Monday, Vanity Fair published an article questioning why a potentially lethal product, NuvaRing contraception, remains available for sale. Yet the real question is: Why do so many doctors, who fully understand the potential health risks, continue to prescribe life-threatening contraceptives to women?
The hard truth is NuvaRing is unexceptional. Other contraceptive products, including the popular Yasmin and its pharmaceutical cousin Yaz, also pose potentially serious risks yet so few doctors, who could easily prescribe a less dangerous product, inform their patients. Meanwhile, the Food and Drug Administration (FDA) convenes hearings in order to listen to the opinions of experts but refuses to acknowledge the voices of women or their families who hope only to warn others that these third generation contraception products may harm or even kill young, healthy women.
A Brief History of the Pill
PBS credits activist Margaret Sanger with coining the term “birth control” some time between the years of 1914 and 1921. At that time, barrier methods, including condoms and the cervical cap, existed, though at various times in the advancing years they were illegal, stigmatized, or limited in both quality and availability. In fact, it wasn’t until 1951 that the hard work of developing a pharmaceutical product that could prevent pregnancy began. At that time, Carl Djerassi, a chemist in Mexico City, synthesized hormones from Mexican yams and though the idea was there, he was unable to test, produce, or distribute a contraceptive product. One year later, three scientists, endocrinologist Gregory Pincus, gynecologist John Rock, and chemist Frank Colton, all began to independently develop synthetic progesterone, and by 1954, the first small scale human trial, involving just 50 women, had begun in Massachusetts. Two years later, a large scale clinical trial was conducted in Puerto Rico. Though the product was deemed 100 percent effective, serious side effects were ignored, and one year later, the FDA offered its approval for severe menstrual disorders.
In 1960, the pill was officially approved for contraceptive purposes. After two years, 1.2 million American women were on the pill and by 1965, that number rose to 6.5 million. Then in 1969, Barbara Seaman published The Doctor’s Case Against the Pill and began a conversation about side effects. Today, it is obvious that these early pills, which contained 150 micrograms of estrogen, amounted to a radical overdose. (Today, oral contraception contains less than 50 micrograms.) Seaman asserted that oral contraceptives, which contained high doses of estrogen, posed potentially fatal health risks, including blood clots, heart attack, and stroke, and that doctors chose not to inform their patients of those risks. As if echoing through the years, nearly identical claims can be heard today.
A few facts: in 2012, Merck made $623 million from NuvaRing sales, while combined sales of Yasmin, Yaz, and Yasminelle amounted to $1.43 billion for Bayer HealthCare Pharmaceuticals. Yet this monetary bonanza came with a price; as of July 2013, Bayer had settled claims against these products, paying nearly $1.4 billion to 6,760 U.S. plaintiffs. Meanwhile, about one-sixth that number of injury lawsuits are still pending against NuvaRing. Claims in both state and federal courts swelled from just over 700 in April 2011 to about 1,163 in May 2013.
Central to these lawsuits is the fact that NuvaRing, a slender plastic ring that is inserted into the vagina from where it releases a steady dose of hormones over a three-week period, contains etonogestrel, a third-generation progestin, which is a type of synthetic hormone. More than second generation progestins, etonogestrel has been found to pose a risk of venous thromboembolism or blood clots. (Merck discloses this risk on both the packaging and its website.) In many cases, blood clots can resolve without trouble, yet in other instances, they may cause great damage to a patient or lead to death. NuvaRing, which originally launched in 2001, is now used by approximately 1.5 million women worldwide. Born into the world that very same year, Bayer's Yasmin was the first birth control pill to use drospirenone, another next generation form of progestin. (Again, blood clot risks are spelled out by Bayer on both the packaging and the website.) In 2006, a reformulated version of Yasmin known as Yaz was approved by the FDA for the treatment of mild acne in women who also wanted birth control and by 2008, Yaz had become the best-selling the birth control pill in the U.S.
Though sales figures and total customers may be compelling, other numbers are equally so. For instance, there are thousands of serious adverse event reports, including complaints of pulmonary embolism, listed on the FDA's Medwatch system against NuvaRing and over ten thousand serious complaints reported against Yaz. Even more powerful than numbers, though, are the words of various family members as well as some of the victims themselves, who testified at a hearing held by the FDA’s Center for Drug Evaluation and Research on December 8 and 9, 2011.
Speaking for his dead daughter, Erica, just 24, Rick Langhart said: "On the Monday before Thanksgiving, we received a phone call from her boyfriend that something had happened to Erica and that the EMTs were at her apartment. She was heard screaming down the hall screaming with her last breath she ever took on her own. The EMTs giving her CPR over the next hour and a half, she suffered three heart attacks, bringing the total to four... After two long days at her bedside, on Thanksgiving, we were told that she had no brain activity and was pronounced dead."
Karen Langhart, also speaking for Erica, said: “Erica's team of doctors — and they were amazing professionals, caring doctors — identified the NuvaRing as the cause of her massive pulmonary embolism and subsequent death. They, in fact, immediately removed her NuvaRing when they learned that she had that.”
Diane Ammons, a retired fifth grade teacher, told the story of her daughter: "Anne's death shocked everyone who knew her. She was young, healthy, athletic, a runner, a physical trainer, and a new lawyer. She ate healthy foods, was a nonsmoker, and had a low BMI.... The medical examiner thoroughly examined and found only a microscopic heart attack…. Anne was prescribed Yaz eight months earlier, not for birth control but for irregular periods, not a life-threatening condition. Anne's physical ailments then started: extraordinary weight gain, hair loss, headaches, insomnia…. Talking with anyone who would listen after Anne's death, most women or someone they know has had a blood clot problem with drospirenone. It is not rare."
Finally, consider the words of Shala Byers, who at age 25 suffered bilateral pulmonary embolisms and a massive deep vein thrombosis: “I was exactly the demographic they were looking for: nonsmoker, athlete, no history of any major medical issues, normal BMI. I was not told then, nor was I told when I was unknowingly switched from Yaz to generic Yaz, that these pills carried a higher risk…. I want to thank the FDA for pointing out the inherent bias of advisory committee members that maintain ties with Bayer Schering. Would those who maintain those ties please raise their hands?"
"Feeling shy?" she continued. "I ask that you remove yourself from the vote entirely. To me, this isn't about getting even, nor is it about banning all birth control. It's about acknowledging that there is a highly destructive birth control on the market and recalling it.” Need anything more be said?