Erika Langhart and Brittany Malone never crossed paths in life. Langhart was raised in Durango, while Malone grew up in California. But they had a lot in common.
Both were gorgeous young women, full of intellect, reared in loving homes, with passionate, idiosyncratic interests. And their parents say the same product killed them: NuvaRing, a form of birth control that uses “desogestrel,” a third-generation progestin that’s been around since the 1990s.
Langhart was 24 when she died after two heart attacks on Thanksgiving in 2011. She graduated magna cum laude from American University in Washington, D.C., quickly enrolled at Georgetown Law School and wanted to have a career in politics. She’d already taken a semester off to work on Sen. John McCain’s 2008 presidential campaign, where she worked as the liaison with the Republican National Committee.
Malone was 23 when she died suddenly after experiencing a quickened heartbeat while visiting her sisters in 2012. Doctors told the family her death was likely caused by a “massive blood clot in her thigh,” said Joe Malone, her father.
Malone graduated from California State University, Chico, with a bachelor of arts in health education. The middle child, Malone was shy as a youngster, her father recalled, but very close to her two sisters, who also went to Chico. They saw each other almost daily on campus and shared friends and clothes into adulthood.
Joe Malone said his family is still reeling. “It was pretty much as traumatic as you can imagine. We lost a sweet, beautiful, precious child who recently got a job as director of activities at an old-age home,” he said.
Brittany’s parents, Joe and Dana Malone, and Erika’s parents, Karen and Rick, want to prevent other women from the same death – one, they say, caused by a medication doctors routinely prescribe.
Karen and Rick Langhart raised Erika in Durango, where they owned The Red Snapper, a downtown restaurant, for 25 years. The Langharts now live in the Phoenix area, but still visit Durango periodically.
Karen Langhart wrote in an email that she and her husband believe third- and fourth-generation birth controls – including NuvaRing, Yaz, Yasmine and Ortho Evra – should not be on the market at all.
“At the very least, we would like to see a black box warning for the NuvaRing with the FDA,” she said. “The problem with labeling alone, we believe, is that it is an unusual young woman, given a prescription by her doctor, who would proceed to read a 36-page label,” maker of NuvaRing she said.
A spokesman for Merck & Co., the pharmaceutical company that makes NuvaRing, did not respond to a voicemail message requesting comment for this story.
In a 2012 interview with the Herald, a Merck spokeswoman said the company reviews “post-marketing adverse events reports” and makes the commitment to monitor the safety of the NuvaRing.
Vanity Fair
Third- and fourth-generation birth controls – and the public health officials who’ve signed off on them – are facing renewed scrutiny since veteran investigative journalist Marie Brenner tracked the dangers associated with NuvaRing in the January 2014 Vanity Fair magazine.
“Court documents filed against Merck state that since the mid-1990s there have been more than 10 studies suggesting that third-generation progestins, including the one used in NuvaRing, are about twice as likely to cause blood clots as those used in other birth-control devices that have an earlier form of progestin,” writes Brenner in Vanity Fair.
In 2005, women filled 5.5 million prescriptions for NuvaRing, which costs from $15 to $80 per month, a sign that its award-winning marketing campaign “Not Your Everyday Birth Control” has worked.
According to a 2012 study published in the British Medical Journal, the risk of suffering a venous thromboembolism, a blood clot in a vein, increased 90 percent for women who used vaginal rings like NuvaRing versus birth control with earlier forms of progestin.
In 2011, the FDA found that rings increased risks of venous thromboembolism, or VTE, 50 percent.
This is not disclosed on NuvaRing’s packaging. Brenner, in Vanity Fair, writes that NuvaRing’s warning states, “the risk of getting blood clots may be greater with the type of progestin in NuvaRing than with some other progestins in certain low-dose birth control pills.”
Brenner asks, “What did Merck mean by saying the risk ‘may be greater?’ Would a young woman use NuvaRing if she knew that the FDA had come up with an increased risk of 26 percent? The number of women affected appeared to be in the thousands, and there were millions of users.”
Justice?
Thousands of lawsuits have been filed against Merck. Compared to older forms of birth control, NuvaRing claims to cause fewer unpleasant side effects, such as acne.
In 2012, NuvaRing made Merck $623 million, according to the Vanity Fair story.
Joe Malone said he doesn’t think the public is adequately aware of the dangers of third-generation birth controls like NuvaRing. “Today, kids in our society are inclined to want ‘next generation’ things – we’ve trained them to think that they are necessarily better.
“But I don’t think the public knows about NuvaRing. I don’t even think doctors understand the serious nature of these third-generation products. And most patients rely on doctors to get their information. The pharmaceutical industry does a very good job highlighting the benefits of their products – and hiding the risks associated with them and talking them away,” he said.
As early as February 2007, four years before Erika’s death and five years before Brittany’s, the group Public Citizen petitioned the FDA to ban third-generation birth-control pills. The petition from Public Citizen, a nonprofit consumer advocacy organization, underlined the danger of blood clots.
“We believe,” Karen Langhart wrote, “had the FDA acted responsibly in response to this petition, our daughter would still be alive.”
The Langharts in December 2011 spoke at an FDA advisory committee hearing on the effects of the patch.
Although a class-action lawsuit against Merck is underway, Joe Malone said he doubts his family will join it as plaintiffs.
“We lost a daughter who was just the most precious, sweet thing you could ever imagine. We spent a week with her in ICU. The only good that’s ever come of her death is that she was able to save the lives of five other people with her organs,” he said, noting that “her heart beats in Texas, and her liver is in somebody in the Bay Area around here.”
He said he’d contacted the FDA to inform them about Brittany’s death. FDA officials did not follow up, except to say he should assume they got everything he sent the agency.
“I was blown away. It was an honest response. But they don’t have enough staff to investigate the death of a beautiful 23-year-old child who was killed by a product that is still on the market?”
cmcallister@durangoherald.com
