One of every five batches of condoms tested in a government inspection program over the last four months failed to meet minimum standards for leaks, according to the U.S. Food and Drug Administration, which termed the failure rate, 1 out of 50 condoms, unexpectedly high.
At the same time, ongoing laboratory research in both the United States and Canada has already led to the conclusion that lambskin condoms, apparently preferred by gays who engage in high-risk sex, allow the leakage of the AIDS, herpes and hepatitis B viruses.
And in a report published last week, a Department of Health and Human Services task force concluded that "there are no clinical (human trial) data supporting the value of condoms" in preventing the spread of a range of diseases, including syphilis, herpes, hepatitis B and human immunodeficiency virus (HIV), the precursor of AIDS.
Together, these developments underscore what is so far a little-noticed but broadening concern over some of the premises of the condom-mania sweeping the U.S. in response to the AIDS crisis. The reliance on condoms as an AIDS protection has escalated--urged, among others, by Surgeon General Dr. C. Everett Koop--even though the condom was never designed or manufactured to control sexually transmitted disease.
USC's Dr. Gerald Bernstein, who is working on a government-funded condom evaluation, summed up the reality of the situation: "Using condoms is not really what people are talking about when they say safe sex . It may be safer sex, but I think it's a misnomer to say condoms are safe sex."
Experts on sexually transmitted diseases, AIDS, in particular, are still reluctant to abandon aggressive promotion of widespread condom use as a means of preventing the spread of a variety of sexual diseases because they believe that, despite everything, condoms are still the best available preventive other than abstinence. But, they say, crucial questions about condoms remain unanswered--and in some cases unposed.
The FDA began inspecting manufacturing plants and warehouses after sending a letter April 7 to all U.S. condom suppliers urging them to be "particularly vigilant" in quality assurance in view of the "urgency" posed by the AIDS epidemic and sexually transmitted disease fears.
In testing done between early April and Aug. 10, the FDA said, 41 of 204 sample batches of condoms were "violative" of minimum government standards. Eleven of 106 American-made condom batches flunked, along with 30 of 98 imported ones, in a test that consisted of filling a condom with water and examining it for leaks. A total of almost 51,000 condoms was tested, and a batch failed if four or more condoms in it leaked. The agency could not say how many individual condoms failed, but the inspection design indicated a minimum failure of about one condom out of every 50.
An FDA spokesman in Washington Monday declined to characterize the condom inspection results and no senior FDA official would discuss the ongoing inspection program. Earlier, the FDA said the failure rates were unexpectedly high. However, the FDA acknowledged that, despite the gravity of the AIDS scare, there still are no mandatory manufacturing quality requirements for condoms and that condoms conform to voluntary, industry-sponsored standards.
A source familiar with the government's condom investigation, speaking on the condition he would not be identified, said the poor test results shocked both condom makers and federal officials. Since the inspections began, makers have ordered several major recalls.
Dr. Sidney Wolfe, of the Ralph Nader-affiliated Health Research Group in Washington, contended that the FDA's failure to require federal condom safety standards is "outrageous."
The Surgeon General was on vacation and unavailable Monday to comment on the developments.
None of the four main U.S. manufacturers did particularly well or particularly poorly. Many of the condoms inspected were imports that are repackaged and sold in the U.S. under a wide variety of brand names. The testing program included both lamb membrane and latex products; the latter comprise the majority of condoms. Latex rubber is a material apparently incapable of leaking small virus organisms unless it is torn or improperly used.
Of the American condom makers, Ansell-Americas of Tinton Falls, N.J., said it would have no comment on the inspection and officials of Carter-Wallace, Inc., of New York did not respond to calls seeking reaction.
But Don Falk, president of Schmid Laboratories of Little Falls, N.J., said "I think all of us recognize that the FDA is looking at condoms in a much more intensive way with the AIDS crisis than when we were simply a contraceptive industry. We understand and appreciate it." A spokesman for Circle Rubber Corp. of Newark said the firm had no reaction to the inspection results but that "the FDA is just doing its job."
Remarkably few studies have ever focused on the extent to which condoms actually prevent the spread of sexually transmitted disease. While some experts believe a definitive study in human patients would be almost impossible, the research so far on condoms' ability to halt the spread of AIDS, for instance, has relied solely on laboratory experiments. The conclusions on lambskin condoms come from ongoing studies in Canada and San Francisco.
Because lambskin condoms are of animal origin, made from intestinal tissue taken from slaughtered lambs, they contain naturally formed pores able to prevent passage of sperm or the viruses of such traditional venereal diseases as syphilis and gonorrhea. But studies indicate the far tinier viruses for AIDS, herpes and hepatitis B--about 30 times smaller than a sperm--may be able to escape.
The alarm was sounded initially in 1986 by Canadian researchers, but the results were questioned then by a UC San Francisco team led by Dr. Marcus Conant. Conant said, however, that new data indicates his initial results were wrong and that the Canadian researchers were right all along. Conant's first study relied on injecting a liquid containing an AIDS-related virus into a condom and measuring leakage. More recent experiments have made use of somewhat different techniques and injections of the HIV itself and herpes viruses.
The Canadian research was conducted by a team headed by Dr. Gerald Minuk, of the University of Manitoba in Winnipeg. The team initially reported that, in a test in which concentrated hepatitis B virus was introduced into a condom stretched out by a vibrator, traces of hepatitis B leaked. A Belgian study confirmed the results.
Minuk said continued research using an electron microscope to explore the lambskin condom has confirmed that the natural material has a layered, mesh-like texture much like two or three pieces of window screen stacked on top of one another. Minuk said it is theoretically possible the AIDS-related virus could pass through.
"I think their data is probably correct," Conant said. "I think the public needs to know that. Whether this leakage (of viruses) is enough to infect a partner . . . isn't known. But (people) relying on condoms to keep them from getting a fatal disease (AIDS) need to be told that if they have any reason to suspect their partners may be infected, they should use latex condoms, not lambskin."
The lambskin condoms--sold in the U.S. primarily under the brand names Fourex and Naturalamb--account for only about 5% of the 325 million condoms sold annually, according to figures compiled by Carter-Wallace, maker of both the Naturalamb and conventional latex Trojan brands. No independent national sales or use data exist.
But although lambskin condoms account for only a fraction of the sales, they are apparently being bought by precisely the group that should avoid them.
Officials of the Pleasure Chest, a Hollywood sex aid shop catering to gays, said lambskin brands enjoy particular popularity in the gay community because they are believed more resistant to tearing and afford greater sexual sensation. Store manager Tom Weitzel said that though lambskin condoms are costlier than latex types, they account for about 30% of condom sales there and that he has difficulty keeping them in stock because of demand.
Interviews with gay men confirmed there is a preference for lambskin products. In Denver, where the local public health department has been monitoring condom-use habits in gay bathhouses, Dr. Frank Judson, the city's director of public health, said investigators questioning bathhouse patrons believe condoms of all types--latex and lamb membrane--have failure rates, including slipping off and breaking, of between 15% and 20%. Judson said Denver officials discourage use of lambskin condoms and he said authorities "have a strong sense" that condom safety performance is highly questionable in anal intercourse.
Changing Usage Patterns
In 1982--the last time contraceptive technique preferences were measured by the government's National Center for Health Statistics, condoms were the choice 12.2% of the 54 million women who regularly practiced birth control. But the national figures were produced before the AIDS scare began and did not include any measure of condom use patterns among gays. Today, said Falk, whose firm makes Fourex and several latex brands, condoms may be the choice of as many as twice the number of contraceptive users as five years ago.
Mark Klein, vice president for marketing of Carter-Wallace, said the company is puzzled by the new conclusions about possible lambskin condom dangers. "We haven't encountered problems with this product," he said, "and now suddenly, someone has come up (with new results) and we're almost in the position where it is hard to refute."
Falk said Schmid is organizing a study of its own that the company hopes will resolve questions about lambskin products. Nevertheless, Falk said, "there is a tremendous void in condom data relative to gays and gay needs and usage."
The developing concern about lambskin condoms prompted the FDA, in its April letter to condom makers, to issue a strongly worded request to manufacturers to discontinue any advertising and promotion claims that the products are capable of preventing transmission of any sexually transmitted disease. The FDA urged manufacturers, "in the interest of prudence," to refrain from claiming natural skin condoms can prevent sexually transmitted disease.
Deficiencies of Data
The larger question of overall condom effectiveness was raised by the Preventive Services Task Force in a report prepared by a team led by Dr. Charles Horsburgh, of the government's Centers for Disease Control in Atlanta. Horsburgh said the conclusions about condoms were not intended as a statement that condoms are ineffective, but as a caution that far less is known about condoms, how they work and their possible deficiencies than most responsible researchers would like.
"It would be nice to have more data and we would like to know more about (condoms)," he said. "The statement that there is no clinical data means that we wish someone would produce some. We hope the condom works (against sexually transmitted disease), but we have found no convincing evidence."
Other experts said they were concerned that publicity about questions about condoms would itself discourage use and possibly increase AIDS dangers for some people in high-risk populations.
"I think it's all we have" to protect against such things as AIDS, said Bernstein, whose condom research project is sponsored by the National Institute of Child Health and Human Development.
The new concerns on condoms have also focused on everything from the effects different types of lubricant may have on condoms to what is--and is not--known about tearing and breakage rates and even the proportion of the time people who say they rely condoms simply neglect to use them or fail to take precautions on leakage after intercourse.
A University of Miami study still in progress reportedly has found that, even in couples in which one person is infected with the AIDS virus and the other is not and who claim to be using condoms regularly, three of 20 uninfected persons developed the virus. Previously published reports found failure rates of between 2% and 10%.
Cecil Fox, a government scientist overseeing condom research, said the Miami findings and other failure-rate studies focusing on actual use in sex--as opposed to laboratory evaluation--also illustrate one of the innate problems of relying on condoms.
"It is hard to tell how reliable these patient assertions are," Fox said. "The data is pretty soft and the biggest cause of condom failure may be alcohol consumption" by people who were high when they had sex and didn't use condoms properly even though they thought they did.
"The whole condom question comes down to the same question as fire extinguishers," Fox said. "If you put fire extinguishers on the wall, it does not mean that people will be able to put a fire out, but they are the best thing we have. The same thing goes for condoms."