The Plan B Debacle: The Sequel
Levonorgestrelan (brand name "Plan B") is an emergency contraceptive that prevents ovulation after unprotected sex and has been shown to reduce the number of unwanted pregnancies and abortions.
By law, if the science showed levonorgestrelan was safe and effective, FDA commissioner Margaret Hamburg was required to approve it for over-the-counter use. Hamburg determined that indeed "there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential."
But in an unprecedented December 6 move, Health and Human Services Secretary Kathleen Sebelius announced she was overruling Hamburg's science-based approval of over-the-counter availability to all females of child-bearing potential. Sebelius argued that ten percent of 11-year olds can get pregnant and so the drug's maker should have specifically studied its use in them (an almost impossible requirement to fulfill), therefore she was rejecting it for all teens under 17.
The last time this happened, it was under Bush administration FDA commissioner Lester Crawford, and it was a major scandal. It should be this time too, and here's why.
The Plan B Debacle: The Original
Levonorgestrelan was first held back from approval for over-the-counter sale by Crawford in 2005 but was available without a prescription in 33 other countries around the world.
At issue was whether the drug caused abortions. If taken within 72 hours of sex, Plan B can prevent pregnancy.
The mainstream medical associations say it works by temporarily preventing the hormonal surge that causes ovulation, using progestin, the drug found in lower doses in daily contraceptive pills. This is supported by several randomized, double-blind, placebo-controlled studies, the "gold standard" for clinical trials.
But religious conservatives argued that it could also prevent implantation of a fertilized egg, which, they said, is tantamount to an abortion.
This claim appeared to run counter to the facts. None of the studies submitted to the FDA demonstrated conclusively that implantation is impaired.
Some medical professionals suggested that the religious conservatives were perhaps confusing progestin-only emergency contraceptives, like Plan B, with other contraceptives that combine progestin and estrogen, but which function very differently. Estrogen is known to alter the endometrium of the uterus, reducing the likelihood of implantation. Progestin is not.
Further complicating the question was what exactly constitutes an abortion.
The Code of Federal Regulations, the National Institutes of Health, and the American College of Obstetricians and Gynecologists have all said that pregnancy starts with the implantation of a fertilized egg, not with the fertilization itself. This is because the majority of fertilized eggs simply do not successfully implant in the uterus, even when no birth control is used.
Also, breastfeeding reduces the chance of pregnancy for up to six months after a woman gives birth and so, under the definitions used by the religious conservatives, breastfeeding itself could be considered "abortive."
And, can a women really be said to be "pregnant" if her body is not undergoing the physiological changes associated with hosting a developing embryo?
Plan B Science Politics
Two independent FDA scientific advisory committees met jointly in December 2003 to review the application for over-the-counter status, and found themselves in a political hurricane.
Forty-four religious conservative members of Congress, including then-House Majority Leader Tom Delay, weighed in on the issue.
"We urge you to reject the petition currently before you to make the morning-after pill as accessible to our nation's teenage daughters as aspirin or hairspray," the letter said, neglecting to mention that at the time a single 2-pill dose of Plan B cost $25 to $30, considerably more than aspirin or hairspray, and had to be asked for over the counter, not found next to bubblegum by the register.
Conservative religious activists questioned the drug's safety and argued that wider availability would encourage more sexual activity and make it easier for men to have sex with underage girls.
"The morning-after pill is a pedophile's best friend," said Wendy Wright, senior policy director for Concerned Women of America.
After lengthy reviews of the data, the scientific advisory committees voted 23 to 4 in favor of the change, which they believed would significantly cut the number of abortions and unintended pregnancies.
They also voted unanimously that the drug could be safely sold over the counter.
The switch to nonprescription status in the United States was endorsed by some 70 scientific organizations, including the American Medical Association, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics.
When Crawford blocked the approval, Susan Wood, then Assistant FDA Commissioner for Women's Health, resigned from her post in protest.
"I can no longer serve as staff when scientific and clinical evidence, fully evaluated and recommended for approval by the professional staff here, has been overruled," she said in an email to staff and colleagues at the time.
On November 14, 2005 the Government Accountability office issued a report showing that of the 67 proposals that FDA advisory committees recommended be approved for non-prescription sales from 1994-2004, the Plan B proposal was the only one not approved.
"As a scientist, I felt it was my responsibility to speak out publicly and to refuse to be part of an ongoing compromise in scientific integrity," Wood told me. "This is why I left government service, and why I felt the scientific integrity question was so important in Science Debate 2008."
Under pressure, on August 24, 2006 the FDA finally approved the drug for over-the-counter use by women 18 and over, but the approved labeling contained a curious statement more supported by politics than science: "In addition, it may inhibit implantation (by altering the endometrium)," even though none of the studies submitted showed this to be conclusive.
On March 23, 2009, U.S. District Judge Edward R. Korman in New York ruled that the FDA's 2006 decision to limit availability of Plan B to women 18 and older was invalid and politically motivated, and instructed the agency to make the drug available to 17-year-olds and to reconsider other restrictions, including whether the drug could be made available to all ages.
Hamburg did this and, based on the science, determined that it could be.
In his 2009 Inaugural address, President Obama pledged to "restore science to its rightful place."
Scientists were jubilant. The pledge sounded like part of the mission statement of the organization I helped to form - ScienceDebate.org and through it, ScienceDebate 2008 - which was supported by tens of thousands of scientists. They saw Obama's pledge as an end to the abuses of science that had occured under the Bush administration.
But on December 6, 2011 that changed. Sebelius intervened, and the supposedly pro-science Obama backed her decision in a most anti-science way.
"As the father of two daughters I think that it is important for us to make sure that we apply some common sense to various rules when it comes to over the counter medicine," Obama said, "and as I understand it, the reason Kathleen made this decision was she could not be confident that a ten-year-old or an eleven-year-old going to a drug store should be able - alongside bubblegum or batteries - be able to buy a medication that potentially if not used properly could end up having an adverse effect."
Unpacking Obama's antiscience assertions
This statement is confused and misleading in so many ways that it is difficult to know where to begin.
First, we're talking about a cost today for Plan B One-Step of about $50. That's a significant barrier in and of itself.
Second, the drug is only available over the counter, not out next to the bubblegum as Obama suggested. Either he vastly misunderstands what is being proposed, which is possible, or he is intentionally misrepresenting the situation. OTC sales of Plan B and Plan B One-Step are restricted, meaning a teen of any age would have to ask a pharmacist for it and receive some education in its proper use - another significant safeguard against it being "not used properly" that would in no way be altered by requiring a teen get a telephone prescription before going to the drug store. Such a transaction with a pharmacist is also a barrier to the kind of casual use Obama implied, which is simply not an accurate picture of the situation.
Third, levonorgestrelan is safer than many painkillers and other medications a child of any age might buy. Acetaminophen, for example, can be fatal if "not used properly" but it's available to everyone with no education whatsoever - and frequently given to ten or eleven year olds, even infants. Also available are common inhalants like nail polish remover and hairspray - products which have their highest rates of abuse among eighth graders. And all those products are out alongside the bubblegum, unlike Plan B.
Fourth, this appears to be a case of the president attempting to parent the nation, applying his morality over the evidence of over a decade of nonpartisan scientific research that has shown the medicine to be safe and to reduce the number of unintended pregnancies and abortions - something that as the father of two girls, he should be supporting.
Fifth, the president's views as a father of two girls are beside the point, and referencing them as a reason for his support of a national policy that runs counter to science and affects hundreds of thousands of families is, frankly, deplorable, and a good example of the kind of authoritarian thinking that is wrong with Washington these days.
Sixth, the use of the emotional image of bubblegum seems to be an appeal to set aside critical thinking faculties that is eerily reminiscent of the arguments used by Tom Delay, and it similarly neglects to mention the high cost of the drug and the fact that it has to be requested over the counter. The notion that it would be casually asked for by young girls who would shell out $50 for it along with a pack of bubblegum is, frankly, not realistic.
Seventh, just 1.97% of the 750,000 annual US teen pregnancies are in girls younger than 15, and only about 0.03% - 3 in 10,000 - are in girls younger than 13. Obama's reference to ten- or eleven-year-old girls is using an extreme outlier as an emotional distraction from the facts: 98% of America's 750,000 annual teen pregnancies are among 15-19 year olds, who have about 200,000 abortions. At a 50% effective rate, Plan B could potentially prevent as many as 100,000 abortions annually by preventing pregnancy in the first place, and by preventing abortions, its use could prevent heartache, suffering, health risk, financial loss, and death.
Eighth, the statement is at cross-purposes to the president's own teen pregnancy prevention initiative, which specially targets African-American and Lantino-American youth, who have a teen pregnancy rate more than double that of whites. The goals of the initiative include "Increase youth access to evidence-based and evidence-informed programs to prevent teen pregnancy," and "Increase the consistent and correct use of condoms and other effective methods of contraception among sexually active youth."
Obama's antiscience politics
Perhaps the president is simply making a political calculation to avoid a bruising election-year battle over the emotional issue of parental control over birth control. It's not clear that this will do that, and in fact it may inflame the issue.
Or perhaps he figures that he has scientists in the bag. After all, nine out of ten scientists who declared a party affiliation in 2009, shortly after his inaugural statement, said they were democrats.
But that's largely because of the terrible abuses scientists saw during the Bush administration - and many pointed specifically to the Plan B debacle.
What scientists care about most is that for the good of everyone in a diverse country, policy decisions are based on data and reason, not personal opinion or belief - and personal opinion and belief is precisely what Obama cited in his decision to back Sebelius. He sit up a false situation - 10-year-olds buying it casually next to bubblegum or batteries, and used that as the justification to deny the science-based policy. The one feeble reference he made to data was to a lack of data in an extreme outlier situation that is almost overwhelmingly refuted by just the few examples given here, and not a reasonable basis to deny it in all other situations. That's not rational, and it runs counter to the science on the issue and our knowledge of reproductive medicine.
The quashing science-based policy by political appointees also runs counter to the spirit of Obama's own scientific integrity policy and is a vast reversal of his pledge to restore science to its rightful place in America.
Pandora's policy box
On a policy level, the decision is just plain bad governance, says Susan Wood.
"It has set a precedent for any future Secretary of a science-based department or agency (of any political stripe) to over-rule the science-based decision making process," Wood told me this morning. "This has the potential to have more impact than just on emergency contraception."
And that is the real problem with both Sebelius's and Obama's decisions. They open the door through precedent for increased authoritarianism and decreased knowledge-based governance.
Any time an administration finds science politically inconvenient, this decision's precedent by a supposedly pro-science president will make it that much easier for future administrations to assert more absolute authority.
That is dangerous for the future of both science and the nation.
Get Shawn Lawrence Otto's new book: Fool Me Twice: Fighting the Assault on Science in America, Starred Kirkus Review; Starred Publishers Weekly review. Visit him at shawnotto.com. Like him on Facebook. Join ScienceDebate.org to get the presidential candidates to debate science.