Still Angry, After All These Years

This probably falls into the 'I'll be sorry for this' category, but what the heck.

COURT REQUIRES FDA TO REVISIT ‘PLAN B’

Tummino v. Torti, (ED NY, March 29, 2009). A NY Federal District court ruled that the FDA must revisit its current ruling on the ‘morning after pill,’ Plan B. Under well-evidenced political pressure from the Bush administration, the FDA dillied and dallied between 2001 and 2006, when it [finally] ruled that Plan B – first approved in 1998 – would be available over the counter only to women 18 years of age and older, with proof of age for the pharmacist. Moreover, the OTC drug had to be kept behind the pharmacy counter. Any woman under the age of 18 needed a doctor’s prescription, which effectively made the ‘morning after’ use of the drug unavailable to the vast majority of women less than 18 years of age.

The remarkable history of Plan B’s wanderings through the Bush FDA is recounted at the

Center for Reproductive Rights website. The CRP was among the petitioners seeking to force the FDA to, first, arrive at a ruling and, secondly, to change its politically determined ruling, once made. Among the highlights of this strange history, as revealed in depositions and testimony noted by the CRP, are these:

“Late Dec. 2003/Jan. 2004: After a panel of FDA experts recommends approval of the Plan B application, Dr. Steven Galson, the head of the office responsible for making the final decision, informs his staff that regular procedures won’t be followed this time, and that they won’t make the final decision. (Jenkins deposition)”
“Dec-Jan 17, 2004: Galson confesses to a co-worker that he has to reject the Plan B application because he’s afraid he’ll lose his job. (Jenkins deposition) Dr. Janet Woodcock, the second in command at the FDA(??), tells a colleague that the agency has to reject the application, then approve the drug later with an age restriction in order to ‘appease the administration's constituents.’ (Houn deposition)”

The full decision is more than worth reading, both for its detailed analysis of the intrusion of political and religion-based intrusions into the drug approval process and for the clarity of Judge Korman’s opinion.

Some highlights of the opinion:

“Plan B is an emergency contraceptive that can be used to reduce the risk of unwanted pregnancy after sexual intercourse. When used as directed, it can reduce the risk of pregnancy by up to 89 percent. Plan B acts mainly by stopping the release of an egg from an ovary. It may also prevent sperm from fertilizing an egg that has been released or, if fertilization has already occurred, block implantation of the resulting embryo in the uterus. Plan B does not have any known serious or long-term side effects, though it may have some mild and short-term side effects, such as nausea or abdominal pain, in some users.” (emphasis added)

Compare this with comments from the Christian News Wire:

“Ignoring patient safety and the damage high dose steroids have on developing female bodies, Korman petulantly insisted the FDA revisit the controversial previous ruling on the abortion drug. Hundreds of women have had serious side effects from Plan B as it has killed millions of preborn babies.”

Sure, because, as we all know, Federal judges are frequently ‘petulant’ in their decisions and far-right Christian news sources are the authority on women’s health matters – more authoritative than the FDA’s medical scientists who recommended that Plan B be more widely available:

“The FDA rejected that application too despite nearly uniform agreement among FDA scientific review staff that women of all ages could use Plan B without a prescription safely and effectively.” (from Tummino v. Torti ; emphasis added)

Admittedly, Judge Korman does seem to have been angered by the Bushies’ shenanigans in interfering with the FDA process (all emphases added):

“…the gravamen of plaintiffs’ claims is that the FDA’s decisions regarding Plan B – on the Citizen Petition and the SNDAs – were arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making. Plaintiffs are right. The FDA repeatedly and unreasonably delayed issuing a decision on Plan B for suspect reasons and, on two occasions, only took action on Plan B to facilitate confirmation of Acting FDA Commissioners, whose confirmation hearings had been held up due to these repeated delays.”

“These political considerations, delays, and implausible justifications for decision-making are not the only evidence of a lack of good faith and reasoned agency decision-making. Indeed, the record is clear that the FDA’s course of conduct regarding Plan B departed in significant ways from the agency’s normal procedures.”

“FDA upper management, including the Commissioner, wrested control over the decision-making on Plan B from staff that normally would issue the final decision on an over-the-counter switch application; the FDA’s denial of non-prescription access without age restriction went against the recommendation of a committee of experts it had empanelled to advise it on Plan B; and the Commissioner – at the behest of political actors – decided to deny non-prescription access to women 16 and younger before FDA scientific review staff had completed their reviews.”

Now, there is much that could be said here, from this being yet another instance of the Bush administration’s obsession with courting the religious right to its indifference to science to its eagerness to corrupt any process for political purposes. But, what intrigues me is the persistence with which self-proclaimed ‘pro-life’ advocates claim to be concerned with the health of women. You know, the already-born and old enough to be indisputably full persons kind. ( Remember when good old C. Everett Koop infuriated the same group of folks by announcing that – despite his expectations to the contrary – there was no evidence that having abortions seriously harmed the psychological well-being of most women who had gone through the experience? )

I don’t buy it. Never have, never will. In the case of Plan B, the façade is especially thin. There is no evidence that there are any serious side effects for any notable number of women who use the medication to prevent pregnancy. Put another way, Plan B is as ‘harmful’ to most women as, maybe, aspirin is to most people. (Just the facts, Ma’am.) And, if we were to think about the ‘side-effects’ of pregnancy – particularly unwanted pregnancy – the possible ill effects of Plan B pale by comparison.

Opponents of Plan B and other contraceptives are not genuinely concerned with the health of women or girls. This is a dodge to cover the on-going effort to impose on the rest of us the rather odd notion that fertilized eggs are '[pre-born] babies' . Since the imposition has not succeeded epistemically, those who adhere to this notion of personhood try to achieve their conception [pun intended] by coercing others in practice.

The falseness of this dodge is offensive enough to those of us into that whole reality-based thing. The hypocrisy is worse. I recognize that ‘hypocrisy’ is now a much devalued accusation. But think about it: these are the same people who claim that anyone who has an abortion or uses an abortifacient is a murderer, that women/girls who become pregnant outside of marriage are sinners [‘sluts,’ in the vernacular], and that pregnant women/girls should be forced to carry every pregnancy to term – their mental and physical health be damned.

So, thanks for the crocodile tears, but I would prefer if these people kept their private religious views, their peculiar biological notions, and their choices for themselves out of our government, our law, and other people’s lives.

Yup, still angry after all these years.