Plan B, Political Pandering, and Religious Beliefs vs. Scientific Facts

Letter to Defend Science Signatories, of which Atheists For Human Rights is one

For the first time ever, the Health and Human Services secretary - Kathleen Sebelius - has publicly overruled the Food and Drug Administration's approval of a medication. Her decision continues the policy of refusing to allow the emergency contraceptive Plan B to be sold over the counter to women under 17 without a prescription. It overruled the FDA that was finally prepared to approve over-the-counter access to minors - a policy recommended by the entire scientific and medical community.

On December 7, after years of delays in approval that have kept young women under 17 from having over-the-counter access to Plan B emergency contraceptives, FDA Commissioner Margaret Hamburg, M.D. released the following statement voicing FDA approval:

"I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that 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."

In her statement the same day, rejecting Plan B and reversing the FDA decision, Sebelius tried to put a "scientific" veneer on her crudely political decision claiming that the company producing the medicine (Teva Pharmaceuticals) had not provided enough data to show that young girls of reproductive age would have the ability to use the product correctly. But this was studied for women as young as 11 years old. Also, ex-FDA administrator Susan Wood noted the hypocrisy and double standard involved in this "logic" saying that there were many drugs already available over the counter that had not been studied in pre-adolescents and that were far more dangerous to them.

"Acetaminophen can be fatal, but it's available to everyone," Dr. Wood noted. "So why are contraceptives singled out every single time when they're actually far safer than what's already out there?"

Common Sense?! For Whom? And on what basis?

President Obama, in a press conference, called this decision "common-sense." "As the father of two daughters," he said, "I think 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."

The New York Times on Dec. 7 got closer to what was really going on: "The decision avoided what could have been a bruising political battle over parental control and contraception during a presidential election."

We live in a society where today one-half of all pregnancies are unplanned, more than 40 percent of children are born to unwed mothers and 1.2 million abortions are performed every year involving one in every 50 women of reproductive age. (See Plan to Widen Availability of Morning-After Pill is Rejected - NY Times 12/7/2011)

We live in a society with reactionary forces hounding women, especially young women and trying to control their reproductive rights and their lives. Many among the forces that oppose emergency contraception also oppose all contraception—for example the Catholic Church opposes a mandate in the medical insurance plan that private medical insurers provide women with contraceptives for free. And many others continue to promote abstinence only sex education.

The American Medical Association, the American Congress of Obstetricians and Gynecologists, and the American Academy of Pediatrics have all strongly endorsed over-the-counter access to Plan B with no age restrictions. And they have all criticized this rejection as the intrusion of politics into what should be a scientific decision. (See Footnote 1)

The FDA's own scientists have thoroughly studied Plan B and repeatedly over a 10-year period given their approval for its general use, only to be repeatedly over-ruled. In 2005 Bush-appointee Susan Wood, then Assistant Commissioner for Women's Health and Director, Office of Women's Health at FDA, resigned in protest of this same trampling by reactionary politics on science, stating:

"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."

Reacting to the current rejection, Wood added that the administration is "abandoning its scientific integrity principles, and blocking a safe and effective contraceptive."

In 2009 A U.S. District Judge ruled that the FDA had "repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons" and forced the FDA to lower the age to 17 and re-review the rationale for its decision.

Kirsten Moore, president of the Reproductive Health Care Technologies Project voiced what many are feeling:

"For me personally this is an incredibly disappointing moment, because I was in the East Room of the White House in March 2009 when [President Obama] signed an executive order saying this administration was committed to restoring scientific integrity to the policymaking process. And that commitment just went up in smoke today."

Footnote 1: Statements from Medical Groups

American Academy of Pediatrics
"As advocates for the health and well-being of all young people, the AAP recommends that adolescents postpone sexual activity until they are fully ready for the emotional, physical and financial consequences of sex," said Dr. Robert Block, AAP president. "However, as physicians who care for our nation's children, it is our responsibility to protect the health of our teenage patients, and an unintended pregnancy can have significant implications for adolescents' physical and emotional health."

American Society for Reproductive Medicine
The ASRM issued a statement from Dolores J. Lamb, the organization's president, that said in part: "We are very disappointed that Secretary Sebelius opted to insert herself into what should be a scientific decision made by the experts at FDA. The data are clear that emergency contraception can be safely used by adolescent women without requiring a prescription. Sadly, it appears that once again our leaders are putting political expediency ahead of reproductive health."

Society For Adolescent Health and Medicine
Added Dr. Leslie Walker, president of SAHM: "Today’s decision by the Department of Health and Human Services is a profound disappointment for the health of adolescent girls and is inconsistent with what we know about the safety and benefits of emergency contraception. Emergency contraception is a safe, effective back-up birth control method for teens and women of all ages to prevent unintended pregnancy."

A Pharmacist's View

Niles Ross, Cedar Rapids IA

Niles Ross, a member of AFHR, is a former pharmacist and a retired pharmaceutical industry professional.

There was a day, when I started out as a pharmacist, that certain products could only be sold by a pharmacist, but were available without a prescription. For the most part it was condoms and other related items. There were other items - and still are - but these are considered potential "drugs of abuse" such as cough medicines with small amounts of codeine, and most recently pseudopeherine (which is one of the ingredients used to make methamphetamine). The "sex products" were slowly moved from behind the counter to self-service.

In 1972, I was an inspector for the New York State Board of Pharmacy, and the restrictions in New York State - a very high Catholic population - were among the most strict in the country. Not only were sales restricted to a pharmacist, but pharmacies could not advertise condoms and related items. If a pharmacy was a national chain, they needed special advertisements that were different within New York State from the rest of the country - this is less difficult than you might think, because a lot of advertisements are local, although certainly not all. What started to blow the lid off this - not entirely, but the start - was Playboy magazine. Playboy broke the unofficial taboo, and started accepting advertising for condoms. The State Board met on this issue, and realized this is a national publication, over which they have no control. They pondered, but realized they could not restrict the sale of Playboy within pharmacies. Then the next barrier fell. Playboy started accepting advertising for purchasing condoms via mail order.

We have historically treated two sets of non-prescription drugs differently from all other products: 1) drugs for which there is a possibility of abuse or addiction; 2) drugs and devices (condoms are "devices") related to sex.

We have other drugs that have real dangers, if not used properly, but they are readily available to anyone, anywhere, without restriction as to age (yes, a 6-year-old), distribution (the restriction of some drugs to pharmacies only have long ago stopped), and for some - aspirin and Tylenol (as well as condoms) in vending machines in the rest room.

Tylenol (acetaminophen) is recently, based on new information, the subject of some real problems, in that "small overdoses" for a brief period of time, can result in some real damage to the liver and kidneys. FDA has issued a warning, and HHS is in charge of FDA (Sebelius "knows or should know") yet there are no age or distribution restrictions on this. Some cough medicines are alcohol based. Need I even go further?

Labels contain cautions and warnings for some drugs not to be used in certain age groups (or other groups - women of child-bearing age) because of lack of data, or inconclusive data, and the potential for harm based on preliminary information.

However, the cautions do not bar those in those age groups from purchasing the medicine, and using it, notwithstanding the cautions. So we have "guarded libertarianism" (my term): give people information and let them make their own decision. Plan B is being treated differently, and uniquely, notwithstanding that there are drugs easily and widely available for which harm is well known and on the label.

The Plan B decision is massively inconsistent with our societal decisions on most things. It is clear to me that science was overruled by politics. We infer religion, or at least political - religious influence - and some columnists are gently exploring it. I say "gently" because there is no proof, and nobody is publicly using the words.

However, science is clear. FDA is given the authority to examine the science, make the decisions, and they have done it. So, what motivated the Plan B decision? Religion, I believe.

Here are civil answers to the questions Dan Nye asked about homosexuality (1-14-12: "Six Questions for supporters of same-sex marriage to ask - forthrightly")

1. Our ancestors were wrong about many things, such as slavery and subjugation of women. We abandoned those ideas because they allowed the mistreatment of people for no worthwhile purpose. That change was innovative and progressive. We are now abandoning the mistreatment of homosexuals for the same reason.

2. Our sexual organs (the external ones we control) exist for several functions, only one of which is reproduction. They certainly exist for pleasure, and so are used primarily for that. The male penis has three functions - urination, pleasure and reproduction. The female clitoris has only one function - pleasure. Homosexuality squares with all of those functions (although reproduction is usually - but not necessarily - achieved indirectly through sperm donation).

3. The human sex drive, being stronger than needed for reproduction (thus suggesting its primary human purpose is pleasure), can indeed be misused. It is more extravagantly misused by heterosexuals, especially in sexual exploitation of women, but can be misused by homosexuals as well. Controlling one's sex drive is a common issue for everyone, regardless of orientation.

4. Yes, adultery and pedophilia are morally wrong because they harm people. Bestiality? We'd have to check with the beast in question as to any harm done. It's just disgusting (or possibly hilarious) to most of us. Yes, those behaviors are probably natural for those who engage in them, but we need to prohibit only those that are harmful. Adults can deal with adultery on their own. Pedophiles, however, have to find a way to control that tendency or we lock them up to ensure the safety of our children. But homosexuality? What is there about it that is harmful when it's between consenting adults? All it really amounts to is scratching an itch. Heterosexual behavior offers a lot more opportunities for immoral (harmful) behavior.

5. When has homosexuality harmed society in any way? It has never been or ever will be prevalent because it involves only a small percentage of the population, is not catching and can't be taught because it's a natural orientation, just one of nature's variations. Heterosexuality has caused far more harm by subjugating women and overpopulating the planet.

6. Some religious people may believe homosexuality leads to perdition, but that is no basis for discriminatory laws against homosexuals. All such laws would be a most egregious unconstitutional establishment of religion with no valid secular justification whatsoever. The Book of Leviticus may have a place in some churches, but there it should stay. It does not belong in our laws, and certainly not in our state Constitution.