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charged debate over morning-after pills and abortion, a divisive issue in this election year, is probably rooted in outdated or incorrect scientific guesses about how the pills work.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.


#EmergencyContraception Past, Present, and Future

Rutgers University Press book exhibit at 2012 American Association for the History of Medicine annual meeting

via RH Reality Check and my book pictured at left. Actually, the title of the RHRC post has the name of a specific emergency contraceptive product and shows a video produced by NARAL ProChoice NY for their Champions of Choice 2012 awards luncheon. The organization, “honored the visionaries behind Plan B. From Sharon Camp, who pioneered this emergency contraceptive product and even founded a pharmaceutical company to bring it to market, to Teva Women’s Health, which not only stands behind the current product but has pushed the FDA to increase access by making it available over-the-counter for all ages.”

This is an excellent video but because it celebrates a particular product it has its limits.  First, it’s not true that no pharmaceutical company was interested in creating an emergency contraceptive for the U.S. market — Roderick Mackenzie created the now defunct company Gynetics specifically for that purpose and got the no longer produced drug Preven approved by FDA first.  Second, the story is framed rather narrowly by the ongoing culture wars over contraception and reproductive rights — e.g. in the repeated use of the phrase “politics trumping science.”  Although important, this framework ignores the ways in which the public shapes what “counts” as scientific knowledge. It also overlooks the specific historical circumstances that lead to the production of new knowledge, especially when this involves a politically controversial health topic such as birth control. Most importantly, this claim treats “the public” as though it were a homogenous entity, ignoring the multiple constituencies who have contributed to reproductive health policy in the United States and the ways in which their positions have changed over time.

Okay, now that I’ve addressed the past and the present (sort of), what about the future?  Well, historians aren’t in that business but I’ll offer some thoughts based on my book’s conclusions. Since the early 1990s, emergency contraception has served as a bridge issue that brought together former adversaries, including feminist health organizations, population and family planning
people, and groups representing women of color who were the main targets of attempts to control the so-called “population crisis” in the United States. In order to bring more radical groups onboard, mainstream population organizations and reproductive health professionals had to overcome much bad faith generated by sexism in the medical profession and the often coercive policies of the population movement during the first half of the twentieth century. A narrow focus on purely technological solutions to
the complex social problem of pregnancy prevention tends to dissolve this fragile alliance. Therefore, as experts and activists develop policies on making new contraceptive options available to all women; it is imperative that the language of rights
and reproductive choice continue to remain at the forefront of these deliberations.

Finally: My report from #SHCY2011

Last month I attended the bi-annual meeting of the Society for the History of Childhood and Youth.  After that, I was fully conferenced out and the thought of writing yet another report was too exhausting to contemplate. So, here at last are some of the highlights — but I’m going to be brief otherwise this will never get done!

My session on Children, School, and Health went well and was well-attended despite being the first panel slot on the first day.  It was also nice to get my paper done and out of the way early.  If you attended and liked (or disliked) what you heard, feel free to comment here.

Later that afternoon, Judith Warner gave the keynote address entitled “The Construction of the Medicated Child” based on her best-selling book, We’ve Got Issues: Children and Parents in the Age of Medication.  As in the book, she deflated the myth that children and adolescents are overdiagnosed and overmedicated for mental health problems.  In reality, many children with mental health issues — especially those who lack health insurance — don’t get good care or worse, get no care at all.  She also reiterated what many scholars in childhood studies have noted about earlier “panics” over issues affecting children (e.g. early motion pictures, television, comic books, and most recently, video games) — that children serve as lighting rods for adult anxieties and social problems that affect the larger culture.

Another important “take-away” came from the discussion following the panel on Childhood in the 1970s.  Lori Rotskoff presented on her work on feminist childrearing in the 1970s and observed that even though feminists were challenging established sexist norms they were still children what was “right” — where is the children’s liberation within women’s liberation, she asked.

I spent most of the conference listening (and knitting) and didn’t take very extensive notes unfortunately.  I also must confess that I skipped the last day so I could attend the Alexander McQueen exhibit at the Metropolitan Museum and see a matinee of “The Normal Heart.” (which was great, but I didn’t like it as much as “Jerusalem” which I saw the night before).

Lesson here — don’t attend so many conferences in so short a span of time!  What was I thinking?

Invigorated and Exhausted from American Association for the History of Medicine meeting

I got back from the annual meeting of the American Association for the History of Medicine meeting yesterday as as usual am bursting with ideas and buried in work.  So, this will be quickie overview with more reflection and analysis at a later date.

First, I’d like to report that my forthcoming book  (cover photo at left) is moving much closer to actually being out.  I received the page proofs about a week ago and am working on getting them back ASAP.  Unfortunately the editor decided not to have them available at the meeting because they aren’t corrected — but there’s always next year.  Hopefully they will be available at the Berkshire Conference of Women Historians next month.

Meanwhile, I got an opportunity to plug my book and establish myself as an authority on the “morning after pill” in an interview for a documentary by Caryn Hunt, President of the Philadelphia chapter of the National Organization for Women.  It was a lot of fun and I wasn’t as nervous as I expected.  Also, I got a new suggestion for a doppelganger. Thanks,  I agree!

My presentation on The Pill at 50: Scientific Commemoration and the Politics of American Memory went very well and I had a substantial audience (at least 30) despite it being on first thing on the last day of the conference.  The reaction was enthusiastic (especially from this leading authority on the history of the Pill) so I’m planning to expand this and submit it to the Bulletin of the History of Medicine.

Since I’m teaching in a public history graduate program, and living in Connecticut, my “commemorative mania” will continue with some kind of commemorative event celebrating the 50th anniversary of Griswold v. Connecticut in 1965 (which follows soon after my own half-century mark).  Not sure what this will be but the folks at Yale and Planned Parenthood are keen so looks like it will happen.  I also told the editor at Rutgers that I’m interested in doing a narrative history (as opposed to a legal history that uses Griswold as a lead-up to Roe v. Wade rather than an event in it’s own right).  As it turns out, a very distinguished senior historian of medicine and public health was one of the witnesses who testified.  It seems that the New Haven police was willing to shut down the clinic so that birth control advocates in the state could use this as a test case, but they needed evidence that the clinic was dispensing birth control.  This historian was a graduate student at Yale and was one of Dr. Buxton’s patients.  She volunteered to get the evidence (a tube of contraceptive jelly) and then went straight to the police department to turn in the incriminating evidence and give a statement.  When she blurted out that contraception was “women’s right”, the Irish cop asked her, “don’t you mean a married woman’s right?” What a story!

I heard lots a great papers and connect with all my history of medicine buddies.  However, work awaits so I’ll have to continue these conference report later (most likely much later since research papers and finals will be landing on my desk shortly).

Back from AHA, report on Task Force on Disability and Paul Longmore Tribute

I’m back from the annual meeting American Historical Association and am going to split my reporting into several parts.  I’ll start with the main reason I attended, which was to represent the Disability History Association at the Open Forum on Disability and Tribute to the work of Paul Longmore on Friday afternoon.  When I first arrived at the session, the room had a bunch of press people taking pictures of the Task force on disability members and frantically moving around equipment.  I thought, wow, this must mean that disability history has arrived.  Awesome!

Wrong:  the press were left over from the previous roundtable on Beverly Gage’s book, The Day Wallstreet Exploded, and the frenzy was to get the sound equipment and cables out of the way so that Michael Rembis could navigate his wheelchair to the table at the front of the room.  Hopefully the pictures the press folks took will appear somewhere along with a report on the Task force, and not just be presented to them as souvenirs!

Seriously, what better way to illustrate Michael’s personal accounts of how degrading, exhausting, and humiliating it is to continually have to ask for accommodations  so that he can do what others take for granted.  For example, Michael couldn’t reach any of the public computers set up in the Hynes convention center because they were on tables too high for him to reach.  I didn’t ask him what he thought about the conference venue — presumable having the various session locations connected by the Prudential center shopping mall was better than trying to navigate the snowy streets of Boston.

The overall results of the Task force’s survey indicate a major disconnect between what chairs/administrators report (i.e. most cases involving disability are resolved satisfactorily), and reports from persons with disabilities, who state that its up to them to make requests and continually badger their HR departments and other powers that be to get those requests honored.  Those who are adjuncts or untenured are reluctant to ask or if they do fear making too many waves by persisting in getting these requests fulfilled.  Michael summed this up by persuasively observing that the notion of “reasonable accommodation” perpetuates the stigmatized, medicalized, individualized model of disability that those of us in disability history have been fighting to eliminate.  Right on!  I’ll wait until the full report comes out before I comment on this further.

Other issues that were discussed included a mentorship program matching graduate students/junior faculty with senior faculty with disabilities; ongoing efforts to get AHA to validate disability history as a legitimate field of study; and how to recruits panels and papers on disability history for the next AHA meeting in 2012.  I made a plug for folks to join DHA (somewhat awkwardly because I didn’t have the forethought to bring promotional materials with me.)

The tribute to the late Paul Longmore was incredibly moving — I will try to get a PDF of the testimonials that were read.  He will be sorely missed.

Speaking of stigma– it disgusts me  how quickly even liberal bloggers are using ableist words like “nutcase” and “whacko” to describe the man who shot Congresswoman Giffords and others at a public event in Arizona yesterday.  [even more moderate terms like “these people” are demoralizing because they peg persons with mental illness as socially deviant “others” ]  According to vaughanbell at Mind Hacks.

I suspect we’re going to hear a great deal more about the issue in the coming weeks, and not all of it positive or well-informed.

This article looks at some of the relevant scientific evidence and some of the misconceptions that invariably arise when such tragic circumstances make headlines.

Shortly after Jared Lee Loughner had been identified as the alleged shooter of Arizona Rep. Gabrielle Giffords, online sleuths turned up pages of rambling text and videos he had created. A wave of amateur diagnoses soon followed, most of which concluded that Loughner was not so much a political extremist as a man suffering from “paranoid schizophrenia.”

For many, the investigation will stop there. No need to explore personal motives, out-of-control grievances or distorted political anger. The mere mention of mental illness is explanation enough. This presumed link between psychiatric disorders and violence has become so entrenched in the public consciousness that the entire weight of the medical evidence is unable to shift it. Severe mental illness, on its own, is not an explanation for violence, but don’t expect to hear that from the media in the coming weeks.”

Here’s a Link to the longer  Slate article ‘Crazy Talk’.

Book is done, off to AHA

Well, the book manuscript is finally done, printed (despite a broken department printer — found one in another department) and sent off to the publisher.  Now I’m gearing up for the annual meeting of the American Historical Association in Boston, which starts tomorrow.  I don’t often attend this meeting  — it’s an inconvenient time of year, I prefer smaller conferences, etc.  — but the chance to meet other digital history folks (aka twitterstorians) had me enthusiastic.  One of them is even more enthusiastic — see this post at the blog Notes from the Field — and I’m looking forward to meeting her and others in person.

I’m also one of the few executive board members of the Disability History Association who can attend the meeting.  So, I’ll be there representing.  If you’re interested in this area, please do come to the Task Force on Disability and  open forum and tribute to the late, great Paul Longmore on Friday afternoon.

As always, I’ll will be knitting during sessions (and in between). Please don’t take offense — it’s better than texting!

If you can’t make the meeting, you can follow some of it on Twitter using #AHA2011.

P.S.  Tenured Radical has a guide to recommended sessions here.  Also see her ongoing series on job interviews.

New Venture for 2011: Knitting Clio to Host a History Carnival

Happy New Year readers!

Over the holidays, I continued to read and post to Twitter (see my stream at right) and discovered that  History Carnival was looking for someone to host an upcoming carnival.  So, I’ll be hosting the History Carnival for February.  Please go to their website to submit nominations.

What is a blog carnival you ask?   Well, it’s not this kind of carnival, and it’s just a coincidence I’m hosting in February (although maybe I’ll work in something about Mardi Gras).  According to if:book, a blog carnival “is an interesting subculture of the web that has been adopted in certain academic, or quasi-academic, circles. A blog carnival is like a roving journal, a rotating showcase of interesting writing from around the blogosphere within a particular discipline. Individual bloggers volunteer to host a carnival on their personal blog, acting as chief editor for that edition. It falls to them to collect noteworthy items, and to sort through suggestions from the community, many of which are direct submissions from authors. On the appointed date (carnivals generally keep to a regular schedule) the carnival gets published and the community is treated to a richly annotated feast of new writing in the field.”

The original carnival was Carnival of the Vanities, started in 2002.  Medieval and early modern historians were a natural for this platform and started Carnivalesque a few years later in 2005, the same year that the History Carnival started.  For an example of a recent History Carnival, check out the January History Carnival at Writing Women’s History.  There’s even a clearinghouse for carnivals here.