The recent overruling of the FDA decision to sell Plan B over the counter (OTC) to children as young as eleven years of age has engendered no small amount of outrage by proponents of the FDA plan, and HHS Secretary Kathleen Sebelius has come in for severe criticism from women’s health and advocacy groups. Setting aside for a moment the undercurrent of abortion and the distrust between warring parties over the issue, this decision by Secretary Sebelius is a victory for the very children the FDA purports to serve and protect.
According to FDA labeling on Plan B:
“Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic.”
That represents a five-fold increase in the incidence of a potentially fatal side effect of the drug’s usage in those taking the drug. The very issue proponents of OTC Plan B sale cite for selling to young adolescents, their fear of parental knowledge and involvement in their sex lives, heightens the risk of fatality in the very young.
Aiding and abetting the young in skirting parental involvement fosters a do-it-yourself gynecology where side-effects such as cramping, nausea, vomiting, and bleeding can serve to reinforce and heighten the fear and distrust that led to the child’s self-medication in the first place. Plan B taken by a child with an existing and untreated endometriosis can lead the child into thinking that the lower abdominal pain and heavy bleeding of a resulting ectopic pregnancy may well be her monthly norm. Such a mistake can be fatal, but what is an already fearful and distrustful child to do? It is entirely unreasonable to expect children, who are notoriously ignorant of their changing physiology, to engage in self-differential diagnosis and admit their clandestine activities to the parents they fear and distrust.
In research conducted by Family Health International (FHI), January, 2003.
“… the sine qua non of an OTC-switch is that patients should be capable of self-medicating by reading the drug’s package insert. The above label comprehension tests for Plan B indicate that safe self-medication is not possible for a significant segment of the population. For example, only 75% of all respondents answered correctly that Plan B should not be taken in the presence of unexplained vaginal bleeding. Among the low-level literacy group that figure declined to 69%. Furthermore, only 67% of all respondents understood that Plan B is designed to serve as a backup for regular contraception methods, not a replacement. Among those of low-literacy this figure dropped to 46%; whereas for women of high literacy the figure was 78%. Obviously, many patients do not understand much of the drug’s package insert, which argues against FDA approval of EC OTC.”
If there are any doubts about the ability of children and teens to self-prescribe such medication and act responsibly, NPR published a story about the work of Harvard’s Dr. Frances Jensen that shows how the child and adolescent brain is underdeveloped in the areas responsible for critical and prudent decision making:
She learned that that it’s not so much what teens are thinking — it’s how.
Jensen says scientists used to think human brain development was pretty complete by age 10. Or as she puts it, that “a teenage brain is just an adult brain with fewer miles on it.”
But it’s not. To begin with, she says, a crucial part of the brain — the frontal lobes — are not fully connected. Really.
“It’s the part of the brain that says: ‘Is this a good idea? What is the consequence of this action?’ ” Jensen says. “It’s not that they don’t have a frontal lobe. And they can use it. But they’re going to access it more slowly.”
Do-it-yourself gynecology is bad medicine for the young, and our daughters deserve better than such callous disregard for their lack of knowledge of their bodies, lack of impulse control, and lack of sufficient neurological development to enable them to make reasonable and informed decisions. For those who lack trust in the experience and wisdom of the adults who know them best, it is all the more imperative that we ensure they don’t fall victim to pharmaceutical merchants and their allies who would exploit the callowness of their youth.
For the women’s groups howling with rage at Sebelius, I remember a time when feminism demanded medicine’s best for women, not do-it-yourself gynecology for our teenage and pre-teen daughters.
~Gerard M. Nadal, Ph.D.
