The First FDA Protest (1975)
by Nancy Berglas a former Network intern
On December 15, 1975, the Food and Drug Administration (FDA) met to debate the risks of menopausal estrogens, deciding whether or not to inform women of the dangers of these products through the creation of Patient Package Inserts (PPIs). Outside of the FDA, the NWHN gathered in a demonstration and memorial service for all of the women who had died because of diethylstilbestrol (DES), the birth control pill, and estrogen replacement therapy. This protest was a first for both the NWHN and the FDA.
In the decades before the protest, the use of estrogen products had grown tremendously, but knowledge of the dangers of these products was slow to reach the public. Questions concerning the safety of estrogens arose with investigations of DES and the Pill. The discovery of the reproductive damage caused by DES led to its recall for use in pregnant women. NWHN founder Barbara Seaman exposed the dangers of oral contraceptives in her 1969 book, The Doctors' Case Against The Pill. Her work led to the Nelson Pill hearings, which resulted in the inclusion of PPIs with each prescription of birth control pills (NN, Jan/Feb 1995).
Despite public warnings, in 1975 many women were still being harmed by these drugs. DES was being prescribed carelessly as a "morning-after pill," and birth control pills continued to produce side effects and fatalities. Then, in December, two studies were published in demonstrating a definitive link between the use of menopausal estrogens and an increased risk of endometrial cancer. For decades, oncologists had considered the possible link of this cancer to estrogen use, but no one had ever mentioned these rumors to the public. For women's health activists, word of the new research was the last straw. After hearing about the New England Journal of Medicine articles that were to be published, Barbara Seaman recalled being given the same warning in 1959 by her aunt, who had died of endometrial cancer after years of estrogen use. Seaman immediately got in contact with NWHN co-founders Alice Wolfson and Belita Cowan to organize an action that would coincide with the article's release as well as with the House hearing on DES.
The decision to hold a protest targeting the FDA, rather than the pharmaceutical industry or physicians associations, was significant. No one had demonstrated against the FDA before. The reasoning of the NWHN was twofold. First, the FDA had regulatory authority to require every drug company to include PPIs. Second, the FDA was, in the words of Wolfson, "supposed to be the watchdog, protecting us." Their purpose was to safeguard the consumer against the industry, but instead seemed to do the absolute reverse. The FDA had failed in its core purpose. The goal of the protest was to bring national attention to the FDA for not adequately protecting the millions of women using estrogenic drugs. The founders wanted to embarrass the FDA into enforcing PPIs for menopausal estrogens, as they had done earlier with the Pill.
Organizing the protest entailed a tremendous effort by three activists. Because she was living in Washington, Wolfson coordinated much of the local planning, using her connections with women's health groups across the country. Many activists worked in her basement, organizing the demonstration and creating large signs that read "Feed Estrogen to the Rats at the FDA" and "Women's Health, Not Drug Company Wealth." Particularly helpful were Jessie Halpern and Ann Sablosky, two government workers who organized the logistics of the event, keeping in touch with Cowan in Michigan, running off flyers, generating a crowd, and making everything run smoothly.
Seaman used her contacts as a writer to organize the day's program. Following the distribution of her book, she had often provided information and support to the families of those who had died because of the Pill. Through this, she met Jim Luggen, whose wife Donna Jean Walter has died of a pulmonary embolism. Together they decided that he would tell his story in the form of a memorial service for his wife, forcing the FDA to understand that real people were being harmed by these drugs. Catherine and David Neill also participated in the memorial service, in remembrance of their daughter, a college student who died from the birth control pill. The memorial service, which was held on the steps of the FDA, honored these women and all of the women who had died because of DES, the Pill, and menopausal estrogens.
In creating the memorial, the NWHN looked for a religious figure to lead the ceremony. In the end, two well known women provided the eulogy. One was Reverend Betty Rosenburg, who had just become one of eleven ordained women priests. Barbara Seaman was pleased that Mary Daly, to her "the most impressive radical name in feminist religious studies," accepted her invitation to help officiate the ceremony and came at her own expense!
At Cowan's suggestion, the demonstration took place at noon to get the attention of the FDA workers having lunch. Both Wolfson and Seaman brought their young children out in the cold to join in the demonstration, where health activists like Sherry Leibowitz, herself a DES daughter, spoke out. The most moving moment was Jim Luggen's tribute to his wife, which, Cowan remembers, "really captured the sense of the tragedy of young healthy women being subjected to these drugs." The event was captured by Marlene Sanders of ABC News, who gave the protest national attention by including it in her 1976 special "Women's Health: A Question of Survival."
A number of significant changes occurred as a result of that December protest. The FDA began the process of requiring that drug manufacturers include PPI's with menopausal estrogens. Two years of debate and lawsuits with the pharmaceutical industry and physicians' associations ensued, with the NWHN supporting the FDA in their efforts. Finally, in late 1977, the FDA was able to enforce this new regulation. The demonstration also resulted in changes in the structure of the FDA. The mechanism for public input' increased, placing consumers on advisory committees and allowing organizations to access FDA information.
The demonstration was also an important step in the growth of the NWHN. For the organization to become a voice for women's health, radical steps were necessary to gather support. Wolfson says part of their goal had always been growth in membership, making people see the young organization as "a force, or at least a potential force." The protest, she continues, "was never an event in itself, but a means to burst into the news and onto the world." Although the founders were hoping for more news coverage on the day of protest, Sanders' program brought much publicity in a few minutes of coverage for the NWHN. ABC News was flooded with calls from women asking how to become involved with this new feminist health group. Therefore, in addition to progress with the FDA, the protest succeeded in organization building for the NWHN.
In the twenty years since this ground breaking event, the NWHN has grown to a membership of over 15,000 and has become a powerful voice for women's health rights. The FDA protest action paved the way for waves of consumer involvement in drug regulation, such as that of AIDS activists in the 1980s. As Alice Wolfson reflected almost twenty years after that first demonstration, "If you have a vision and are willing to make it happen, with a small group of people you can accomplish a lot."
Nov/Dec 1995 issue of the Network News