More Condoms Fail in UCLA Study; FDA Concerned

Condom-failure rates more than double those uncovered last year by the U.S. Food and Drug Administration were to be reported today by UCLA researchers, a finding that an FDA official said could lead to mandatory expiration dates for condoms.

At the same time, the UCLA research discovered that mineral oil--a common lubricating ingredient in baby oil and Vaseline--may break down the latex rubber in condoms, posing a “grave risk” in anal sex, a risk they emphasized that applies to heterosexuals and homosexuals.

However, the UCLA research team also found that condoms made of natural lamb membranes are a better preventive against passage of the AIDS virus than previously thought. But in another phase of the project, a new survey found the condom-use situation may be significantly complicated by the fact that one-third of the men questioned at a gay pride event never use condoms or seldom use them.

The UCLA results are important because condoms have been considered the front-line defense against transmission of the AIDS virus among sexually active adults.

FDA Deputy Commissioner James Benson said that if the study’s preliminary failure rates are confirmed, the government may consider requiring expiration dates for condoms similar to those now required on milk cartons. Condoms, he said, might have to be sold within six months of manufacture. Benson said his understanding of the findings is that storage conditions and shelf-life considerations may affect a condom’s ability to prevent the transmission of the acquired immune deficiency syndrome virus.

“If, in fact, that’s the problem--if condoms are getting an increased leak rate due to aging and we can support that--then certainly (an expiration date requirement) is something that could be done,” Benson said in a telephone interview. “We may want to do something about encouraging manufacturers and distributors not to let the things sit around.”

The federally funded UCLA findings are to be officially presented today at the Fourth International Conference on AIDS in Stockholm.

FDA and UCLA officials have said they believe improper storage techniques in wholesale warehouses were responsible for last year’s discovery of breakage rates in one brand of the 31 being tested by UCLA last year. The batch was so prone to breakage and leakage that internal secrecy codes in the research were broken so the FDA could order a recall of two batches of Protex Contracept Plus brand condoms.

The new UCLA findings are based on tests of condoms bought through the normal public wholesale and retail channels. UCLA’s purchases included condoms that had been shipped and stored in warehouses and other distribution facilities. The FDA tests are performed in condom factories on products that have just been manufactured.

The UCLA study performed two separate tests of the ability of water to leak out of condoms--a standard type of review used by the FDA and other regulatory agencies. More than 1,100 condoms were included in each batch and a batch failed if at least one condom leaked. In the first leakage test, 40% of the batches failed. In the second, 20% of the batches failed.

In the FDA condom inspection program begun last year, 15.6% or 81 of 520 batches failed--a rate slightly below the second UCLA test and less than half that of the UCLA study’s first evaluation.

Generally Effective

However, the principal investigator for the UCLA study said researchers have concluded that, overall, many U.S. condom brands now on the market provide effective barrier protection against the AIDS virus if they are stored properly and used with lubricants that don’t compromise them.

Despite some alarming findings in the research, said Dr. Roger Detels, “These results suggest that condoms can reduce the risk of transmission of HIV (human immunodeficiency virus) very significantly, and that’s good news.

“I prefer to look at this as the glass being half full rather than half empty,” he said.

Serious Questions Linger

Nevertheless, he added, the new research raises serious questions about some condom products and condom-use habits and suggests that prophylactics should not be widely seen as 100% insurance against AIDS.

The UCLA study is chiefly concerned with the ability of condoms to prevent AIDS and the focus has meant much of the interest in the research pertains to gays. But Detels and Ann Coulson, another UCLA researcher, emphasized that heterosexual couples concerned about AIDS should also be wary. “Condoms were designed to prevent conception,” Coulson said. “But the fertile period is only two to three days a month. The infectious period (for AIDS) is 365 days a year, so the risk is higher.”

UCLA experts said they expect to present their complete findings--including brand name rankings of effective and ineffective condoms--to the FDA early next month. In presenting their results at the Stockholm conference, however, the UCLA research team--which included members drawn from the staffs of UCLA, USC and the Mariposa Foundation--identified no specific brands.

All 31 brands in the UCLA research are American-made or distributed by U.S. firms. Detels said the Stockholm presentations are based on tests of the first of three batches of each brand. He cautioned that subsequent tests--almost completed--may disclose different performance characteristics among batches.

Coulson said the study’s focus on American condom brands raises the possibility that products made in the Far East--a common source in the U.S. market--perform significantly worse than U.S. ones. In the FDA’s condom-testing program, foreign-made products were found to fail twice as often as American condoms. “There may be much worse problems with Asian-made condoms,” Coulson said. “We don’t know.”

The UCLA testing was also led by Drs. Bruce Voeller, Gerald Bernstein and Robert Nakamura. So far, the study has also found that:

- When products containing mineral oil--in such products as baby oil, Vaseline and most other non-soluble lubricants, particularly those marketed specifically to gays--were used in conjunction with condoms made of latex rubber, 12 of 23 condoms failed and permitted passage of HIV. The result, the UCLA researchers said, underscores the need to avoid mineral oil lubricants in favor of water-based products, like K-Y Jelly.

“Numerous products used as sex lubricants contain mineral oil,” the UCLA team concluded, “and may pose grave risk to condom users.”

- In a controversial experiment, the UCLA researchers found that 47% of the condom batches failed a test in which latex rubber condoms are assessed for their ability to inhibit passage of an electric current through the latex membrane. The test is intended to detect very small potential leaks in the sheath but FDA and condom industry experts say the test may be too sensitive and that it sometimes detects the harmless chemicals on the condoms that function as an electrical conductor. All of the 30 condom brands passed a test in which the prophylactic is inflated to test its air bursting pressure.

- In a newly developed test designed to simulate the vigorous stresses of anal sex, condoms whose performance was ranked in initial laboratory screenings varied in effectiveness once live HIV was introduced. Of the eight condom brands that performed best in the initial screening, none permitted passage of HIV; four of five of the lowest-scoring brands allowed the AIDS virus through.

“These results are in disagreement with prior studies . . . which suggested that all condoms prevent leakage of HIV,” the UCLA study reported.

- Condoms made of natural lamb intestinal membranes did not permit the HIV virus to leak even though questions had been raised by researchers elsewhere about the ability of the AIDS virus to escape through pores in the natural tissue. None of 20 lamb membrane condoms permitted leakage of HIV in the UCLA test. Detels speculated the natural pores may be too small to permit passage of the AIDS virus.

- Spermicides used in conjunction with condoms were highly effective in limiting the spread of the AIDS virus, with spermicides able to prevent transmission even in some condoms that broke during simulated sex. Spermicides tested--including nonoxynol-9, the most common U.S. type--were generally able to prevent transmission of viruses for herpes and other sexually transmitted diseases. However, none of eight spermicides tested was able to kill the virus for chlamydia, the most common venereal disease in the United States today.

- A survey of almost 1,300 gay men at a gay pride festival in June of last year found that, though half them admitted they practiced anal sex, 14.5% never used a condom and 16.2% did so only sometimes. Of the 1,100 who said they practiced oral sex, 59.4% said they never used condoms and 19% said they did so only sometimes.

“We were a little worried that we would find that (low rate of condom-use) and, indeed, we did,” Coulson said. “We find a surprisingly high number of individuals, given the information that has been in the community--or was in the community for one or two years prior to the survey--who use condoms sometimes or not at all.”