In a hard-hitting investigative report appearing on the Huffington Post, Sabrina Siddiqui details the years-long series of intrigues between Nuva Ring manufacturer (formerly Organon and now Merck, Inc.) and the FDA to cover up disturbing evidence of danger that appeared during clinical trials for the drug.
Nuva Ring, the world's first contraceptive vaginal ring, delivers hormones directly into the bloodstream, stopping ovulation by releasing a combination of the hormones estrogen and progestin into the body. This method of delivery causes what experts call hormone "spikes" that make women more susceptible to blood clots.
Evidence of this danger was seen in the earliest trials when a healthy woman in her 20's developed a blood clot which an investigator determined was probably due to the Ring.
As a result, the FDA wanted the manufacturer, Organon, to include a warning about increased blood clot risk - also known as venous thromboemolism or VTE - in its packaging insert.
Organon execs opposed the recommendation because the warning might scare off women and their doctors from using a product they believed could bring in billions of dollars if successful.
"We should really try to get it out of the text," Wim Mens, from Organon's regulatory affairs division at company headquarters in Oss, Netherlands, wrote to colleagues in an email in the fall of 2000.
So began the interplay with the FDA which resulted in Organon agreeing to some of the other recommendations from the Agency to use as a "bargaining chip" to enable them to exclude "more important issues" such as the VTE warning and other bleeding data from the clinical trials, according to internal company emails.
"Americans may assume that the fine print in a drug's packaging represents the collective scientific knowledge about that medication, allowing doctors and patients to make informed health care decisions. In fact, negotiations between pharmaceutical companies and the FDA over warning labels are common during the drug approval process, with drugmakers endeavoring to cherry-pick what's included in order to present their products in the best possible light," Siddiqui explains.
"There's always a tug between the FDA and the manufacturer as to what the label is," Sidney Wolfe, founder and senior adviser of Public Citizen's Health Research Group, a public health advocacy organization, told The Huffington Post.
The process is skewed in favor of drug companies because the FDA relies on them to provide clinical trials and other data the agency uses to evaluate drugs, Siddiqui writes. In addition, 70 percent of the funds for FDA reviews come from the industry.
As a result, Wolfe said, "these battles are tilted even further against public health and safety."
This could explain why other studies that have produced alarming evidence of the dangers of this contraceptive were also ignored.
For instance, an FDA-funded study released in 2011, which looked at more than 800,000 women using some form of birth control between 2001 and 2008, found that the risk of developing blood clots for NuvaRing users could increase by as much as 56 percent under some circumstances, Siddiqui reports.
A year later, a Danish study examined more than 1.6 million women and found that those using a vaginal ring had a 6.5 times increased risk of developing VTE. One of the researchers in this study, Dr. Ojvind Lidegaard, was responsible for forcing a label change on Yaz and Yasmin birth control pills against which there are more than 12,000 injury lawsuits pending.
These numbers are much more than mere statistics to Diane Agresta, the mother of 27 year-old Lyndsey Agresta of Cleveland who had been using NuvaRing for barely a month when she started to hemorrhage in her brain. She went on to suffer a massive stroke that required the removal of two-thirds of her right cerebral hemisphere and left her confined to a bed in a long-term acute care hospital. Six months later, when doctors could do nothing further for her, she was sent into hospice where she died a week later. Doctors believe her death was due to a blood clot caused by NuvaRing.
Besides the death of her daughter and the agony her grandson is experiencing while he struggles to cope without his mother, Diane suffers an even greater pain in knowing that if Lyndsey had been better informed about NuvaRing, none of this might have happened.
More than a thousand women feel the same way and are now suing Merck over NuvaRing. The women are alleging that the device was not properly tested nor appropriately labeled to warn women and their doctors about the true scope of the increased risk of blood clots. The first trial is set for April in the Eastern District of Missouri.
Meanwhile, NuvaRing is now one of the most popular forms of birth control in the world with more than 1.5 million using it in more than 50 countries. Last year, it generated sales of $623 million globally for Merck.
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