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FDA Makes Plan B Contraceptive Available to 15-Year-Olds

With President Obama’s Endorsement, Federal Agency Authorizes Over-the-Counter Distribution of ‘Morning-After Pill’

BY Sue Ellen Browder

May 19-June 1, 2013 Issue | Posted 5/10/13 at 4:03 PM

 

WASHINGTON — President Barack Obama, who once said he believed as a "father of two" that Plan B shouldn’t be sold without medical oversight to kids under age 17, now says he is "comfortable" with the Food and Drug Administration’s May 1 decision to make the contraceptive/abortifacient drug available over the counter to 15-year-olds.

"I suspect the president is caving a bit to the pro-abortion lobby, which gives him a lot of financial support," said Family Research Council attorney Anna Higgins. "I think he got a lot of heat from them."

While denying that the Plan B One-Step "morning-after pill" can cause abortions, the pro-abortion lobby has been very gung ho for the medication.

Even so, the administration seemed to temper its position May 1 by filing a lawsuit to overturn a New York circuit-court ruling to force the FDA to make the drug available to a child of any age with no questions asked.

Although at this writing no recent polls have been done to gauge public sentiment on the issue, Higgins said, "It’s just common sense that most parents would be horrified by the idea of this drug being distributed to young kids without their permission."

Manufactured by Teva Women’s Health Inc., Plan B One-Step is the same drug as Plan B, but it is taken in one dose rather than two.

 

Based on Science?

Obama told reporters the FDA decision was based on "solid scientific evidence."

But Donna Harrison, executive director of the American Association of Pro-Life Obstetricians and Gynecologists, said that, from an evidence-based scientific standpoint, the FDA’s move is "a foolish decision."

"No one has studied the effect of Plan B in that age group," Harrison said, "so we don’t know if it’s safe or not."

She charged that the Obama administration and the FDA are "experimenting with our young girls."

Pointing to "the rights of parents to be involved in the most critical health care and lifestyle decisions of their children," Marie Hilliard of the National Catholic Bioethics Center in Philadelphia called the new FDA ruling "a real tragedy."

"This is a huge attack on the family and government intruding upon family life and the rights of parents," Hilliard said.

Anna Franzonello, staff attorney with Americans United for Life, calls Plan B One-Step "a statutory-rape cover-up drug. With Plan B, an older boy or man who’s having sex with a 12-year-old can simply cover his tracks by giving her the drug every time he rapes her."

"According to Planned Parenthood’s own ‘fact sheets,’ 4.5 out of 10 pregnant adolescents likely have a history of abuse," Franzonello said.

"So when the Obama administration and the FDA make Plan B readily available to girls and boys as young as 15 over the counter, we’re removing a health-care provider from a situation where we know abuse is likely, a situation where we know sex could be coerced."

 

Side Effects

Harrison said many questions about this drug remain unanswerable because the studies simply haven’t been done. But even those questions that can be answered are seldom asked.

Side effects of Plan B One-Step, listed on a Princeton University website, include leg pains, chest pain, cough, shortness of breath, severe headaches, blurred vision and trouble speaking.

"Any of these can be a sign of a stroke from a blood clot," Hilliard said. She said parents should be watching for these symptoms after their children take the pill, yet they will now be "completely in the dark" about them.

Girls taking the drug also bear a higher-than-average risk of ectopic pregnancy, Hilliard said.

According to critics of the FDA’s decision, unknown long-term side effects may be as, if not more, disturbing.

"At a time when girls are developing their normal menstrual cycles, Plan B One-Step will put high-dose progesterone into their systems," Harrison said. "Nobody knows what that will do for their future fertility."

"It’s hard to say what this drug is going to do if it’s used once in a blue moon," said Karen Brauer, president of Pharmacists for Life International. "But if it becomes a pill teen girls use fairly often, it will slow down bone deposition." She said 50% of bone mass is laid down during a girl’s teenage years. Bones get thicker and bigger. Progestins, the hormones in Plan B, slow down this process. "If any of the progesterone-only class of birth control gets used fairly often or continually," Brauer said, "osteoporosis is the result."

 

Not Very Effective

The promise is that if it’s taken up to 120 hours after sexual relations, Plan B One-Step will lower unplanned pregnancy rates and thereby lower the "need" for abortions.

But, in fact, Brauer said, "At best, Plan B is only about 60% effective — less so than the withdrawal method."

When young girls are taught to rely on a pill that doesn’t work very well, Brauer said, the upshot could be pregnancies they weren’t prepared for — and perhaps even an increase in abortion rates.

Having reviewed all the scientific literature on the subject, Harrison concludes, "This stuff doesn’t work. If you look at population-based studies where Plan B has been given out, not one of them shows a decrease in either the pregnancy rate or the abortion rate."

One of the most recent studies to illustrate this point was done at the University of Nottingham and published in 2011 in the Journal of Health Economics.

The study found emergency contraception had no effect on unwanted teen pregnancy rates or abortion rates, but was linked to increased rates of sexually transmitted diseases.

"Essentially, the finding that the promotion of emergency contraception has no effect on unwanted teen pregnancy rates or abortion has been found multiple times in a vast range of different settings and using alternative research designs," said University of Nottingham researcher David Paton. "Indeed, as far as I am aware, not a single study in a peer-reviewed academic journal has found that promotion of (or easier access to) emergency contraception significantly reduces unwanted pregnancy/abortion rates. So this finding is hard to challenge."

Mary Davenport, an obstetrician-gynecologist in private practice in El Sobrente, Calif., said, "It’s not evidence-based and scientific for the FDA to approve this drug for 15-year-olds. The decision has got to be based on some ideology."

Another fact young girls and their parents seldom hear is that the drug is effective only four days out of the month. "If a girl takes Plan B five days to one day before ovulation, then it prevents a clinically recognized pregnancy at the end of her monthly cycle," Harrison said. "But if she takes it at any other time during her cycle, it doesn’t work."

"So we’re loading these young kids with high-dose hormones. It doesn’t work. We’re isolating them from good care. And we may be interfering with their future fertility," she said.

In short, she said, "The people who run the FDA aren’t stupid. But this time they’ve made a really bad decision."

Sue Ellen Browder writes from Ukiah, California.