PRI Petitions FDA to Remove Norplant, Citing Risks
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. These problems have been largely unreported, sometimes be
cause population control officials failed to record them.
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). 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.
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 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 about adverse conditions related to Norplant insertion.
These FDA officials concluded that "reporting rates for stroke and (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."
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 , 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.
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 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
1 PRI staff, "Norplant alleged to cause blindness," May 1996; 6(3):5.
3 Findings, "Hormone may increase AIDS risk, 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," , 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. 85(4):538-42.
6 , notice of emergency motion, filed in Circuit Court of Cook County, Illinois 93 L 11096.
Taken from the August 1996 issue of "HLI Reports." To subscribe contact: HLI Reports 7845 Airpark Road, Suite E Gaithersburg, MD 20879