3 July 1996
FDA Deputy Commissioner
Dr. Lester Crawford
Food & Drug Administration
200 C Street, SW
Washington, DC 20204
Dear Dr. Crawford,
This is to draw you attention to additional information about the possible link between Norplant’s progesterone-based approach to contraception and an increased risk of contracting HIV.
As you know we cited the possibility of just such an increased risk in our petition, based on a study which was conducted by researchers at the Aaron Diamond AIDS Research Center in New York. At the time we filed the petition, detailed information about the study was not available but more has come to light since our filing.
The World Health Organization, based in Geneva, Switzerland, announced this week that the Aaron Diamond Study had not only found an elevated infection rate among monkeys who were given subdermal progesterone implants but also found that the vaginal epithelia of the monkeys with the implants were “significantly reduced.”
This confirms what we have long suspected about such systems like Norplant and we concur with Dr. Marx and his colleagues in their suspicions about this risk; the very presence of progesterone likely thins the vaginal wall and thus makes it far more vulnerable to infection during intercourse.
I am including a copy of the WHO announcement for your review.
We trust you will take it into consideration when you reflect upon whether to take Norplant off the market in the United States.
Sincerely,
