PRI Petitions FDA to Remove Norplant, Citing Risks
by Paul Gallagher
The Population Research Institute recently flied a petition with
the Food and Drug Administration, asking the FDA to rescind its
approval of the contraceptive device Norplant and to halt its
sales in the United States. PRI Director Steven W. Mosher
announced the petition at a 27 June press conference held at the
National Press Club in Washington, D.C.
Norplant, a hormonal contraceptive system that sometimes acts as
an abortifacient, is surgically inserted under the skin of a
woman's upper arm. For the next five years it gradually releases a
synthetic progesterone known as levonorgestrel into the
bloodstream, thereby inhibiting ovulation and often preventing
implantation of an unborn child.
International organizations often cite Norplant's approval by the
FDA to justify their efforts to market and distribute this drug
delivery system to unsuspecting women in the developing world.
"We have evidence that Norplant has caused untold suffering among
women, both here in the United States and around the world," said
Mosher. "We at PRI could not, in good conscience, simply stand by
and allow this dangerous drug delivery system to continue to be
used on women."
The PRI petition asks the FDA to withdraw
Norplant's approval for sale for the following three reasons:
1) American women with Norplant implants have suffered a much
wider variety of adverse health conditions than was anticipated
when this contraceptive system was approved in late 1990. These
adverse health conditions have been serious, and include such
grave health threats as tumors, blindness, lengthy bouts of
bleeding (hypermenorrhea), and pseudo tumor cerebri> (increased
intracranial fluid pressure).
2) There is evidence from outside the United States which suggests
that women in a number of other countries have experienced similar
problems with Norplant.[1] These problems have been largely
unreported, sometimes be
cause population control officials failed to record them.[2]
3) A recent medical study suggests the use of Norplant thins the
vaginal wall and may put women at increased risk of contracting
the human immunodeficiency virus (HIV)
and of developing acquired immune deficiency syndrome (AIDS).[3]
While it has long been known that hormonal-based contraceptives do
not protect women from sexually transmitted diseases, the
discovery of an increased AIDS risk factor is significant.
The use of condoms-recommended by Norplant advocates following the
release of the study mentioned above- cannot sufficiently
compensate for this increased susceptibility to HIV, since the
failure rate of condoms has been conservatively placed, in many
parts of the world, at 13 percent.[4]
PRI decided to file the petition after discovering abuses in
Norplant trials overseas, and relating these to the serious
medical consequences experienced by many women in the United
States who used the implants. "The suffering of women in the U.S.
and abroad because of this drug was identical-and too gripping to
ignore," Mosher said.
"Women in Bangladesh and Haiti testify they have endured terrible
cases of hypermenorrhea-continuous bleeding for months-after
having Norplant inserted," he added. "Now we find American women
with identical symptoms. Women in Bangladesh developed problems
with their eyesight after they were given Norplant. Now we find
women in the U.S. who have developed <pseudo tumor cerebri> after
having Norplant implanted, whose optic nerves have been crushed,
blinding them completely or causing a significant loss of vision.
The worldwide pattern of serious medical conditions was also too
clear to ignore."
During the course of its research on Norplant, PRI found support
from an unexpected source. Officials at the FDA and at Norplant's
manufacturer, Wyeth-Ayerst, were also concerned about the adverse
medical conditions being reported. After reviewing data collected
through FDA's voluntary reporting system (known as MedWatch), two
FDA officials authored an article in <Obstetrics and Gynecology>
about adverse conditions related to Norplant insertion.
These FDA officials concluded that "reporting rates for stroke and
<pseudo tumor cerebri> (which reflect under-reporting of an
unknown magnitude) were close enough to the expected rates (which
reflect all causes) to suggest that Norplant users may be at an
increased risk of developing these disorders."[5]
On 24 July 1994 Wyeth-Ayerst itself promulgated a revised and
greatly expanded set of guidelines for doctors and clinics
involved in the sale and insertion of Norplant. These new
guidelines went far beyond those which had originally been issued,
mentioning no fewer than 23 new, separate adverse health
conditions related to Norplant, including <pseudo tumor cerebri>,
stroke, arm pain and numbness.
Unfortunately this new information on adverse health conditions is
alleged not to have been provided to the hundreds of thousands of
women currently using Norplant, nor, it is further alleged, were
physicians or clinics required to inform prospective Norplant
users of this new information.[6]
A further indication that Wyeth-Ayerst was itself uneasy about
Norplant's side effects came in the form of an article, dated 17
September 1995, in the <Cleveland Plain Dealer.> The article
revealed that Norplant's manufacturer has undertaken a major long-
term study of Norplant's effects, especially on the teenage girls
who were among the principal consumers of this new drug delivery
system when it first appeared on the market.
The story also asserts that, at the time when Norplant was first
approved for use in the United States, certain FDA officials were
uneasy about the "difference in reporting side effects. between
Norplant trials conducted in the United States and those conducted
in the developing world. PRI's own petition offers further
documentation on this point, leaving little doubt that some
"studies" of Norplant conducted in the developing world have been
both ethically unsound and scientifically questionable.
"While I do not wish to predict what action the FDA will take in
this election year," Mosher commented. "I believe that we at PRI
have submitted a very strong petition, backed by convincing
documentation, that Norplant should be taken off the market. If
this happens, women not only in the U.S., but around the world,
will benefit."
Paul Gallagher is the editor of <HLI Reports.>
ENDNOTES
1 PRI staff, "Norplant alleged to cause blindness," <Population
Research Institute Review,> May 1996; 6(3):5.
2 Ibid.
3 Findings, "Hormone may increase AIDS risk, <The Washington
Post,> 6 May 1996 p. A6 also NICHD News Notes, National Institutes
of Health, "Monkeys given progesterone more likely to become
infected with HIV," 6 May 1996.
4 Steiner, M; Piedrahita, C; Joanis, C; Glover, L; Spruyt A,
"Condom breakage and slippage rates among study participants in
eight countries," <International Family Planning Perspectives>,
June 1994; 20(2):55-8.
6 Wysowski, DK and Green, L. "Serious adverse events in Norplant
users reported to the Food and Drug Administration's Medwatch
spontaneous reporting system. <Obstetrics and Gynecology>
85(4):538-42.
6 <Jane Doe v. Wyeth-Ayerst>, notice of emergency motion, filed in
Circuit Court of Cook County, Illinois 93 L 11096.
Taken from the August 1996 issue of "HLI Reports."
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