By STUART H. SMITH
Imagine a massive public health crisis in the United States that affects tens of thousands of people. Now imagine that the government had a simple tool at its disposal that could prevent this kind of physical and psychological trauma. You might think that I’m writing about America’s deadly outbreak of gun violence, which has made headlines this summer from Dayton to El Paso.
But actually I’m talking about a different crisis that affects even more people – all of them children — and which could be sharply reduced with one simple step that lacks the bitter political animus of the gun debate. The issue at hand involves babies born to mothers who used opioids during pregnancy – babies who tend to develop a condition called Neonatal Abstinence Syndrome, or NAS.
Experts say that state and federal governments have grossly underestimated the number of NAS babies currently born in the United States, as the addiction crisis triggered by Big Pharma’s greed in pushing painkillers refuses to fade. They say an accurate accounting would find a minimum of 250,000 children — and possibly two or three times that every year born with NAS. These kids will face chronic symptoms such as trembling and seizures, gastrointestinal problems, and an inability to sleep. Their numbers are more than eight times higher than the last official estimate from the government.
For more than a year now, I’ve been working with a team of attorneyscalled the Opioid Justice Team who are fighting for any settlement of the massive court fight pitting more than 2,000 localities against Big Pharma to include a medical monitoring fund for the estimated hundreds of thousands of kids born with NAS syndrome. But our team has also been pushing for radical measures that would prevent many of these unfortunate cases.
In March, two lawyers on our team — Scott Bickford and Celeste Brustowicz — filed a request for a preliminary injunction requiring that nearly all prescriptions for opioids to women of child-bearing age be written only after the woman tests negatively for pregnancy.
It’s hardly a radical idea. Currently, doctors in the United States who treat young women of child-bearing age with acne are required to administer a urine pregnancy test before prescribing Accutane, a drug that’s been positively linked to birth defects. Such programs have shown that doctors, patients, pharmacies and the big pharmaceutical companies are perfectly capable of acting affirmatively to protect young mothers, and fetal development. Yet such a program for opioids remains on hold, despite the severity of the U.S. crisis.
Unfortunately, this is par for the course. The serious consequences of the American opioid epidemic are well known to the government’s public health experts in the federal Centers for Disease Control and Prevention, but regulatory agencies like the Food and Drug Administration, or FDA, still fail to take meaningful actions.
Earlier this year, an article in the publication Pediatrics looked at all the available studies to better understand the patterns regarding opioid use during pregnancy and genetic malformations, more commonly known as birth defects. It found that 17 out of 30 applicable scientific studies showed statistically significant associations between drug use and these malformations. In particular, it found strong associations with oral clefts and ventricular septal defects/atrial septal defects as well as clubfoot.
The report in Pediatrics also makes clear that the crisis is largely the result of doctors overprescribing opioid painkillers, which in turn was often the result of overly aggressive marketing campaigns by the big pharmaceutical companies that continued even as evidence of the health hazards mounted. The article noted that opioids have been prescribed to an estimated 14 percent to 22 percent of American women during pregnancy — a truly shocking number.
Our Opioid Justice Team is now pursuing class-action suits on behalf of opioid-dependent babies and the children of mothers who were prescribed opioid painkillers in 34 out of the 48 states where hospitals are required to report NAS births. The goal of these legal actions is to compel the big drug manufacturers and distributors who made billions of dollars in profits by aggressively pushing these painkillers to pay for the medical care these children will be needing, in many cases, for the rest of their lives.
Our ultimate goal is to avoid a repeat of the landmark case against Big Tobacco, which led to a settlement that was a financial windfall for states and local governments which plowed these dollars into balancing their stressed budgets, with little left for smoking prevention and cessation programs. Given the substantial needs and the substantial numbers of opioid-dependent babies, such an outcome would be a non-starter in this case.
In recent months, we’ve argued that these children need to be recognized as their own legal class within the national opioid litigation, which is currently before U.S. District Court Judge Daniel A. Polster in Cleveland. That hasn’t happened yet, but we are continuing to fight for this cause and we won’t give up until the final pound of the gavel. Our goal is medical monitoring trust fund, the only real justice for kids born into NAS.
But our most fervent wish is that new NAS babies aren’t brought into the world when such a difficult outcome can be avoided. With experts predicting that even under the best scenarios the opioid crisis will not abate for several years, our call for pregnancy testing remains the best and most humane solution to the problem. It’s way past time to take America’s opioid crisis seriously – and to act.
Stuart H. Smith is a leading strategist for the Opioid Justice Team, a group of medical and legal experts fighting on behalf of infants born opioid-dependent due to the mother’s use of prescription drugs while pregnant.