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Journal of the National Cancer Institute. 2004 Jul 7; 96(13):985.A politically challenged debate about labeling condoms with warnings about the link between human papillomavirus (HPV) and cervical cancer has erupted following a related Congressional hearing on the issue in March. Although the dispute centers on the protection of women from cervical cancer, the debate is just as much about ideology: premarital abstinence or monogamy in marriage versus condom use for those who choose to be sexually active. The hearings, called by Rep. Mark Souder (R-lnd.) at the urging of Tom Coburn, M.D., co-chair of the Presidential Advisory Committee on HIV/AIDS continue to raise questions about a public law Coburn authored in 2000 and that former President Bill Clinton signed days before leaving office. Souder confronted the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention with his belief that the agencies had not complied with the public law. (excerpt)
Women's preferences for vaginal antimicrobial contraceptives III. Choice of a formulation, applicator, and packaging.
CONTRACEPTION. 1998 Oct; 58(4):245-9.New vaginal antimicrobial contraceptives are under development to provide women with a means of protection against sexually transmitted diseases, including HIV, under their control. A descriptive study conducted in Campinas, Sao Paulo State, Brazil, in 1996-97 assessed the preferences of 635 adolescent and adult women from low, middle, and high socioeconomic groups in terms of dosage forms, width, length, applicator color, and packaging. 38-40% of women in the two age and two social class groups indicated a preference for a gel formulation and about 18% favored a cream. A film was the least acceptable formulation. The main reasons given for selecting a particular vaginal formulation were ease of use (39%), no or pleasant odor (27%), no color (23%), ability to use an applicator for insertion (21%), no requirement to wait for the product to dissolve (15%), non-messiness (13%), and ease of storage and transport (12%). The main reasons for rejecting a formulation were discomfort (32%), plastic appearance (25%), mistrust of the method's effectiveness (22%), insertion difficulties (19%), and messiness (13%). A prefilled single-dose applicator was preferred by about 60% of respondents. These findings can be used to guide the development of novel products that are easy and fast to use as well as effective and acceptable.
British Journal of Family Planning. 1996 Oct; 22(3):139-41.Faced with an annual increase in the number of individuals infected by heterosexual transmission of HIV in Scotland, health authorities in Lothian have sought innovative ways to reduce the threat of HIV transmission. One such measure is the "Take Care Campaign," which presents individuals with a range of safe and safer sex behavior choices to choose from at different stages of their life (abstinence, choosing to avoid penetrative intercourse, using a condom, and remaining in a longterm monogamous relationship with an uninfected partner). In 1992, a pilot study was initiated which involved providing doctors with a special pack containing oral contraceptives (OCs) and condoms. The purpose of this study was to make it easier for physicians to discuss HIV prevention while prescribing OCs, to link the prescription of OCs with the condom in the minds of the physicians and clients, and to provide women with a way to carry condoms in their handbags. The 92 women involved in the study all found the pack acceptable, and, at 3-month follow-up, nearly half kept it in their handbags. All 16 physicians found the pack helpful in raising the topic of HIV prevention, and 14 women stated that it helped them raise the subject with their partners. The success of this pilot program led to development of a pill/OC pack that would accommodate 3 condoms, a leaflet, and 80% of the brands of OCs available locally. The pack is intended to be given to first-time OC users. More than half of the general practitioners in the Lothian area have ordered packs.
CONTRACEPTIVE TECHNOLOGY UPDATE. 1995 Jan; 16(1):9-10.You walk into a drugstore to buy a package of plastic condoms. You happen to notice the label says that no one's sure how well they protect you from pregnancy or sexually transmitted diseases (STDs) like AIDS. Then, the label indirectly points you in the direction of latex condoms. What would you do? Some observers familiar with the condom industry speculate that the restrictive labeling carried on each package of the new plastic condoms for men will not interfere with consumers' purchasing decisions. Other predict an instant replay of the situation faced by makers of the polyurethane Reality female condom: A lack of data on pregnancy rates and STD rates resulted in a label touting latex as a superior product, which in turn caused an onslaught of negative press about the first plastic condom. The US Food and Drug Administration, finding itself in a similar position with approving plastic condoms for men, recently released interim labeling to be followed by all manufacturers who want to sell the new male condoms. Essentially, the manufacturers must point out on the front of the condom box that the product is "for latex-sensitive condom users," and on the back of the box must tell a potential buyer that risks for pregnancy and STDs are not known for the product. Upon reading this disclaimer, the consumer then reads that "latex condoms for men, if used correctly with every act of vaginal intercourse, are highly effective at preventing pregnancy, as well as STDs, including AIDS (HIV infection)." (full text)
CONTRACEPTION REPORT. 1993 Nov; 4(5):14.In 1993, the Food and Drug Administration (FDA) issued new labeling guidelines for oral contraceptives, intrauterine devices (IUDs), implantable and injectable contraceptives, and natural membrane condoms. The prevalence of sexually transmitted diseases (STDs) and the AIDS epidemic prompted the FDA to take this action as part of an on-going education effort to reduce the risk in sexually active individuals, particularly adolescents and young adults. In spite of strong educational efforts, many adolescents and young adults. In spite of strong educational efforts, many adolescents and young adults, are continuing to engage in high-risk sexual behavior. The required statement for oral contraceptives, subdermal implants, injectables, and IUDs is: "This product is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases." For latex condoms the message reads: "If used properly, latex condoms will help reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases." For female condoms the label reads: "If you are not going to use a male latex condom, you can use a female condom to help protect yourself and your partner." The message on latex condoms will appear on individual condom wrappers as well as on the outer package. Manufacturers will add a similar statement to patient and physician leaflets provided with the products. Other contraceptives that may be relabeled in the future include spermicides, cervical caps, diaphragms, and the contraceptive sponge. The new contraceptive labeling effort is part of a broader initiative of the US Public Health Service regarding women's health that focuses on health issues and diseases in women, including reproductive disorders, breast and other cancers, and substance abuse.
[Letter concerning] public health message regarding which contraceptives provide protection against sexually transmitted diseases (STDs) and which do not.
[Unpublished] . 2 p.In 1983, the US Food and Drug Administration (FDA) informed various consumer groups that it now required manufacturers to note on certain contraceptive labels that the product does not protect against sexually transmitted diseases (STDs), including HIV infection. FDA also asked for help in communicating this message to others. The contraceptives include oral contraceptives (OCs), Norplant, Depo-Provera, and IUDs. FDA is in the process of reviewing scientific studies regarding spermicides, Today Sponge, cervical caps, and diaphragms before taking any action on the relabeling of these contraceptives. The modified information must be conspicuously displayed and must be clear, understandable to the consumer, and not overshadowed by other information. FDA has taken this action in an attempt to eliminate the confusion created by the information of previous labels and contraceptive packages concerning STDs and HIV transmission. Various consumer representatives and health professionals had informers FDA that this information confused people who practice risky sexual behavior, especially teenagers and young adults. Since 1987, FDA has recommended that natural-membrane condoms be labeled as inferior to latex condoms in providing protection against STDs. Individual latex condom wrappers and the outer packages not state: "If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other STDs. "The natural-membrane condom packages read: "This product is intended to prevent pregnancy. It does not protect against AIDS and other STDs. In order to help reduce the risk of infection of many STDs, including AIDS, use a latex condom." FDA requires almost identical labeling on packages for OCs, Norplant, Depo-Provera, and IUDs, but does not require the statement about using a latex condom.
FDA MEDICAL BULLETIN. 1993 Jun; 23(2):4-5.The US Food and Drug Administration (FDA) has notified the manufacturers of oral contraceptives, IUDs implantable and injectable contraceptives, and natural membrane (lambskin) condoms that labeling accompanying their products must state in clear language displayed prominently that they do not provide protection from sexually transmitted diseases (STDs) including AIDS. FDA is taking this action as part of ongoing education efforts to reduce the risk of HIV infection and other STDs in sexually active individuals, particularly adolescents and young adults. Since 1987, FDA has strongly recommended that the labeling on latex condoms provide information regarding their effectiveness in preventing pregnancy and protecting users from STDs. Oral contraceptives, Norplant, Depo Provera, natural membrane (lambskin) condoms, and IUDs are intended to prevent pregnancy and do not protect against HIV infection (AIDS) and other STDs. If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other STDs. This message is to appear on individual condom wrappers, as well as on the outer package. FDA, is conjunction with the National Institutes of Health and the national Centers for Disease Control and Prevention, is currently reviewing the scientific literature to determine whether the labeling for other contraceptives, such as spermicides, cervical caps, diaphragms, and the newly approved female condom should be changed as well.
Research Triangle Park, North Carolina, Family Health International [FHI], 1989 Nov. , 4,  p.Under contract with the U.S. Agency for International Development (USAID), Family Health International compared 2 brands of condoms for acceptability in Mali, Sri Lanka, and the Dominican Republic. Lifestyle 3, 3.4 mils thick, was compared with Prime, 2.6 mils, to determine whether the thicker of the 2 could be potentially distributed by USAID in developing countries. 65 current condom users, sexually active, and free of STDs for the past year were provided with the Lifestyle 3 condoms, informed that they were thicker, and then interviewed after 1 month of use. 8 condoms were given to each user in the Dominican Republic, and 15 for each in Sri Lanka and Mali. No study data was available for Sri Lanka due to political unrest. Lifestyle 3 was, however, well-accepted in Mali and the Dominican Republic, with additional strength and security cited as extremely desirable factors by over 1/2 of the study participants. Greater protection against both pregnancy and AIDS was considered important. Almost all who were interested in buying the stronger condoms said that they would pay more for them. Lifestyle 3 condoms were also reported to be more comfortable with sensitivity comparable to Prime. The breakage rate for the stronger condom was 1:143, comparable to Consumer Report's March, 1989, study results of 1:140. The Lifestyle 3's labelless silver foil packaging was also found to be overwhelmingly preferred to the standard plastic packaging of other brands. Addition studies of both breakage rates and consumer preference for condom packaging are encouraged. Limited market introduction of Lifestyle 3 is also suggested.
OUTLOOK. 1988 Jun; 6(2):9-10.Since latex condoms provide the best protection from sexually transmitted diseases and AIDS for those engaging in sexual intercourse, health professionals and educators promote their use. Regulators and representatives from organizations that determine standards for the condom industry are reassessing standard to ensure that all condoms are of equal high equality. The American Society for Testing and Materials (ASTM) reexamines its guidelines every 5 years. In 1988, an ASTM task force made up of industry, government, and consumer representatives reviewed quantitative measures including condom strength, tests for pinholes, and test limits. Further, the US Food and Drug Administration is reviewing its quality assurance tests for condoms and has increased condom sample testing. The British Standards Institute is concentrating its efforts on reexamining condom strength criteria. Changes in Australian standards are in the making also. Many developing and developed countries use the condom standards and specifications created by the International Organization for Standardization (ISO) which proposes guidelines for standards organizations worldwide. Thailand now uses the ISO condom standard and China is considering a standard similar to the ISO standard. In February 1988, >75% of the voting members of the ISO approved the draft form of the packaging and labeling section of the condom standard. Members continue to debate about condom specifications, e.g., appropriate thickness, and testing procedures. As of October 1988, they had not yet approved the draft section on sampling plans and requirements. The ISO proposes a certification program for condom manufactures which requires them to meet production, packaging, labeling, and finished product criteria.
AMERICAN JOURNAL OF NURSING. 1989 Oct; 89(10):1266.The Food and Drug Administration recently reviewed its warning that natural membrane condoms do not provide a sufficient barrier to prevent the transmission of all sexually transmitted diseases (STDs) (Medical Devices Bulletin, June 1989). The FDA has asked manufacturers of both the natural membrane and latex condoms to modify their package labeling so that it clearly states the intended use: to prevent pregnancy or/and to prevent STD transmission. Labels will have to specify which STD may be prevented by the use of the product. Firms can wait until the next package printing to revise their labeling, as long as that printing takes place within the next year. If manufacturers believe that their natural membrane condoms provide protection against certain STDs, they must submit premarketing data to the FDA to support their claims. (full text)