Condoms' reliability disputed

4 U.S. agencies rate effectiveness higher than PEPFAR

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The major U.S. government program engaged in the worldwide war on the HIV/AIDS epidemic requires those in the field to tell at-risk communities that latex condoms aren't very reliable in preventing transmission of the disease, and instead to emphasize abstinence and fidelity programs.

But several key government agencies and the condom industry disagree with that approach, saying the message is wrong. They maintain that condoms are a vital weapon in fighting the spread of the disease and that they are more effective than the government program acknowledges.

The report, summarizing a workshop in 2000 co-sponsored by the U.S. Agency for International Development (USAID), the Federal Drug Administration, the National Institutes of Health and the Centers for Disease Control and Prevention, found that condoms are "essentially impermeable to particles the size of [sexually transmitted disease] pathogens."

In 2004, the Joint United Nations Program on HIV/AIDS (UNAIDS), the World Health Organization and the United Nations Population Fund released a joint position statement supporting the availability of condoms universally, not only to the parts of the population that are at high risk for contracting HIV, as the President's Emergency Plan for AIDS Relief (PEPFAR) provides, but also to the general population.

Despite those findings, the $15 billion PEPFAR program has been saying that condoms are only 80 to 90 percent effective. The study cited by PEPFAR giving this low range of effectiveness was not exclusively a latex condom study and could have included natural membrane or lambskin condoms which are not recommended by the CDC for disease prevention.

According to the CDC, "only latex or polyurethane condoms provide a highly effective mechanical barrier." USAID refused to comment on this issue but did confirm that it distributes only 100 percent natural latex condoms.

Also, studies show that youth being taught about HIV prevention using PEPFAR's so-called ABC approach, for "Abstinence," "Be Faithful" and "correct and consistent Condom use," don't have a clear understanding of the condom component.

In a 2006 survey of 1,365 Kenyan youths released by the Population Council, only 13 percent of those who had received ABC training defined consistent condom use correctly and many viewed condom use as negative. The survey found that a significant percentage "indicated that condoms were ineffective for HIV prevention because they leaked or burst. …"
 

Family Health International's Julie Pulerwitz, research director of the Population Council's Horizons Program, conducted the surveys in Kenya and said it was clear that the youths were receiving positive messages about the Abstinence and Be Faithful components and had received negative messages about correct and consistent Condom use. "If you're trying to have a balanced approach and all three of those behaviors are vital to HIV prevention, then you need to address directly the negative views," she said.

One participant of the survey said, "We are told [that condoms have] small holes that can allow the virus to go through." An adult in another group surveyed explained how they were taught about condoms' ineffectiveness: "They bring condoms and put in water, then they dry. After about five minutes the bottoms start becoming wet, implying that it is passing water through."

Every condom distributed through USAID is made of natural latex and subject to a battery of tests and standards. Unless incorrectly used, there is no reason for a hole to develop in a condom once it has left the factory, according to Suren Solanki, head of innovation and development for SSL International, the world's leading condom manufacturer, which uses the brand name Durex.

According to Solanki, stringent testing is conducted at every stage of manufacturing, from checking the raw latex batches to electronic testing of every condom to ensure product integrity. In addition, various national bodies — Durex condoms are sold in more than 160 countries — "audit our manufacturing sites and test our products in their own laboratories," he said

In those labs, randomly selected condoms are measured for thickness, length, strength and elasticity. They are also tested for leakage. If one condom fails any of the tests, the entire batch is thrown away.

International standards require that 99.7 percent of condoms be free from holes. Condoms distributed through the PEPFAR program meet these standards. According to Solanki, the odds of finding a hole in a Durex condom are less than 0.1 percent.

To help ensure correct use of the product and reduce the possibility of breakage, all U.S.-manufactured and FDA-approved latex condoms are required to include a "Directions for Use" and "Precautions" insert or labeling.

U.S. studies and the report by the four U.S. agencies estimate breakage rates to be between 0.4 percent and 2.3 percent.

To those questioning the effectiveness of condoms, Solanki said, "There is no technical debate about the value of condoms in preventing transmission of various STIs and HIV on a global scale — they work and are our only real ammunition to curb the spread of these infections."

Norman Hearst, a professor of medicine at the University of California, San Francisco, has spent 20 years researching HIV/AIDS in developing countries. In a 2003 report funded by UNAIDS, he concluded that condoms were effective 90 percent of the time based on an aggregate study of all studies done on condom effectiveness.

Hearst does not criticize PEPFAR for using the 80 to 90 percent figure, but he believes that condom effectiveness is more in the range of 85 to 90 percent. "You could argue whether it is the top or bottom of that range. … The bottom line is we won't ever have an exact number."

But worrying that a condom might be permeable, he maintains, is focusing on the wrong risk. "Condoms, when they fail, it's very seldom or almost never due to holes in the latex or things going through, somehow passing through the latex. It's exceedingly rare and it much more happens because they break, or they slip or people don't use them correctly," Hearst said. "Those things are a hundred or thousand times more common than holes in a condom."

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