Woman says Wash U research trial of birth control gave her permanent injuries

Public health advocates have praised the innovative project as a way to promote birth control to impoverished young women who are often uninsured.

Others, including the National Catholic Register, have argued that providing free contraceptive devices to women and teenagers in the St. Louis area could increase rates of sexually transmitted diseases.

As part of the project, research subjects were provided their choice of no-cost contraception for three years.

Washington University School of Medicine has heralded the success of the project, saying it has resulted in fewer pregnancies and fewer abortions. And a new study has found that the project did not increase risky sexual behavior.

But a lawsuit by a 27-year-old woman has accused the university of conducting an unethical research trial of a contraceptive device called Mirena as part of the CHOICE project.

Mirena is a small, T-shaped plastic frame that’s inserted into the uterus by a health care provider. It releases a hormone — a type of progestin — to prevent pregnancy for up to five years after insertion.

Deanna Delancy of St. Louis has sued the medical school, saying that her participation in a clinical study involving off-label usage of Mirena injured her for life, resulting in two heart surgeries and a chronic condition.

“I don’t feel like they were informative about it,” Delancy said in a brief telephone interview. “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.”

Delancy, a lab associate, said researchers sent her gift cards for groceries, fuel and convenience items after she filled out medical surveys.

Washington University School of Medicine denied the lawsuit’s allegations, saying it puts the highest priority on conducting research in a manner that protects the rights of participants.

Delancy’s lawsuit, filed last year in St. Louis Circuit Court, names additional defendants including Barnes-Jewish Hospital, Dr. Lorie M. Harper, and unnamed individual members of the medical school’s Institutional Review Board (IRB), whose responsibility is to ensure that a research trial is designed and conducted in an ethical manner and that research subjects are protected. A trial is scheduled for next year.

Barnes-Jewish Hospital declined to comment.

“Research has to be done, but I question the wisdom of people participating in off-label medical experiments without being fully apprised of the risks,” said Alvin Wolff Jr., a Clayton attorney who represents Delancy.

Where vulnerable populations such as inmates, the mentally disabled, children, pregnant women, or economically or educationally disadvantaged people are research subjects, IRBs “must put into place additional safeguards to protect them,” the complaint states.

According to the lawsuit, the researchers ignored prescribing information published by the medical device maker, Bayer HealthCare Pharmaceuticals, and implanted Mirena immediately after Delancy gave birth.

In court papers, Delancy said the Mirena device resulted in complications, including two heart valve surgeries and a long-term need to take Coumadin, a blood thinner, to prevent heart attacks, strokes and blood clots.

Bayer was initially named a defendant, but managed to extricate itself. In published literature, Bayer recommends that Mirena not be inserted any earlier than four to six weeks after a woman gives birth. After delivery, the lawsuit says, the uterus may be prone to infection.

Washington University researchers asked Bayer several years ago to support their Mirena research trials by supplying free IUDs. Bayer declined, making it clear to the researchers that for legal reasons it distances itself from studies involving off-label uses of its products.

Mirena, a type of intrauterine device (IUD), was approved in 2000 by the Food and Drug Administration. Since 2001, the FDA has received tens of thousands of complaints regarding complications from Mirena, including spontaneous migration of the device in the body and perforations of the uterus. Hundreds of lawsuits have been filed in federal and state courts nationwide against Bayer by women allegedly injured by Mirena.

“Bayer takes the safety of our products very seriously. For that reason, we continuously review the safety profile of all of our products worldwide,” said Rosemarie Yancosek, a Bayer spokeswoman. “Based on the totality of data available to Bayer since the launch of Mirena in 2001, a positive benefit-risk profile continues to be observed ...”

The CHOICE project, which was 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 initiated a “randomized clinical trial” with plans to enroll about 200 women: Mirena would be inserted in about half of the subjects immediately after child birth; in the others, Mirena would be inserted four to eight weeks after delivery.

Harper, the Mirena trial’s principal investigator, is now affiliated with the University of Alabama Medical School in Birmingham, Ala. Harper did not return telephone calls.

Dr. David Eisenberg, an assistant professor of obstetrics and gynecology at Washington University School of Medicine, was a co-principal investigator on the Mirena trials, according to a spring 2011 medical school bulletin. But his role in the trials is unclear.

Phone calls to Eisenberg and three other researchers involved in the CHOICE project were referred to Diane Duke Williams, a spokeswoman for Washington University School of Medicine.

In response to questions about the Mirena trials, the medical school said in a written statement it would vigorously refute the lawsuit’s allegations.

“Washington University places the highest priority on conducting clinical research in a manner that protects the rights of those enrolled in the research,” it said. “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.”

According to the medical school, the Centers for Disease Control and Prevention as well as the World Health Organization say the benefits of immediate postpartum insertion of an IUD outweigh the risks.

“Physicians and investigators commonly use a drug or device outside of its manufacturer’s labeling, within their medical judgment, and the permission or consent of the manufacturer, in this case Bayer, was not sought or required,” the medical school said.

According to ClinicalTrials.gov, 53 women were enrolled in the Mirena study. The “collaborator” for the clinical trials was the Society of Family Planning, a Philadelphia-based group whose board includes physicians and researchers. The ages of women eligible for the trials was listed as 14 to 45. The study was completed in December 2012, but its results have not been published.

The primary purpose of the randomized trial, the study’s protocol says, was to determine whether insertion of Mirena immediately after delivery would result in greater use of the contraceptive than if insertion occurred four to eight weeks after delivery. The secondary purpose was to determine the safety of insertion immediately after delivery.

According to the lawsuit, Washington University researchers failed to explain that one of the purposes of the clinical trials was “to assess the safety of post-placental insertion of Mirena despite the warning by Bayer that Mirena should not be inserted earlier than four to six weeks after a woman gives birth.”

Delancy said she was asked during a doctor’s visit — months before delivery of her third child — whether she would like to join a program for free birth control.

The research trial was unethical, the suit alleges, in part because Delancy was never informed of the purposes of the research trial, its risks or benefits, and also because it “targeted the economically disadvantaged.” When asked to define that term, Wolff said it included “poor people who live in the city and can’t afford birth control.”

“It is unclear whether Ms. Delancy was provided or executed an Informed Consent Document,” the lawsuit states. “Certainly, if she were not, this would be a gross violation of the regulations governing human subject research.”

On April 9, 2011, Delancy gave birth at Barnes-Jewish Hospital. Immediately following discharge of the placenta, medical personnel inserted Mirena. Within days, Delancy developed endocarditis — a heart condition — and began experiencing pain and sickness, the suit says.

Ten days after delivery of her child, Delancy was rushed to the emergency room. She subsequently had two heart surgeries and suffered “agonizing aches, pains and mental anguish,” the suit alleges.

Delancy said Friday that her ongoing medical problems have interfered with her family life. “I do have three small children (ages 8, 5 and 2) and cannot interact with them like I used to — riding bikes, playing kickball, and tumbling,” she said.