Condom study raises questions – Consumer Reports study features results of tests for condom strength – Pharmacy
Condom study raises questions
MT. VERNON, N.Y. – A Consumer Reports study which features results of tests for condom strength has left at least one condom manufacturer questioning the methodology of the study.
The study, published in the March issue of the magazine, used a standard Food and Drug Administration (FDA)-accepted water-leakage test and also ranked condoms according to how they survived air-burst testing. Currently, the FDA does not use air-burst testing on condoms. Under such testing, condoms are inflated until they break.
Some unhappy condom manufacturers have problems with the study. “The FDA refuses to rank condoms,” said Lew Brenner, senior vp of Ansell-Americas, maker of LifeStyles brand condoms. “The water-leakage test is reliable, and all of the condoms Consumer Reports tested passed the water-leakage test.”
Indeed, the article reported that only one or two of the 16,000 condoms Consumer Reports tested turned up leaky. The overall leakage rate for each model, according to the study, fell within the FDA’s tolerance of four failures per 1,000 condoms.
Dr. Tom Lowe, deputy director of the FDA’s office of health affairs, said the FDA currently uses the water-leakage test as a test of reliability. “The FDA feels that the water leakage test is a reasonable test of quality control,” he said.
Problems cropped up with the second phase of the study, the air-burst testing. “The problem with an air-burst test is that there is no correlation between the test and the ability of a condom to protect against `germ and sperm.’ You can blow something up the size of the Goodyear blimp, but that doesn’t mean it’s not permeable.”
Stands behind study
Consumer Reports stands behind the methodology of the study. “We did do a water-leakage test as well as an airburst test. The air-burst test was done to predict condom breakage during use,” said Marnie Goodman, media liaison for Consumer Reports.
Goodman said that a reader’s survey, in which 3,300 readers responded to an 8-page questionnaire, was also conducted. Although not reported in the article, Goodman said, “What we found from user surveys was that condoms do break. People are concerned about breakage. One can see from see from the ratings which condoms did best in the airburst test and which will be more likely to break during use.”
Dr. Norm Estrin, vp-science and technology of the Health Industry Manufacturers Association (HIMA), said as far as he’s concerned, all of the condoms passed the study.
“I’m pleased with the study in terms of Consumer Reports stating that condoms are a valid way to protect against sexually transmitted diseases,” said Dr. Estrin. “I do have problems with the airburst methodology. I don’t think you can rank condoms using this test.
Dr. Estrin is concerned about the sample size of condoms tested. “I don’t believe that they statistically used enough batches to make the study valid.”
Dr. Lowe from the FDA said, “Testing one sample from a single batch of condoms is questionable. There is variability in batches.”
Ansell’s Brenner is upset with the study for additional reasons. “The condom ranked second is identical to the condom ranked 37th, except for spermicide,” he said. “That doesn’t make sense.”
Although Consumer Reports’ Goodman said, “We made it clear that some of the models were the same,” she could not give a reason why the identical condoms were ranked differently.
Brenner is also not happy that the magazine tested and ranked a product which Ansell had voluntarily recalled.
“Some LifeStyles extra-strength condoms with nonoxynol-9 on the tip were voluntarily recalled by Ansell,” he said. “It’s shocking that they would test the product anyway.”
Ansell voluntarily recalled the product when a consumer in Hawaii reported breakage during use. Ansell then examined the lot, recalled it, then recalled an additional 33 lots, although no problem was found in any additional condoms, according to Brenner.
Consumer’s Goodman said the condoms were recalled long after the product had been purchased and tested for the study. “We make it clear in the study that Ansell had recalled the lots,” she said. “We were concerned because it was a recall from the chain of distribution, not a consumer recall.”
Brenner holds that he is upset not only about the effects of the study on Ansell’s products, but about consumer and retailer confusion which may result.
“Condoms are the fastest growing product category and the highest OTC profit item. Aside from the dollars and cents issue, this is a health issue,” he said. “Our field people are being asked about the quality of condoms in general.”
“This article confuses consumers and retailers about condoms,” said Brenner. “Part of the way to get more people to use condoms is to make them more widely available.” Part of that, said Brenner, is ensuring that consumers have faith in the product’s reliability.
“I would hope that consumer confusion is not a danger,” said the FDA’s Dr. Lowe. “When you publish any study, the results can be misinterpreted by the public. After reading the study, my impression was that condoms do work and they are of high quality. But people have to be using the condoms right.” Even Consumer Reports can’t monitor that.
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