New cautions issued on babies and anesthesia, newborn screenings

newborninhospital_mhi_default-300x199Some new cautions have been issued on some key aspects of children’s health care. The federal government is increasing its warnings on anesthetic use for children and expectant moms, while a newspaper investigation is raising issues with common newborn screenings and their inconsistency and inaccuracy. Meantime, a health news site is adding to questions about a much-touted program to reduce head trauma harms in kids’ athletics.

FDA warnings on anesthetics for babies, expectant moms

Let’s start with the federal Food and Drug Administration cautions on “repeated and lengthy use of general anesthetic and sedation drugs” with children younger than 3 and pregnant women. The agency says it has been studying potential harms of these powerful medications for these two groups since 1999, and will label almost a dozen common anesthetics and sedation drugs with new warnings.

The FDA says increasing evidence, mostly from animal studies and anecdotal information on patients, indicates that repeated, prolonged exposure to general anesthetics and sedation may affect the brain, nervous system, and cognitive development in the young.

The agency cautions that caregivers should balance the pain relief the drugs offer in long, complex procedures, and the harm that patients can suffer without it. The FDA isn’t expressing concern about onetime use or in emergency situations. But it says that parents and expectant mothers should get full, detailed information about potential harms of these meds, which typically put patients into a deep sleep after injection into a vein or inhalation via mask.

The drugs (by generic name) include: ketamine, injected lorazepam, pentobarbital, and propofol. The FDA is asking doctors, parents, and others to report adverse side-effects from anesthetics and sedation drugs.

I’ve seen in my practice the harms that can occur with pediatric anesthetics. Patients younger than 3, because they are so tiny, are vulnerable to the smallest error with these potent drugs. Medical science has come far in their skilled use of anesthetics to benefit infant patients, who once were not given pain relief as readily as were adults and older children received it because babies were thought to not have as highly developed sensation of hurt. This view has been reversed, with children playing key roles in receiving advancing pain treatments. Although anesthetics and anesthesiologists, the medical doctor-specialists who administer them, are highly regulated, errors still occur with potential serious injury or death.

Questions on newborn screenings

The Milwaukee Journal-Sentinel deserves credit for its continuing scrutiny of medical testing, notably its latest investigation of newborn screenings. The paper says these have become widespread and routine, with 98 percent of the 4 million infants undergoing genetic exams, administered by states, for almost five dozen different genetic disorders. Advocates hail this effort for saving 12,000 lives annually.

But the tests also have their flaws, and the paper says too few experts want to talk about the patients and conditions missed.

One huge challenge in newborn screening, the investigation finds, rests in allowing each state to decide what conditions will be tested for, and how vigorously. Some states screen for conditions that others ignore. All the screens are meant to flag babies and conditions of concern, not necessarily to provide heavier-duty diagnoses, so states and laboratories processing the screenings operate with varying standards and approaches, often based on time, cost, and other resources. The Journal-Sentinel says of the process:

It’s a balance of time, money and science [and our] investigation has found that the science is often ignored. Testing varies significantly between states, some of which don’t follow scientific standards or common sense. The consequences can be devastating, yet changes in a lab are often made only after a child dies or suffers irreversible harm. When a child becomes brain damaged and faces a lifetime of expensive care, the lab usually can’t be sued to cover any costs. That falls to parents and taxpayers through Medicaid and other programs for children and adults with disabilities. Mistakes in newborn screening can crop up anywhere in the process — blood could be collected incorrectly; a test might be botched or misread; samples may be sent late to state labs, as a 2013 Journal Sentinel investigation found. But even when everything goes according to plan — and all procedures are followed — children still suffer because underlying policies are flawed.

The paper details the agonizing experience of a family whose son was screened for propionic acidemia, which the paper says is “a disorder where the body can’t process certain fats or proteins.” If treated early, which is why newborns are screened for it in Wisconsin, the condition’s harms can be averted.

But the state-run screen, where a 2 score is considered cause for further testing, turned up a result for the boy at 0.1998380. His pediatrician did not question the numbers, because the overall result was labeled “normal” by the lab. The boy now suffers cognitive and developmental challenges, which became the focus of a civil suit. The family had to sue its pediatrician because the state lab had legal protections as a government agency.

The investigation is worth reading—and I won’t give away its ending. It clearly raises issues of concern, including major issues about the need for nationwide consistency, high standards, and oversight of newborn screenings, as well as those who perform them. I see all too many tragic harms that occur in pediatric care in my practice, and I know that medical experts, like pathologists who must analyze and interpret scientific tests in volume, can be all too fallible—with horrible results.

A flawed answer to averting head trauma in kids’ athletics?

Because the series is still rolling out, it’s tough to know all of what MedPageToday, the online health information site, has fully to say in its promised multi-part scrutiny of Heads Up, a program rolled out quickly in 2003 by the federal Centers for Disease Control and Prevention and partners to avert the harms of head trauma in kids’ athletics.

The initiative has gotten a lot of publicity, and CDC leaders have praised it, as have some independent researchers, as one tool to increase concussion awareness among young athletes, their parents, and coaches.

Although states, youth leagues, young athletes and their parents all have responded to the serious issues surrounding head trauma, MedPageToday says that the Heads Up program should not be hyped and that it needs to evolve with increasing concussion awareness in sports, much of it driven by extensive media coverage, especially of the billion-dollar crisis in professional football.

I see the tragic results of brain injuries in my practice, and I’ve written extensively about the National Football League and its leaders failure to step up to deal better with one of the most significant health challenges to their game. I’ve noted that the New York Times, for example, debunked an NFL effort to take excessive claim for the Heads Up program and to exaggerate its results based on dubious research and data.

How much criticism should CDC leaders share in this, and should they ratchet back their claims for the program? Let’s see what more MedPageToday has to say on the topic.

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