Food and Drug Administration

The Woman Who Stood Between America and an Epidemic of Birth Defects

You may or may not be old enough to remember the horror of Thalidomide, a drug that caused thousands of birth defects in Britain, Canada, and West Germany in the late 1959s and early ’60s. It didn’t do much harm in the U.S. because the drug was never approved by the FDA. Therein lies a story, much of it the work of Frances Oldham Kelsey. The Federal Food, Drug, and Cosmetic Act was passed in 1938, in no small part due to Kelsey’s work.

Kelsey was first introduced to the dangers of mass marketed unsafe pharmaceuticals in 1937, when the FDA enlisted Geiling to solve…

Anesthesia for youngsters is a tricky calculation

baby having surgery
Short, one-time bouts of anesthesia probably don’t cause lasting harm to children’s brains, several studies suggest. But scientists have a lot to learn about anesthetics’ lasting effects, particularly in the youngest patients.

If your young child is facing ear tubes, an MRI or even extensive dental work, you’ve probably got a lot of concerns. One of them may be about whether the drugs used to render your child briefly unconscious can permanently harm his brain. Here’s the frustrating answer: No one knows.

“It’s a tough conundrum for parents of kids who need procedures,” says pediatric anesthesiologist Mary Ellen McCann, a pediatric anesthesiologist at Boston Children’s Hospital. “Everything has risks and benefits,” but in this case, the decision to go ahead with surgery is made more difficult by an incomplete understanding of anesthesia’s risks for babies and young children. Some studies suggest that single, short exposures to anesthesia aren’t dangerous. Still, scientists and doctors say that we desperately need more data before we really understand what anesthesia does to developing brains.

It helps to know this nonanswer comes with a lot of baggage, a sign that a lot of very smart and committed people are trying to answer the question. In December, the FDA issued a drug safety communication about anesthetics that sounded alarming, beginning with a warning that “repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.” FDA recommended more conversations between parents and doctors, in the hopes of delaying surgeries that can safely wait, and the amount of anesthesia exposure in this potentially vulnerable population.

The trouble with that statement, though, is that it raises concerns without answering them, says pediatric anesthesiologist Dean Andropoulos of Texas Children’s Hospital in Houston. And that concern might lead to worse outcomes for their youngest patients. “Until reassuring new information from well-designed clinical trials is available, we are concerned that the FDA…