I normally read through the latest literature, synthesize my findings, and write my own piece on a topic or theme. However, L.V. Anderson’s recent articlein Slate Magazine, “We Should Have a Better Condom by Now. Here’s Why We Don’t.” is so comprehensive, it just needs to be reshared and read in it’s entirety.
Just one thought on what Ansell’s Skyn brand is trying to accomplish – a REVOLUTION. Often times, this is the best way to get people’s attention in marketing a tired product – make it appear revolutionary and that it will fundamentally shift your perceptions of using such a product. Think about Dyson vacuum cleaners, with the promise of being the most revolutionary vacuum ever created…all I wanted for several years was a Dyson, and I didn’t even own my own place!
Below is the entire article for your reading pleasure and would love your comments on what you think in the comments sex-tion!
In 1993, Danny Resnic was having anal sex during a casual hookup in Miami Beach when his partner’s latex condom broke. Resnic had been using condoms ever since the man he describes as “my best friend and love of my life” died from AIDS in 1984. “I have always been looking for a monogamous relationship and was never really happy with casual sex,” he says, but in the gay subculture of Miami Beach, where he’d moved from California in 1991, casual sex was the norm. When Resnic slept with men he didn’t know, he insisted on condoms.
After several weeks of worrying about the broken condom, Resnic got tested for HIV. The test came back positive.
The odds of contracting HIV from a single act of unprotected anal sex are extremely low—experts put the risk below 1 in 100. “I couldn’t believe it,” Resnic says today. “‘Cause I was really vigilant. I lost all my friends during the AIDS crisis, and I used condoms religiously. And then when one broke, I thought, ‘How could that happen?’ ”
Resnic became obsessed with answering that question: He read everything he could find about condoms at his local public library in Miami. He learned how latex condoms are made (by dipping phallic molds into vats of liquid latex, which is peeled off after it dries), and how they are regulated (the Food and Drug Administration considers condoms medical devices and dictates how they are manufactured and labeled). He discovered that three publicly traded companies—the makers of LifeStyles, Durex, and Trojan—controlled almost the entire market. And he figured out that, since the introduction of the rolled latex condom in the 1920s, not much about condoms had changed.
I met Resnic for lunch in Los Angeles last September and was struck by his intensity all these years later. To illustrate his astonishment at what he’d learned about condoms, he gestured at the salt and pepper shakers and bottle of olive oil between us. “Everything on this table—these jars, these nozzles—every year they come out with a better product,” he said. “But not the condom! And I found that baffling. I couldn’t understand it. I was like, ‘I don’t get it. Why haven’t they made some crazy new design? Why is it still the same thing, and no one likes it?’ ”
Resnic decided to rectify the problem. He set out to build a better condom—one that he hoped would make protected sex feel as good as unprotected sex (a guy can dream!), and one that wouldn’t break like the one that broke on him. Resnic set aside everything he’d learned about latex condoms and tried to start from scratch, asking: What might a condom look like if it were designed with pleasure in mind, instead of mass production and profit margins? He had taken some product design classes in college, but didn’t know much about biomedical engineering. He spent years thinking, sketching, and researching patents. In 2001, Resnic bought some wood at Home Depot, carved it into a mold with a jigsaw, sanded it down, dipped it in liquid latex, and created the first prototype of his condom in his home, which was, at the time, a house boat on Marina del Rey.
But Resnic didn’t want to stick to latex. He began experimenting with silicone—the flexible, durable material found in spatulas and charity awareness bracelets. He found a silicone manufacturer to formulate a recipe with the precise combination of tensile strength and elasticity he was looking for, and then found a medical device manufacturer to make silicone prototypes. Using grant money from the National Institutes of Health, he conducted small clinical trials with condoms that fit much more loosely than latex condoms, designed to be pulled on like a mitten instead of rolled on, allowing freedom of movement inside, and to provide sensation for men from the interior of the condom, which is lubricated. (In 2014, a former employee accused Resnic of misusing NIH funds; Resnic denies the allegations.)
All the while, Resnic kept tweaking. He says he’s developed more than 127 versions of what he now calls the Origami condom, because it is folded rather than rolled. “The whole concept of the rolled condom is flawed,” Resnic told me shortly before asking our server for a Mediterranean lamb burger. “The premise is transferring sensation through the material. That’s equivalent to trying to taste your lunch with Saran wrap on your tongue.”
Resnic is not the only one who has been trying to build a better condom. In November 2013, the Bill and Melinda Gates Foundation began distributing $100,000 grants to teams of researchers who’d submitted proposals for “the Next Generation of Condom.” The Gates Foundation hopes that at least one of the grantees will develop a product that men in the developing world want to use, which will consequently have “substantial benefits for global health, both in terms of reducing the incidence of unplanned pregnancies and in prevention of infection with HIV or other STIs.” The winning proposals include Resnic’s; a condom made of graphene, which is a form of carbon that’s a single atom thick; a condom incorporating plant-based antioxidants; and an “ultra-sheer wrapping condom” made of polyethylene, a type of plastic often used in packaging. Meanwhile, in 2014 a California inventor raised more than $100,000 on the crowdfunding site IndieGoGo to develop the Galactic Cap, a condom designed to fit snugly on the head of the penis while leaving the shaft bare.
Most people do not like latex condoms. The vintage version of Resnic’s Saran wrap metaphor is that using a condom is like taking a shower with a raincoat on. Latex condoms can cause pain and irritation in men and women with latex allergies or sensitivities. They’re difficult and time-consuming to unroll in the heat of the moment. Condoms squeeze some men’s penises uncomfortably; for other men, they’re too long or prone to slipping off mid-coitus. Latex decreases sensation, doesn’t warm up easily, and smells and tastes funny.
For a paper called “ ‘And Isn’t That the Point?’: Pleasure and Contraceptive Decisions,” published in Contraception last year, Gallaudet University sociologist Julie Fennell interviewed 30 men and 30 women about their experiences with condoms. “The most enthusiastic endorsement that several people … offered was, ‘They don’t bother me,’ ” writes Fennell. “Both women and men mentioned disliking the smell, taste, feeling, inconvenience, and sense of wastefulness of condoms.” Fennell drew the title of her paper from something a woman named Millie said, “It’s not the same feeling, it’s not the same closeness. It doesn’t feel as good. And isn’t that the point?”
It’s not just that a lot of people don’t like the way latex condoms feel. They also don’t use them. In the 2010 National Survey of Sexual Health and Behavior, the largest-ever nationally representative sexuality study, 45 percent of men and 63 percent of women who’d most recently had sex with a “new acquaintance” hadn’t used a condom. More alarmingly, 75 percent of women who weren’t using a back-up birth control method reported not using a condom the last time they’d had sex. Adults who’d had anal sex in the past year—the highest-risk sexual act with regard to HIV transmission—said they’d used condoms only 20 percent of the time.
Unsurprisingly, there’s a correlation between not liking condoms and not using them: The authors of a 2007 study of condoms and sexual pleasure wrote, “Men who believed that condoms reduced pleasure were less likely to use them.” And in a 2013 study in which researchers interviewed men who used condoms inconsistently, “By far the most frequently reported downside of using a condom was diminished physiological sensation.”
It’s this connection that inspired the Gates Foundation to get involved. As a program director for the Gates Foundation wrote in a blog post about the condom grants, “It may seem obvious, but the success and impact of any public health tool hinges on that tool being used consistently and correctly by those who need it.” This is as true in America as it is in sub-Saharan Africa—in spite of the availability of birth control and treatments for STIs, America has the highest rates of unintended pregnancies and HIV transmission in the developed world. From a public health perspective, condom effectiveness is a numbers game. As Ron Frezieres, a Gates grantee who has designed and executed clinical contraceptive trials for more than 30 years, says, “Even if a condom had twice the breakage rate … but everybody loves it, it enhances sex—maybe that’s really incredible, to get 100 percent product utilization of a product that breaks 2 percent [instead of] a 50 percent utilization of a condom that breaks 1 percent.”
Condom compliance—the ability and willingness to use condoms consistently and correctly—has always been a big problem. The Gates Foundation knows it, and so do all of us who’ve decided to just chance it during sex, even when the Trojan is sitting right there on our bedside table. A more enjoyable condom—a condom that people want to use—could significantly reduce STIs and unwanted pregnancies, both in America and abroad. So why hasn’t the always unpopular latex condom ever faced any serious competition in the condom aisle? Why, after all these years, is latex still king?
In 1960, the Food and Drug Administration approved the birth control pill for contraception, giving women a reliable means of controlling their fertility for the first time ever. The introduction of antibiotics in the 1930s and ’40s had already made gonorrhea and syphilis simple to cure, and other venereal diseases (as STIs were called at the time) were treatable or manageable. This all meant that most Americans, straight and gay, were willing to take their chances on unprotected sex. Condom sales plunged. “Between 1965 and 1970, condom use declined 22 percent,” reports sociologist Joshua Gamson in his essay “Rubber Wars.” “From the mid-1970s to the mid-1980s, U.S. condom sales fell by half.”
In 1981, the Centers for Disease Control identified a disturbing trend that gay men in New York, San Francisco, and Los Angeles already knew about: Young, healthy-seeming gay men were dying, often suddenly, from rare forms of pneumonia and cancer. “Gay-related immune deficiency,” as researchers first dubbed AIDS, was as poorly understood as it was terrifying. In the absence of scientific consensus, a doctor and researcher named Joseph Sonnabend theorized that AIDS was the cumulative effect of repeated exposure to various STIs. This theory went further than suggesting that promiscuity increased one’s odds of getting AIDS—it suggested that promiscuity was the cause of AIDS.
This was not a popular idea among the gay men of Greenwich Village, who had embraced sexual liberation as a means of defying heteronormative strictures, and who saw bathhouses and sex clubs as safe spaces. (Shortly before the outbreak of AIDS, one gay activist infamously said, “Gay men should wear their sexually transmitted diseases like red badges of courage in a war against a sex-negative society.”) But it was Sonnabend’s soon-discredited theory that led to the rise of safe sex as we know it.
In the summer of 1982, Sonnabend introduced his patient Michael Callen to his other patient Richard Berkowitz, hoping they could help spread his message. Berkowitz was a writer who made his living primarily as an S&M hustler; Callen was a singer who estimated he’d slept with 3,000 men in his 10 years living in New York City. Both men turned 27 that year, and both found hope in Sonnabend’s hypothesis: If promiscuity had made them sick, then perhaps changing their sexual practices could make them well.
In his 2003 memoir, Stayin’ Alive: The Invention of Safe Sex, Berkowitz recalls telling other men with AIDS symptoms, “My doctor told me that I can get better and avoid progressing to full-blown AIDS if I stop fucking around and give my body a chance to heal from years of taking recreational drugs and getting sexually transmitted diseases.” Callen and Berkowitz wanted to spread the word, and thought their own licentious histories made them the perfect messengers.
Their first attempt at advocacy didn’t go over well. “We Know Who We Are,” an essay published in the gay newspaper the New York Native in November 1982, declared, “The present health crisis is a direct result of the unprecedented promiscuity that has occurred since Stonewall” and offered little practical advice about continuing to have sex in the age of AIDS. Callen and Berkowitz were inundated with hate mail from their peers and accused of being “sex-negative propagandists.”
Berkowitz and Callen’s second attempt, a 1983 booklet called How to Have Sex in an Epidemic: One Approach, set aside the judgmental language and offered an idea few gay men had previously considered: Use condoms.
In 1983, the idea that gay men would have sex with condoms was a joke. One lone health clinic in New York, the Gay Men’s Health Project, had attempted to distribute condoms in bathhouses in the 1970s, but they found few takers. According to one of the clinic’s founders, gay men of that era thought of condoms as a contraceptive for straight people and many of them “had no idea how to use them.” Callen’s former partner concurs: “Condoms were basically completely foreign to 99 percent of gay men,” he told filmmaker Daryl Wein in the 2008 documentary Sex Positive. “So, yeah, the idea that gay men would have sex using condoms was revolutionary.”
Today, the idea that gay men should wear condoms to protect themselves from HIV is a given—although the advent of Truvada, a daily pill that can protect people who take it from HIV infection, may change that. Many of the lessons of How to Have Sex in an Epidemic are familiar to anyone who’s ever taken a decent sex-ed class. But some of the book’s messages surprised me. For one thing, instead of telling men to use condoms and leaving it at that—like, say, the CDC does on its current webpage about gay and bisexual men’s sexual health—Berkowitz, Callen, and Sonnabend offered alternative methods of mitigating risk, like pulling out to ejaculate at the end of intercourse, and spitting after performing oral sex. (Today, spitting and swallowing are considered equally low-risk, while letting semen linger in your mouth might increase your risk of getting HIV.) They acknowledged that these practices are riskier than using a condom, but they seemed more interested in meeting sexually active gay men where they were than in preaching about ideal behaviors.
As the safe-sex message spread from Greenwich Village to the rest of the country, the nuance of How to Have Sex in an Epidemic got lost. Surgeon General C. Everett Koop, the Reagan appointee legendary for speaking frankly about AIDS and sex in spite of his evangelical background, began talking about condoms in 1986. In his “Surgeon General’s Report on Acquired Immune Deficiency Syndrome,” Koop wrote: “If you jointly decide to have sex, you must protect your partner by always using a rubber (condom) during (start to finish) sexual intercourse (vagina or rectum).” America, terrified of the disease that had already killed almost 25,000 people, listened. Between 1986 and 1987, condom sales at drugstores jumped 20 percent nationwide, according to a study published in the American Journal of Public Health. The New York Times catalogued the revived interest in condoms in a 1986 article titled “Back to a Basic Contraceptive,” which profiled an “attractive” widow named Anne who bought a packet of condoms “despite some embarrassment caused by the proximity of two youths to the drug store counter and her confusion at the variety of brands and styles available.” The next year, a sensitivity-challenged condom executive called AIDS “a condom marketer’s dream.”
Most of the condoms sold in the mid-’80s were, as they are now, latex. But another category of condoms experienced sales growth between 1986 and 1988, according to that American Journal of Public Health study: Lambskin condoms, which How to Have Sex in an Epidemic championed as “thin, sensitive and durable.” Even Anne, the New York Times’ attractive widow, ended up buying lambskin condoms.
Lambskin condoms are also known as natural membrane condoms, or sometimes just “skins.” According to Aine Collier’s comprehensive history of the prophylactic, The Humble Little Condom, condoms made from the intestinal lining of mammals have been around for millennia. Sausage-makers in Europe often ran a side business making condoms. Lambskin condoms look quite a bit like sausage casings—they are thin, translucent, and slimy when wet—and, as How to Have Sex in an Epidemic suggested, they are very strong. When I first held one in my hands, at a small condom manufacturer in California, I tried to break it by tugging on it and poking at it with my fingernails, but failed. Throughout history, people washed and reused their lambskin condoms. According to Collier, the oldest surviving condom is a reusable pig-intestine prophylactic from 1640s Sweden. Reusing these condoms is probably not sanitary—don’t do it!—but my point is that the material holds up to repeated stresses.
Sonnabend says durability was the main reason he and his acolytes endorsed these condoms. “We recommended lambskin condoms in our original condom proposals because of informal reports of latex condom breakage during anal sex,” he told me in an email. “Of course we had no definite information that condoms—latex or lambskin—were completely impermeable to anything smaller than spermatozoa.” But given what Sonnabend knew at the time, it seemed safer to suggest lambskin. “The sense was that lambskin condoms didn’t break in anal sex,” he added later over Skype.
There are four things you need to know about lambskin condoms. The first is that, yes, they are strong. The second is that they’re quite expensive compared to latex: These days, a 10-pack of Trojan Naturalamb, the only lambskin condom currently available in the United States, costs about $32 on Amazon. (Compare that to about $14 for a 36-pack of Trojan latex condoms.) The third is that they can give off scents ranging from fruity to fishy to gamy. The fourth is that they feel much better than latex condoms. “Because they have the capacity to heat up to your body temperature, they transmit sensation more effectively than latex,” explained a journalist in the gay magazine NYQ in an article about lambskin condoms in 1992. “Many people who have tried lambskins will never go back to latex.”
A condom that feels good and doesn’t break would seem to be a godsend, from a public-health perspective. But lambskin never gained traction because it didn’t pass the tests devised by scientists at the height of the AIDS crisis to evaluate condoms—tests that, with the benefit of hindsight, seem shortsighted.
In 1983, when How to Have Sex in an Epidemic was published, scientists had no data about the effectiveness of lambskin condoms—or latex condoms, for that matter—against HIV and other STIs. Research was badly needed, and a few researchers at the FDA, at gay health foundations, and at various universities were up to the task. But how do you test whether a condom protects against viruses during sexual intercourse? Human studies were out of the question; it would be an enormous ethical violation to potentially expose people to deadly pathogens. So AIDS researchers came up with some creative—and some absurd—ways of simulating sexual intercourse in the laboratory.
In the first few condom studies, published between 1983 and 1987, scientists filled each condom with a few milliliters of a virus-laden solution—about the same volume as the amount of semen in a typical ejaculation. The researchers then layered the condom between the plunger and the barrel of a plastic syringe and pumped the syringe to mimic the thrusting of a penis. Later researchers aimed for more anatomical realism: A study presented in 1988 used “a simulated coitus model (SCM) comprising a stainless steel receptacle and a condom-sheathed plastic piston,” which pumped each condom 50 times. “The effect was comparable to 50 postejaculatory strokes, an unrealistic event for most people,” the lead author conceded later. But just in case 50 postejaculatory strokes were too few, a team at the University of Calgary fit each virus-filled condom over an 8-inch mechanical vibrator and lowered the device, vibrating, into a saline-filled beaker for 30 minutes before testing the saline for traces of virus. Later researchers dispensed with the sex toys and simply filled each condom with a vast quantity of viral serum—up to 1¼ cups—and left it submerged in saline solution for a period of time ranging from one minute to four hours before testing for leakage. Sometimes these condoms were pressurized; sometimes not.
The scientists who studied the porousness of condoms in the 1980s and 1990s had a tendency to exaggerate everything: how much semen men ejaculate, how long condoms remain in contact with genitals after ejaculation, and how many times men continue to thrust after ejaculation. They also had a tendency to exaggerate the amount of virus found in semen, using relatively high-concentration solutions as a proxy for ejaculate. These exaggerations were not unintentional: “It seems better to err on the side of excessive demands on the condom than too lenient ones,” wrote one researcher in 1990. But the exaggerations mean that the results of each study are not necessarily relevant to men who remain inside their partners for only a few seconds after ejaculation.
And what were those results? I was able to find 11 studies published in medical journals or presented at scientific conferences between 1983 and 1999 that attempted to gauge the porosity of lambskin condoms. Most of these studies were very small, testing only a few or a few dozen condoms, which means that their conclusions aren’t exactly watertight, so to speak. Only three studies filled the condoms with solutions that actually contained HIV. Exactly one of the 34 condoms tested in these three studies leaked HIV—a 3 percent failure rate—but that one condom comes with an asterisk: Other researchers later criticized the inconsistent data from the study in which the leaky condom was found, suggesting that a lab technician might have made an error.
A few other studies looked at other infectious viruses, namely, herpes simplex and hepatitis B. Similar to HIV, 96 percent of the herpes-filled condoms did not leak the virus. But two studies showed that 5 out of 5 hepatitis B-filled condoms did leak. This makes sense, physics-wise: HIV and herpes simplex are both fairly large viruses, with infective particles between 90 and 150 nanometers in size, while most of the pores in lambskin condoms have been estimated to be around 50 nanometers wide. The hepatitis B virus is around 40 nanometers wide.
By this time, researchers knew from laboratory tests that intact latex condoms were impervious to all viruses. Clearly, lambskin was not: As the FDA’s own scientists concluded in 1990, “the natural membrane condom may not be totally protective in actual-use conditions.” But the same scientists later concluded, “In general, exposure to semen from breakage appears to be greater than from holes, even for holes in natural membrane condoms.” The imperfect protection afforded by lambskin, when coupled with its advantages in terms of strength and sensation, might be a tradeoff some people would be willing to make.
Adam Glickman, the founder of Condomania—America’s first condom shop when it opened in 1991, and a beloved fixture of Greenwich Village until it closed in 2007—has long endorsed lambskin condoms. “I did my homework, and when people had asked me about it, I would give them the facts as I knew them,” he told me. “I said, ‘This is a study the FDA did, this is how they did it. These are other studies that I respect that are contrary. All I can tell you is the facts, and you can make a decision.’ And then if I was ever asked ‘Well, would you use one for STD protection?’ I’d say, ‘Yes, absolutely.’ ”
Howard Cyr, a co-author of the FDA’s studies on lambskin condoms, was more circumspect. When I spoke to him on the phone, he emphasized that latex is a “better product” than lambskin. “If you have a better product around, use the latex,” he said. “Don’t use the natural membrane condom.” But when I asked him whether it made sense to encourage people to use condoms regardless of whether they were latex, he responded, “That’s quite logical. Natural membrane would be better than nothing, would be better than a broken condom, yes.”
But have you ever used a lambskin condom? Most people I’ve asked haven’t. “We have two young women who just started working for us,” condom inventor Mark McGlothlin told me. “They’re biomedical engineers, and they have internships with us—and they had never heard of a natural skin condom before, no less seen one.”
That’s because, in 1991, the FDA began requiring lambskin condoms to carry a label stating, “Not to be used for prevention of sexually transmitted diseases (STDs). To help reduce the risk of catching or spreading many STDs, use only latex condoms.” You will find a very similar label on boxes of Trojan Naturalamb condoms today. Fourex natural skin condoms went off the market in the late 1990s; a former researcher for London International Group, which made Fourex, said the FDA’s stringent labeling contributed to the company’s decision to pull the condoms.
When I asked an FDA representative about the necessity of those labels on lambskin condoms, he wrote, “Based on our interpretation of the published literature, lambskin condoms are not effective against transmission of STIs” and pointed me toward an informational CDC webpage claiming that lambskin condoms “have pores up to 1,500 nm in diameter … more than 10 times the diameter of HIV and more than 25 times that of HBV [hepatitis B].” Indeed, a 1987 study looked at alcohol-soaked, dried, and then metal-coated lambskin condoms under a microscope and found a pore with a diameter of 1.5 microns. But FDA scientists later wrote that, based on their own research—which involved submerging virus-filled condoms into a beaker of solution for several hours—“Our data suggest that the effective maximum pore or hole size is probably an order of magnitude smaller.”
If lambskin condoms are indeed mostly-but-not-entirely effective against HIV, as those early condom studies suggested, that might translate to hundreds or thousands of failures each year. But that doesn’t mean a lambskin condom “does not protect against HIV infection and other sexually transmitted diseases,” as current FDA labeling lingo would have it. In fact, consistently using lambskin condoms, which feel better than latex during sex, would provide more protection against HIV and other STIs than inconsistently using latex condoms.
So why did the FDA insist on labeling that made lambskin condoms seem entirely ineffectual against STIs, despite evidence to the contrary, and why didn’t condom manufacturers fight back? People were scared, and understandably so. “The concern about HIV/AIDS in the middle ’80s was as anxious as the one about Ebola today,” says Donald Marlowe, the former director of the FDA’s Center for Devices and Radiological Health. And—as we’ve seen with Ebola—fear can lead people and institutions to make irrational, overcautious decisions. In this case, fear of AIDS led the public health establishment to rule out a condom that protected against most STIs, that didn’t break, and that people liked using.
In a small laboratory in an office park in northern San Diego filled with Mason jars, a Vitamix blender, and glass phalluses, Gates Foundation grantee Mark McGlothlin showed me a few prototypes of his reconstituted collagen condom. McGlothlin is trying to develop a condom that marries the sensation of lambskin with the security of latex. His idea is to take common agricultural waste products, like cow tendons and fish skins, break them down to pure collagen, blend them with plasticizers, and turn the resulting soup into film. The preliminary condoms he showed me were soft and thin, but they broke very easily; I was able to pull one apart using the same amount of pressure I might use to tear a basil leaf. “When you have something that’s intact to start with, sort of like the skin condom, it comes from the animal that way, it’s intact. It has the advantage that Mother Nature put it all together correctly,” McGlothlin said. “We’re trying to tear all that apart and then put it back together, and I have to admit, we’re not as skilled as Mother Nature at putting it back together.” (He has since created a stronger prototype.)
McGlothlin is a condom inventing vet. He started our interview by dipping a Naturalamb condom in some water, blowing up a latex condom into a balloon twice as big as his head, stretching a polyethylene condom until it lost its shape, and inviting me to put my finger inside a Tenga masturbation aid. McGlothlin is in his late 50s, with bushy black eyebrows, thinning gray hair, and a slight paunch; his voice is slightly nasal and has an unmistakable trace of a Chicago accent. McGlothlin met his wife, Alice, when they were both working at Baxter, a health care and pharmaceutical company, in Chicago. They moved to San Diego to start their own medical equipment company, Apex Medical Technologies, in 1985, and had three daughters who are now in their teens and 20s.
At Baxter, McGlothlin had worked on kidney dialysis equipment, heart-lung machines, blood donation equipment, and other medical devices that contain polyurethane. So by the time he launched Apex, McGlothlin was known as a polyurethane expert. When the AIDS crisis hit, McGlothlin devoted his knowledge of polyurethane to developing a brand-new type of prophylactic—what would eventually become the first commercially available polyurethane condom.
Polyurethane is an enormously versatile polymer. You’ve probably encountered it in the foam in your mattress, or the insulation in the walls of your house, or the soles of your sneakers. The polyurethane film that McGlothlin hoped to turn into a condom has properties of both rubber and plastic—it stretches without breaking, but it doesn’t have nearly as much give as latex. What it lacks in stretchiness, however, polyurethane makes up for in strength—McGlothlin believed he could make a polyurethane condom twice as thin as latex but just as durable. Unlike latex, polyurethane film is also transparent, odorless, and hypoallergenic, and, like lambskin condoms, it transmits heat.
McGlothlin says that it took him about 18 months to come up with a viable polyurethane condom prototype in the mid-’80s. In 1990, he sold the condom to London International Group (a corporation that, at the time, made Durex condoms and was one of the top condom distributors in America). LIG called the condom Avanti, and spent the next four years trying to bring it to market. When the Avanti condom finally went on sale in 1994, a reproductive health advocate told Reuters it might be “the condom of the future.” That person was wrong.
The primary obstacle to getting a new non-latex condom to market, then and now, is the need for clinical trials. Latex condoms don’t have to be tested in human studies to get FDA approval—as long as a manufacturer can demonstrate that its new latex condom is “substantially equivalent” to an existing latex condom in terms of materials, length, width, and other physical specifications, that latex condom can be sold. But makers of “new material condoms” must demonstrate that their product performs comparably to latex when used by real, live sex partners.
Today, the protocol for a 1,000-use slippage and breakage study—the type of clinical condom trial required by the FDA for new condom designs—is well established. At the California Family Health Council, which has conducted dozens of condom acceptability trials, researchers usually enroll between 200 and 400 monogamous, STI-free heterosexual couples who are using a backup form of birth control, like the pill or an IUD. Each couple receives three to five commercially available latex condoms, and three to five of the new condom being tested. The condoms are unlabeled, and participants don’t know which condom they’re getting first (although when you’re comparing two condoms that look different—like latex and polyurethane—it’s obvious). The couples are instructed to use the condoms for vaginal intercourse and then individually write detailed reports about who put the condom on, which sexual positions they engaged in, how long the sex lasted, whether they used additional lubricant, whether they had an orgasm, and—crucially—whether the condom slipped off or broke during intercourse. The couples also attend detailed in-person interviews with researchers, and the man has to submit penis measurements. Each member of the couple usually receives $100 for his or her participation. All in all, a 1000-use condom performance study costs between $500,000 and $1 million.
But in the early 1990s, when McGlothlin and LIG wanted to test their polyurethane condom with humans, the FDA did not have guidelines in place. So the FDA improvised its regulation and labeling of the polyurethane condom, making a lot of mistakes along the way.
The FDA cleared McGlothlin’s condom for sale in 1991, declaring it “substantially equivalent” to existing latex condoms, based on a preliminary clinical trial of 187 couples that indicated that it broke 0.8 percent of the time, compared to 2 percent for latex condoms. But that clearance wasn’t the FDA’s final word on the matter. “My reading of the situation at the time was that the FDA didn’t think a small company like [McGlothlin’s] would be able to get this kind of product to market, and they didn’t necessarily apply the same stringent requirements that they would have done had it been a large company coming in,” says William Potter, the former scientific director for LIG. But soon thereafter, the NIH and LIG began to show interest in McGlothlin’s condom—the NIH for its potential public-health benefits, and LIG for its money-making benefits. Once the research organization and the condom company began pouring millions of dollars into bringing McGlothlin’s condom to the market, the FDA changed its tune.
Between 1991 and 1995, the NIH funded five clinical trials to test a number of different prototypes McGlothlin had created, which varied in thickness, size, and lubrication. Most of these trials used a relatively small number of couples—between 19 and 39—and some of the prototypes broke between 9 and 15 percent of the time. According to McGlothlin, these high breakage rates were by design. “We made a series of polyurethane condoms: thick ones, thin ones, regular thickness ones, baggy ones, skinny ones, because we were trying to understand condom breakage … so we purposely made things that would break,” he told me. With the NIH grants, McGlothlin says he was basically throwing different models at the wall to see what would stick. But an NIH researcher told USA Today that she didn’t know whether the test condoms were the same as the ones intended for sale, which would cause problems down the line.
Meanwhile, LIG, having settled on a model that seemed to break at low rates, funded several of its own studies to prove to the FDA that the condom it wanted to sell was safe. These studies tested thousands of condom uses by more than 1,000 couples overall, and the resulting breakage rates ranged from 0.4 to 2.1 percent, compared to an estimated average of 2 percent for latex. (Later studies would show a slightly higher breakage rate.)
Even though the FDA had officially already cleared the condom to be sold with a label claiming that it was effective against pregnancy and STIs, it got cold feet at the last minute. After the first packages of the Avanti condom had already been printed, the agency made LIG replace the original labeling with a label that stated that the condom’s effectiveness was uncertain and that it was intended only for latex-sensitive users—not exactly the kind of label that makes boxes fly off shelves. “We let it go on the market with interim labeling very carefully,” Lillian Yin, then the director of the gynecological division of the FDA’s office of Device Evaluation, told a reporter for the newsletter AIDS Alert at the time. “We are not encouraging it for the general public.”
The FDA also called for a new clinical study following a letter from an NIH researcher who feared that the FDA was clearing a subpar condom for sale. “We knew about the NICHHD data,” Yin said in 1995. “But if you have London International saying they are OK and NICHHD saying they are not, we thought the most reasonable thing was to have them do the studies again.” A current FDA spokesman told me, “I was unable to locate evidence FDA would not allow the Avanti condom to be marketed immediately following clearance.”
McGlothlin and LIG could have hit the pause button and attempted to convince the FDA to drop the restrictive labeling. But at this point, McGlothlin had devoted about seven years of his life to developing the Avanti condom. LIG had poured millions of dollars into research and had built a factory specifically for polyurethane condoms in Cambridge, England. McGlothlin recalls a conversation he had with Potter at the time: “It’s kind of like, OK, do we sit here and fight another five years or more to try to get the good labeling and have it as a mainstream product, or do we want something to break the logjam, to get a toehold and get something on the market and see if people even like them or whatever? And I was an advocate to say—and maybe I’m my own worst enemy—like, OK, let’s do whatever it takes to get something on the market and see what happens.”
The whole experience left McGlothlin bitter. “The process was so unfair,” he recalls. Though the FDA would eventually let manufacturers label polyurethane condoms as effective against pregnancy and STIs, the label also still emphasizes that they are for people with latex allergies. When I asked an FDA spokesman about the labeling on polyurethane condoms, he wrote, “Synthetic male condoms offer a high level of protection against pregnancy and STI transmission, but as a group, they are slightly less effective than natural rubber latex condoms.” Today, the only polyurethane condoms sold in America are by Trojan; a series of mergers and acquisitions between 1999 and 2010 killed off both LIG and the Avanti polyurethane condom. In spite of its many benefits, the Avanti condom is the condom of the past, not the future.
The FDA was given the authority to impose standards on condoms with the passage of the Medical Device Regulation Act of 1976. Understandably, it spent the next decade focusing on more consequential, complex medical devices—pacemakers, ventilators, that sort of thing. So when, in 1986, the surgeon general began promoting condoms to prevent AIDS, the FDA was caught off guard. “All the division chiefs got together one Friday afternoon and said, ‘What do we know about condoms? What do we know about latex?’ We knew nothing,” says Don Marlowe, the former director of the FDA’s Center for Devices and Radiological Health, the branch that is charged with regulating condoms.
So the FDA went looking for answers. “In the space of four months, I got on an airplane and visited every condom manufacturer in the United States,” Marlowe recently recalled from the kitchen table of his home in Rockville, Maryland. He found that manufacturers varied wildly in their techniques and test methods, and that those test methods didn’t even necessarily have any basis in science. And so the FDA began to try to improve the tests.
At the time, condom companies were supposed to adhere to a standard created by a private, not-for-profit standards development organization called American Society for Testing and Materials, whose rules hadn’t changed much since the 1940s. The ASTM condom subcommittee was, back then, populated mostly by scientists and sales representatives from condom companies, all of whom had an interest in keeping the standard favorable to their bottom line. When, in the wake of the surgeon general’s call to action, FDA representatives joined the ASTM subcommittee in the late ’80s, they came with an implicit threat. Since the FDA had the power to change labeling and recall products, the agency “became the 800-pound gorilla in the room,” says Marlowe.
Before FDA representatives joined the ASTM condom group, quality assurance was pretty much left up to the manufacturer’s discretion: Some manufacturers filled condoms with water to test for holes, some filled them with air, some examined them visually, but the specifics of each test were open to interpretation. Now, the ASTM condom standard was rewritten at the FDA’s prompting to systematize different test methods. To make sure condoms don’t have any holes, instructions were given for the water leak test, which, according to the current ASTM standard, “is most sensitive when the condom is filled with water while hanging vertically, its top is closed off, and the condom is moved into horizontal positions and squeezed while it is examined for leaks.” To test condom strength, the air burst test, in which randomly selected condoms are filled with air to determine the volume and pressure at which they burst, won out over the tensile strength test, which stretched condoms mechanically to determine the force required to rip them. Minimum length, minimum width, maximum thickness, storage conditions, and protein content of latex condoms were all precisely defined.
When I first found out that the government makes condom manufacturers blow up their condoms like balloons to determine their strength, I laughed. But, by all accounts, the quality of latex condoms has gotten much, much better and more consistent as a result of strengthened ASTM standards. Gone are the days of enormous condom recalls, and laboratory tests showing that 1 out of 8 latex condom brands leaked HIV. (Although well-made latex is impervious to viruses, shoddy manufacturing practices can and once did leave tiny holes in condoms.)
But that strict quality control, with its emphasis on easily reproducible laboratory tests, comes with a downside. Adam Glickman, the founder of Condomania, and a condom inventor named Frank Sadlo, discovered that downside in 2006.
In August 2003, 3½ years prior, Glickman had begun selling the condoms Sadlo invented, a range of custom-fit latex condoms called TheyFit, which had been cleared by the FDA in 2001. TheyFit came in 55 sizes, ranging from 3 inches to 10 inches in length and from 1½ to 2½ inches in width (measured when the condoms were laid flat). Men found out their size by downloading a ruler-shaped template from the Internet, printing and cutting it out, and using it to determine the length and circumference of their erect penis.
TheyFit was a hit at Condomania, and understandably so: Human penis size varies enormously, and while latex stretches, it feels much better to wear a condom that sits comfortably on the penis than one that squeezes it—or, in the event that the condom is too long, bruises the base of the penis with its extra material. Furthermore, a clinical trial conducted by the Kinsey Institute indicated that TheyFit condoms broke half as often as conventional condoms, with especially noticeable differences in breakage rates among men with larger penises.
TheyFit condoms sold faster than any other product in Condomania’s history, and Glickman says he never received a single consumer complaint about them. (Glickman is not an impartial observer—Condomania had an exclusive deal with TheyFit and was the only company to market and sell the condoms. However, I was unable to find a single entry related to TheyFit in the FDA’s database of complaints about medical devices.) In surveys that Glickman conducted, consumers raved about the condoms, writing things like: “Changed my sex life. I was always suffocating in other brands or they were wide enough but too long,” and “For the first time, after making love, I didn’t have a bruised purple ring around the base of my penis from the condom’s ring,” and “Excellent product that allows the full use of my penis in the love making experience.”
In spite of their niche popularity and excellent clinical trial results, the FDA challenged the acceptability of TheyFit condoms in December 2006, apparently having noticed—more than five years after clearing the condoms for sale—that some of the 55 sizes did not meet ASTM dimensional requirements. The smaller sizes, in particular, didn’t hold the requisite volume of air and water in the air-burst test and the water-leak test, because they were, well, smaller. Sadlo, who confirms Glickman’s account, was given 30 days to remove his condom from the market, and, after consulting with an attorney, complied. (“The FDA is unable to comment on why a manufacturer discontinued marketing a device,” the FDA spokesman told me when I tried to confirm Glickman and Sadlo’s story.)
Glickman was enormously frustrated by the experience. He had been trying for years to make money selling condoms, starting in the late-1980s, when, as a college student, he branded a batch of latex condoms with his school mascot, Jumbo the Elephant, and went from dorm room to dorm room selling them. For Glickman, TheyFit was an amazing opportunity to get people excited about using condoms. But the FDA didn’t see it that way. “They just saw their regulation,” says Glickman. In his view, the FDA “didn’t know how to change the regulation; they didn’t seem to care to want to change the regulation.”
In 2011, the international equivalent of the ASTM, called the International Standards Organization, finally settled on testing methods for a broader range of sizes. That same year, TheyFit began selling an expanded range of 95 sizes in the European Union. But the ASTM has been slow to change. In December 2013, when the ASTM subcommittee voted on expanding the size range allowed in the standard, everyone was in favor except for FDA representatives, citing concerns that small condoms might not fit over the mandrels used to administer the air-burst test, according to an ASTM committee member.
Glickman believes that what happened to TheyFit shows that the FDA is unconcerned with how sexually active Americans actually have sex. Here’s more proof: The FDA does not sanction condoms for anal sex.
Latex condoms are not, and have never been, approved by the FDA for use during anal sex. Clinical trials comparing experimental condoms to existing latex condoms enroll only straight couples and instruct them to use the condoms for vaginal intercourse. (The commonly cited latex condom failure rate of 2 percent came out of these clinical trials.) When Marlowe and his colleagues at the FDA began trying to improve condom standards in the late 1980s and early 1990s, they looked at the scientific literature on the physics of sex and found that there had been virtually no studies of anal sex. “There is uncertainty as to the level of protection that condoms designed for use during VI [vaginal intercourse] can provide during AI [anal intercourse],” wrote the authors of a 1997 FDA review of the scientific literature on anal sex. Since that FDA review was written, American researchers have conducted only a handful of additional surveys of the condom experiences for people having anal sex, plus the clinical trial for TheyFit condoms, which studied breakage and slippage during both anal and vaginal intercourse. One of those surveys suggested that failure rates during anal sex are similar to those during vaginal sex—around 2 percent—which aligns with the results of a European trial. But in the TheyFit study, 7.4 percent of standard sized latex condoms failed during anal intercourse, versus 5.7 percent of fitted condoms. Meanwhile, a recently published analysis suggests that condoms are less effective against HIV when used by gay men than when used by straight couples. Clearly, more research is needed.
It is inconceivable that the effectiveness of latex condoms during a sex act practiced by an estimated one-third of Americans—the sex act associated with the highest risk of HIV transmission—is virtually unknown. HIV/AIDS, which in the 1980s was spread primarily by anal sex among gay men, is the reason the government started seriously regulating condoms in the first place. How could this happen? Ron Frezieres, a researcher at the California Family Health Council who helped test Avanti and develop the standard 1,000-use condom trial back in the 1990s (and another Gates grantee), thinks that the lack of research on anal sex is because condom manufacturers don’t want to be associated with gay sex in the public eye. “It’s a little political, because I don’t think the sponsors”—i.e., condom manufacturers—“necessarily want their name identified in publications that they’ve done this big anal research study,” Frezieres told me. “The FDA would love the information, and I also think the NIH would love the information, but they also don’t want to be known as funding the anal intercourse study.” Take a moment to imagine how Republicans in Congress might react if the NIH used taxpayer dollars to study the mechanics of anal sex.
Marlowe, the former FDA standards director, also places the blame on manufacturers. “It’s the sponsor of the product that’s going to promote this change in the labeling to reflect anal intercourse. Where is he getting an advantage by doing that? What is the incentive to him to do that? He’s already selling a successful product.”
Carol Carrozza, a representative of Ansell, the maker of LifeStyles, blames the FDA instead. “There are no anal specific condoms because they don’t have criteria for testing specifically for that use,” she told me.
I asked Marlowe what he thought about the lack of anal-approved condoms today. He paused for a long time and then said, “I think there’s enough design safety built into the product that we’re getting that I’m not anxious about it. But do I know? No.”
A bright-eyed, grinning young woman, who is lounging in bed wearing a matching navy blue bra and panties, stares straight into the camera and declares, “I love sex. And I don’t like condoms.” Her smile intensifies as she remembers her latest tryst. “But these condoms are made differently.”
This is a commercial for Skyn Condoms, the first FDA-authorized condom made of polyisoprene. Ansell, the maker of Skyn (and Lifestyles), claims in the fine print at the bottom of the ad that polyisoprene is “a revolutionary material.” There are no FDA standards for using the term “revolutionary” to describe a condom. “Don’t ask me details,” says the actress in the ad. “Frankly, I don’t care. All I know is, they felt different than anything I’ve tried before.”
If the actress did know the details, she might be disappointed. Polyisoprene is synthetic latex. It is chemically almost identical to latex, but since it’s made from petrochemicals instead of tree fluid, it lacks the proteins that some people are allergic to. To get a sense of just how non-revolutionary Skyn condoms are, look at their FDA application summary, which refers to the product as a “lubricated polyisoprene latex male condom” and confirms that it meets both ASTM and ISO test standards for latex condoms.
This is not to dismiss the polyisoprene condom: Polyisoprene is slightly softer and stretchier than natural latex, and in a marketing survey by Ansell, 97 percent of people who’d tried it said they’d recommend Skyn. Ansell also says that in a clinical trial, participants rated Skyn significantly higher in terms of sensitivity and comfort than either latex or polyurethane condoms, although Ansell’s rep declined to share the details of that trial with me.
But to call polyisoprene “revolutionary”—a term that Durex’s new polyisoprene condom also uses in its marketing materials—is funny and sad. More than 30 years after the AIDS crisis began—more than 30 years after the advent of the safe-sex movement—a synthetic latex condom counts as revolutionary?
If you believe Danny Resnic, hard at work on his Origami condom, polyisoprene is a symptom of Americans’ failure of imagination when it comes to condoms. “When I first told people I was developing a new condom, they went, ‘Well, what could be different about a condom?’ ” he said. “They couldn’t imagine anything different, because there’s never been anything different.” Resnic thinks men have become desensitized by latex condoms. “They’ve come to accept that level of sensation as the maximum.” If they use condoms at all.
Resnic’s original idea was to build the perfect condom, one that wouldn’t break, would protect against all viruses, would feel as good for the wearer as unprotected sex, would be affordable, and would be approved for anal sex by the FDA.
But building a perfect condom is more complicated than he thought. He conducted a few small clinical trials of his silicone model with funding from the NIH, and after incorporating feedback from those trials into his design, he decided to take his male condom in a surprising direction: It will now be made out of latex. Resnic still hopes to incorporate silicone into an internal condom—meant to be worn inside the vagina or anus, like a female condom—which he’ll be testing in South Africa this spring with his $100,000 from the Gates Foundation. But for his male condoms—which will still be roomier than existing condoms and pulled on instead of rolled on—Resnic says it just makes more sense to use latex, which would make it possible to manufacture his condom in existing condom factories.
Resnic also hopes that by making the Origami condom out of latex, he’ll be able to get easy clearance from the FDA. If he can prove to the FDA that the Origami condom is “substantially equivalent” to latex condoms that are already on the market, and that it meets the ASTM and ISO standards for latex condoms, Resnic won’t have to do an expensive, 1,000-use clinical trial—he’ll just be able to sell his condom.
The federal government has spent the last quarter-century telling Americans that latex condoms are our only option for both pregnancy protection and disease prevention. The appeal of the mantra “use a latex condom correctly every time you have sex”—as a Surgeon General’s report put it in 1992, and as has been repeated in innumerable pamphlets and classrooms since—is its simplicity. By endorsing a one-size-fits-all latex template without qualification, the FDA doesn’t have to think about the nuances and messy realities of how people have sex: the fact that anal sex is different from vaginal sex, that penises come in a range of sizes, and that safe sex is a risk-reward calculation, not a perfect solution.
Since I started working on this article, I’ve become fond of polyurethane condoms, which transmit the heat of my partner’s body and don’t get dry. I’ve made this personal risk-reward calculation—you might make a different one, and even stick with latex. The point is, we all need a condom that we’ll actually pull out of our nightstand or wallet and use—and that’s a lot easier to do when sex with that condom feels good.