Over the last few years, prenatal screenings have become part of the pre-delivery medical routine for many parents-to-be.
Over the last few years, prenatal screenings have become part of the pre-delivery medical routine for many parents-to-be. Cell-free DNA prenatal screenings can indicate to expectant parents whether their child is at risk for a chromosomal abnormality. However, you might be surprised to learn that half of the warnings produced by these screenings turn out to be false positives. Equally troubling is the lack of requirements to inform parents of the shortcomings of these screenings — leaving open the possibility that parents will accept them as fact.
As a mom who received difficult news about my own pregnancy, I want other expectant parents to have full and accurate information about the benefits and limits of the information that’s being presented to them.
Clearly, cell-free DNA prenatal screenings can be a valuable tool. They’re simple blood tests that can signal whether a baby is at risk for a chromosomal abnormality. However, the screenings are far from perfect. While they can detect a potential problem or the likelihood of a baby being at risk for a chromosomal abnormality, they’re not a conclusive test — and parents should be made aware of their limitations.
The New England Center for Investigative Reporting found that companies responsible for creating and distributing the tests — from $800 -$2,000 apiece — are overselling the accuracy of the results, and failing to educate physicians and patients about the significant risk of false alarms. Additionally, physicians aren’t required to follow the medical professional guidelines to educate parents about the risk of false results. Consequently, the investigation found, they aren’t.
That’s a problem, two recent studies show that the screenings can produce false alarms half of the time. In another study, samples from two people — both women who weren’t even pregnant — were sent to five testing companies for analysis, and three came back telling those women that they were carrying a healthy baby.
It’s time for Congress to make sure the federal agencies that regulate medical technology correct this situation and empower parents with information about their pregnancy. No one should be making decisions without knowing the limits of these screenings, and I’m pursuing legislative solutions to ensure that parents have certainty.
Fortunately, we’ve had some preliminary success. A congressional committee in June approved the spending bill for federal health agencies like the Center for Disease Control (CDC), and it included a directive I authored requiring the CDC to report how it’s ensuring providers and parents are being educated about prenatal screenings. Fortunately, the main association for obstetricians and gynecologists supports this effort, along with the March of Dimes, the National Down Syndrome Society and other leading groups focused on prenatal health.
These top medical professional associations have developed professional guidelines to inform parents and doctors on the risks, benefits, and alternatives to prenatal testing but it could take up to 10 years for these guidelines to circulate.
That’s too long, which is why I’ve introduced bipartisan legislation to speed up this process. It requires the CDC to develop educational materials on cell free DNA prenatal screenings and get the information into the hands of doctors and parents much sooner.
I’ll never forget the moment my husband and I were told that we faced a challenging pregnancy. It was a helpless feeling. However, we knew that if we understood the risks and the opportunities, we could chart the best course for our daughter.
Any parent given this news faces a situation fraught with challenges. We must make sure they’re equipped with all the facts.
