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.

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]

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 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.

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.