Population Group Demands Halt of Norplant Sales
Cites Health Risks to Women and Targeting of Minority Populations
EMBARGOED FOR RELEASE:
Contact: Anne DeLong
Noon: June 27, 1996
(301) 670-1864
WASHINGTON, DC — The Population Research Institute (PRI) today filed a formal petition with the U.S. Food and Drug Administration (FDA) seeking to halt the sale of the contraceptive device, Norplant.
At a Washington news conference, PRI Executive Director Steven Mosher called Norplant a “seriously flawed drug delivery system,” and outlined the basis for the petition:
An unacceptably high risk/benefit ratio, especially compared to other progesterone-related drug-delivery systems The potential for causing serious disability A wide range of other adverse health conditions after insertion An unknown long-term health risk, particularly for adolescents A possible link with AIDS because of increased risk of HIV transmission
“In light of the overwhelming evidence of serious side effects, it is surprising that the manufacturer has not voluntarily withdrawn Norplant from the market while further tests are conducted, and unconscionable of the U.S. government to allow the FDA seal of approval to remain on this product,” Mosher said.
“The automobile industry routinely recalls vehicles when there is the slightest hint of any defect, and last week the government grounded ValuJet. Where is equal concern and compassion for the health of women?”
A startling documentary, “The Human Laboratory,” produced by the British Broadcasting Corporation (BBC), exposes the unprofessional way Norplant clinical trials were conducted in Bangladesh and Haiti, where international norms governing medical testing were violated. The BBC program was aired in Great Britain in the fall of 1995 but has not been broadcast in the U.S.
In the documentary women testify to severe side effects, state that they were not advised of the experimental nature of Norplant, nor of the risks involved, and report that they were denied removal of the implants.
The Population Council (NY) owns the patent for Norplant, which was developed by embryologist Sheldon Segal of the Rockefeller Foundation. It was approved by the FDA for use in the U.S. on 10 December 1990, and is manufactured by Wyeth-Ayerst, a division of American Home Products.
The Norplant system consists of six small flexible capsules filled with a synthetic progesterone, levonorgestrel. The capsules are inserted under the skin of a woman’s upper arm to prevent pregnancy for up to five years. An estimated 1 million women in the U.S. and 2.5 million worldwide have been inserted with Norplant. In the U.S., insertion and removal of the Norplant system costs between $300-600.
Norplant was tested on women beginning in1972 in several developing countries, including Haiti, Brazil, Indonesia, Bangladesh, Jamaica, Chile, and the Dominican Republic. The U.S. Agency for International Development (USAID) provided most of the $20 million in costs.
To date, approximately 50,000 lawsuits have been filed in the U.S. against Wyeth-Ayerst by women who have allegedly experienced severe side effects. At today’s news conference Kim Colglazier of Elkart, Indiana, and Lynn Triezenburg of Elwood, Illinois, testified about their experiences with the contraceptive device. Ms. Colglazier, 23, began to lose the vision in her right eye only four days after the insertion of Norplant in 1992, and within a week she was totally blind in that eye. Ms. Triezenberg, 24, experienced severe headaches, gained 55 pounds and experienced vision loss so severe she requires bifocals. Six months after Norplant was inserted, she asked to have it removed. The doctor was unable to locate the implants, however, and four hours of surgery ensued leaving her severely scarred. Both woman have joined in a class action lawsuit against the manufacturer.
Recent research suggests that women implanted with the Norplant system may dramatically increase their risk of contracting AIDS, because of increased risk of HIV transmission. A study at the Aaron Diamond AIDS Research Center (NY) released in May 1996, demonstrated that monkeys injected with the progesterone hormone were seven times more likely to become infected with the simian immune deficiency virus (SIV) when exposed vaginally. Researchers theorize that the thinning of the vaginal wall by progesterone increases the likelihood viral penetration.
Joining in support of the PRI petition at today’s news conference was Patricia Lyman Bast of the American Center for Law and Justice, Rev. Johnny Hunter of the Life Education and Resource Network (LEARN), and Anthony Levatino, MD, JD, a member of the American College of Obstetricians and Gynecologists.
The Population Research Institute was established in 1989 as a non-profit, non-partisan research and educational organization, and conducts research on population, development and environmental issues. A major area of PRI concern is the investigation of human rights abuses in the name of population control around the world.
To contact the FDA about this matter write:
FDA
Dockets Branch
Room 1-23; 12420 Parklawn Drive
Rockville, MD 20857
Docket 96P0215