Memo to signers of the “Call to Discontinue N-9 for Rectal Use” re: accomplishments to date

March, 2004

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To: Signers of the “Call to Discontinue N-9 for Rectal Use”

From:Anna Forbes, Global North Programs Coordinator, Global Campaign for Microbicides

Re:Accomplishments to date

Date:March 17, 2004

On September 26, 2002, the Global Campaign for Microbicides held a press conference to launch the "Call to Discontinue Nonoxynol-9 for Rectal Use.” N-9 is the active ingredient in over-the-counter contraceptive products sold in the US and elsewhere and is added in smaller amounts to some sexual lubricants and to the outer surface of some condoms. Endorsed by 65 organizations and 27 scientists to date, the Call was developed to address the fact that many individuals are still seeking out and using lubricants and condoms containing Nonoxynol-9 in the mistaken belief that they offer added protection against HIV and other STDs. In fact, these products may increase the user's risk of infection.

The Call makes four demands. It urges:

manufacturers of condoms and sexual lubricants that contain Nonoxynol-9 to stop adding N-9 to their products.

retail outlets to discontinue stocking these products.

public health establishments, service providers and advocates to use every means at their disposal to get the message to consumers that N-9 does not help prevent HIV or STDs and should NOT be used rectally.

re-doubled efforts to develop products that can (unlike N-9) be used safely and effectively in both the vagina and rectum to help prevent HIV infection

Since the call was issued in 2002, the following progress has been made as a result of our advocacy action:

Among Manufacturers

Nine condom and lubricant manufacturers to date --including Johnson and Johnson, Mayer Laboratories, Inc., HardCover (a Canadian condom manufacturer) and Planned Parenthood Federation of America—have agreed to the coalition's request to remove N-9 from their products. This list (see end of memo) includes all three of the major manufacturers of N-9-containing lubricants in the US.

In December, 2003, SSL International plc became the first of the three largest condom manufacturers (Ansell Ltd., Church and Dwight Company, Inc., and SSL International plc) to discontinue the addition of N-9 to its condoms. Based in the UK, SSL International produces Durex condoms, which it describes as the “only global condom brand, sold in more than 140 countries, with approximately 22% of the global branded condom market.” Existing stocks of Durex brand N-9 condoms, bearing a label message cautioning that they should only be used vaginally, will be in distribution until they sell out. All Durex condoms now in production, however, are being manufactured without N-9.

The remaining two major condom manufacturers--Ansell Ltd. and the Church and Dwight Company, Inc.—have not agreed to discontinue N-9 use. They argue that N-9 provides back-up protection against pregnancy if a condom breaks -- a position that none of the major women’s health advocates, including IPPF and the National Women’s Health Network (US), supports.

Among Retailers

On February 26, CondomDepot.com, a leading, US-based on-line condom retailers, announced that it had discontinued sale of all products containing N-9. They report that a few of their customers, angered by the decision, have switched to other retailers in order to buy N-9 condoms. But the company doesn't expect a major economic impact, since most public queries regarding the new policy have ended positively when customers are advised about the potential risks associated with N-9 condom use.

Among Advocates:

In the US, at the federal level:

Over a year ago (January 16, 2003), the FDA issued draft regulations that would require manufacturers to add new warning labels to all over-the-counter (OTC) vaginal contraceptive drug products containing N-9. These warnings will advise consumers that N-9 contraceptives do not protect against HIV or other STDs and that frequent use of such products can increase vaginal irritation thus, possibly, increasing HIV risk. The Global Campaign submitted public comment on the proposed regulations pointing out (among other things) that they were insufficient because: (1) they do not address the risks posed by N-9 on condoms and lubricants and (2) they do not address the fact that, although spermicides with N-9 are designed for vaginal use, some people use them during anal intercourse. Any warning label applied to them, therefore, should explicitly warn that rectal insertion of these products can increase HIV and STDs risk. These regulations have not yet been issued in final form.

In California

State Assemblyman Paul Koretz (D-West Hollywood) introduced a resolution in the State Assembly in March, 2003 urging the federal Food and Drug Administration (FDA) to ban the sale of sexual lubricants and condoms that contain nonoxynol-9 (while allowing its use as an over-the-counter spermicide for vaginal use only). The resolution also urges manufacturers to stop producing -- and retailers to stop selling -- these harmful products.

The resolution met with substantial resistance based, not on the merits of banning N-9 condoms, but on legislators' discomfort with addressing a sexual health issue in policy discussion. However, with the support of Assembly Speaker Herb Wesson and a coalition of health policy organizations that included the Global Campaign for Microbicides, Koretz held a press conference and brought national media attention to the N-9 issue and to the condom industry's refusal to accept a negotiated phase-out of N-9 condoms. Koretz also convinced the state's highest ranking public health official, Health Services Director Diana M. Bontá, R.N., Dr.P.H., to send a letter to the Commissioner of the FDA calling for the removal of N-9 from condoms.

In Washington state

In Washington, the Northwest Campaign for Microbicides persuaded the Seattle/King County Health Department to post a warning message on its web site regarding the danger of using N-9 products rectally. They are now planning to reproduce this “health department approved” message on "point of sales" placards and post them in retail establishments where condoms are sold.

In Pennsylvania

The Pennsylvania Campaign for Microbicides discovered that the Philadelphia Health Department was still distributing N-9 condoms to NGOs it funds under HIV/AIDS contracts. They contacted the Department's AIDS Activities Coordinating Office (AACO) and persuaded them to adopt a policy of only distributing condoms without N-9. They are now working to persuade their local and state health departments to make the same decision with regard to condoms distributed in publicly funded family planning programs.

In Canada

Upon inquiring, MAG-Net (a microbicides advocacy network convened nationwide by the Canadian AIDS Society) found that Health Canada (the Canadian Ministry of Health) had issued statements advising that condoms without N-9 are preferable for public health distribution. MAG-Net is working now to persuade Health Canada to prohibit condoms containing N-9 in Canada. In the mean time, they are urging the Director of the Medical Devices Bureau of Health Canada to issue a public alert concerning condoms containing N-9 and their effects when used anally and vaginally.

MAGNet has also contacted the Canadian Association of Chain Drug Stores and the Canadian Pharmacists Association on this issue. The Canadian Association of Chain Drug Stores has indicated that they might be willing to send an information bulletin regarding the potential risks associated with N-9 condoms to their membership. No response has yet been received from the Canadian Pharmacists Association.

Finally, MAGNet contacted Planned Parenthood Federation of Canada and Canadian Public Health Association regarding their respective positions on N-9 condoms. PPFC strongly encourages its affiliates not to distribute N-9 condoms and has adopted a position statement against them. CPHA doesn’t have a policy on condoms with N-9 but is actively considering proposing such a resolution at their next annual meeting.

In the UK

The UK Campaign for Microbicides has issued its own "UK Call for the Removal of N-9 from Condoms and Lubricants" (based in the Global Campaign's Call) and is gathering endorsements for it from leading scientists, advocates and NGOs in their region. They are also drafting a letter to the office of the UK Secretary for Public Health urging her to recommend that, as there is no benefit to N9 in condoms and lubricants, it should be removed. N-9 condoms are still being supplied by the UK's National Health Service clinics but the UK Campaign is working to persuade the government to change its policy regarding their distribution.

Manufacturers that have removed N-9 from their condoms and lubricants:

Bcummings Co.

Elbow Grease

HardCover Products Inc.

HardCover Condoms

Lubegel Personal Lubricant

IPPF European Network

Condoms made by Enet, a subsidiary company

Johnson & Johnson

KY Plus

Condoms distributed in Latin America

Mayer Laboratories

Aqua Lube Plus

Kimono Condoms

Maxx Condoms

Planned Parenthood

Planned Parenthood Condoms

SSL International plc

Durex Condoms

Top Gel and Sensilube Personal Lubricants

Trimensa

ForPlay Plus

Westridge Laboratories

ID-Glide Plus

Retailers that have discontinued sale of N-9 condoms and lubricants

CondonDepot.com

Manufacturers still refusing to remove N-9

  • Ansell Ltd.,

Lifestyles Condoms

  • Church and Dwight Company, Inc.

Trojan Condoms