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.

“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.

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.

The Next YAZ?

In the flood of media commemorating the 50th anniversary of FDA approval of the birth control pill, this story from the Washington Post about its newest iteration may just slide under your radar: FDA approves new birth control pill from Bayer.

Bayer, as you may recall, is the manufacturer of Yaz and Yasmin, which is currently facing more than 1100 U.S. lawsuits and two Canadian class action suits. The new drug, Natazia, contains various dosing of estrogen and progestin throughout the cycle, making it the first four-phase hormonal contraceptive. The new pill uses dienogest, rather than drospirenone, the synthetic progestin in Yaz that is the apparent source of its dangerous side effects. The most common side effects of Natazia in clinical trials included irregular bleeding, headaches, nausea, and vomiting.

Yaz and Yasmin are Bayer’s best-selling prescriptions, by the way –  combined sales for 2009 were $1.64 billion.

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.

Who Lacks Health Literacy?

You may have heard the news that 23 hormone replacement therapy lawsuits filed by women diagnosed with breast cancer were dismissed by a New York judge this week. Judge Martin Shulman granted Pfizer’s motion to dismiss for two reasons: the plaintiff’s delayed filing exceeded the the three-year statute of limitations in New York, and that “the potential risk of contracting breast cancer from taking HRT medication was well known at all times out there in the stream of public information.” Oddly, Judge Shulman simultaneously asserted “that the debate over HRT health problems has not yet been settled.”

I can’t argue about exceeding the statute of limitations, but it’s difficult for a judge to assert that breast cancer risk of hormone therapy is well known public information. The Lancet reported today that up to half of US adults have trouble interpreting medical information, displaying low levels of health literacy. Health literacy, according to The Lancet, is the ability to comprehend and use medical information that can affect access to and use of the health-care system. Health literacy is more than reading and comprehending news reports of medical issues (which are often of poor quality – see Health News Review for sharp analysis of health news); one must also know how to navigate the complexities of the health care system, including knowing how and when to question one’s physicians and pharmacists.

It’s also hard to argue that HT risks are well known when gynecologists, the primary prescribers of HT, refuse to believe the scientific evidence. In 2000 – well after 1990s publication of data from the Heart and Estrogen/Progestin Replacement Study (HERS), a prospective, randomized, double-blind study of 2,763 women with coronary disease which found no benefit of hormones in preventing heart disease – 94.6% of American gynecologists surveyed recommended HT during menopause. Denial continued even after the Women’s Health Initiative (WHI) study – a large, prospective, randomized placebo-controlled trial of estrogen (with and without progestin) in healthy menopausal women – was stopped early in July 2002, because the treated group experienced higher rates of breast cancer, cardiovascular disease, as well as other risks of harm.

WHI was a large, primary prevention trial that contained enough subjects (more than 27,000) to answer the research question; used a design widely acknowledged to be the standard in testing therapeutic efficacy; tested Prempro, the most popular hormone combination; and was monitored by a data safety monitoring board using pre-established criteria. Practitioners should have been satisfied that the question of estrogen as a health-protecting drug had been resolved. Instead, a storm of protest erupted from physicians who could not, or would not, believe the results. Objections to the WHI results (almost exclusively from gynecologists) were so widespread that the media characterized the WHI results as confusing and controversial.

In truth, there was no confusion about the data, which were monotonously consistent with HERS and other randomized controlled studies. [Fugh-Berman & Scialli, 2006]

Why do gynecologists, judges, and others still regard this question as unsettled? Scholars offer several explanations. Paula Derry (board member of the Society for Menstrual Cycle Research) proposed in a 2008 article that faulty decision-making criteria are in play, such as

not valuing rigorous scientific thinking (e.g., ignoring normal rules for judging what counts as scientific evidence, sometimes while claiming to be scientific); not placing a primary value on avoiding harm (e.g., considering heart disease outcomes while not simultaneously considering other risks such as stroke); and basing judgments on a preconception about menopause (i.e., that menopause is an estrogen deficiency disease that causes health problems). [Derry, 2008]

Adriane Fugh-Berman and Anthony Scialli also say the perception of menopause as an estrogen deficiency disease still influences doctors. They speculate that certain features of the unique culture of obstetrician-gynecologists are involved in the continuing promotion of HT. For example, gynecologists are one of few medical specialties that see mostly healthy patients.

Managing medications in healthy women gives a doctor something to do and ensures a continuing relationship with women no longer in need of obstetric expertise.The promise of eternal youth ensures the patients’ consent and gratitude. Healthy women require little or no monitoring and are resilient enough to survive most prescriptions.

Personality factors may play a role, as they cite sources that claim certain types of persons are drawn to gynecological practice. And “reliance on expert opinion and personal experience rather than on evidence from randomized controlled trials may be common among physicians in general.”

Fugh-Berman and Scialli assert that many of those experts are actually sales representatives from pharmaceutical companies. That takes us back to marketing of menopause.

References:

Derry, Paula S.(2008). Update on Hormones, Menopause, and Heart Disease: Evaluating Professional Responses to
the Women’s Health Initiative. Health Care for Women International, 29:7, 720-737

Fugh-Berman, Adriane, and Scialli, Anthony R. (2006). Gynecologists and Estrogen: An Affair of the Heart. Perspectives in Biology and Medicine, 49:1, 115–30

“You can’t bias a jury with the truth”

That was Zoe Littlepage’s response to Pfizer’s request to a judge that her law firm remove this video press release about Pfizer’s malfeasance regarding cancer risk of Prempro, their menopause hormone therapy drug. The motion reads, in part, “Plaintiff’s counsel should be compelled to remove this video from the Internet and refrain from making any further inflammatory and prejudicial public statements.”

No word on when the court will make its decision, but Oscar Chase, a professor of legal ethics at New York University School of Law, said a lawyer’s use of YouTube videos to promote his or her case isn’t all that different from a press release.

“We might say it is typical lawyer grandstanding,” Chase said in an interview. “The danger of jury tainting is outweighed by the public’s right to know.”

(Alert readers may recall seeing this video at re:Cycling last month.)