Condom Study Finding Wide Differences Among Brands

An ongoing federally funded UCLA study has uncovered dramatic differences among 31 condom brands in their ability to protect against leakage of the AIDS virus, The Times has learned.

Preliminary rankings from the study--and related test results that evaluated some products for their ability to impede the spread of the AIDS virus--indicate that at least eight condom brands offer excellent protection against the virus while at least five are of apparently questionable effectiveness.

The test results were turned over within the last month to the National Institute of Child Health and Human Development in Bethesda, Md., but the brand-name findings have been withheld from public release on the orders of Surgeon General C. Everett Koop, according to an institute spokeswoman.

No Comment on Data

Jim Brown, a spokesman for Koop, said the surgeon general was “aware of the preliminary data but he is not going to be commenting on it.” Other federal officials stressed the preliminary nature of the findings and warned against drawing detailed conclusions from them.

But an expert involved in the study contended that its results raise questions about the wisdom of the nation’s AIDS-prevention strategy, which has advocated condom use in general without acknowledging that there may be major differences in protection among the four dozen U.S.-made brands sold in this country.

“I think these results certainly tell us right off that one condom is not the same as the next,” said UCLA researcher Bruce Voeller. “Koop and AIDS groups and others promoting condoms have been very careless about that point.”

The rankings show that the eight best-performing condoms in tests measuring, among other things, water leakage, air pressure resistance and package effectiveness were all manufactured by two of the nation’s four major condom makers, Circle Rubber Corp. of Newark, and Schmid Laboratories of Little Falls, N.J.

Adhesive Seal

The top-ranked condom, with a combined index score of 98.9 on a scale of 100, was the heavily advertised Mentor brand, which includes an adhesive seal to prevent leakage of semen, the human immunodeficiency virus (HIV, which causes AIDS) or viruses of other sexually transmitted diseases. The condom is distributed by Mentor Corp. of El Paso, Tex., but manufactured by Circle Rubber.

The seven other top-ranked condoms were the Ramses Non-Lube, Ramses Sensitol, Sheik Elite and Durex Nuform, all made by Schmid and its British parent company, and the Gold Circle Coin, Gold Circle and Pleaser products made by Circle Rubber.

The five lowest-ranked condoms included the Trojan Ribbed Natural and Trojan Ribbed, made by Carter-Wallace Inc. of New York, and three products, Lifestyles Conture, Lifestyles Nuda and Contracept Plus, made by the Ansell Personal Products Division of Ansell-Americas of Tinton Falls, N.J.

The Contracept Plus, distributed by National Sanitary Laboratories of Lincolnwood, Ill., was the subject of a U.S. Food and Drug Administration recall last year after UCLA researchers discovered defects in one batch of the prophylactics.

Mechanical Simulation

Ansell makes three condoms--Prime, Nuda Plus and Tahiti--that were ranked slightly higher than the five lowest-scoring condoms. Three other Trojan products, the Trojan-Enz, Trojan-Enz Lubricated and Trojan Plus, were in the middle of the ranking scale.

In a secondary test for HIV leakage, the top eight and bottom five brands in the ranking were put through a mechanical intercourse simulation designed by researchers at the Mariposa Foundation in Los Angeles. The Lifestyles Conture, Trojan Ribbed Natural, Trojan Ribbed and Contracept Plus all showed evidence of virus leakage. One in 10 condoms tested leaked in each brand, except for the Contracept Plus, which leaked virus 10 of the 25 times it was tested.

All of the ranked condoms are made of latex rubber. The researchers also tested 20 prophylactics made of lamb membrane. All 20 were of the Fourex brand made by Schmid and no HIV leakage was detected.

To draw up the preliminary rankings, the research program tested 1,152 individual prophylactics from one lot of each condom brand bought from wholesale stocks in Southern California. Additional tests are being conducted on two more batches of each brand. A source said results of the second tests are generally consistent with those of the first.

The tests included primarily American-made condoms available for sale in the United States but also experimental products and some condoms sold only in Europe, Canada or Japan.

Declined Comment

Dr. Roger Detels, principal investigator for the UCLA study, did not return calls, and most major U.S. manufacturers would not comment. Bill Moran, chairman of Schmid Laboratories, called the favorable ranking of his firm’s products welcome news but questioned whether lab tests could reliably differentiate among brands.

Norman Estrin, vice president of the Health Industry Manufacturers Assn., the condom makers’ trade group, said “we obviously can’t comment on a study we haven’t seen, but it’s obvious to me that the results can only be regarded as preliminary.”

Estrin said the organization could not address the question of whether condom brands provide differing level of protection against AIDS. “I don’t think you can tell anything from the study,” he said. “I don’t think people should lose faith in condoms as a result of some preliminary information. Remember there are other government and independent studies that have shown that condoms are an effective barrier (against HIV.)”

There was no clear relationship between the condom rankings and recalls the FDA has ordered since April, 1987, as part of its program of checking batches of condoms in factories for water leakage. According to the FDA, the top-ranked condom in the UCLA ratings, Mentor, was the subject of one batch recall, as were the third-ranked Ramses Sensitol and sixth-ranked Sheik Elite.

The FDA also ordered two separate recalls of the 25th-ranked Arouse, distributed by National Sanitary Laboratories. Excita Extra, ranked 14, and Embrace Her, ranked 10, also were recalled.

Dr. Jeffrey Perlman, the National Institute of Child Health and Human Development official who is monitoring the UCLA research contract, characterized the data obtained by The Times as preliminary. He said the final results from the study will be turned over to the FDA for further action.

More Testing Needed

Perlman said the study was not initially designed to rank condoms by performance but rather to select condoms that could safely be used in a large clinical trial to assess the ability of condoms to prevent AIDS infection in humans. “Whether there are significant differences among condom brands hasn’t been ruled out,” he said. “But it wasn’t the intention of the study to answer that question. Much more extensive testing will have to be undertaken.

“I don’t think we have any information right now to be differentiating . . . on the basis of brands. All we can do is identify (individual) lots of (bad condoms) and pull them off the market.”

Dr. Cecil Fox, an HIV transmission expert at the National Cancer Institute who is close to Koop, also raised questions about the scientific validity of the rankings and of the associated leakage tests.

Fox said he was concerned that publication of the rankings might endanger public confidence in condom use as a safe-sex technique. “What I’m afraid is going to happen is you will publish the (list) and some number of people will say, ‘Since condoms don’t work, we won’t use them,’ and they are going to get infected,” Fox said.

“Are the same brands going to fail next week or next year?” he asked. “These guys tested some condoms and found there are condoms in the marketplace that are not as good as other condoms. The problem is this is always going to be true. (The solution is for) the standards to be tightened up so that all condoms are of the same quality. You don’t get that by doing it through a National Institutes of Health (research) contract. You get that by politicians influencing the policies of the FDA.”

‘Too Dangerous’

Fox also warned against considering any condom effective protection against AIDS when used in anal sex, which is practiced by many homosexuals. “I think the surgeon general has made the statement that anal intercourse is too dangerous to be practiced under any circumstances,” he said.

Voeller said the HIV leakage results were improved when spermicides containing the chemical nonoxynol-9 were used. CONDOM RELIABILITY Preliminary results on a scale of 0 to 100, based on safety and effectiveness.

Score Brand 98.9 Mentor 91.3 Ramses Non-Lube 91.3 Ramses Sensitol 85.2 Gold Circle Coin 83.7 Gold Circle 83.7 Sheik Elite 81.7 Durex Nuform 80.2 Pleaser 78.7 Ramses Extra 77.3 Embrace Her 77.2 Hot Rubber (1) 76.6 Lifestyles Stimula 75.3 Ramses NuForm 74.8 Excita Extra 74.5 Parrish (2) 71.9 Yamabuki 1 (3) 71.4 Trojan-Enz 71.1 Trojan-Enz Lubricated 70.4 Duo (1) 69.9 Shields (4) 69.9 Trojan Plus 68.4 Zero 0-2000 (3) 68.1 Prime 66.8 Lifestyles Nuda Plus 64.1 Arouse 62.7 Tahiti 60.9 Lifestyles Conture 60.6 Lifestyles Nuda 57.7 Trojan Ribbed Natural 50.9 Trojan Ribbed 21.3 Contracept Plus

(1) Marketed in Europe (2) Experimental, not for sale (3) Marketed in Japan (4) Marketed in Canada