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PRI petitions to withdraw Norplant: Group seeks FDA’s disapproval of contraceptive on medical grounds


The Population Research Institute struck another blow against coercive population control worldwide when, on 27 June 1996, it formally petitioned the United States Food and Drug Administration (FDA) to withdraw its approval of Norplant for sale in the United States.

Norplant, a hormonal contraceptive system, is surgically inserted under the skin of a woman’s upper arm. For the next five years it gradually releases a synthetic progesterone, levonorgestrel, into the bloodstream thereby inhibiting ovulation and implantation. 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 Steven W. Mosher, Executive Director of Population Research Institute. “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.”

Reasons for action

The PRI petition asks the FDA to withdraw Norplant’s approval for sale for the following three reasons:

First, 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).

Second, there is evidence from outside the United States which suggests that women in a number of rather countries have experienced similar problems with Norplant.1 These problems have been largely unreported, however; in some cases because population control officials failed to record them.2

Third, a recent medical study suggests that 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%.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 US and abroad as a result of this drug was identical — and too gripping to ignore,” said Mosher, adding:

Women in Bangladesh and Haiti testify they have endured terrible cases of hypermenorrhea — continuous bleeding for months — after having Norplant inserted. 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 US who have developed pseudo tumor cerebri after having Norplant implanted, and 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.

Others concerned too

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, who were also concerned about the adverse medical conditions being reported.

After reviewing data collected through FDA’s voluntary reporting system, called MedWatch, two FDA officials authored an article in Obstetrics and Gynecology about adverse conditions related to Norplant insertion. They 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

Guidelines reissued

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

Wyeth starts study

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 US, 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 US, but around the world, will benefit.”

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,” Washington Post, 6 May 1996 p. A6 also NICHD News Notes, National Institutes of Health, “Monkeys given progesterone more likely to become infected with SIV,” 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.

5 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 vs. Wyeth-Ayerst, notice of emergency motion, filed in Circuit Court of Cook County, Illinois 93 L 11096.

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