Dropping of Plan B restrictions divides medical community

On April 5, Federal Judge Edward Korman of the eastern district of New York ordered the U.S. Food and Drug Administration to drop age restrictions required to purchase the emergency contraceptive Plan B One-Step and its generic equivalents, giving the FDA 30 days to change requirements that girls 16 and younger provide a doctor’s prescription.

But some have questioned whether girls as young as 10 or 11, of which only about 10 percent are able to conceive, according to FDA reports, would be able to handle the hormone or whether the drug could have detrimental side effects.

Dr. Shaun Jester, OB-GYN at Nason Hospital, Roaring Spring, said a judge shouldn’t be allowed to practice medicine and the hormone could hurt young girls whose bodies aren’t developed enough to handle Plan B.

“I believe, personally, the motive is political,” Jester said, adding that if he can’t buy cough syrup without a driver’s license, there’s no reason why a young pubescent girl should be able to buy hormones over the counter.

Jester said the political motivation is tied to the Affordable Care Act, often called Obamacare. He said the law’s proponents hope emergency contraceptives and, eventually, medications like birth control, will be made available over the counter.

Korman, however, wrote in his decision that Obama administration officials overruled FDA recommendations about the age restriction in an “arbitrary, capricious and unreasonable” way because President Barack Obama was up for re-election when abortion and women’s issues were especially divisive.

Jester cited lawsuits filed by Hobby Lobby’s evangelical Christian owner, who sued over a federal mandate requiring employee-provided insurance to cover birth control. He said some doctors and insurance companies invoke a right of conscience in refusing to prescribe medicine that violates their own religious, moral or ethical beliefs.

Once certain medications are over the counter, “there’s nothing to stop the right of conscience,” he said.

Jester also disagrees with the judge’s decision, however, because he said patients may not be fully aware of what the morning-after pill does.

“In medicine, the term abortion can apply” only after an egg, fertilized with sperm, is implanted in a woman’s uterus,” Jester said. Anything that happens before that “doesn’t count.”

But the medical definition doesn’t state that life hasn’t begun, he said, and if someone believes a fertilized egg is a person, then it’s an abortion to prevent an egg from attaching to the uterus.

“You just can’t call it an abortion,” he said, “but it causes a layperson’s definition of an abortion.”

According to the Mayo Clinic, recent studies suggest that pills like Plan B do not prevent implantation, but only prevent pregnancy by delaying or preventing ovulation or blocking fertilization altogether.

Blair Medical Associates pediatrician Dr. Kelly Kane said the issue is a hot topic, but the American Academy of Pediatrics favored the decision to lift age restrictions and does not view the morning-after pill as an abortion pill.

Kane said the academy’s position is that the point of Plan B is to prevent ovulation and, therefore, is contraception.

“And it’s not likely to have any effects” if someone’s already pregnant, she said. “It shouldn’t be against [an anti-abortion activist’s] belief system.”

Kane said there are a lot of varying beliefs, but said the academy’s stance is that, realistically, doctors could and should have been talking with patients about sex and giving out prescriptions for emergency contraceptives – to be used in case condoms or other preventative methods fail.

“Sex doesn’t always begin at 17,” Kane said, and the academy’s view is a realistic one.

Jester said his additional objections stem from some of his own cases, and his office is handling two pregnancies right now, one the result of incest and the other from statutory rape.

If Plan B was over the counter in cases like those, “I easily could have never seen them,” he said. “They would have continued to be abused.”

Jester also said there isn’t enough research on the long-term effects of the hormone and no restrictions in place to prevent a young teenager or pre-teen from taking Plan B repeatedly.

Emergency contraceptives like Plan B carry a warning that it shouldn’t be used as regular birth control and have limits with how often it can be taken.

But the dose of the hormone in Plan B, Jester said, is 10 times higher than the dose used in some other contraceptives.

“The FDA approval specifically states that safety and efficacy have only been established in women of reproductive age, which they generally consider to be 17,” Jester said.

He cited a 2009 FDA report which states: “Safety and efficacy are expected to be the same for postpubertal adolescents less than 17 years and for users 17 years and older.”

Emphasizing “expected,” Jester also said the warnings against misuse and the potential side effects are great and can interact with other medicines.

Teenagers and younger adolescents won’t know enough to read the warnings, he said, and cannot be trusted to make such a serious medical decision.

The FDA reported one death of a person 16 or younger from levonorgestrel, the hormone in medications like Plan B, between 2002 and 2012, as well as 15 other serious but nonfatal cases.

Other cases involved complications from drug inefficacy and irregular menstrual cycles to dizziness and loss of consciousness. In four cases, patients vomited blood.

Kane said, however, that Plan B isn’t likely to be dangerous when used properly.

There is a higher risk of ectopic pregnancy, and there are some potential side effects, but Plan B is a more palatable option than some alternatives, Kane said, and many doctors realize that accidents can and do happen.

Condoms break, fall off and sometimes fail, especially when not being used properly, she said.

The thought of a young teenager trying to grow up and succeed in life while caring for a baby is enough of a reason for the Academy and many doctors to approve the age-restriction removal, she said.

Mirror Staff Writer Kelly Cernetich is at 946-7520.