Blog of the Society for Menstrual Cycle Research

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

May 15th, 2012 by Elizabeth Kissling

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.

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“Lives will be saved” – the FDA decision not to ban Bayer’s birth control pill

April 18th, 2012 by Elizabeth Kissling

Guest Post by Holly Grigg-Spall

 

Photo by Monik Markus // CC 2.0

How many of us read the inserts included in a packet of pills? How many decide not to take the pills on the basis of the information enclosed?  The rapidly reeled-off list of side effects stated at the end of a televised advert for a new drug has more comedic value than serious consequence to most. If we do have doubts, many of us will rely on the reassurance of a doctor, and then take the pill anyway.

I recently wrote a piece for Ms. Magazine Blog outlining the FDA reappraisal of top-selling oral contraceptives Yaz and Yasmin. It was discovered that drugs such as these containing drospirenone held a significantly higher risk of causing blood clots. Research by the FDA and other bodies suggested this conclusion was definite, while research funded by the pharmaceutical company behind these billion-dollar products, Bayer, suggested the opposite conclusion to be true: that there was no increased risk evident. A team of experts, some of which had financial ties to the company, voted against having the pills taken off the market when presented with the question of whether the risks of taking these pills outweighed the benefits.

Bayer is facing 11,300 lawsuits from women who have been seriously injured and family members of women who have died after taking one of the company’s bestselling hormonal contraceptives. They have settled the first 500 addressed with a total of $110 million in payouts. When discussing this process with a lawyer representing many of the women I was told that Bayer would do anything to avoid a trial wherein the full spectrum of their marketing strategies would be revealed.

The FDA came to the decision to add into the insert included with these drugs a statement of the discovery of “conflicting” research that suggested the pills had a higher risk of causing blood clots  (up to three times higher) – acknowledging the discrepancy of the research funded by Bayer and giving it equal standing as that performed by other bodies including the FDA itself.

Prior to this decision being announced a number of women’s health groups got together to write a letter to the FDA asking that they look again at the question put to the board of experts. They argued that the correct comparison for the board to consider would be between drospirenone-containing contraceptives and other oral contraceptives, and not between Bayer’s drugs and unwanted pregnancy. In the final sentence, they remarked that they believed that “lives will be saved” if the pills were no longer on the market. They met with the FDA and one representative asked that the FDA strongly reassess its acceptance of Bayer-funded research. Another asked that the drugs no longer be prescribed and that the FDA “get back to the arc of history and progress that protects women while supporting their contraceptive needs.”

The new labeling will state the “conflicting” findings and advise that women speak to their doctor if concerned. The official statement on this decision, relayed through the media coverage, reminded women that when compared to pregnancy the risk of development of a blood clot was insignificant. They also asked that women currently taking the drugs not stop doing so. Despite the FDA studies suggesting the blood clot risk is particularly high for women under 30, the statement compounded the understanding that the issue is only relevant to those over 35,  those overweight, those that smoke, and those with relevant medical history.

Some recent news about Hot Flushes and Night Sweats

October 25th, 2011 by Chris Hitchcock

Prevalence of Hot Flushes and Night Sweats in UK women 54-65

In a new, large (over 10 000 women)  survey of UK women aged 54-65, Myra Hunter and colleagues reported on the proportion of women who have hot flushes and night sweats (HF/NS), and on how frequent and bothersome they found them. Surprisingly, they did not find a difference across ages; 54% of women reported that they currently experienced hot flushes and/or night sweats, and this was as true for women in their mid-60′s as in their mid-50′s. Current users of hormone therapy were less likely to have current HF/NS, while those who had discontinued hormone therapy were more likely to have HF/NS compared with never users. It is common to think that HF/NS last for 2-5 years in a woman’s early 50′s. This study suggests that there is a need for therapies that are effective and can be used safely for a much longer duration.

FDA says no to Pristiq for (Post)Menopausal Hot Flushes

In early September, the US FDA (Food and Drug Administration) turned down Pfizer’s request to market it’s antidepressant drug, Pristiq, as a treatment for hot flushes in menopausal women. Pfizer inherited Pristiq when it acquired Wyeth (makers of the hormone therapy medication PremPro).  This is the first anti-depressant to seek official approval for this indication, although there has been research and promotion of antidepressants as alternative, non-hormonal, off-label medications for vasomotor symptoms (hot flushes and night sweats) for some time.

Perhaps not surprisingly, there has been little coverage of this in the media, as contrasted with the coverage of the various steps towards this point.

I have noticed that when a drug therapy is approved or takes a step along the path towards approval, news coverage is general and widespread. When there is a hitch in the approval process, often only the financial markets pick up the story, because it affects share values. However, there is an article in Medscape that provides more background on the history of this application.

 

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Counterfeit EC in Circulation

July 29th, 2011 by Elizabeth Kissling

The U.S. Food and Drug Administration has issued a warning to consumers not to use the emergency birth control medicine labeled as Evital. The drug is not safe or effective in preventing pregnancy. The packaging label of the potentially ineffective and suspect counterfeit version says, “Evital Anticonceptivo de emergencia, 1.5 mg, 1 tablet”, by “Fluter Domull”. It has not been approved for use in the United States, but may be in distribution in some U.S. Hispanic communities.

The FDA is asking that people who have seen this version of the drug contact them with information.  Approved versions of EC are available over-the-counter and by prescription to those 17 and older.

[via Feministing.com]

 

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S.A.N.E Vax Objects to FDA Ruling Gardasil Use for Anal Cancer

December 29th, 2010 by Elizabeth Kissling

Guest post by Leslie Botha, S.A.N.E. Vax

Increasing Number of Consumers are Concerned over HPV Vaccine Safety

The FDA’s December 22, 2010 ruling to expand the use of Gardasil for anal cancer prevention is unacceptable, according to Norma Erickson, President of S.A.N.E Vax. Last Wednesday, the U.S. Food and Drug Administration approved Gardasil for the prevention of anal cancer and associated pre-cancer lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years. Immediately, the news flooded the media – with many postings on HIV/AIDS sites.

However, medical consumers are unaware the 2010 Gardasil® Patient Product Information (PPI) states if a woman has “…immune problems, like HIV infection, cancer, or takes medicines that affect the immune system” they must be reported to the health care provider. This should be of grave concern to HIV/AID patients and their physicians who may consider the vaccine to “prevent” anal cancer.

Gardasil is already approved for the same age population for the prevention of cervical, vulvar, and vaginal cancer and the associated precancerous lesions caused by HPV types 6, 11, 16, and 18 in females, and for the prevention of genital warts caused by types 6 and 11 in both males and females in the same age group. 
This same demographic has reported over 20,915 adverse reactions – mostly from Gardasil to VAERS – the Vaccine Adverse Event Reporting System. In addition, 89 deaths and 382 abnormal pap tests post vaccination have been reported with an estimated 1 to 10% of the population filing, according to the National Vaccine Information Center. The rate of deaths and adverse reactions are reported as a percentage of doses distributed, not doses actually administered, and therefore CDC statistics on reported injuries likely misrepresent their frequency.

Data on adverse reactions from males ages 9 to 26 are just starting to be reported to VAERS. Hundreds of social media sited, journalists, researchers and educators have joined forces to publicly decry the faulty science, data, research and fast-tracking of this vaccine through the FDA.

Of course, Merck & Co. denies a causal relationship between the adverse reactions and deaths to their award-winning vaccine. However, on December 20, the QMI News Agency in Canada reported a Quebec coroner can’t explain why a 14-year-old girl died after receiving a dose of the Gardasil vaccine. Even though coroner Michel Ferland’s report concludes the adolescent girl died from drowning, and while there is no evidence the shot killed the teenager, he is refusing to rule out a link between Gardasil and her death. On December 13, Michael Smith, North American Correspondent, MedPage Today wrote an article titled: Many Fail to Finish HPV Series as Recommended stating that “…Many girls and young women may not be completing all three doses of the quadrivalent human papillomavirus vaccine in a timely fashion…” According to Dr. Lea Widdice, Cincinnati Children’s Hospital Medical Center; in a single-institution retrospective analysis, only 14% of girls and young women completed all three doses within seven months of the first, and only 28% did so within 12 months.

Although statistical data was cited for non-compliance, SANE VAX wants to know if the girls were surveyed for their reasons in not completing the vaccine series. Until the true reasons are known, consumers must remain wary about the potential health dangers from the administration of Gardasil and Cervarix.

According to the FDA there are limitations on the use and effectiveness of Gardasil:

  • GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening.

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

May 25th, 2010 by Elizabeth Kissling
Photo from http://www.flickr.com/photos/blmurch/486046904/  // CC BY 2.0

Photo from http://www.flickr.com/photos/blmurch/486046904/ // CC BY 2.0

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.

New Drug for Heavy Periods

November 14th, 2009 by Elizabeth Kissling
Image by Brittany Reed

Image by Brittany Reed

The FDA announced yesterday that they have approved tranexamic acid tablets for the treatment of heavy menstrual bleeding, under the brand name Lysteda. According to the press release, approximately 3 million US women experience heavy bleeding, usually with no underlying health condition. The report states that there was  a statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking placebo.

As is the case with many newly approved drugs, tranexamic acid is not a new drug but an approval for a new usage: tranexamic acid has been used in injection form more than 20 years to reduce bleeding during tooth extraction in people with hemophilia (a blood disorder in which blood lacks a clotting factor).

Although it’s unlikely that anyone using hormonal contraceptives would also have heavy menstrual bleeding (remember, hormonal contraceptives suppress menstruation), the new drug comes with a big warning: taking Lysteda along with hormonal contraceptives increases one’s risk of blood clots, stroke, or heart attack.

I’m not a biochemist or a physician, but it sounds like Lysteda is a viable alternative for women who are currently taking (or recommended to take) hormonal contraceptives for the management of menstrual bleeding.

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What is the future of YAZ?

September 26th, 2009 by Elizabeth Kissling

The popular birth control pill, Yaz is in the news again. Readers may remember that last autumn, Bayer (the maker of Yaz) was sanctioned by the FDA for their television commercials, “because they encourage use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with Yaz.” The FDA actually required Bayer not only to end the advertising campaign immediately but to make amends by publicizing corrective information — an unusually bold move from the FDA. That led to the ad shown at right.

Bayer was cited by the FDA again earlier this year, for failure to follow proper quality control in the plant that manufactures the synthetic hormones used in Yaz.

Bayer is now defending itself against 74 lawsuits filed by users who developed health problems, such as blood clots or heart attacks. Bayer is taking the FDA citations seriously and plans to “defend itself vigorously against the suits.” Dr. David A. Grimes, a clinical professor of obstetrics and gynecology at the University of North Carolina medical school and paid consultant to Bayer says the risk of injury from Yaz is tiny. “My dictum is that a multiple of a rare event is still a rare event,” says Grimes. And the New York Times seems far more concerned with how the FDA citations and the lawsuits will affect Yaz’ image and sales than they are with women’s health.

Didn’t these people learn anything from the saga of the Dalkon Shield?

October 2, 2009

Edited to Add: The New York Times report neglected to mention that Swissmedic is investigating the death of a young woman from the effects of pulmonary embolism that may be linked to her use of Yaz.

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Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.