| 
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it is surprising that the manufacturer has not voluntarily withdrawn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 |
