My historical detective work on #Emergency Contraception coverage in New York Times

Over the past two weeks there has been a robust discussion on the International Consortium for Emergency Contraception listserv about reporting in the New York Times discussing recent findings on how emergency contraception works.  According to this article, “an examination by The New York Times has found that the federally approved labels and medical Web sites do not reflect what the science shows. Studies have not established that emergency contraceptive pills prevent fertilized eggs from implanting in the womb, leading scientists say. Rather, the pills delay ovulation, the release of eggs from ovaries that occurs before eggs are fertilized, and some pills also thicken cervical mucus so sperm have trouble swimming.

It turns out that the politically charged debate over morning-after pills and abortion, a divisive issue in this election year, is probably rooted in outdated or incorrect scientific guesses about how the pills work. Because they block creation of fertilized eggs, they would not meet abortion opponents’ definition of abortion-inducing drugs. In contrast, RU-486, a medication prescribed for terminating pregnancies, destroys implanted embryos.

The notion that morning-after pills prevent eggs from implanting stems from the Food and Drug Administration’s decision during the drug-approval process to mention that possibility on the label — despite lack of scientific proof, scientists say, and objections by the manufacturer of Plan B, the pill on the market the longest.”

I’ll let scientists comment on the emerging scientific consensus on this and comment on what this says about historical research. While researching my book, I’ve spent countless hours reading and re-reading FDA transcripts and I have no recollection of any such objections from the manufacturer of Plan B, which at that time was Women’s Capital Corporation.  Shortly after this article appeared,  Newsweek Senior Editor Sarah Blustain contacted me to find out more about the FDA’s decision. She asked whether this was a political compromise imposed on the manufacturers of Plan B by FDA.  I told her that I didn’t recall any of this so went back and looked at the transcripts available on the FDA website.  I couldn’t find anything in the original New Drug Application for Plan B filed by Women’s Capital Corporation.  After some further digging, I found the relevant discussion in a transcript from a joint meeting of the FDA Non-prescription Drug Advisory Committee (NDAC) and the Advisory Committee for Reproductive Health Drugs (ACRHD) held on December 16, 2003. However, I didn’t find any objections from scientists who presented on behalf of the manufacturer of Plan B.  The relevant section starts on page 288 of the PDF version.  First, Dr. Joseph Stanford, a member of the ACHRD asks:

“I understand, again, that the data that we have on mechanism of action for Plan B is imperfect, incomplete, but I think it’s a
critical issue for those women who want to understand how it works and have informed consent for use. So along those lines I have a question from Appendix 6 from the sponsor’s book. They list all of the answers to Question 7 about — after they
showed the women the package, they said, “Without looking at the label, tell me what Plan B is used for,” and then classified answers as either correct and acceptable or correct but not acceptable or not correct and not acceptable, and they list them
verbatim. And among the ones that are listed as correct and acceptable are a number of women who said that — one of them is, for example, an abortion type  thing for the day after. One was them was to kill a fertilized egg, and basically showing that some women had that understanding, and it was classified by the company as a correct and acceptable understanding of
what the product is for. And so I’m just wondering for the FDA did they also classify those particular answers as correct
and acceptable for what the product is for.”

NDAC chairman Louis Cantilena  then called Karen Lechter from FDA Dr. Leonard Segal answered, “Dr. Lechter unfortunately had to leave, and I don’t know that I can actually specifically address how she did hercalculation in her review on that particular issue. My assumption is though that she probably followed the sponsor’s categorization.” Chairman Cantilena answers, “There were a few tables that she showed in her presentation where she had asterisks where there was, you know, a difference between her, you know, assessment and the sponsors. But I don’t recall if that specific issue was asterisked or not.”

Dr. Valerie Montgomery Rice from ACRHD says, “I think that one of the things that Dr. Stanford is getting to — and you can tell me if I’m wrong — is a matter of informed consent such that the patient is as fully informed as possible based on all of the information that we know about how this product works.

So I guess I would ask the sponsor first.  When you’ve done surveys, if you have — and you may not have this information — in women who have taken emergency contraception and then you’ve asked them the question of how they  perceive, first of all, the medication worked, besides one of these studies because during that time, I think when you are dealing with that immediate issue of needing emergency contraception or even within the first couple of weeks while you’re waiting for that cycle to come, your perception of how it works may be different than when you sit down and really think about it.  So I think that’s one point.

And then, you know, even with my background, having a lot of experience with infertility and giving a lot progesterone, et cetera, and I’ve reviewed the literature, there is some data out there that really does suggest at very high dosages that there may be the possibility that you’re interfering with the implantation.

And so I guess my comfort level would definitely — I would definitely be a lot more comfortable making sure that the patient or the woman who makes that decision is as informed as possible that there potentially is a possibility that still gives that woman enough information to make an informed decision and not dilute any of her rights in deciding to proceed with this medication.”

Dr. Carole Ben-Maimon, one of the physicians presenting on behalf of Women’s Capital Corporation, answered:

“We are very sensitive to the fact that there are differing views not only of how this could potentially work, but also when pregnancy begins.  And so there are actually statements in the labeling with regard to the implantation issue in order to provide women information so that they understand and that they know that this could potentially prevent implantation.

Again, we believe the data is overwhelming.  We believe the medical definition, which is that pregnancy starts at implantation, is a critical point to keep in mind, but we are sensitive to the issues that others — the opinions of others.”

In other words, not only was there no objection from those representing Women’s Capital Corporation, they actually provided the information about possible effects on implantation that went into the label for Plan B. Now, this doesn’t meant that there weren’t objections from someone either from WCC or elsewhere — but I can’t find this in the official record.

So what’s the point here?  Well, what bugs me about the New York Times coverage is that it grossly oversimplifies the FDA approval process and assumes that anyone who worked for FDA or served on its advisory committees were only there to enforce the political will of the Bush administration.  In fact, the committee members mentioned above are respected members of the reproductive health community who were asking important, nuanced scientific and ethical questions that had nothing to do with the culture wars over reproductive rights.  (Dr. Montgomery Rice, for example, is Dean of Morehouse School of Medicine who has worked extensively on health issues affecting women of color — and we historians of women’s health all know how poorly women of color were and sometimes still are treated by medical researchers — e.g. the field trials for the original contraceptive pills in Puerto Rico and Haiti).  So, naturally informed consent would be a critical concern for her.

I would be interested to find out whom the NYT reporter interviewed for this story. I don’t think anyone is purposely trying to rewrite history but they may have selective memories.


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