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charged debate over morning-after pills and abortion, a divisive issue in this election year, is probably rooted in outdated or incorrect scientific guesses about how the pills work.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

I’m Still here, just been very busy

Hi fans,

Wow, it’s been quite a month.  Shortly after my last post, I did a preview of my new book the Emergency Contraception Jamboree sponsored by International Consortium for Emergency Contraception. The meeting was very informative and fun, not quite a Jamboree though (never got the full story on that — apparently in the early days the group was a lot smaller and more informal.  Plus, given the depressing state of birth control politics in the U.S., I’m sure a party was just the thing to lift people’s spirits).

Then, I came back and got slammed by a (brief) illness, then mid-terms, and then yet another power outage, this time from the “October surprise” snow storm.  (fortunately I was able to stay with my new “gentleman caller” i.e. boyfriend who still had electricity, heat, and hot water).  So, I’ve been struggling to get caught up since.  I’m sure glad a long weekend in just ahead!

 

Two Invitations from Judy Norsigian of Our Bodies Ourselves

Yesterday I got an exciting email from Judy Norsigian, asking me if I’d finished my book on the history of emergency contraception (yes!) and even more thrilling, whether I’d like to guest blog on the history of EC for Our Bodies, Our Blog.  My reply was — you betcha!  (Okay, that’s not exactly what I said but that’s what I meant).  So, here I have an opportunity to plug my work to a larger audience than the dozen or so folks who read Knitting Clio.

The second invitation was to a 40th anniversary celebration of Our Bodies, Ourselves that will be held in Cambridge on October 1st.  Unfortunately I have a prior commitment that day but said I’d spread the word about it.  So, for more information, go here.

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).

Blogging for Emergency Contraception

via Back Up Your Birth Control.  Today is the 10th annual national day of action for Back Up Your Birth Control, a media campaign sponsored by the National Institute for Reproductive Health. I’ve agreed to blog to raise awareness about this.

Because I’m a shameless self-promoter, I’m also going to start with an update on my forthcoming book, The Morning After: A History of Emergency Contraception in the United States.  The page proofs will be arriving in a couple of weeks.  Meanwhile, here’s the blurb that will appear on the publisher’s website, catalog, and the book cover:

“Since 2006, when the “morning-after pill” Plan B was first sold over the counter, sales of emergency contraceptives have soared, becoming an $80 million industry in the United States and throughout the Western world. But emergency contraception is nothing new. It has a long and often contentious history as the subject of clashes not only between medical researchers and religious groups, but also between different factions of feminist health advocates.

The Morning After tells the story of emergency contraception in America from the 1960s to the present day and, more importantly, it tells the story of the women who have used it. Side-stepping simplistic readings of these women as either radical feminist trailblazers or guinea pigs for the pharmaceutical industry, medical historian Heather Munro Prescott offers a portrait of how ordinary women participated in the development and popularization of emergency contraception, bringing a groundbreaking technology into the mainstream with the potential to radically alter reproductive health practices.”

I had to stop somewhere, so the book shortchanges the most recent developments — especially the most recent efforts to use of social media to raise awareness of EC. [BTW, the Back Up Your Birth Control campaign has a Facebook page and you can find related posts on Twitter using #backitup and/or by following @nirhealth).

The use of the Web to promote EC originated in the early 1990s with the emergency contraception website at Princeton. The Back Up Your Birth Control Campaign began amidst the battle to get the FDA to approve Plan B as an over-the-counter drug.  What’s interesting to me as a historian is the use of graphic artist J. Howard Miller’s “We Can Do It” poster, which he created for Westinghouse under the sponsorship of War Production Board (this image should not be confused with the Norman Rockwell painting “Rosie the Riveter” that appeared on the cover of the Saturday Evening Post May 29, 1943, and is still under copyright.  The Rockwell paiting was recently acquired by the Bentonville Museum in Arkansas, founded by Wal-mart heiress Alice Walton and the Walton Family Foundation — oh the irony!).  Personally, I like the Rockwell image better, but do you think the Waltons will allow anyone to use it without paying major $$ — not bloody likely!  “We Can Do It” does not have such copyright restrictions, so various groups use it freely.  (for more on these images and American popular culture, go here).  It’s become a feminist icon of female empowerment, but this article demonstrates that “during World War II the empowering rhetorical appeal of this Westinghouse image was circumscribed by the conditions of its use and by several other posters in its series.”

Returning to EC — the history of the various awareness campaigns over the years is fascinating but was nearly impossible to illustrate in the book because, like many of us, the organizations that created these images didn’t preserve them once they were no longer useful.  Others put them on their websites, then discarded the original files.  Then there’s the problem of finding the copyright holder and getting permission from him/her.  Here’s an image that I couldn’t use because there was no digital file that had a high enough resolution for reproduction — it also nicely sums up my frustrations with the whole process:

image courtesy of Canadian Federation for Sexual Health

So, here’s a recommendation for the Back Up Your Birth Control Campaign — back up your “born digital” materials and preserve your digital heritage!

Trumbull Library presentation on Henrietta Lacks and the Immortal Life of Health Care Inequalities

Earlier this week, I helped lead a discussion of Rebecca Skloot’s book The Immortal Life of Henrietta Lacks as part of the Trumbull public library‘s One Book One Town series.  My co-leader was Laura Stark from the Science and Society/Department of Sociology at Wesleyan University.  Laura was a fact-checker for the book while she was a fellow at the Office of National Institutes of Health History.  Laura focused on points raised in her forthcoming book, Behind Closed Doors: IRBs and the Making of Ethical Research, which will be published in November with The University of Chicago Press.  She looked at how the treatment of human subjects in the United States has evolved since the Second World War and this impacts Institutional Review Boards today.  My emphasis was on standards of care for cervical cancer patients then and now, and how this intersected with prevailing issues of race, gender, and class.   As Skloot observes, Henrietta’s care was typical of teaching hospitals at this time, and Johns Hopkins was one of the few in the region that admitted African American patients (albeit in segregated wards).  During the 1940s and early 1950s, there was no Medicaid and third party private insurance was only beginning to become an employee  benefit.  So, as a “charity patient” Henrietta received state of the art cancer treatment that many at that time could not afford.  The care would have been the same had she been white.  Yet, the prevailing attitude at the time was that since “charity cases” were treated for free, doctors were entitled to use them in research, whether the patients realized it or not. Henrietta’s doctor once wrote, “Hopkins, with its large indigent black population, had no dearth of clinical material.”

Also, epidemiological studies of cervical cancer tended to reinforce cultural prejudices about race and socioeconomic status of the time period. By the early 1950s, researchers noticed that cervical cancer was common in prostitutes and others with multiple sexual partners; rare in Jewish and Muslim women; and practically non-existent in nuns and virgins.  There was considerable debate about whether this was due to an infectious agent or genetics. The notion that different races had propensity to certain diseases was common  — e.g. blacks were characterized as a “notoriously syphilis-soaked race” while Jewish persons were believed to be more prone to respiratory illnesses like TB. So, “race medicine” included the theory that Jewish and Muslim women were more likely to develop cervical cancer because of their “race.”  We now know that male circumcision helps prevent the transmission of sexually transmitted infections, such as the human papilloma viruses that cause many genital cancers. Starting in the 1950s, scientists explored the link between adolescent sexual activity and the development of cervical cancer later in life. Several epidemiological studies published in the 1950s and early 1960s indicated that women who married before age 20 appeared to be at higher risk for cervical cancer. Some speculated that women who had multiple “broken marriages” were especially susceptible. Some cancer researchers hypothesized that some kind of infectious agent transmitted by male partners was a contributing factor, and that the adolescent cervix was especially vulnerable to “epithelial transformation” by exposure to such an agent. Given that a disproportionate number of patients were nonwhite, non-Jewish women of low socioeconomic status, recommended that routine pap smears were especially important for “nonvirgins” from underprivileged groups. These findings also tended to reinforce prevailing stereotypes about the links between disease risk, race, and class – those living in poverty – especially if they were nonwhite – more likely to be “promiscuous.”

At the same time, the introduction of Pap smear led to the notion that “cancer was curable” if caught early — this provided the justification for annual gynecological examinations.  Prior to Medicaid,  a young woman of Henrietta’s social class would not have had access to routine preventive medical care. Thus, the health disparities indicated by cervical cancer studies were used to justify government funded preventive screening for those living in poverty.

Another recent development has been efforts by health activists to make medical research more inclusive.  As Eileen Nechas and Denise Foley show in their book Unequal Treatment reformers fought to make sure that all studies funded by NIH included women, racial minorities, children and adolescents, where appropriate, historically “decisions on what aspect of health to study, on what research protocol to fund” were based “not only on scientific merit . . . but on a judgment of social worth. What is valuable to medicine is who is valuable to society, and that is white men.”  Since the late 1980, health activists fought to make sure that all studies funded by NIH included women, racial minorities, children and adolescents, where appropriate; and made sure that diseases that disproportionately affected these groups got “equal time” and money.

Here are the discussion questions we gave to the audience:

Should people have a right to control what’s done with their tissues once they’re removed from their bodies? And who, if anyone, should profit from those tissues?

Deborah says, “But I always have thought it was strange, if our mother cells done so much for medicine, how come her family can’t afford to see no doctors? Don’t make no sense” (page 9).   Should Lacks family be compensated by those who profited from research on HeLa cells?

How does this story relate to recent history of health care reform, and attempts to expand access to medical advances made possible by research on HeLa and other human tissues?

How can medical professionals recognize that certain diseases affect certain racial/ethnic groups without replicating prejudices of old “race medicine”?