I’ve been a relatively vocal critic of unregulated over-the-counter and direct-to-consumer screening kits for years, and moreso in the last few, as 23andMe flirted with the DTC genetic screening market. I felt (and still believe) that yanking the 23andMe kits was necessary because they’d not been validated and had no overight or FDA approval. Perhaps not surprisingly, the most common pushback I received on this
This Boston Globe story, by Beth Daley at the New England Center for Investigative Reporting, helps to prove my point: people do make life-changing decisions based on the results of screenings and unregulated (or non-regulated) tests, instead of diagnostic tests. Aside from being a very big problem, this can often be incredibly tragic:
Now, evidence is building that some women are terminating pregnancies based on the screening tests alone. A recent study … found that 6.2 percent of women who received test results showing their fetus at high risk for a chromosomal condition terminated pregnancies without getting a diagnostic test such as an amniocentesis.
And at Stanford University, there have been at least three cases of women aborting healthy fetuses that had received a high-risk screen result. …
In one of the three Stanford cases, the woman actually obtained a confirmatory test and was told the fetus was fine, but aborted anyway because of her faith in the screening companyâ€™s accuracy claims. â€œShe felt it couldnâ€™t be wrong.â€
And no, these screening kits aren’t subject to regulation, because yay, loopholes. Expect them to be closed in oh, nine years, give or take.
It’s always nice to have another point of data to support an argument.
And yes, possibly I’m humming a revised version of a song from West Side Story, as I idly think about sending this link to people who told me there was just no way people’d make life-changing choices without doctor feedback/approval. I feel petty, oh so petty, I feel petty and witty and bright,...