Saturday, December 30, 2006

Welcome, Bob! [SK]

As you can see from Bob's post earlier today (re: Henry Hyde), the LTI blog has a new contributor!

Bob Perry is a graduate of the United States Naval Academy and later he served as an aviator in the U.S. Marine Corps. During his time of service, he completed the Marine Corp's most challenging aviation training to become a tactical instructor pilot for the AV-8B Harrier Jump Jet.

Bob's also a thinker. Along the way, he earned a Masters Degree in Christian Apologetics (Highest Honors) at Biola University.

After 8 years in the Corps, Bob switched cockpits to pursue a career in commercial aviation. He now serves as a Captain for a major U.S. airline....and a welcome contributor to this blog!

Read more about Bob here.

Thank You, Mr. Hyde [Bob]

Pro-Lifers will be missing one of their greatest public advocates next month when the new Congress returns to Washington. Henry Hyde (R, Illinois 6) chose not to run for reelection. Hyde has served for 32 years in the U.S. Congress and has been one the pro-life movement’s staunchest advocates.

As Scott has argued here many times, the ways to achieve the pro-life agenda are many and varied. Sometimes they are not as obvious as they may seem and sometimes the politicians who can help achieve them are not the most obvious choices. We wrestle with these issues in the real world and must make our choices accordingly – even if it means having to swallow some pretty tough pills to back some less than optimal candidates along the way. Henry Hyde disappointed many of us when some of his moral failings came to light after the Clinton impeachment debacle. This proved nothing more than that Hyde, like the rest of us, is a fallible human being. But when it comes to advancing pro-life issues, few can hold a candle to him.

Like many social conservatives, Hyde started out as a Democrat, became disillusioned with the left-wing agenda of that party, and switched to the Republican Party as a result. In a recent issue of National Review, Hyde admits that, like many of us in our younger days, he “had never really thought much about abortion.” But that all changed when a fellow Illinois state congressman asked him to co-sponsor a bill to liberalize Illinois abortion law. Hyde considered the legislation by reading a book: The Vanishing Right to Live, by Charles Rice “[and] became convinced that abortion was evil.” Hyde’s subsequent self-education on the issue led to the passage of the Hyde Amendment in 1977, a bill that, by the “fairly conservative estimate” of The National Right to Life Committee’s Douglas Johnson, “has saved 1 million human lives in the 30 years that it has been in effect.”

Henry Hyde’s success in this area can be traced to a couple self-evident truths on which he based his opposition to the so-called “pro-choice” agenda. In his 1984 rebuttal to a Mario Cuomo speech at the University of Notre Dame, Hyde condemned …

the rise of militant secular-separationist perspective on the constitutional questions that seek to rule religiously based values “out of order” in the public arena

and specifically targeted “abortion liberty” as …

a profoundly narrow-minded, illiberal position; it constricts rather than expands, the scope of liberty properly understood (emphasis mine)

On behalf of those million human beings he helped save, I would like to thank Henry Hyde for his commitment to protect the most vulnerable in our society. Would that there were more politicians with the same principled conviction.

It's All About You [Serge]

This other post by Doug Groothuis inspired by the choice for Time's person of the year acknowledges some issues when it is all about you:

You matter to us. You do. You are worth it. It's all about You. You can do it. You have done it. You can have it. You have it all. You will do it. We know You. You are special. Everyone will like You; it is guaranteed. You deserve the best. In fact, You are the best. You for You, in You, ever You, world with You, Amen.
We are developing a culture in which our young people more and more are being led to believe that life is all about them. Our personal entertainment options are now increasingly personalized and geared towards, of course, us.

However, some of the most rewarding experience in a person's life occur when it is not about us at all. In fact, parenting could be described as the "anti-you". Most of "you" takes a back seat to the needs of another human being. Yet parenting can be the most rewarding experience in our lifetimes.

Of course, it makes you wonder if many of this generation will look back like the mother in this parody. The biggest rewards of this life are times in which it is not all about me.

Friday, December 29, 2006

No Need for New Year's Resolutions [SK]

In a series of refusals and affirmations, Douglas Groothius says perfectly what needs to be done in 2007:

1. I refuse to waste time on trivia: that means 95% of popular culture. Instead, I will center on study, teaching, preaching, writing, and mentoring.

2. I refuse to accept the anti-intellectualism (and even misology) of American evangelicalism. Instead I will teach, preach, and write in ways that demand concentration; I will write what ignites the intellect; I will preach as deeply as I can and dare you to come with me.

3. I refuse to dumb down anything, anywhere, any time. Instead I will inspire people to rise to the occasion intellectually.

4. I refuse to join those Christians who seldom read or reflect on the Bible. Instead I will read it, reread it, study it, memorize it, and meditate on it. I will try to incorporate it increasingly into my thoughts and words.

5. I refuse to seek no more than "personal peace and affluence" (as Francis Schaeffer put it thirty years ago) for my life. Instead, I will contribute to Kingdom endeavors here and abroad.

6. I refuse to tolerate bad preaching, superficial books, or kitschy Christian culture (Precious Moments, Thomas Kinkaide, etc., ad nauseum). Instead I will seek out the best, praise it, and challenge underachievers to climb higher.

7. I refuse to ever play a video game. Instead, I will look for Kingdom opportunities in the land of the living.

8. I refuse to waste time on small talk. Instead, I will endeavor to make all my words count for eternity.

9. I refuse to speak in cliches or outworn adjectives ("awesome," "cool," etc.). Instead I will try to find the right word for the right thought. Or say nothing.

10. I refuse to pose. Instead, I will live.

11. I refuse to accept the de facto deism of so many evangelicals who do not seek God for supernatural manifestations of Christ's Kingdom (healing, signs and wonders). Instead, I will seek (but never presume upon) God's miraculous, supernatural presence in this dark world.

12. I refuse to confine the Kingdom of God to America. Instead, I will keep an eagle eye for ways I can bless, encourage, and edify Christ-followers around the world.

13. I refuse to consign Christian women to second-class status in the church, the home, or the world. Instead, I will support and encourage gifted women to serve God in accord with their gifts and opportunities.

14. I refuse to preach only to the choir, to limit my ministry to the church, Christian school, parachurch, and so on. Instead, I will in every way possible seek to inject Christian truth creatively into culture through my writing and teaching, to colonize alien lands with truths not normally found there.

15. I refuse to follow any trend simply because it is a trend. Instead, I will seek to discern the hand of God in the world.

None of this can be achieved in my own power: "Yet not I but Christ who lives in me."

Thursday, December 28, 2006

Another Study Shows No Decrease in Pregnancy Rates for Women With Better Access to EC [Serge]

I've been a bit busy with other projects, and Scott's been busy blowin up the blog (just kidding Scott), but I've recently been able to continue to research Plan B emergency contraceptive. This study right here is the fourth one that has been unable to show a decrease in pregnancy rates with a group with increased access to emergency contraception. This is pretty amazing, and yet I don't believe anyone has reported on it. Here is an excerpt from the abstract:

OBJECTIVE: To assess how a strategy to maximize access to emergency contraceptive pills would affect rates of pregnancy and sexually transmitted infections. METHODS: Sexually active women, 14-24 years old, were randomly assigned to two methods of access to emergency contraceptive pills: increased access (two packages of pills dispensed in advance with unlimited resupply at no charge) or standard access (pills dispensed when needed at usual charges). Participants were followed for 1 year to assess incidence of pregnancy, gonorrhea, chlamydia, and trichomonas. RESULTS: The numbers of women enrolled in the increased and standard access groups were 746 and 744, respectively. More than 93% of participants completed a full year of follow-up. The incidence of pregnancy was similar in both groups (increased access group: 9.9/100 woman years, 95% confidence interval [CI] 7.7-12.6; standard access group: 10.5/100 woman years, 95% CI 8.2-13.2). Aggregate rates of gonorrhea, chlamydia, and trichomonas were also similar in the two groups (increased access group: 6.9/100 woman years, 95% CI 5.1-9.1; standard access group: 7.6/100 woman years, 95% CI 5.7-9.9). The increased access group used emergency contraceptive pills substantially more often and sooner after coitus than the standard access group. No other differences were noted between groups in self-reported measures of sexual behavior and contraceptive use. CONCLUSION: This intensive strategy to enhance access to emergency contraceptive pills substantially increased use of the method and had no adverse impact on risk of sexually transmitted infections. However, it did not show benefit in decreasing pregnancy rates.
In other words, having greater access to EC allowed women to use it more often than standard access, yet there was no statistically significant decrease in pregnancy rates within the two groups.

Friday, December 22, 2006

I Wish Rick Warren Had Said This [SK]

...on Wolf Blitzer's show.

(NOTE: Because the LTI Blog was accidently deleted on December 22, we are reposting recent entries. While the text from some of those entries was recovered, the original links to the posts are lost, along with all reader comments. We apologize for this error and hope you will comment on those posts we are able to restore.)

The dialogue below is a reconstruction by me.

BLITZER: What did you think of Barack Obama?

WARREN: He's an amazing man in many ways and I'm glad to work with him fighting AIDS.

BLITZER: Do you think he’s got it? In other words, he’s got that potential like so many other presidential prospects, to be the president of the United States?

WARREN: It depends what you mean by "got it," Wolf. Does he have charisma and the incredible ability to connect with people? Absolutely. He's definitely got that. But charisma alone does not qualify him for the presidency. You must also weigh how Senator Obama will use that gift of communication, for good or for evil? Ronald Reagan and Abraham Lincoln were both incredible communicators and they used their gifts to promote justice for the weakest and most vulnerable members of the human family. Lincoln spoke on behalf of slaves and Reagan for the innocent unborn. Both awakened people to important first principles found in the Declaration of Independence, namely, that humans have certain rights by nature that no government can legitimately take away. The right to liberty and the right to life are two of those basic rights. And though I consider Senator Obama a friend and value our relationship, he's yet to recognize that all human beings have a right to life. That's why, I believe, he's mistakenly voted to allow partial-birth abortion and destructive embryo research. That's regrettable, because in the past we used to discriminate on the basis of skin color and gender, as Senator Obama knows firsthand. Now, however, with elective abortion and embryonic stem-cell research, we discriminate on the basis of size, level of development, location, and dependency. We've simply swapped one form of discrimination for another. I'm hopeful Senator Obama will come to see that.

BLITZER: But what if he doesn't agree with you on abortion or embryonic stem cell research? Those are very divisive issues. Won't that hurt your friendship?

WARREN: As a Christian, I should tolerate people and treat them with respect even when I think their ideas mistaken. I don't have to pretend that all positions on a controversial issue are equally valid to model love and friendship. But at the same time, I cannot remain silent when a friend--especially one in leadership--holds positions fundamentally at odds with a Christian worldview. And taking human life without justification is not consistent with that worldview. So, yes, I must speak out on that.

BLITZER: Even if it offends your friend?

WARREN: Wolf, the very idea of tolerating people presupposes you think they are wrong on some matters moral and intellectual. Otherwise, I'm not tolerating people--I'm agreeing with them! Here’s the key point: Just because I disagree with Senator Obama's support for elective abortion does not mean I can't respect him as a friend and work with him on cures for AIDS. In fact, the same principle that drives me to work with him on AIDS compels me to oppose him on abortion--namely, that all human life should be respected and cared for. What's so hard about that?

BlITZER: Do you think Senator Obama has good character?

WARREN: Yes, and that's why I ultimately hope he'll reconsider his position on the right to life. Look, he's got a whole lot right already. He understands that discrimination is wrong. He knows that skin color and gender are lousy reasons for denying justice to vulnerable human beings. He's got a heart of compassion for the weak. I just wish he’d apply that same heart of compassion to the unborn members of the human family.

BLITZER: Ultimately, this is a partisan issue, isn’t it? Surely you know that most Republicans favor restrictions on abortion while most Democrats want it to remain legal. At the end of the day, aren’t you asking him to behave like a Republican?

WARREN: No, I’m asking him to be a better Democrat. Sadly, my friend Senator Obama believes human beings that are in the wrong location or have the wrong level of development do not deserve the protection of law. This view is elitist and exclusive. It violates the principle that once made the Democratic Party great: its basic commitment to protect the weakest and most vulnerable members of the human family. I want him to return to that principle and uphold justice for all human beings. He doesn’t have to change parties to do that.

Note: Thanks to Greg Koukl for wording on the tolerance section above.

Accidental Delete [SK]

Folks, bear with us. We'll recover as many of the previous posts as we can.

Wednesday, December 20, 2006

Is the Pro-Life View Connected to Racism? [Serge]

Quite a charge leveled by Pejar in the comments here and his accompanying post here. Here's his summary, followed by the fisking it deserves:

Both the white supremacist and pro-life view require that a genetic fact (respectively being white and being human) is crucial for deciding who should be protected. On the other hand both the anti-racist and pro-choice positions say that genetic facts are irrelevant and that what is important is the characteristics of beings as beings, ie that they have some kind of consciousness to violate. This does not include very early zygotes.

To argue otherwise asserts that the mere genetic fact of humanity is determinative, and this is exactly what white supremacists argued (and argue) about the genetic fact of being white.
First, Pejar asserts that pro-lifers require a "genetic" fact to decide who should be protected. I believe he is repeating the oft-repeated straw man that we believe human value is based on an entity that possesses human DNA. This is simply wrong. In fact, I just removed 4 wisdom teeth that had the "genetic fact" of human DNA. One can argue that the human DNA in those wisdom teeth is more "human" than a child with Down syndrome, which has an extra chromosome. However, pro-lifers do not value the tooth more than the child. It is not the "genetic fact" of humanity that matters, but the biologic certainty that comes with a living organism of the species homo sapiens that gives us value.

Second, Pejar asserts that white supremacists also depend on the "genetic fact" of race for their discrimination. This is simply wrong. White supremacists base their discrimination on physical appearance, not on genetic content. Just like those who look at an early human embryo and claim that it isn't human because it does not "look like us", they practice their foul discrimination based on appearance.

Third, from his post on the topic, look at the things that Pejar believe are more better determinants of human worth than membership in our species:
People recognised that protection was needed because of the ability to suffer and feel pain or to grow and flourish. This is common to all colours and unifies our conception of those worthy of moral consideration.
Maybe they didn't mention this at Oxford Law School, but aren't the characteristics of being able to feel pain also genetically determined? There is DNA that codes for the whole complex in our nervous system which allows us to experience and feel pain, and the development of each and every one is controlled by human DNA. By his own criteria, the characteristics he asserts are important are just as genetically determined as skin color. They are just as much a "genetic fact", using his vocabulary.

Fourth, I know a bit about this because right now there are 6 human beings walking around not feeling pain from surgery because I have temporarily changed their ability to feel pain by the use of local anesthetic. By Pejar's criterion, I have somehow changed their human worth and deservedness for protection as a result. Furthermore, I have earlier today effected their humanness even more by rendering them unconscious during the surgery. This makes no sense, but is inevitable using his criteria for human value.

Lastly, the pro-abortion choice view uses arbitrary criteria to decide which human beings live and which die. The truth of the matter is that the brain of a newborn is far more similar to the brain of a third trimester fetus than an adult. It is more similar in appearance, size, and function. Yet Pejar asserts that it is OK to kill the fetus but (I assume) not OK to kill the newborn. This is discriminatory.

The pro-life view is open to all. All human beings, as beings, are worthy of protection and should not be killed because they do not fit into an arbitrary criterion that gives then value. That is the true liberal, non-discriminatory position.

Tuesday, December 19, 2006

Warren on Obama Again [Serge]

I'm not sure that this changes anything, but is anyone else uncomfortable with the coziness that Warren is displaying to one who advocates for the intentional death of pre-natal humans?

BLITZER: What did you think of Barack Obama?

WARREN: He’s an amazing man. I think…

BLITZER: Do you think he’s got it? In other words, he’s got that potential like so many other presidential prospects, to be the president of the United States?

WARREN: I think he does.

BLITZER: Because?

WARREN: I think he has good character. I think both Sam Brownback and Barack Obama — the reason I invited them both, first, they’ll tell you the truth. They’re not just going to beat around the bush. They’ll tell you what they believe. And I appreciate that.

Second, they’re men of civility. And I’m so tired of the rudeness we’ve got in our society where people are just mean to each other. We need to return to civility, which says, I treat you with respect even if I violently disagree with you. That we’ve lost the “civil” in civilization.

Friday, December 15, 2006

The False Dilemma Fallacy [Serge] practiced by pro-lifers:

The debate over incremental anti-abortion laws, versus working toward the goal of stopping abortion altogether, is a necessary crisis of conscience for pro-lifers. Its resolution will determine the future of abortion in America.
Not only is this a logical fallacy, it is a particularly sloppy and mean-spirited one. It should be clear that every one who is pro-life is attempting to stop abortion altogether. This issue in not one of goals, but of tactics. The question is: what is the quickest and most effective way to end the evil of abortion?

If the "future of abortion in America" is best addressed by making laws that make abortion illegal without exception as the only acceptable tactic, I believe abortion will continue to be common for a very, very long time. That tactic did not work out very well 2 months ago in one of the most pro-life states (see S. Dakota), so can someone offer an argument that it would work throughout the rest of the country?

In the meantime, claiming that your tactic is the only one that works towards the goal of stopping abortion altogether is simply wrong and an utter misrepresentation or lack of the ability to understand an argument. Our opponents must be loving this.

Thursday, December 14, 2006

Unprotected [Serge]

Danielle Crittenden hits the nail on the head in her description of the inability of the medical field to address problems young students face today. Read the whole thing, but this will give you a flavor:

Heather is not an unrepresentative case. The author meets patients who cannot sleep, who mutilate themselves, who exhibit every symptom of psychic distress. Often they don't even know why they feel the way they do. As these girls see it, they are acting like sensible, responsible adults: They practice "safe sex" and limit their partners to a mere two or three per year.

They are following the best advice that modern psychology can offer. They are enjoying their sexual freedom, experimenting, discovering themselves. They can't understand what might be wrong. And yet something is wrong. As the author observes, surveys have found that "sexually active teenage girls were more than three times as likely to be depressed, and nearly three times as likely to have had a suicide attempt, than girls who were not sexually active."

And should all this joyous experimentation end in externally verifiable effects--should girls find themselves afflicted with a disease or an unwanted pregnancy--then (and only then) do their campus "women's health" departments go to work for them. They will book the abortion, hand out a condom or prescribe a course of antibiotic treatment. And then they will pat their young patients on the shoulder and send them back into the world, without an admonishing word about the conduct that got them into trouble in the first place.

The Pistons Need Me [Serge]

Who can hold Duane Wade in check? I can. Despite Scott actually witnessing my slow-motion defensive skills at Biola a few years ago on the court, the stuff that I do held Wade scoreless for 2 games this week.

Wednesday, December 13, 2006

RE: Warren, Obama - Some Concerns [Serge]

I actually agree with virtually everything Scott said here, and I also must admit that many of the criticisms of Warren have been off base. However, I do have two concerns about Warren's decision to allow Obama use of his pulpit.

First, although I agree that you should not have to pass a religious litmus test to join in the fight against injustice, from what I understand Obama did use his opportunity to speak of his faith and convictions. His inclusion and discussion of his faith makes it appear that his pro-abortion choice advocacy, including having his wife sending out a fund raising letter in favor of partial birth abortion, is simply a in-house discussion amongst brothers. In other words, allowing Obama to speak of his faith in that context masks the clear differences in worldviews. If he wishes to limit the discussion on HIV, I would have no concerns.

Second, it seems the main reason Obama was there was to appeal to evangelicals and soften his clear opposition to many things that are Biblically sound. Here is a sample of a Time article describing what Obama accomplished: The invitation works perfectly for Obama. Through his autobiography The Audacity of Hope and his public statements, the Senator had already positioned himself as one of the rare potential Democratic Presidential candidates who can truly talk the Christian talk. Today's speech can only reinforce that impression. Says Collin Hansen, an associate editor at the Evangelical monthly Christianity Today, " I think the Senator's political team, or whoever's making the decision, was smart to associate him with Warren. It suggests that there are Evangelical moderates that they can work with, or reach, or maybe even attract their votes." We should not be interested in helping a politician who will advance the cause of evil if he reaches his goal of the presidency to fool us by "talking our language". If this places Obama one step closer to the White House, I believe it may not be a such a noble idea.

In short, we need to accept the help of others who differ from us theologically and in some ways ideologically if they wish to fight for justice. Nat Hentoff would be welcome to speak about abortion in my church anytime he would like to. However, we need to be careful that we are not, even unsuspectingly, providing one who clearly promotes evil an avenue to do so.

Update: Case in point. This story from the Chicago Tribune. In the approximately 25 paragraphs exactly one discusses the AIDS epidemic. The rest of the story speaks of Obama's attempt to court evangelicals.

Friday, December 8, 2006

Dead Solid Perfect in the National Post [Serge]

The National Post, who doesn't seem particularly pro-life, seems to understand this debate better than any mainstream press that I have encountered. Read the whole thing, but here is a good excerpt:

Pro-Choice, Pro-Censorship

Student governments and student activists (often indistinguishable) do not usually deserve the scrutiny of the national press, on the sensible grounds that imprudent decisions made by novice politicians in the hothouse campus environment are best left ignored. Moreover, as is well known, student governments are usually comprised of a rather small and often radical segment of the student body, the majority of which never bother to vote in campus elections, and pay no attention to what their alleged representatives are doing. Don't blame Carleton students for their government.

That said, CUSA's action is Orwellian, mean-spirited and more than a little weird.

CUSA's policy is aimed at what it calls the "anti-choice" agenda. Their anti-anti-choice solution is to do what they can to penalize students who argue for a different choice. The new policy at least clarifies that CUSA is not "pro-choice" at all, but flat-out pro-abortion. In CUSA's conception, choice means denying students the choice of forming clubs to reflect their interests. It is straight out of Orwell's 1984.

At Queen's University, for instance, the campus pro-life club was re-established recently after many years of inactivity. The issue arose at Carleton when a new club -- Carleton Lifeline -- held a debate on campus and increased its profile. Anecdotally, it appears that pro-life students are more confident of taking part in campus life today.

That makes CUSA's decision, frankly, mean-spirited. To the extent that pro-life students want to organize themselves, it is mark of civic engagement, a willingness to question campus orthodoxies, and of no little courage, given the hostile environment on campus. A vibrant campus should welcome such students. To set them aside for special, punitive treatment fails even the basic test of courtesy, to say nothing of fairness.

Moreover, the CUSA policy is oddly pointless. If the campus is as enthusiastically pro-abortion as CUSA claims, what added advantage is to be gained from this policy, at a serious cost in terms of the university's reputation as a place of debate and free speech?

Wednesday, November 29, 2006

Is the Pro-life View Comparable to Racism? [Serge]

CUSA president Shawn Menard is the gift that keeps on giving. Here he is on radio station 580 CFRA being interviewed about CUCA's attempt to restrict access to pro-life groups. During the interview, he claims to support free debate about abortion on campus, except for groups whose goal is to recriminalize abortion. I guess he thinks its OK to not support the pro-abortion choice view, as long as you act as if you do. Or something.

However, that is not the most outrageous thing that he said. In the last two minutes, the host asked him about the difference between supporting a cause (like same sex marriage) and not providing access or resources for any group who disagrees with that cause. I can't adequately describe Menard's response, but it is pretty self-explanatory on the recording. He's not helping his cause by making himself more accessible.

Related: "Pro-Choice" University: No Free Thinkers Allowed [SK]
More on Carleton University [Serge]
CBC PIcks Up the Carleton University Story [Serge]
You Are Free to Choose Any Speech That Agrees With Us [Serge]

Thursday, September 7, 2006

Plan B EC: Others Question its Effectiveness [Serge]

Here is a very recent letter to the editor in the Journal Pediatrics that poses some of the same questions that I have regarding the efficacy of emergency contraception (Pediatrics 117:4 April 2006, p1448).

To the Editor.-

The American Academy of Pediatrics Committee on Adolescence policy statement on emergency contraception1 reports the effectiveness of the Yuzpe regimen (ethinyl estradiol and levonorgestrel) in terms of a pregnancy reduction of 70% to 80% and of levonorgestrel-only emergency contraception of 85%. These estimates are outdated. Using current methods for estimating effectiveness, the effectiveness rates seem to be in the range of 50% to 66% and 72% to 80%, respectively.2-5 Because there are no randomized trials with a placebo arm, considerable uncertainty remains about the effectiveness of emergency contraception.3,5

The policy statement also proposes that "[e]mergency contraception has tremendous potential to reduce unintended pregnancy rates in teens and adults." This statement remains, as yet, a hypothesis that is unsupported by empirical evidence. Several studies have failed to document a decrease in rates of unintended pregnancy or abortion in populations that are provided with advance access to emergency contraception.6-8 This suggests that the studies that have demonstrated no changes in sexual behavior with advance access (other than increased use of emergency contraception) have used inadequate surrogate end points or have failed to detect small changes in sexual behavior that were nevertheless sufficient to negate any decrease in unintended pregnancy.

Joseph B. Stanford, MD, MSPH

Department of Family and Preventive Medicine

University of Utah

Salt Lake City, UT 84108

Rafael T. Mikolajczyk, MD

Department of Public Health Medicine

School of Public Health

University of Bielefeld

D-33501 Bielefeld, Germany

Wednesday, September 6, 2006

Plan B: Is the FDA Using Outdated, Inaccurate Information? [Serge]

An e-mailer recently asked about the fact that the FDA does list prevention of implantation as a potential mechanism of action of Plan B. You can see that in the FDA Q&A here as well as the package insert here. Does the FDA know something that we don't?

The FDA relies on information provided by the manufacturer for the mechanism of action of any medication (they do not do their own research). I responded to the information provided by the manufacturer in this post here. In short, the manufacturer has a responsibility to list any possible mechanisms of action for any medications. Since there is an open question in the literature regarding the mechanism of Plan B, and since post-fertilization events are listed as one possible mechanism, it is not surprising (nor particularly helpful) that interruption of implantation is included as a possible mechanism of action.

In other words, the fact that the manufacturer mentions this as a possible mechanism is evidence that the question is an open one that we have no definitive answers to. Therefore, the presence of this information by the FDA does not trump the most recent literature on the topic. In fact, the opposite is true.

I can illustrate this in another way that does not directly address the mechanism of action of Plan B. The manufacturer makes this claim in its literature, and its repeated on the packaging of Plan B that the FDA agreed to:

A double-blind, controlled clinical trial in 1,955 evaluable women compared the efficacy and safety of Plan B (one 0.75 mg tablet of levonorgestrel taken within 72 hours of intercourse, and one tablet taken 12 hours later) to the Yuzpe regimen (two tablets of 0.25 mg levonorgestrel and 0.05 mg ethinyl estradiol, taken within 72 hours of intercourse, and two tablets taken 12 hours later). Plan B was at least as effective as the Yuzpe regimen in preventing pregnancy. After a single act of intercourse, the expected pregnancy rate of 8% (with no contraception) was reduced to approximately 1% with Plan B. Thus, Plan B reduced the expected number of pregnancies by 89%.

The exact citation isn't listed, but clearly they were citing this study from 1998 (both studies had 1955 women enrolled), Lancet 1998 Aug 8;352(9126):428-33. This is the same study that I posted about here. They used a crude method of determining ovulation: they added 14 days to the last period. The primary author for this paper was H Von Hertzen.

In other words, the FDA is allowing data 8 years old that used a very inaccurate way of determining ovulation, which is essential in determining effectiveness in stopping pregnancy. In fact, the author of that study has more recently contributed to an article which acknowledges the inaccuracy of their data in estimating the expected rate of pregnancy(Contraception 2003 Apr;67(4):259-65.)

This article, in which Von Hertzen is an author, states in the abstract:

The expected pregnancy rate among typical users was 6.2% in the Population Council trial and 7.4% in the WHO trial based on conception probabilities by cycle day relative to the day of ovulation. Based on conception probabilities by cycle day relative to the first day of bleeding, the expected pregnancy rates dropped to 5.4% and 5.2%, respectively. The two trials yield conflicting evidence regarding whether effectiveness declines with treatment delay. CONCLUSIONS: Our results suggest that the absolute levels of effectiveness for the Yuzpe regimen of emergency contraception and the cost-effectiveness of this regimen have probably been overstated when based on conception probabilities by cycle day relative to day of ovulation.

Although the authors only mention the Yuzpe regimen the same pregnancy estimation was also used to determine the efficacy of Plan B. If the effectiveness of the Yuzpe regimen had been overstated, then the same can be inferred with Plan B. It should also be noted that even with the "more accurate" method of determining ovulation, there is a significant chance for error in determining the actual date of ovulation.

I hope I haven't lost anyone. Here's the bottom line: the FDA is allowing the manufacturer of Plan B to claim that it can be almost 90% effective based on a study from 1998. This study has been shown to be inaccurate due to its crude way of estimating ovulation. This fact was pointed out by none other than the author of the original study. Yet there it is on the packaging being readied for OTC sale.

Still confident in the FDA information now? There is significant reason why we should not be. In any event, it should be clear that the information given by the FTC does not refute more recent scientific studies.

Tuesday, September 5, 2006

Plan B EC: What is its Real Effectiveness? [Serge]

Sixth in a series.

I wish to challenge the most compelling line of evidence that Plan B works at least some if the time via a post-fertilization mechanism. In this post, I believe those who are very pro-emergency contraception will be quite disappointed.

The most common evidence used to support a post-fertilization effect of Plan B is its proposed effectiveness. Quoting from this post:

1. The reported effectiveness of EC cannot be fully explained by a suppression of ovulation. In other words, if EC worked through non-fertilization events, we would not expect it to be as effective as it appears to be. Therefore there must be some post-fertilization event that is responsible for at least part of its effectiveness.

The effectiveness of Plan B is reported to be somewhere between 90 and 75% in stopping an unintended pregnancy. If this is true, it seems impossible that it could work via a purely anti-ovulatory action. As Steve states here, the most important question to ask would be when did a woman ovulate. If Plan B is taken after a woman ovulates, and it contributes to the 75% effectiveness, then it must work at least part of the time via a post-fertilization event.

If, on the other hand, Plan B works through predominantly anti-ovulatory actions, its effectiveness would be expected to be less than 75%. What does the data support? If one looks at some of the more recent studies, it is reasonable to conclude that the effectiveness of EC is significantly less than 75%.

First, it is a known fact that studying the effectiveness of EC is quite challenging. The main reason is that in order to have a comparison group, an accurate determination of the date of ovulation is essential. An ideal study would use a placebo control group - but that would entail giving a woman who is seeking to prevent a pregnancy a placebo, which is considered unethical. For that reason, estimates of ovulation are used. It has been shown that these estimations are often very inaccurate, as shown by this article: (Contraception 2003 Apr;67(4):259-65)

Calculations of the efficacy of EC depend on knowing the timing of intercourse in relation to the estimated day of ovulation. The results of this study suggest that these calculations are likely to be inaccurate for a significant minority of women.

Is there evidence that EC may not be effective as advertised? Absolutely. I will cite two very recent studies. In this article about EC in JAMA (JAMA 2005;293:54-62), the authors specifically choose a number of women that would have direct access to EC vs pharmacy access in order to show a difference in pregnancy rate between the two groups (they choose about 890 women in each group). They say so in the article, and this was not a small study. As it was, the group who had to go to the pharmacy to get EC used it 197 times, while the group who had direct access used it 309 times. The result on pregnancy: absolutely nothing! The pregnancy rate for the first group was identical despite the fact that they used EC one third more often. This caused the authors of the study to state:

While we set out to demonstrate a large reduction in pregnancy rates, even a10% or 20% reduction in unintended pregnancy rates would be a significant and desirable public health achievement.

What ever happened to 75%? They set out to demonstrate a large reduction in pregnancies, and got zero despite the fact that so many more women took EC. Now they would be happy to see a 10-20% reduction. This is solid evidence that in the "real world", EC doesn't work nearly as often as stated.

Here's one more (Contraception 69 (2004) 361-366). These researchers showed that having EC at home did not reduce pregnancy or abortion rates in that population. Lest anyone think that my reasoning is novel here, the authors seem to agree with me:

Finally, it is possible that EC may be less effective than we belief. Estimates of efficacy are unsubstantiated by randomized trials. Efficacy is based on rather unreliable data and a great many assumptions [28] and have been questioned both in the past [29] and more recently [30].

In conclusion, I believe there is an increasing amount of evidence that the proposed efficacy of EC is not nearly what was originally thought. There is no doubt in my mind that those who support increased access of EC as a public policy issue are not in any hurry to publicize this data. On the other hand, the decreased efficacy of EC is also key evidence that Plan B works predominately prior to ovulation.

Friday, September 1, 2006

Plan B EC: No Morphological Changes Found in Endometrium [Serge]

Fifth in a series.

In this post, I spoke of three evidences that have been presented to support a post-fertilization mechanism of action from Plan B EC. I promised to challenge each one, and this was #2:

2. Since EC has the same types of hormones found in regular oral contraceptives, and there is evidence that regular OCs can have a post-fertilization event, then it stands to reason that EC would also have a post-fertilization mechanism of action.

I believe this point is the easiest one to refute, and my research in this area has turned up some surprises.

First, this point implies that there is a known post-fertilization effect from regular OCs. There is no consensus on that issue, and there is no direct evidence that OCs cause a "hostile endometrium." However, even if you believe that regular OCs do cause abortions, that does not indicate that Plan B EC does work via a post-fertilization event. This was a surprising aspect of this research: if Plan B acts after fertilization, the evidence states argues that it must do so by a mechanism that is different than regular OCs. I will show why.

Most who believe that regular OCs can act as an abortifacient use what I call the "hostile endometrium" theory". The theory is that continued use of OCs create a thinner, less vascular endometrium that would be less likely to accept an embryo attempting to implant. Randy Alcorn, who has written extensively on this topic, explains it this way:

When the Pill thins the endometrium, it seems self-evident a zygote attempting to implant has a smaller likelihood of survival. A woman taking the Pill puts any conceived child at greater risk of being aborted than if the Pill were not being taken...

First, after a woman stops taking the Pill, it usually takes several cycles for her menstrual flow to increase to the volume of women who are not on the Pill. This suggests to most objective researchers that the endometrium is slow to recover from its Pill-induced thinning

Now if the effect of regular OCs take months to for a woman's body to "undo", then how does Plan B EC create a hostile environment in a matter of hours? It seems that if EC works via a post-fertilization event, it must use some different mechanism than regular OCs, which appears to be based on a chronic thinning of the endometrium.

However, I did not have to depend on the argument of the last paragraph. There is actually experimental evidence that shows that Plan B taken after ovulation does not have any significant change in the morphology of the endometrium. Take a look at the abstract here and the full article here that presents this evidence. (Contraception. 2001 Oct;64(4):227-34.) They performed endometrial biopsies on women who took Plan B EC and control groups and found no difference in the morphology between the two. The paper states:

No significant changes were observed between treated and control specimens in any of the studied parameters. No significant differences among groups were observed. Of particular importance was the finding that the predecidual changes as evaluated by the presence of prominent spiral arteries, which are considered crucial for implantation [24], were not altered by LNG.

Remember, the proposed mechanism of regular OCs is to create a significantly thinner endometrium. This does not occur when a woman takes Plan B.

Although the medications are the same, if Plan B acts to cause abortions, it seems to have to do so via a different mechanism than does regular OCs. Instead of being evidence for a post-fertilization mechanism of action, this actually gives support to the theory that Plan B does not act after ovulation.