4 Popular Condoms Leak AIDS Virus in Clinical Tests

Four of the nation’s most popular condom brands permitted the AIDS virus to escape in laboratory tests conducted for UCLA, prompting researchers to warn users they should not assume that all condoms work equally well in preventing spread of the disease.

The researchers found that the AIDS virus leaked in one of the 10 condoms tested in each of three brands, and six of 25 tested in the fourth.

“The chance of using a defective condom is small,” the study concluded, but the laboratory results “suggest that all condoms may not be equally effective in preventing (AIDS) transmission.”

That conclusion conflicts with a key element of the federal government’s AIDS-prevention strategy, which assumed that all condoms blocked the transmission of the AIDS virus with equal effectiveness. The government has emphasized condom use without regard to possible differences among brands.

The 1,000-page report of the federally funded study, obtained Monday by The Times under the Freedom of Information Act, also listed 10 top-ranked condom brands that performed well in a wide variety of laboratory tests.

Overall, among the thousands of condoms tested, the study found that 0.66% of condoms--more than one of every 200--failed, either allowing water or air to escape, breaking in tensile strength tests or leaking the AIDS virus.

The researchers called for more effective condom-safety programs by the U.S. Food and Drug Administration--with inspectors taking samples from retail store shelves instead of factory stocks. But in a final report of the UCLA study, they emphasized that “the use of even the lowest-scoring condom we tested is preferable to not using a condom for disease prevention.”

Release of the report by the government’s National Institute on Child Health and Human Development was scheduled for last April but was delayed several times.

Tests for ability to prevent leakage of the human immunodeficiency virus (HIV), which causes AIDS, were separate from a broader laboratory evaluation of condom effectiveness, in which hundreds of condoms of each of 31 different brands were tested. However, eight of the 10 top names in the wider laboratory tests also were tested for leakage of the AIDS virus, and none leaked.

All but one of the condom brands tested are made of latex rubber. But the AIDS virus tests also included one brand, Fourex Natural Skins, made of lamb membrane--a material whose AIDS-prevention ability had been questioned in earlier studies.

In the UCLA study, however, researchers at the Los Angeles-based Mariposa Foundation, a partner in the research, were unable to detect AIDS virus leakage in 25 lambskin condoms in a test designed to simulate stresses in sex. The report concluded that concern about the AIDS safety of lambskin condoms, which some users prefer in the belief they are more resistant to breakage than latex products, “is open to question.”

The latex rubber condoms that permitted the AIDS virus to escape--either through pinholes, tears or pores in the rubber membrane--included the Lifestyles Conture, made by Ansell Americas, the Trojan Naturalube and Trojan Ribbed, made by Carter-Wallace, and the Contracept Plus, manufactured by National Sanitary Laboratories.

The Contracept Plus test (in which six of the 25 leaked) was based on a batch of condoms that had deteriorated badly during wholesale storage, according to the report.

The top-10 ranking was dominated by products manufactured by Schmid Laboratories, which markets the Ramses and Sheik condom brands, and Circle Rubber Corp., which makes such products as Gold Circle, Gold Circle Coin and Pleaser.

The UCLA report found the Mentor brand to be apparently the highest-ranking. However, because the Mentor Corp. changed the manufacturer of the condom it markets after the UCLA testing was completed, researchers said the ranking was open to question.

Officials of Ansell Americas could not be reached for comment and a spokesman for Carter-Wallace said officials could not comment on the report because they had not seen it. Norman Estrin, vice president of the Health Industry Manufacturers Assn., a Washington-based trade group representing the condom industry, questioned the validity of the UCLA results.

“I certainly don’t think you can distinguish brands on the basis of these studies,” Estrin said. “I think it would be a mistake to purchase condoms based on any kind of rankings. All of these brands meet FDA standards and the consumer should have confidence in condoms as an aid in protecting people against HIV infection.”

CONDOMS RATED BY UCLA STUDY

Rankings were based on a variety of criteria, including tests of water and air leakage, tensile strength and other factors.

AVERAGE RANK SCORE* BRAND NAME MANUFACTURER 1. 92.5 Mentor** Mentor Corp. 2. 89.5 Ramses Sensitol Schmid Laboratories 3. 88.9 Ramses non-lubricated Schmid Laboratories 4. 87.9 Gold Circle Coin Circle Rubber 5. 86.0 Gold Circle Circle Rubber 86.0 Sheik Elite Schmid Laboratories 7. 78.0 Durex Nuform Schmid Laboratories 8. 76.8 Trojan-Enz Carter-Wallace 9. 74.9 Lifestyles Stimula Ansell Americas 10. 70.9 Pleaser Circle Rubber

CONDOMS AND LEAKAGE OF THE AIDS VIRUS

The UCLA condom study subjected 14 condom brands to additional tests to specifically determine if they would permit leakage of the human immunodeficiency virus (HIV). Tests were conducted among the eight brands of latex rubber condoms that scored highest in the study’s initial ranking of 31 brands and the five latex brands that scored lowest. One brand of natural lambskin condoms--Fourex Natural Skins--was also tested to determine if that material allows passage of the AIDS virus. Tests were conducted on 10 condoms of each brand using a machine that simulates the stresses of actual intercourse.

All eight of the high-ranking brands successfully prevented passage of the AIDS virus. They are:

Mentor** (Mentor Corp.)

Ramses Non-Lubricated (Schmid Laboratories)

Ramses Sensitol (Schmid Laboratories)

Gold Circle Coin (Circle Rubber)

Gold Circle (Circle Rubber)

Sheik Elite (Schmid Laboratories)

Durex Nuform (Schmid Laboratories)

Pleaser (Circle Rubber)

Four of five of the lowest-ranking brands in the original survey leaked the AIDS virus. They are:

Lifestyles Conture (Ansell Americas)

Trojan Naturalube (Carter Wallace)

Trojan Ribbed (Carter Wallace)

Contracept Plus*** (National Sanitary Laboratories)

The fifth brand, Lifestyles Nuda (Ansell Americas), showed no AIDS virus leakage.

The study tested 25 Fourex Natural Skins (Schmid Laboratories) condoms, but none showed any evidence of leakage.

NOTES:

* Score is average of scores for three separate batches of condoms subjected to extensive laboratory tests. Score is on a scale of 0 to 100.

** The distributor of the Mentor condom changed its manufacturer after the UCLA research was conducted. The test results do not reflect performance of the current condom sold under the Mentor name.

*** The U.S. Food and Drug Administration ordered a recall of the batch of Contracept Plus condoms used in the research after UCLA scientists notified the FDA of a massive failure rate, in which six of 25 Contracept Plus condoms permitted passage of HIV. The other three brands had failures in one of 10 condoms tested.