FDA's standstill on N-9 endangering women's lives

November 22, 2004

This hasn't been a banner year for the Food & Drug Administration as guardian of our health and safety, for a storm of controversy has been following the agency like the black cloud that hovered over the head of cartoon character Mr. Mxyzptlk.

This hasn't been a banner year for the Food & Drug Administration as guardian of our health and safety, for a storm of controversy has been following the agency like the black cloud that hovered over the head of cartoon character Mr. Mxyzptlk.

If the FDA isn't being accused of suppressing documents about antidepressants and failing to safeguard children's health, then it's being taken to task for not granting OTC status to the morning-after pill.

But what about the FDA's foot-dragging over the issue of nonoxynol-9? For decades, N-9 was accepted as the leading OTC spermicide, then it was a failed candidate to become an effective microbicide, and now it's been unmasked as a corrosive that attacks the female reproductive system.

Designated as OTCs, vaginal contraceptive drug products with N-9 sat on the bottom shelf of pharmacies. Though displayed in a less than ideal location, the cream, jelly, suppositories, film, and spray continued to sell during the past decades. And N-9 was initially advertised on the products themselves as a preventive for HIV and sexually transmitted diseases. Then came the warning sirens.

When reports first surfaced in 1995-1996, studies showed African women who frequently used products containing N-9 experienced untoward reactions. Frequently was later defined as "more than once daily." Further studies done through 2000 confirmed and expanded the earlier results. Later studies showed that there were additional problems. As the negative evidence mounted, UNAIDS and the World Health Organization issued a warning about N-9. Following their lead, the Centers for Disease Control & Prevention issued a letter in August 2000, that said "... given that N-9 has now been proven ineffective against HIV transmission, the possibility of risk, with no benefit, indicates N-9 should not be recommended as effective HIV prevention."

Researchers had now realized that instead of preventing HIV and STDs, N-9 could actually facilitate infections because of the lesions it caused, for the lesions could lead to an easy entry for HIV or STDs.

The FDA finally took note of all this activity and issued a proposal in the Federal Register on Jan. 16, 2003. The agency offered a 90-day period for comment to be heard on the issue.

The Federal Register entry frequently uses the word irritation to describe the symptoms N-9 produces. However, I believe the gyne-syndrome that N-9 produces, exemplified by bleeding, burning, lesions, and other symptoms, far exceeds the neutral term irritation.

The FDA sent this issue off to the Center for Devices and Radiological Health to study the problem. To no one's surprise, CDRH is still studying the condom question. To their credit, most condom manufacturers have voluntarily removed N-9 from their product lines. Some companies, however, have not and still market condoms with N-9.

Throughout this period, the FDA has done nothing to publicly clarify the problem. Worse, it clings to its less than adequate "solution" to relabel the OTCs with warnings and then return them to the shelf. If this were an ideal world and consumers read, understood, and followed the information on warning labels frequently displayed on OTCs, there would be little to contest.

However, in a recent study of OTC drugs, the National Council on Patient Information & Education said that only one out of five consumers actually reads those OTC labels. What about the other 80%?

I see four possible solutions: (1) Convert the products to Rx only. (2) Put the products behind the Rx counter, so that consumers would have to ask for them and R.Ph.s would be able to counsel them. (3) Ask manufacturers to voluntarily remove their products from the marketplace. (4) Ask manufacturers to remove N-9 from their products and participate in a search for a safe and effective replacement.

Research and development is costly and time-consuming, but is the potential pain or loss of life to consumers any less costly?