Pre-Natal Screening Danger

“Oversold” and “misunderstood” prenatal screening tests “prompt abortions”

By Dave Andrusko

The Chapmans

NRL News Today tries to keep up with the latest diagnostic tests that are marketed to pregnant women, usually as a way of determining the baby’s sex or whether he or she has Down syndrome. And the reason is obvious!
What critics call the “de-selection of our children”–abortion–is the result anywhere from 70% to more than 90% of the time when the mother is told the test has found that the baby has Down syndrome. And, of course, the menace of sex-selective abortions is no longer largely confined to China, India, and South Korea.
The results of an in-depth investigation by The New England Center for Investigative Reporting, reported Monday in the Boston Globe, reveals that there are an alarming number of false positives in the newest wave of prenatal screening tests with babies being aborted as a result of the error. [1]
The headline for the Globe story, written by Beth Daley and New England Center for Investigative Reporting, is “Oversold and misunderstood Prenatal screening tests prompt abortions.”
There are numerous problems but at the core, according to Daley, is that these companies

are overselling the accuracy of their tests and doing little to educate expecting parents or their doctors about the significant risks of false alarms.

Two recent industry-funded studies show that test results indicating a fetus is at high risk for a chromosomal condition can be a false alarm half of the time. And the rate of false alarms goes up the more rare the condition, such as Trisomy 13, which almost always causes death.

Put another way, there is

a huge and crucial difference between a test that can detect a potential problem and one reliable enough to diagnose a life-threatening condition for certain. The screening test only does the first. … [S]ome companies blur the distinction between the results of their screening tests and a true diagnosis, potentially confusing patients and doctors about the trustworthiness and meaning of their test results. Illumina, for example, claims its Verifi screen has “near-diagnostic accuracy,” a term medical experts say has no meaning.

The three-month investigation concluded, Daley wrote, that “Companies selling the most popular of these screens do not make it clear enough to patients and doctors that the results of their tests are not reliable enough to make a diagnosis.”

And babies die as a result. Evidence is building from this “overselling” of screening techniques

that some women are terminating pregnancies based on the screening tests alone. A recent study by another California-based testing company, Natera Inc., which offers a screen called Panorama, 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.

“The worry is women are terminating without really knowing if [the initial test result] is true or not,” said Athena Cherry, professor of pathology at the Stanford University School of Medicine, whose lab examined the cells of the healthy aborted fetuses.

People put so much faith in these tests that one “woman actually obtained a confirmatory test and was told the fetus was fine, but aborted anyway because of her faith in the screening company’s accuracy claims,” Daley wrote. “‘She felt it couldn’t be wrong,’ [Prof. Athena] Cherry said.”

An interesting sidebar in the story is that there is a loophole that allows unregulated tests that goes back to the mid-70s—back when there were just a few simple tests performed in a single lab. However

In the past decade, for-profit companies have used that regulatory running room to develop complex tests to diagnose or screen for conditions ranging from cancer to Lyme disease and now, fetal chromosomal conditions. Not all of the tests undergo robust independent review and it is challenging for the public to distinguish good and bad tests, according to medical experts.

The story of Stacie and Lincoln Chapman is the narrative Daley builds her story around. Fortunately, it has a happy ending.

Dr. Jayme Sloan told Stacey Chapman the test (called MaterniT21 PLUS) has a 99 percent detection rate—and that her three-month-old son had Edward syndrome . “Though Sloan offered additional testing to confirm the result, a distraught Chapman said she wanted to terminate the pregnancy immediately,” Daley wrote.
As she was “steeling herself” to abort, Dr. Sloan called her back and urged her to wait. Stacie Chapman did.

Chapman had a diagnostic test and learned her son did not have Edwards syndrome. A healthy Lincoln Samuel just turned 1 and has a wide smile that reminds Chapman of her recently deceased father.

However briefly considered, their decision to abort — informed by the MaterniT21’s advertised 99 percent detection statistic — haunts them to this day.

“He is so perfect,’’ Chapman, 43, said, choking up as she watched her son play with a toy lamb. “I almost terminated him.”

And while they were very grateful that Dr. Sloan called back, Stacey Chapman is “conflicted.” She told Daley that “Sloan did not stress that the test was just a screen that could be wrong.”

“I didn’t seek this test out — this test was offered to me by the doctor’s office. They should know how it performs,’’ Chapman said, adding that she would never have considered a pregnancy termination if she had better understood the odds that her result could be wrong.

[1] There are also false negatives; parents are told their baby does not have (say) Down syndrome or Edwards syndrome when the child does. The Globe story does not investigate this aspect much, but as we have reported on many occasions, parents can and do sue for either “wrongful life” or “wrongful birth,” saying they would have aborted had they know the baby’s condition.

Source: NRLC News