women’s health movement

It’s National Women’s Health Week — Celebrate and Reminisce with the FDA

Activism, Birth Control, Health Care, Law/Legal, politics

I admit, I didn’t know that this is National Women’s Health Week until I received a reminder in my inbox from a U.S. FDA mailing list, letting me know about the Food & Drug Administration’s role in promoting Women’s Health. They’ve published a brochure (available in both HTML and PDF versions) commemorating 100 Years of Protecting and Promoting Women’s Health.

Image Source: Public Domain

Society for Menstrual Cycle Research members and other women’s health advocates and activists will want to look through the list of the accomplishments the FDA claims responsibility for and lists as unequivocal improvements in women’s health.

For instance, we’ve had many discussions at re:Cycling about the FDA approval of the pill in 1960 as one holding mixed benefits for women, and not always the best choice for women’s health. The brochure also asserts that in 1970, “FDA initiated the first package insert written for consumers to explain to women the benefits and potential risks of oral contraceptives.” That happened in 1970, but Barbara Seaman, Alice Wolfson, and the other founding mothers of the National Women’s Health Network had more to do with its initiation than the FDA.

And here’s another inspiring quote from the FDA brochure:

1980: Making Tampon Use Safer

Problem: In 1980, there were 814 confirmed cases of menstrual related Toxic Shock Syndrome (TSS) and 38 deaths from the disease.
Response: FDA began requiring all tampon packages to include package inserts educating women about the risk of TSS and how to prevent it. In 1997, there were only five confirmed menstrually-related TSS cases and no deaths. The tampon package inserts with TSS information continue to be used today.

Sure, the FDA is proud of those safety rules now, but in 1982 the agency asked the industry to come up with their own voluntary standards because they did NOT want to regulate tampon safety. After years of pressure and organizing from Boston Women’s Health Collective members Esther Rome and Judy Norsigian, activist Jill Wolhander, researcher Nancy Reame, and others to standardize tampon absorbency ratings, the FDA finally enacted regulations in 1989, by court order. Nine years after 38 women died from a tampon-related illness.

Just last year, the FDA could have made another decision that would almost certainly save women’s lives, by removing birth control pills containing the synthetic progesterone drospirenone from the market, but instead the advisory panel voted by a four-person margin that the drugs’ benefit outweighed the risks.

You know what else isn’t on the list? Emergency contraception, a.k.a. the Morning After Pill and Plan B. The agency hemmed and hawed and delayed unconscionably for years, until finally approving it for limited over-the-counter availability in 2006 — a year after Susan Wood walked out of the FDA Office of Women’s Health for good over what she believed to be “willful disregard of scientific evidence showing Plan B to be safe.”

Celebrating organizational achievements that advance and protect women’s health is a fine thing. I’m glad Frances Kelsey withheld approval of Thalidomide in 1960, and for the most part, I’m glad the FDA is on the job. But while we’re celebrating women’s health and reminding everyone to be active, eat healthy, and get preventive health care (if they are so fortunate to have access to health care), let’s also celebrate the activists and advocates that keep agencies like the FDA in line.

How the Pill Gave Birth to the Women’s Health Movement

Activism, Birth Control, books, Pharmaceutical

Only a latter-day Rip Van Winkle could avoid knowing that this month marks the 50th anniversary of the FDA’s approval of Enovid, the world’s first birth control pill. Hundreds of newspaper and magazine articles have marked this anniversary.

Many incorrectly credit the pill with giving birth to feminism. As Elaine Tyler May notes in the current issue of Ms., the pill didn’t start the feminist movement but was in the right place at the right time:

The timing could not have been better. The feminist movement gained momentum just as the Pill became available. With the ability to control their fertility, women could take full advantage of new opportunities for education, careers and participation in public life.

But in the midst of all this celebrating, we’ve neglected another anniversary: 2010 marks the 40th anniversary of U.S.  Senator Gaylord Nelson’s congressional hearings about the pill’s safety profile, which arguably did launch the women’s health movement.

That launch received a giant shove from Barbara Seaman, a magazine writer who published a book called The Doctor’s Case Against the Pill in 1969, and Alice Wolfson, a then-student and feminist activist. Seaman’s book documented medical risks of the pill–such as blood clots, decreased sex drive, mood disorders and certain cancers, and she alleged that the pharmaceutical industry had suppressed such information. Sen. Nelson was investigating other allegations against the pharmaceutical industry and read Seaman’s book, which motivated him to take on the pill as well.

At the time of the hearings, Wolfson was part of an activist collective known as D.C. Women’s Liberation. In discussing whether or not to attend the hearings, Wolfson and several other members discovered they all had experienced negative side effects of the pill, which their physicians had not warned them about. That revelation led to something bigger. As Wolfson later wrote in her memoir, “We went to the Hill to get information. We left having started a social movement.”

At the Nelson pill hearings, as they soon became known, medical experts delivered testimony about the known risks of synthetic estrogen, one of the main ingredients in birth control pills. No pill users were on the agenda. The only woman who testified was Dr. Elizabeth Connell, who expressed the fear that if dangers of the pill were publicized, women would give up birth control entirely. Connell said she worried that would lead to an explosion of unwanted pregnancies, or “Nelson babies.”

Alice Wolfson says she doesn’t remember the exact tipping point in the hearings that prompted her to speak up, but I like to think it was the moment when a medical researcher testified, “Estrogen is to cancer what fertilizer is to wheat.” Wolfson and other women raised their hands politely to comment, but when Sen. Gaylord refused to recognize them, they began shouting their questions.

Why weren’t we told about side effects?

Why aren’t any women testifying?

What happened to the women in the Puerto Rico study?

Why are you using women as guinea pigs?

Why are you letting the drug companies murder us for their profit and convenience?

The feminists immediately had the attention of reporters, and a movement was born. Seaman and Wolfson met during one of the breaks in testimony, and eventually worked together to create the National Women’s Health Network – still a vibrant and vital advocacy organization for women’s health.

The Nelson pill hearings eventually led to lower doses of estrogen in the pill (today’s oral contraceptives are about 1/10th the strength of Enovid) and perhaps more importantly, the introduction of patient package inserts, PPIs. The new FDA requirements resulted in the inclusion of printed information about risks, ingredients and side effects in pill packets, and eventually in all pharmaceuticals.

Women’s health activists went on to work for tampon safety regulations in the 1980s, resulting in an FDA mandate for consistency of absorbency ratings and warnings regarding tampon-associated Toxic Shock Syndrome (TSS); withdrawal of fen-Phen diet pills in the 1990s; ongoing revisions of the ACOG guidelines for VBAC (vaginal birth after cesarean) and so many other issues in support of women’s health, safety and well-being.

Cross-posted at Ms. magazine blog.