Human Nature: Science, Technology, and Life.

Coitus Interceptus

I'm just back from vacation and trying to catch up on the war in Gaza. More on that later. But first, something I didn't have a chance to get to before the break: the Vatican's latest pronouncement on fertility technology. Apparently the men in Rome are having trouble understanding some nuances of the female reproductive system.

The pronouncement comes in the form of Dignitas Personae, an instruction from the Congregation for the Doctrine of the Faith, which articulates official Catholic positions. This document covers several interesting topics, which I hope to get to in the days ahead. But the one that calls for rebuttal right away is the section on "[n]ew forms of interception and contragestation." It says:

Alongside methods of preventing pregnancy which are, properly speaking, contraceptive, that is, which prevent conception following from a sexual act, there are other technical means which act after fertilization, when the embryo is already constituted, either before or after implantation in the uterine wall. Such methods are interceptive if they interfere with the embryo before implantation and contragestative if they cause the elimination of the embryo once implanted.

This is an astute and useful set of distinctions. Unfortunately, the CDF immediately proceeds to violate them. Here's its next paragraph:

In order to promote wider use of interceptive methods [a footnote here specifies "morning-after pills"], it is sometimes stated that the way in which they function is not sufficiently understood. It is true that there is not always complete knowledge of the way that different pharmaceuticals operate, but scientific studies indicate that the effect of inhibiting implantation is certainly present, even if this does not mean that such interceptives cause an abortion every time they are used. ...

Really? Is the effect of inhibiting implantation "certainly present"? Let's review the mechanics of morning-after pills, specifically levonorgestrel, marketed as Plan B. The problem with the CDF's statement is that this "interceptive" is chemically identical to the best-known contraceptive: the pill. And the risk that this drug

will prevent implantation of an embryo is purely theoretical. There is no documented case of such a tragedy, since we have no way to verify conception inside a woman's body prior to implantation without causing the embryo's death. Even theoretically, the risk is vanishingly small, since the primary effect of oral contraception is to prevent ovulation, and the secondary effect is to prevent fertilization. To classify oral contraception as abortifacient, one would have to posit a scenario in which the drug fails to block ovulation, then fails to block fertilization, and yet somehow, having proved impotent at every other task, manages to prevent implantation.

So, the assertion of an anti-implantation effect is theoretically unsound. But what do the data show? Two years ago, the world's leading expert on levonorgestrel, James Trussell, co-authored an analysis of the available research in the Journal of the American Medical Association. The analysis confirmed that that anti-ovulation effects wipe out any data suggesting a possible anti-implantation effect. It concluded:

Published evidence clearly indicates that Plan B can interfere with sperm migration by altering the cervical and uterine environment, and that preovulatory use of Plan B usually suppresses the LH surge either completely or partially, which in turn either prevents ovulation or leads to the release of ova that are resistant to fertilization. Epidemiological evidence rules strongly against interruption of fallopian tube function by Plan B. Evidence that would support direct involvement of endometrial damage or luteal dysfunction in Plan B's contraceptive mechanism is either weak or lacking altogether. Both epidemiologic and clinical studies of Plan B's efficacy in relation to the timing of ovulation are inconsistent with the hypothesis that Plan B acts to prevent implantation.

In fact:

Progestational drugs, including levonorgestrel, are used therapeutically in assisted reproduction because they increase the rate of successful implantation and pregnancy. That observation a priori reduces the likelihood that Plan B interferes with implantation; it even raises the counterintuitive but undocumented possibility that Plan B used after ovulation might actually prevent the loss of at least some of the 40% of fertilized ova that ordinarily fail spontaneously to implant or to survive after implantation.

So, in summary:

[T]he ability of Plan B to interfere with implantation remains speculative, since virtually no evidence supports that mechanism and some evidence contradicts it. ... [T]he best available evidence indicates that Plan B's ability to prevent pregnancy can be fully accounted for by mechanisms that do not involve interference with postfertilization events.

So much for the question of effect. But what about the other part of the moral equation: intent? The Vatican document, still referring to morning-after pills, says that "anyone who seeks to prevent the implantation of an embryo which may possibly have been conceived and who therefore either requests or prescribes such a pharmaceutical, generally intends abortion."

But a woman who requests a morning-after pill doesn't necessarily seek to prevent an embryo's implantation. In fact, as we just showed, it would be irrational of her to seek that effect, since no evidence supports it. In fact, given the evidence, it would make just as much sense for her to request the pill in order to prevent embryonic loss. And anyone who has ever taken a morning-after pill knows that at that moment, your actual intent is to avert pregnancy at the earliest possible stage of the process, which happens to be ovulation.

Bottom line: The perceptive analytical framework established by Dignitas Personae, combined with the best scientific evidence and analysis, clearly implies that morning-after pills are contraceptives, not interceptives. Therefore, from the standpoint of respecting embryonic life, you may take them in good conscience.

Contraceptive Fudge: Addendum

In yesterday's post on the proposed HHS abortion "conscience" regulation, I overlooked a very important quote from Secretary Leavitt. Rob Stein of the Washington Post relates the following exchange from Leavitt's Aug. 21 conference call with reporters:

But when pressed about whether the regulation would protect health-care workers who consider birth control pills, Plan B and other forms of contraception to be equivalent to abortion, Leavitt said: "This regulation does not seek to resolve any ambiguity in that area. It focuses on abortion and focuses on physicians' conscience in relation to that."

Ambiguity is precisely what pharmacists have asserted in lawsuits demanding the right to withhold hormonal contraceptives. While framing the regulation as neutral, Leavitt is lending support to their position. And, as noted yesterday, the regulation explicitly applies to pharmacies (see page 24 of the PDF) which dispense contraceptives but do not perform surgical abortions.

When it comes to conscience rights, I'm a libertarian. As a pharmacist, you have every right to refuse to fill contraceptive prescriptions. But your customers have every right to boycott your store, and your employer has every right to fire you. If you don't like your employer's policy, open your own pharmacy.

The HHS regulation is not neutral. It uses government leverage to prevent employers from insisting that their employees honor consumer choice. In the name of one freedom, it suppresses another. And in the name of ambiguity, it lends official support to lawsuits that would extend this government intervention from abortion to contraception.

You can add your own views, pro or con, at consciencecomment@hhs.gov.

Contraceptive Fudge

HHS Secretary Michael Leavitt has issued a final version of his proposed regulation to protect medical conscience (PDF). As predicted, he has dropped the sentence that originally defined abortion as "any of the various procedures—including the prescription, dispensing and administration of any drug or the performance of any procedure or any other action—that results in the termination of the life of a human being in utero between conception and natural birth, whether before or after implantation."

Leavitt has also chosen to leave open the possibility that the regulation will be applied that way. In that case, it would protect a provider's right to withhold oral contraception, which theoretically could prevent implantation of an embryo. Pharmacists and Catholic hospitals are already waging legal battles to assert this right.

The proposed regulation is 42 pages long. I'm embarrassed to tell you that I read it last week during my vacation. I was looking for a definition of abortion. I'll save you the trouble: There is none. The regulation draws no distinction between abortion and contraception.

In his blog, Leavitt has twice addressed the contraception question. On Aug. 7, he said his intent was to protect the right of conscience, not to define contraceptives as abortion. This left open the obvious next question: Intent aside, does the right of conscience protected by the regulation include the right to withhold hormonal contraception on the grounds asserted by pharmacist litigants: that it might be abortifacient? Two weeks ago, I invited Leavitt to answer that question. He has ignored it.

He has, however, answered a similar challenge from Mary Jane Gallagher, the president of the National Family Planning and Reproductive Health Association. In an Aug. 11 blog post, Leavitt quoted and rebutted her:

"Who's going to provide access to contraceptives services if the administration provides this large loophole to deny services?" [said Gallagher.] CQ reported Ms. Gallagher continued: "Providers are ‘given an oath—now they get to pick and choose what they want to do' if a regulation is issued, she said."

So, according to Ms. Gallagher's ideology, if a person goes to medical school they lose their right of conscience. ... There is something I'd like to point out to Ms Gallagher and the people she represents. It is currently a violation of three separate federal laws to compel medical practitioners to perform a procedure that violates their conscience.

Gallagher is explicitly talking about contraception. And Leavitt's response is to invoke conscience rights.

Last week, Leavitt said some practitioners might "press the definition" in the final HHS regulation and argue that hormonal contraception is abortion. They certainly will. Pharmacists for Life International is already on the case. So is the Christian Legal Society. Concerned Women for America says the equation of hormonal contraception with abortion, explicit in the original draft of the regulation, was right all along.

And when these litigants argue that the regulation implicitly covers contraception, they'll have lots of help from Leavitt. They can cite his response to Gallagher. They can also point out that the regulation explicitly lists pharmacies as a category of "affected entities." (See Page 24.) Last time I checked, pharmacies didn't do surgical abortions.

The argument on the other side will be that Leavitt has said he's not targeting birth control. "This regulation is not about contraception," he said in a conference call last week. "It's about abortion and conscience." But Leavitt has said the same thing about abortion itself. "This is not a discussion about the rights of a woman to get an abortion," he wrote in his blog. "This is about the right of a doctor to not participate if he or she chooses for reasons they consider a matter of conscience." Leavitt's point, in other words, is that the regulation doesn't ban anything; it just protects the right not to facilitate it. As he put it in the conference call, "There is nothing in this rule that would in any way change a patient's right to a legal procedure." But in asserting this right of refusal, the rule doesn't distinguish between surgical abortion and theoretically abortifacient drugs.

Birth-Control Blur

Last Tuesday, I wrote about a draft regulation, circulated by the Department of Health and Human Services, that would protect the right of private employees to refuse to facilitate any abortifacient chemical or activity. The draft rule defined abortion as "any of the various procedures—including the prescription, dispensing and administration of any drug or the performance of any procedure or any other action—that results in the termination of the life of a human being in utero between conception and natural birth, whether before or after implantation." It would thereby encompass the right to withhold oral contraception, which theoretically could prevent implantation of an embryo.

On Friday, HHS Secretary Mike Leavitt wrote a blog post about the draft rule. According to the Washington Post, Leavitt "denied that [the] draft regulation would redefine common birth control methods as abortion and protect the rights of doctors and other health-care workers who refuse to provide them."

Really? Where's the denial?

Here's the relevant part of Leavitt's post:

An early draft of the regulations found its way into public circulation before it had reached my review. It contained words that lead some to conclude my intent is to deal with the subject of contraceptives, somehow defining them as abortion. Not true.
The Bush Administration has consistently supported the unborn. However, the issue I asked to be addressed in this regulation is not abortion or contraceptives, but the legal right medical practitioners have to practice according to their conscience and patients should be able to choose a doctor who has beliefs like his or hers.
The Department is still contemplating if it will issue a regulation or not. If it does, it will be directly focused on the protection of practitioner conscience.

Leavitt's post says his intent is to protect the right of conscience, not to define contraceptives as abortion. It doesn't deny that the final version of the rule will have the effect of treating some contraceptives as abortion. And there's every reason to believe it will do just that.

Leavitt writes as though conscience protection is a separate issue from the blurring of abortion with contraception. It isn't. A rule that guarantees the pro-life conscience rights of doctors, pharmacists, and other private employees is limited only by what those employees believe. And what many of them believe, as the Post's Rob Stein has documented, is that oral contraceptives are wrong because they can prevent implantation.

If you think Leavitt won't extend conscience protections that far, you haven't met his boss. Nine years ago, when George W. Bush was running for president, Tim Russert asked him: "Do you believe life begins at conception?" Bush replied: "I do." Two years later, as he prohibited federal funding of embryo-destructive stem-cell research, Bush repeated, "I think life begins at conception." Referring to pre-implantation embryos, Bush wrote that "it is unethical to end life," even to save the lives of others.

How can Leavitt fail to extend conscience protections to a pharmacist who refuses to fill a birth-control prescription because, like Bush, he believes that life begins at conception? If that belief is good enough to bar funding of stem-cell research, why isn't it good enough for the pharmacist?

If Leavitt really wants to clarify this question, he can do so by writing one more post in which he stipulates that the HHS rule, if issued, will not extend to drugs or procedures that act prior to implantation. I'm betting a month's supply of birth-control pills that he won't.