misunderstood (Hell, yeah)? How reliable is the test itself? And most importantly, does the average patient know to ask these questions? That's where my "the FDA is right" comes from.
Please don't yell in my direction. It's my opinion. Information in unqualified hands with no place to turn for additional clarification is dangerous. Again, my opinion. And the biggest reason why I DO agree with the FDA.
Having barely scratched the surface on "the FDA is right," there is a flip side.
IF the goal of 23andMe is to crowd-source the data so there is a wealth of information available for research, then I think the FDA has overstepped and they need to back off. In this scenario, they indeed ARE standing between a patient community willing to supply information and the research community who needs that information so medical advances can be made more quickly and with greater efficiency.
I have more questions before I can truly choose a side but if it is about amassing data, the test should stay. Hands down.
If it is about individual test results, not so much. I respect those who feel differently but please consider this. You may be one of the science savvy people, or perhaps it's something to do "just because." And that's fine. But, as an advocate who is trying to look at this from many angles, a substantial group of people might be adversely affected unless 23andMe provides extensive explanations written in language that is easily understood by most when reporting results.
And still, I do believe advance understanding of the ramifications of test results is one of the most important components. In other words, pre-test counseling.......
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