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.

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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]

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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.

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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.

 

Through The Grapevine: writing for Alcoholics Anonymous

By Anne Garner, Curator of Rare Books and Manuscripts

Alcoholics Anonymous first issued The Grapevine in June of 1944, seventy-four years ago this month.  In the journal’s inaugural issue, an uncredited author recounts the founding of the publication “in a big, smoke-filled room” where “six ink-stained wretches sipped at their Cokes … a cashier, a radio script writer: an author: a bookseller: an art director: a wife and mother of two.”  When questioned on the journal’s purpose, the mother of two explains.  It’s about “A.A.’s whole design of living.  There’s going to be a big, full-page on local group doings … and we’re planning to get all the big general stuff on alcoholism into the paper.  Best of all, we think, is the Servicemen’s Letter page…”[1]

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While managed by senior advisor and Alcoholics Anonymous founder Bill W., The Grapevine was conceived and established by a handful of New York “A.A.” women. In “–the story of your magazine – – ” published in the December 1948 issue, the initial idea for the serial publication was credited to “Lois K., a New York member,” who suggested a trial run. A preliminary meeting between Lois K. and three other women in the program, Priscilla P., Grace O. and Marty M. (the latter was the founder of the National Committee for Education on Alcoholism) solved initial questions about content and funding.  They also decided that male representation was needed, and added two men to their staff, Chase H. and Abbott T. Alcoholics Anonymous founder Bill W. gave the plan his blessing, and in his first editorial for the publication, called The Grapevine, “a lighted lamp.”[2]

The initial print run was 1,200 copies, and demand was steady. Members voted on October 3, 1945 to designate The Grapevine as the initial periodical of A.A.  In 1944 and 1945, the journal was produced entirely by non-paid volunteers; by 1948, The Grapevine was supported by four paid staff.  In September of 1948, a smaller, pocket format was conceived (the earliest editions bear a fruit-heavy vine on the cover with the issue information but no title, in an instance of design safeguarding anonymity.)

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The first edition of “Alcoholics Anonymous,” or “the Big Book,” (1939) included only one essay about a female in recovery.  But from the beginning, The Grapevine was more inclusive of women’s stories.  An early article by founding member Grace O. focused on female membership and the perceived challenges by men of women at meetings.  Here, she ticks out some of the complaints expressed by male members, who believed “women talk too much,” “many women form attachments that are too intense,” “women’s feelings get hurt too often,” and that they frequently “are attention demanders;” she concludes that the way forward is with patience and acknowledgement of common purpose.[3]  As Leslie Jamison writes in her 2018 book, The Recovering, “Describing the ‘traditional beliefs’ that inflect how male and female drinking have been understood differently, one clinical textbook puts it like this. ‘Intoxication in a woman was thought to signal a failure of control over her family relationships.’”[4]

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A selection of The Grapevine from 1948-1949.

4Grapevine_t_May1949_v5n2_WatermarkedPnina Levy demonstrates that in the earliest years of the organization men and women shared editorial and writing responsibilities for the serial, though the organization wasn’t always able to shake the entrenched cultural and social gender stereotypes of the early post-War period.[5] A May 1949 article, “Lady A.A.s Get Their Heads Together” acknowledged the challenges of “scurrying to fix dinner, wash dishes, prepare kids for bed, dress yourself and make the meeting across town by 8 o’clock.”[6]  In a “Vino Vignette” published in a 1946 issue, Esther E. tells of the difficulties of moving to her new town of San Antonio to kindle a regular meeting because she’s a woman. She’s successful assembling a group of three females and one male; eventually, as she says, “‘evah-thing’ caught fire.”  The December 1955 issue has no less than five articles by women, including articles about co-ed sponsorship, a narrative of a former female prisoner in recovery, and “My Son and I and AA,” written by a New York program mother.[7]

Today, The Grapevine is still in print, along with La Vina, for Spanish audiences.  Current information about subscriptions and excerpts from past issues can be found here.

References
[1] Anonymous. “Grapevine’ in Bow.” The Grapevine.  June 1944. Vol 1, No. 1.
[2] Anonymous.  “—the story of your magazine—“ The Grapevine. December 1948. Vol 5, No. 7; Bill W., “The Shape of Things to Come,” The Grapevine. June 1944. Vol. 1, No. 1.
[3] Grace O. “Women in A.A. Face Special Problems.” The Grapevine. October 1946. Vol. 3, No. 5, P. 1, pp 6 – 7, 10.
[4] Leslie Jamison. The Recovering.  New York: Little Brown, 2018.
[5] Pnina Levi. “Gender and Alcoholism: Pioneering alcoholic women’s contribution to Alcoholics Anonymous, 1937 – 60.”  Social History of Alcohol and Drugs. 2015. Vol. 29, pp. 112-35.
[6] Anonymous. “Lady A.A.’s Get Their Heads Together.” The Grapevine.  May 1949. Vol. 5, No. 12, p. 11.
[7]  See, “I’ve Changed My Tune,” “My Son and I and AA,” “Adding Up the Score,” “A Lady’s Gripe,” “I’ve Got What I Want for Christmas,” all from The Grapevine. December 1955.  Vol. 12, No. 7.Shop ad_book arts

Symbols in a Life of Psychic Tension

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This gallery contains 5 photos.

By Johanna Goldberg, Information Services Librarian Forget the articles: Advertisements can be the most interesting part of medical journals from decades past. The ads below, published in the American Journal of Obstetrics and Gynecology between 1940 and 1970, show how … Continue reading