A committee studying revisions in condom manufacturing standards, which are due to expire at the end of this year, has tentatively decided to propose no major changes for the moment but will evaluate a new testing procedure that could lead to more stringent standards, the Times learned Wednesday.
The chairman of the working group refused on Wednesday to discuss details of the deliberations but other members said the decision was reaffirmed Tuesday in a closed meeting in Cincinnati.
Relevance of Lab Tests Debated
The deliberations arose because experts can't agree on the relevance of lab tests as an indicator of how well condoms prevent the spread of the human immunodeficiency virus (HIV), the precursor of AIDS.
The situation presents a potentially significant problem to public health officials trying to determine how effective condoms may be against AIDS and how quality differences among different condom brands can be determined.
The 13-member committee is a subgroup of the American Society for Testing and Materials, a private agency based in Philadelphia that sets standards and specifications for many types of goods, manufacturing processes and engineering services. Final action and any change is not expected until late this year and must be approved by a vote of the society's membership.
Don Marlowe of the FDA's Center for Devices and Radiological Health, and a member of the committee, said the ASTM had arranged a special evaluation by seven laboratories, including one at the U.S. Food and Drug Administration, of a new method of testing condoms by inflating them and measuring the pressures and air volumes required to make them burst.
Committee chairman Mohan Kosamia, of Carter-Wallace, Inc., a New Jersey prophylactic manufacturer, refused comment.
But Marlowe and other committee members said the attempt to add the air-burst test to the standard had been complicated by the growing uncertainty over the relevance of laboratory measurements to the performance of condoms in actual use in sexual situations where spread of HIV is a risk.
The issue had been comparatively insignificant as long as condoms were primarily intended to prevent pregnancy. But with the emergence of AIDS and because the HIV and hepatitis virus are smaller than sperm, "this (the condom) becomes a low-tech product with a high-tech concern" Marlowe said, in terms of its role as a front-line defense against AIDS.
Marlowe and Prakesh Reddy of Schmid Laboratories, another condom maker, said the air-burst test will be evaluated under specially formulated laboratory conditions. Each lab will test condoms from a lot of 3,000 made by a single manufacturer.
Marlowe said the ASTM condom committee, which has been working on a revision of the manufacturing standard for several months, has been aware of work by a federally funded condom research program at UCLA, one of whose researchers is on the committee.
Using an inflation test developed by the International Organization of Standardization (ISO), the UCLA test found that all but one of 31 condom brands tested in the first of three phases of a major new study passed the inflation test while as many as 40% of batches of condoms failed water leakage tests.
In the UCLA study, the results of which were presented at an AIDS conference in Stockholm Wednesday, condoms were able to withstand as much as three times the air pressure required by the experimental ISO standard and all of them exceeded the required air volume. By contrast, 20% of the same condom batches in one test and 40% in another test failed to meet water leakage standards.