Health Highlights: Sept. 13, 2019
FDA to Assess First Drug Meant to Prevent Peanut Allergy Fertility Clinic Sued by White Couple Who Had Asian Baby
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA to Assess First Drug Meant to Prevent Peanut Allergy
A panel of experts at the U.S. Food and Drug Administration is set to weigh the pros and cons of what could be the first drug ever approved to prevent peanut allergy.
The medicine is called Palforzia, and its capsule contains a pharmaceutical-grade dose of the peanut protein. It's called "exposure therapy," aimed at safely desensitizing children to potentially life-threatening peanut allergy.
In one clinical trial, kids who took Palforzia for a year were eventually able to tolerate the equivalent of two peanuts, the Washington Post reported.
But the drug had a downside, too: An increase in allergic reactions plus the need for injections with an epinephrine "pen" to ease those reactions, the Post noted.
No one is calling Palforzia a cure for peanut allergy: Patients will still need to avoid peanuts and carry devices to treat an allergic reaction in an emergency. It's hoped, though, that Palforzia might help ease concerns about inadvertent exposure to peanut in small amounts.
The drug's maker, Aimmune, is seeking FDA approval for kids ages 4 to 17.
"For a family with high anxiety and a significant burden of anxiety and fear from living with peanut allergy, this might give that extra buffer of safety," Marcus Shaker, a pediatric allergist at Dartmouth's Geisel School of Medicine, told the Post.
"They're still going to need to strictly avoid peanuts, but [this will help] to let go of some of the fear they may have," said Shaker, who wasn't involved in the clinical trial.
That trial involved 551 people, 496 of them children. About a tenth of people in the trial dropped out due to side effects such as allergic reactions, abdominal pain or vomiting, the Post said. Fourteen percent of people who did have an allergic reaction needed to use an epinephrine pen to ease that reaction, twice as many as in the arm of the trial where patients got a "dummy" placebo pill.
All of that has patients and researchers uncertain as to which way the FDA panel will decide.
"I think we need more data on what it's going to mean to patients and how it's going to change their level of risk perception and change their quality of life," Shaker said. He believes Palforzia is "a little bittersweet for everybody. Everyone's happy to see something happening, and yet it's not what we asked for from Santa Claus."
Fertility Clinic Sued by White Couple Who Had Asian Baby
A New Jersey fertility clinic is being sued by a white couple who had an Asian baby.
The baby girl was born in 2013 to Kristina Koedderich and Drew Wasilewski after in vitro fertilization at the Institute for Reproductive Medicine and Science at St. Barnabas. By the time the baby was two, the couple realized something was amiss and a DNA test revealed that the girl was only related to Koedderich, CBS News reported.
The couple, now divorced, allege in their lawsuit that Koedderich received sperm that was not from Wasilewski, and that the sperm harbored a genetic disorder. Along with monetary damages, the couple wants information on their daughter's biological father.
The fertility clinic has been ordered to provide a list of sperm donors.
"The problem we have here, what happened to Drew's sperm?" said the family's attorney, David Mazie, CBS News reported. "It was supposed to be inseminated that day. So if it didn't go into Kristina, is it someone else who he fathered? "
"If I have other children, I want them to know who I am," Wasilewski said.
The "integrity of our treatment processes are paramount and we are taking this matter very seriously," according to a statement from the clinic, CBS News reported.
More than 78,000 babies were born as a result of reproductive technology performed at U.S. fertility clinics in 2017, according to the Centers for Disease Control and Prevention.
However, no single governmental agency regulates the fertility industry as a whole, CBS News reported.