- Associated Press - Monday, March 24, 2014

ST. LOUIS (AP) - A Washington University research project that provides free birth control to the poor and uninsured is under scrutiny for its off-label use of a contraceptive insert.

The research project, known as Contraceptive CHOICE, provides free birth control devices to women and teenagers in the St. Louis area for three years. The university says the study has led to fewer pregnancies and fewer abortions and does not increase risky sexual behavior, the St. Louis Post-Dispatch (bit.ly/ONvckI) reported.

Deanna Delancy, 27, is suing the university’s medical school over what she calls an unethical research trial with a contraceptive device called Mirena, a small, T-shaped plastic frame that’s inserted into the uterus by a health care provider and releases a hormone to prevent pregnancy for up to five years.

Delancy said researchers sent her gift cards for groceries, fuel and convenience items after she filled out medical surveys. But she said using the device soon after she gave birth resulted in two heart valve surgeries and a chronic illness, requiring her to take a blood thinner to prevent heart attacks, strokes and blood clots.

“I don’t feel like they were informative about it,” Delancy, a lab associate, said. “If I knew it was a clinical trial or research, I wouldn’t have joined. I basically feel like they bribed me with free birth control and gift cards.”

The university denies the allegations in the lawsuit, which was filed in 2013, saying in court documents that it puts the highest priority on conducting research in a manner that protects participants’ rights.

The lawsuit also names as defendants Barnes-Jewish Hospital, Dr. Lorie M. Harper, and unnamed members of the medical school’s Institutional Review Board, which monitors the impact of research trials on the subjects’ health. A trial is scheduled for next year.

The complaint alleges university researchers ignored prescribing information published by Mirena maker Bayer HealthCare Pharmaceuticals, which says the device can’t be inserted earlier than four to six weeks after a woman gives birth. Delancy had it implanted immediately after. Bayer was initially named as a defendant but was removed from the suit because it had told the Washington University researchers that, for legal reasons, it distances itself from studies involving off-label uses.

Mirena was approved in 2000 by the U.S. Food and Drug Administration. Since 2001, the federal agency has received tens of thousands of complaints regarding complications from the device, including spontaneous migration in the body and perforations of the uterus. Hundreds of lawsuits have been filed in federal and state courts nationwide against Bayer.

“Bayer takes the safety of our products very seriously. For that reason, we continuously review the safety profile of all of our products worldwide,” Bayer spokeswoman Rosemarie Yancosek said.

In a written statement, the university noted “all participants went through a consent process that involved a one-on-one discussion of the risks and benefits as well as a written consent form that addressed the risks and benefits. All participants signed the consent prior to the onset of labor.”

Barnes-Jewish Hospital declined to comment. The trial’s principal researcher, who is affiliated with the University of Alabama Medical School, did not return the newspaper’s telephone calls seeking a response.

The CHOICE project, sponsored by an anonymous foundation, sought to provide free contraceptives to 7,500 to 10,000 women over a four-year period. In October 2010, the medical school started a randomized clinical trial with plans to enroll about 200 women. Mirena would be inserted in about half of the subjects immediately after childbirth and the rest would have it inserted four to eight weeks after delivery.

Delancy said days after giving birth in April 2011, she developed endocarditis and began experiencing pain and sickness, according to the lawsuit. Ten days after delivery, she was rushed to the emergency room.


Information from: St. Louis Post-Dispatch, https://www.stltoday.com



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