A decade ago heralded an exhilarating time for medical scientists: The sequencing of the human genome – the foundation for all human life; the genetic “instruction manual” from which each of us is created. This historic effort ushered in a new, supposedly more accurate platform of prenatal screening tests, which are primarily designed to determine if a fetus has inherited a debilitating or fatal genetic disease.
Hundreds of thousands of newly-pregnant women have taken these tests in the past couple of years – through an everyday blood sample taken in their doctor’s office. Many women have considered this process “no big deal.” But a recent investigation by the New England Center for Investigative Reporting has discovered that companies manufacturing these tests have been overselling and overstating their accuracy, while simultaneously doing little to inform expecting parents, or their doctors, about the serious risks that these tests can produce ‘false alarms.’
As a Boston defective medical products attorney, I have seen these types of cases before, but with the advent of aggressive pharmaceutical company marketing, we’ve begun to see a lot more of them. And the news is disturbing. One of these new prenatal tests is called “MaterniT21,” and it has rocketed into this market over the past three years. The screen claims to detect with near-perfect accuracy whether a fetus may have Down Syndrome or Edwards Syndrome – terrible chromosomal abnormalities, which cause death and horrific physical and neurological defects. Tests that claim to detect a fast- growing list of other prenatal defects are also rapidly being developed.
But a not-so-funny thing happened on the way to the medical forum: MaterniT21, and other prenatal tests, completely escaped FDA testing or regulation. How? Due to a regulatory loophole (and leave it to Big Pharma to find a legal loophole,) the companies that manufacture and market these tests are free of government oversight. They also operate free of any required independent analysis that might support their marketing claims of accuracy. Doctors usually get that critical information from company salespeople. The loophole that allows certain unregulated medical tests originated in the mid-1970s, when the FDA first began to oversee diagnostic tests. The FDA exempted what then was a small amount of relatively simple tests that were conducted in a single lab – in a hospital, for example.
Advertisements and marketing for these prenatal screens are – so typical of pharmaceutical ads – filled with happiness and positivity. In this case, ads full of sunny skies, and calm, very pregnant women — including visible assurances that the tests can be trusted. Marketing pamphlets for MaterniT21 promise “Never maybe.” Another manufacturer, Panorama, has advertised on its web site that its test is “99% Accurate, Simple & Trusted.”
Big money, of course, drives these campaigns. Industry analysts estimate that the number of these prenatal screening tests have reached almost 800,000 performed in the United States since 2011. Several of these companies are racing to corner a market that some experts have estimated could be worth $3.6 billion, globally, by 2019.
With all this market push and almost no FDA regulation, you can guess what happened next. I’ll discuss this, and why it’s so important to couples wishing to conceive or who are now in the early stages of a pregnancy, in my next post in a few days.