Amy Rae’s Legacy

Longtime readers of re:Cycling are probably familiar with the story of Amy Rae Elifritz, who died from tampon-induced Toxic Shock Syndrome (TSS) in 2010, and became the namesake of ARE in You ARE Loved, the educational foundation started by her mother, Lisa Elifritz. This summer marks the second anniversary of Amy’s death, and the Elifritz family is suing the hospital where she was treated for medical malpractice, and the makers of Playtex tampons for negligence and liability.

Details of the suit are not available due to Indiana’s malpractice laws, but the two-part investigative report about TSS conducted last year by Indianapolis television station WISH-TV8 is available here (part 1) and here (part 2). Phillip Tierno, the microbiologist who first identified the connection between synthetic fibres in tampons and TSS more than 30 years ago, is among those interviewed.

The findings of the WISH-TV8 investigative team, led by reporter Karen Hensel, inspired Rep. Carolyn B. Moloney (D-NY) to introduce the Robin Danielson Act to Congress for a fourth time, on June 23, 2011. Moloney first introduced a similar bill, called the Tampon Safety and Research Act, in 1997. The bill would have required independent research on tampon safety, under the auspices of the NIH, to determine whether dioxins, synthetic fibres, and other additives are present in femcare products and to assess their health risks. The bill was introduced in 1997 and in 1999, but never got out of subcommittee. In 2001, it was renamed “The Robin Danielson Act”, after a woman who died of tampon-related TSS in 1998, in hopes that removing the word “tampon” from the title might speed its progress. The bill was introduced again in early 2003 and quickly moved to the House Subcommittee on Health, where it slowly died. The 2011 edition has so far acquired three co-sponsors and been referred to the House Subcommittee on Health, where it currently rests.

The Danielson act would also authorize and compel the Centers for Disease Control (CDC) to develop a “program to collect, analyze, and make available data on toxic shock syndrome, including data on the causes of such syndrome”. Making a compelling case for the bill is complicated by the fact that there are presently no national data on cases of TSS in the U.S. TSS is a nationally notifiable disease that states must report to the CDC, but reporting by the states is voluntary. Amy Rae Elifritz’s home state of Indiana did not begin collecting data on TSS until 2009.

I don’t know the Elifritz family, but my heart hurts for the loss of their daughter. It hurts for them even more when I read the online comments about the lawsuit and the WISH-TV8 investigation that accuse them of “greed” for suing and Amy of “stupidity” for not reading or not following the warnings on the tampon box. Aside from the insensitivity and cruelty of saying such things to a grieving mother, they’re just not true. Amy’s mother is certain that she did read and heed the instructions on the box, but that’s not enough.

It remains controversial whether it is how long one wears a tampon or the fibre content of the tampon itself that is correlated with the growth of bacterial toxins in the bloodstream. The preponderance of evidence would suggest that it’s more likely about the fibres, especially since the manufacturers have the confidence to have withdrawn the warnings not to leave tampons in overnight from the required package inserts several years ago. (Those package inserts were required by court order, by the way, nine years after 38 women died from a tampon-related illness, because the industry refused to implement voluntary standards.)

Accusing the Elifritz family of greed is even worse. Lisa Elifritz started the non-profit foundation, You ARE Loved, for the sole purposes of raising awareness of tampon-related TSS and providing factual information about menstruation. Dedicating your life to preventing the cause of your daughter’s untimely death is just about the least greedy thing a person can do. And I’m pretty sure it’s not very profitable.

The “greedy” remark was about filing medical malpractice and corporate negligence lawsuits, of course, not about starting an educational foundation. But these suits are likely to drag out over a period of years, and require the Elifritz family to relive every agonizing moment of Amy’s last days in painful, public bas-relief. There are easier ways to make money. I have to believe this is about justice — making it impossible for a team of emergency room doctors to be unable to recognize signs and symptoms of TSS. Impossible for FDA regulators and tampon manufacturers to be so cavalier about women’s health. And impossible for girls and women not to know that the femcare industry isn’t looking out for them — they’ve got to look out for themselves.

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

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.

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

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.

Is this additional text in an insert enough? Cynthia Pearson of the National Women’s Health Network has given an unqualified no as her response to the decision.  If no is the answer, then what needs to happen next? At this time I’ve seen no coverage outside of news reports that has shown the response of the wider feminist, or just female, community.

When I heard that the FDA was asking for a comparison between pregnancy risks and the risks of Yaz and Yasmin, and that the women’s health groups were calling for, in their letter to the FDA, a comparison between these oral contraceptives and other brands not containing drospirenone, I immediately wanted to know why the comparison was not between using these pills and not using them — as in using other forms of non-hormonal contraception with similar effectiveness. This would produce the biggest gap, and put the statistics in starker relief.

There is too much dependent on the FDA not acknowledging the efficacy of non-hormonal contraceptives or admitting that research funded by the pharmaceutical company producing the drug is not reliable. These were for some years the most popular oral contraceptives. It is important that it is believed that there truly is an “arc of history and progress that protects women.”

Even the women’s health group representatives appear to understand this as a blip in an other uninterrupted history of outstanding service. To my mind, such behavior by the FDA should raise some serious suspicions of their motivating force. They advise that women should discuss this with their doctors – doctors who probably know less than I do, due to time constraints, inclination, as well as doctors that could well be directly or indirectly benefitting from backing Bayer.

If it’s taken this long to get a tentative admission of the blood clot risk, what do we not know about the other side effects of these pills? What were the benefits, outside of preventing pregnancy, of Yaz and Yasmin that the FDA saw as so important to women?

The reaction of the women’s health groups suggests an attempt to work within the system, rather than against it.  Does the FDA see itself as protecting the freedom of the millions of women who decided to take Bayer’s oral contraceptives, the millions that made it a bestseller? When a corporation can and will do anything to sell its product in ways that even the most cynical consumer would find shocking can we uphold the notion of informed consent?

We live in a very different time to 1970 when the result of the Nelson Pill Hearings was the inclusion of an insert in birth control pill packets. Then, the other noise of advertising – both overt and hidden – was not loud enough to drown out the message. We are now far happier with corporations telling us what to do than we are with being dictated to by the government. Consumer-driven choice keeps women on the pill – with doctors swapping them between the many brands as side effects appear. Laura Wershler and I put together a guide to a birth control rebellion. We live with a culture that stresses there is no alternative – to the pill or the system that supports it.

To quote a recent New Yorker piece by Margaret Talbot, by the way of Karl Marx, perhaps we must admit that – “Women make their own circumstances but not under circumstances of their own making” – and work from there.

Counterfeit EC in Circulation

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]

 

Breaking News: Pfizer ordered to pay millions in PremPro cases

Pfizer, which now owns Wyeth’s PremPro synthetic progestin-estrogen combination that was widely taken for relief of discomforts that sometimes accompany menopause, has been ordered to pay damages in two separate cases this week. The company must pay more than $10 million in damages to an Arkansas woman after an appeals court reinstated a jury verdict. And yesterday in Pennsylvania, an appeals court overturned a previous ruling that Pfizer’s Wyeth unit deserved a new trial in the case of a Philadelphia woman who had been awarded $1.5 million in compensatory damages and $8.6 million in punitive damages on her claim.

Problems with YAZ making news again

An Oklahoma City news program prepared this investigation about health risks of Bayer’s best-selling birth control pill, YAZ, with dramatic personal stories. The video cannot be embedded here, but you can watch it and read the news story here.

Previous commentary and reporting about YAZ at re:Cycling: The Next YAZ, What’s Up with YAZ?, and The Future of YAZ. For more about YAZ, see the reporting of our friend, Holly Grigg-Spall, at Sweetening the Pill.

For Now, Your Genes Belong to You

Guest Post by Barbara A. Brenner Executive Director, Breast Cancer Action

One of the saddest aspects of capitalism is that companies think they can and should own anything they get their hands on. Some time ago, they started obtaining patents on human genes, including two genes implicated in breast cancer: BRCA1 and BRCA2.

The company that obtained the patents on these genes is called Myriad Genetics. With the patents, Myriad controls both the tests given to women to see if they carry mutations on these genes that may predisposed them to breast and ovarian cancer, as well as all the research related to the genes.

How can anyone own our genes? Up until now, no court has been asked that question. But last week, in a ground breaking decision, a federal judge in New York declared that Myriad’s patents on the breast cancer genes are invalid because they patent a part of nature.

That may seem like an obvious thing to most of us, but the research community is up in arms about how their inability to patent genes will inhibit their ability to innovate new treatments. Sounds plausible, but don’t be fooled. These patents are more about making money than they are about taking care of people who are sick.

Breast Cancer Action, an education and advocacy organization that carries the voices of people affected by breast cancer, was a plaintiff in the lawsuit brought by the American Civil Liberties Union against Myriad over the patents. Because — unlike almost all other breast cancer organizations — we don’t accept funding from Myriad or other companies that profit from breast cancer, we could stand up for  the interests of patients who either couldn’t afford the very expensive test, or who couldn’t learn what their “ambiguous” test results meant because the research wasn’t being done to find out.

Ambiguous gene test results are not uncommon, and they are most often found in women who are not white. So, once again, the worst impact of health policy – in this case, the policy to allow genes to be patented – fell on the people who were most likely to have the worst breast cancer outcomes.

Thanks to the ACLU, the Public Patent Foundation and a federal judge, the patents on the breast cancer genes are now invalid. That means that, once the decision becomes final, new tests will be on the market, and researchers will be able to pursue a greater understanding of what mutations on the genes mean.

Myriad will appeal. The case will probably eventually end up in the US Supreme Court. Myriad might get a stay of the trial court ruling pending that appeal. If they do, we’ll have to wait for our genes to be returned once again to their rightful owners – us.

Reprinted with permission.

Today in Unnecessary Inventions

An Israeli inventor has applied for a patent for a device to shorten the duration of menstrual flow. Apparently it works by insertion into the vagina and “delivering pressure oscillations and/or acoustic waves and/or shock waves to the vagina and cervix to change the flow properties of menses fluid”, which causes the rate of blood flow to increase so that total time of bleeding decreases. Also, “the device also includes an absorbent member attached to the pressure oscillations generating unit for absorbing menstrual secretions.” In other words, there’s a built-in tampon to catch the increased flow.

For my money, that little device looks and sounds a lot more uncomfortable than wearing pads or tampons.