Side Effects May Include

By Emily Miranker, Events & Projects Manager

You’re curled up on your couch watching the latest episode of a favorite show when a commercial break comes along. An actor with amazingly white teeth goes from an unhappy to a happy face suddenly able to go about their regular life without discomfort, all thanks to Some Medication. As the ad spot wraps up, a soothing and fast-talking voice rattles off a litany of side effects: dizziness, loss of appetite, dry mouth, nausea, indigestion, insomnia, and so on.

Side effects wordcloud_FDA

Finding and Learning About Side Effects, FDA.gov.

I grew up used to the recitation of possible side effects and long lists of them stapled to prescriptions from the pharmacy. “Yeah, yeah; might get a headache…” But there is huge importance in a regular headache and a headache that presages something medically serious. Mrs. Anne St. C. of Buffalo, NY was not used to these warnings in the 1960s. Because they didn’t exist.

The inclusion of side effects, also called adverse events by the Food and Drug Administration, was an incredibly important milestone for patients and informed consumer choice. We owe these warning labels to another milestone event in public health; the oral contraceptive, the first of which was Enovid, approved for prevention of pregnancy in the United States in 1960.[1] This was a game changer for American women, and within two years 1.2 million women were taking the pill.[2]

AJOG_v83n3_Feb1-1962_Enovid_watermark

Advertisement for Enovid. American Journal of Obstetrics and Gynecology, Vol. 83 No. 3, February 1, 1962.

One of those women was Anne St. C.

Wife of a professor at a local [Buffalo, NY] university, mother of three and a user of the pill, [she] called her gynecologist and asked, “Is the pill safe? Should I be taking it?” Dr. K. snapped, “Of course, it’s all right for you to take the pill. If it weren’t, I’d never have prescribed it.” Anne did not tell the doctor the real reason why was she calling. In the preceding two weeks she had experienced several attacks of dizziness and double vision. She had also suffered from stiffness in the neck. If she had not been cowed by her doctor’s brusqueness, she might have detailed her symptoms. In that case, the doctor’s reaction might have been quite different. As it was, Anne had a stroke exactly eight days later.[3]

In that Anne survived her stroke, she was lucky. For other women, the side effects were fatal.

Two points about the world in which the oral contraceptives came to market. First, in assessing the safety of the pill, regulators focused on its “ability to prevent pregnancy because pregnancy and delivery were inherently medically risky”[4] and since the pill was effective in that objective, it met the law’s safety requirement. Second, the pill was approved before the dangers of thalidomide‑ discovered to cause birth defects in children whose mothers took it for morning sickness‑ were known and the consequent Kefauver Harris Amendment (“Drug Efficacy Amendment”) of 1962 passed.[5]

When Anne St. C. was taking the pill, doctor-patient relationships existed in the context of the 1938 Federal Food, Drug, and Cosmetic Act. That act required pharmaceutical companies to make information about drug safety available to physicians. When patients got information it was “through the filters of the prescribing physicians and the dispensing pharmacist.”[6] The balance of power rested with the medical practitioner. Come the late 1960s, the burgeoning feminist and consumer rights movements challenged the status quo of the doctor-patient relationship. The balance of power was  questioned and began to shift.

Barbara-Seaman2-300x448_ahrp

Barbara Seaman, Alliance for Human Research Protection.

Journalist Barbara Seaman, exposed the dangers of the pill in her 1969 book The Doctors’ Case Against the Pill. She wrote that “a typical package insert that is supplied with one of the most popular oral contraceptives…lists more than 50 side effects of the pill, including a number that can be fatal…Relatively few women ever see these warnings because they are written for physicians; doctors or pharmacists usually remove them from the pill packages,” advocating that it was the patient’s privilege to decide. A woman was “entitled to know the risks and give her informed consent.”[7]

Seaman’s book brought the issue to the attention of Wisconsin Senator Gaylord Nelson (organizer of the first Earth Day). In January 1970 Nelson instigated Congressional hearings on the safety of the pill and the sufficiency of information about its side effects.[8] Attending the hearings, Seaman and fellow activist Alice Wolfson (both future founders of the National Women’s Health Network) were struck by “the fact that there were no women testifying and that there are no women on panel.”[9] Wolfson’s collective, D.C. Women’s Liberation, organized women to position themselves in the hearings’ audiences and outside the Capitol to voice their twofold concerns; the dangers of the pill and the exclusionary structure of the hearings. The feminist activists’ strategic interruptions at the hearings and protests outside the Capitol captured media attention.

Policeman Approaching Young Feminists

D.C. Women’s Liberation demonstrators at the Nelson Hearings, 1970

Amid the media coverage the feminists brought, FDA Commissioner Dr. Charles Edwards announced on the final day of the hearings “that his agency planned to require a … package insert in every package of birth control pills … written by the FDA in lay language and directed to the patient.”[10] While compromise about the writing and scope of the inserts continued, the activists’ efforts laid the groundwork for the warnings that come with all prescription packages today. And today’s pills contain lower doses of hormones than the first Enovid pill.[11]

We continue this important work in increasing the public health literacy and access at the Academy with our Language Access in Chain Pharmacies project, which supports multilingual medication labels. Being able to understand firsthand how to use and any risks or side effect is immensely empowering for a patient and goes a long way to fostering trust in the healthcare system.

Special thanks to Allison Piazza for research assistance with this post.
References:
[1] Suzanne White Junod. FDA’s Approval of the First Oral Contraceptive, Enovid. Update. 1998, July-August. https://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/ProductRegulation/UCM593499.pdf Accessed July 9, 2018.
[2] Alexandra Nikolchev. A brief history of the birth control pill. Need to Know on PBS. http://www.pbs.org/wnet/need-to-know/health/a-brief-history-of-the-birth-control-pill/480/ Published May 7, 2010. Accessed July 10, 2018.
[3] Barbara Seaman. The Doctors’ Case Against the Pill. New York: Peter H. Wyden, Inc., 1969: 109.
[4] Junod. https://www.fda.gov/downloads/AboutFDA/WhatWeDo/History/ProductRegulation/UCM593499.pdf Accessed July 12, 2018.
[5] Sam Peltzman. An Evaluation of Consumer Protection Legislation: The 1962 Drug Amendments. The Journal of Political Economy, Vol. 81, No. 5. 1973 Sept-Oct.
[6] Elizabeth Siegel Watkins. Expanding Consumer Information: The Origin of the Patient Package Insert. Advancing Consumer Interest, Vol. 10, 1. 1998.
[7] Seaman, 9 & 15.
[8] Nikolchev. A brief history of the birth control pill. http://www.pbs.org/wnet/need-to-know/health/a-brief-history-of-the-birth-control-pill/480/ Accessed July 10, 2018.
[9] National Women’s Health Network. https://nwhn.org/pill-hearings/ Accessed July 12, 2018.
[10] Watkins. Expanding Consumer Information. 1998.
[11] Pamela Verma Liao. Half a century of the oral contraceptive pill. Can Fam Physician, Vol. 58, No. 12. 2012 December. Accessed August 24, 2018.

 

That Sex Book at Downton Abbey

By Anne Garner, Curator, Center for the History of Medicine and Public Health

Mary Crawley hands Anna Bates a book by Marie Stopes in Downton Abbey.

Mary Crawley hands Anna Bates a book by Marie Stopes in Downton Abbey.

When Downton Abbey’s Mary Crawley decides to go away for the week with her beau, she sends her maid, Anna Bates, to the pharmacy equipped with a slim little volume. “I have a copy of Marie Stopes’ book,” she tells Anna. The purpose of the errand is to obtain birth control. The book that Anna shows the pharmacist’s wife is probably Wise Parenthood.1

It is early 1924. Anna’s embarrassment at her errand and the disapproval of the pharmacist’s wife are not inconsistent with the social climate of the time. By the end of World War I, attitudes towards sex and birth control were changing. And yet, the public dialogue about sexual matters was still in many ways as it had been in the previous century. During the Victorian era, notions of female identity were tied up in the absolute categories of wife and mother on the one hand, or prostitute on the other. There was little room for nuance, and public acknowledgement of the sexual lives of a large number of single and married women was completely off the table. A reticence to speak about sexual matters persisted at the family level, where sex was not typically discussed between parents and children, and, in many cases, between husbands and wives. Access to accurate medical information about sexual activity was often restricted to doctors. The effect was poor information and general anxiety on the topic.

Marie Stopes. In Marie Stopes and Birth Control, 1974.

Marie Stopes. In Marie Stopes and Birth Control, 1974.

The publication of Marie Stopes’ Married Love in 1918 marked a deliberate attempt by the author to talk to women directly about the physical aspects of married life. Within these pages, Stopes argued that sex should not only be discussed between partners, but that it should be enjoyed by both men and women equally.

Stopes (1880-1958), a paleobotanist and campaigner for women’s rights, was the author of numerous books on social welfare, many concerning birth control (see Peter Eaton’s valuable checklist for a complete list). Married Love was a kind of self-help book designed to help couples understand each other’s physical and emotional needs. When it was published in March 1918, post-war women embraced the book. The initial 2,000 copy run sold out in the first fortnight. Eaton counts 28 editions, and translations into more than a dozen languages. By 1921, sales had topped 100,000 copies.2 An early ban of the book in America on obscenity charges was overturned in 1931, by the same judge who overturned the ban on James Joyce’s Ulysses (one of our copies contains many clippings saved by an interested reader about the many legal challenges against the book).

An ad for Married Love.

An ad for Married Love, affixed to a small announcement of the publication of “A New American Edition” in 1931, after the court decision.

The title page of Stopes’ Wise Parenthood.

In addition to lawsuits, the publication of Married Love prompted fan letters containing many questions.3 Women wanted more specific instructions on birth control methods. Stopes obliged eight months later, with the publication of Wise Parenthood in November 1918.

Wise Parenthood, a slender volume of 33 pages, describes a number of birth control options, including condoms, withdrawal, and the rhythm method. Her strongest recommendation is for a rubber cervical cap with a quinine pessary. This was smaller than the modern diaphragm, and it fit over the cervix. It was probably this cap that Mary sends Anna to secure for her; in the next episode, she gives “the thing,” as she calls it, to Anna to hide in the cottage she shares with her husband, Mr. Bates.

A reviewer for The Medical Times wrote of Wise Parenthood a month after publication:

“The author ably presents the case for birth control from the scientific point of view. She criticizes several of the more important birth control methods at present employed, and she gives a detailed description of a method which she considers reliable and safe…No medical man or medical woman should fail to secure a copy and read it carefully.”4

By the time of Wise Parenthood’s publication, the use of birth control had some traction with the upper classes. But for the poor, most likely to suffer from lack of access to contraception, it was a different story. Stopes believed that poor families—exhausted, physically spent mothers, hard-working fathers who would now need to work harder, and children—all suffered unnecessarily without access to family planning.

By the early 1920s, Stopes made advocacy of birth control for the working classes her biggest cause.5 In 1921, Stopes opened the first British family-planning clinic in north London. A staff comprised of both male and female nurses and doctors offered free birth control advice. By 1925, the clinic moved to central London, and instituted a mail-order birth control service6 (note to Anna Bates: for future reference, that mail-order service could save an awkward moment or two).

The cover of "Babies and Unrest."

The cover of “Babies and Unrest.”

Stopes founded the Society for Constructive Birth Control in 1921.7 During her lifetime, she published a number of pamphlets advocating birth control use for the poor, including “Babies and Unrest,” for the American Voluntary Parenthood League, founded in 1919 by Mary Dennett. A guide to Dennett’s papers can be found here. Stopes also wrote and edited a newsletter, “Birth Control News,” for many years.

Image from "Babies and Unrest."

Image from “Babies and Unrest.”

Stopes’ legacy was not unproblematic. For much of her life, she was a supporter of the eugenics movement. In her book Radiant Motherhood (1920), Stopes advocates sterilization for those supposedly unfit for parenthood. Despite these challenging views, her birth-control activism translated to real solutions for real families, and radically improved access to contraception for working families everywhere. Her work contributed significantly to a shift towards permissiveness for family planning both in England and America.

One of our two copies of Wise Parenthood has an introduction by the English novelist Arnold Bennett. Stopes herself wrote poetry and novels, many at our library, including the poetry volume Love Songs for Young Lovers. It is worth noting that one of our copies of Wise Parenthood still bears a restricted call number left over from an earlier era (though it is now accessible to the public, bar none).

References

1.Special thanks to Arlene Shaner, reference librarian for historical collections, for her positive identification of Wise Parenthood as that sex book. Not to mention her devotion to Downton Abbey.

2. “Marie Charlotte Carmichael Stopes.” Dictionary of Medical Biography. Westport, Connecticut: Greenwood, 2007. V. 5. pp. 1195-1196.

3. Stopes-Roe, Harry Verdon with Ian Scott. Marie Stopes and Birth Control. London: Priory, 1974. P. 42.

4. As quoted in an advertisement for the 7th edition, revised and enlarged, of Wise Parenthood, in the 9th Edition (London: Putnam, 1920) of Married Love.

5. Stopes-Roe, Harry Verdon with Ian Scott, 1974. P. 43.

6. Stopes-Roe, Harry Verdon with Ian Scott, 1974. P. 43.

7. “Marie Charlotte Carmichael Stopes.” Dictionary of Medical Biography. Westport, Connecticut: Greenwood, 2007. V. 5. pp. 1195-1196.