Sex without fear of disease or conceptionis that so much to ask? Well, yes, it turns out.
Photographs by Charles Steck
For the last 20 minutes, the doctor sitting across from me has been stubbornly matter-of-fact and terribly boring. Which is a pretty mean feat, considering that he’s been talking about sex.
It isn’t until I ask Dr. Henry Gabelnick why there have been so few advances in contraceptive science in the last 40 yearsand essentially none in the last decadethat he finally starts to get excited. “That’s not true,” he snaps.
He pulls himself out of his seat and walks across his office’s blue carpet to a bookshelf. Gabelnick is the director of the Contraceptive Research and Development Program, otherwise known as CONRAD, a nonprofit organization in Arlington, that standsthanks to a recent grant from Microsoft’s Bill Gatesat the forefront of our nation’s effort to invent new birth control methods. Gabelnick starts rummaging through a few boxes until he finds what he’s looking for. Suddenly, there’s a look on his face that I haven’t seen before: Gabelnick is grinning.
Holding a box of Reality Female Condoms up in the air, he stands there, fiddling with the product’s packaging. “They haven’t been very successful in penetrating the private market, and the reason for that is they look like that,” he says, and out drops a long, limp, yellowish polyurethane tube that resembles the sheath of plastic a newspaper is delivered in.
It takes a while for this to sink in: Who out there is using a female rubber? Drugstores certainly don’t seem to sell the thing. (I’ve been looking recently and haven’t found one.) That’s primarily because after this minor triumph was made available in 1993, it was treated as some kind of novelty item. Newspaper columnists swiftly swatted it down. “I was disappointed by the bad press it got,” Gabelnick laments. “They ridiculed it because of the noise it made and because of the way it looked.”
I can understand why. Not to contribute to the product’s share of negative press, but it hardly constitutes a major leap in birth control. As far as I can tell, a female version of the condom is a little bit like tartar-control toothpaste. Sure, it’s nice to have handy, but no one’s calling it a revolution in teeth-cleaning. On a visit to the Planned Parenthood clinic near the White House recently, no one can locate a single female condom for me. The clinic’s clients “laugh at it,” a counselor explains.
Not only is the female condom large and cumbersome, but in the middle of sexof all timesit forces out a squeaking noise that sounds like a balloon releasing air. One user (from Canada) tells me, “It’s like having sex with a bag.” And at about $3 a pop, it’s a lot more expensive than your traditional male prophylactic, which costs less than a dollar. More important, a vagina-fitting condombecause it is made of polyurethaneisn’t nearly as effective as the traditional male rubber in preventing pregnancy or the spread of sexually transmitted diseases (STDs). Right now, however, it has become de rigueur among researchers to overstate the female condom’s importance. It is, after all, the sole method women themselves can use to prevent getting an STD during sex.
Safe sex is not an easy proposition for women or men. It is generally messy, ugly, disruptive, clumsy, uncomfortable, time-consuming, and a real downer. Treating, say, hay fever (one pill for 24 hours of nondrowsy relief) or impotence (pop a Viagra and you’re ready for action) is rather simple nowadays. Yet neither of these ailments has ever posed anything approaching a widespread health crisis.
Unprotected sex has spawned health crises of global proportions, yet the solutions are fraught with hassles. Every 13 minutes, someone in the United States is infected with HIV, according to the Centers for Disease Control. Four million women have chlamydia in this country. Forty million Americans have genital herpes, with half a million new cases reported every year. At the same time, more than 3 million accidental pregnancies occur in this country annually.
Of course, there is an important distinction between contraceptives and safe-sex methods, but they are very often lumped together because of the condom, which serves both purposes. In fact, aside from abstinence, the only way to protect yourself from STDs right now is still the condoma device that has been around, in one form or another, since the hunters and gatherers. On the wall of a cave in France, there’s an illustration of a man using a condomanimal guts of some kindduring sex. The painting is estimated to be 12,000 to 15,000 years old.
Why are we still relying on Flintstone Age technology when it comes to having safe sex? That’s the question that’s brought me to CONRAD. Conrad, funded primarily by the federal U.S. Agency for International Development (USAID), has emerged as the nation’s leading organization researching new birth control methods. Since the pill was approved by the Food and Drug Administration (FDA) 40 years ago, remarkably few new contraceptives have been concocted. Oddly enough, a federal report indicated with some certainty back in 1982 that we’d see 30 new technologies of this kind on the market by the year 2000, 20 of which were supposed to be developed in the ’90s. Yet, while scientists have been dreaming up the most amazing things over the last 10 years, from cloning sheep to mapping the human genome, there hasn’t been one radical breakthrough as far as contraceptives are concerned. Unless, that is, you happen to consider the female condom or new ways to distribute the hormones found in the pill radical.
The Norplant implant is one such hormonal method of birth control. It was approved in 1990 and is cited as another recent advance by Gabelnick. The vital difference between Norplant and the pill is that a woman who uses it doesn’t have to remember to take something orally every day. Instead, six rods the size of toothpicks are inserted under the skin of her upper arm. For the next five years, these rods release hormones that keep her from ovulating. About 1 million American women and 5 million women worldwide have used the contraceptive.
But the Norplant device hasn’t been such a boon. In August, Wyeth-Ayerst Labs, the Pennsylvania-based manufacturer, announced that it was halting all shipments of the contraceptive and warned doctors not to use implants distributed since October. The company said that these kits may not be potent enough to prevent pregnancy. The precaution was perhaps a wise one, considering that Norplant has been the object of a number of class-action lawsuits. Last year, Wyeth settled a huge lawsuit filed by about 36,000 women who had complained of nasty side effects from the hormones, such as irregular menstrual bleeding. The company agreed to pay each woman $1,500.
Lawsuits, naturally, lead to bad publicity, which leads to poor sales. The Norplant case is no exception. Sales plummeted sharply, from $120 million in 1993 to $4 million in 1997. The company, meanwhile, has spent at least $40 million battling implant lawsuits, according to the Philadelphia Inquirer. Many of these suits have been based on bungled removals of the product, which resulted in scarring and pain. Most were either thrown out or settled after adjudicators determined that Wyeth wasn’t really to blame for the complications. Still, once the Norplant device is inserted, it requires surgeryalbeit minorto remove it. That may not be everyone’s idea of futuristic technology.
Nor may Depo-Provera, the only other contraceptive besides the female condom and Norplant approved by the FDA during the ’90s. Not unlike Norplant, Depo-Provera is a hormonal contraceptive, but it is delivered by way of a shot and lasts for three months. A woman may find the shot a quick, easy fix, but she also may come to resent putting up with the drug for the entire three-month period. Should she change her mind or find the weight gain, acne, and mood swings sometimes associated with Depo-Provera intolerable, she’s out of luck.
A few weeks ago, another shot method, Lunelle, was approved by the FDA. Lunelle works in the same way that Depo-Provera doeswith the same side effectsbut it lasts only 30 days. It should
be available to the public sometime in the next few months.
In truth, the female condom, Norplant, Depo-Provera, and Lunelle are really just twists on products that have been on the market for decades. They don’t amount to anything as imaginative as the oral contraceptive pill. When the pill was introduced, in 1960, it was a culture-rocking phenomenon. The freedom was radicalizingand partly responsible for the ensuing sexual revolution and the women’s liberation movement.
Many predicted that the pill would also spark a contraceptive revolution. But if it did, the troops went home before the fighting ever started. The amount of money spent on contraceptive research is dwindling. It reached a peak in 1972, nine years before the first AIDS cases were reported in New York and California. To make matters worse, the number of contraceptive choicesat least in the short termis in danger of shrinking. The latest blow came in July, when researchers reported conclusively that nonoxynol-9the world’s leading spermicidecan cause vaginal lesions and possibly leaves its users more vulnerable to diseases such as AIDS.
“Why isn’t more being done, and why aren’t new methods being developed?” asks Megan Gottemoeller, a women’s health advocate at the Center for Health and Gender Equity, a nonprofit group based in Takoma Park that promotes women’s health issues. “It’s because we’re talking about sex and we’re talking about”suddenly her voice drops to a whisper”the vagina!”
Those who oppose abortion are famous for their effectiveness. They’ve been effective in turning family planning clinics into near-fortesses, scaring abortion-service providers, impelling doctors to migrate to other areas of medicine, and causing women to think twice about terminating pregnancies. They’ve been effective in lobbying politicians and getting pro-life candidates elected. But what may be a surprise to some is that they’ve also been pivotal in stifling the invention and deployment of new birth control products and the development of safe-sex devices other than the condom.
The abortion pill, referred to as RU-486, is a particularly dramatic example. After years of controversy, the mifepristone pill was approved only last month by the FDAand that approval came with several restrictions that could make it hard to get. Abortion opponents despise mifepristone because, like a surgical abortion procedure, it terminates a pregnancy by forcing an embryo out of the uterus before the embryo has a chance to mature. The pill works by stifling a natural hormone in the uterus, thereby making the uterine lining start to slough off. A second drug, which is prescribed in tandem with mifepristone, then causes the uterus to eject the embryo and lining.
The abortion pill could have been on the market in the United States for almost 12 years now. Not surprisingly, though, after the drug was developed, the French company that manufactured it refused to bring it here. Company executives were worried about the anticipated backlash from America’s notorious anti-abortion soldiers. And then-President George Bush had vowed to do all he could to stop the abortion pill from invading the United States. So the company turned the product licenses over to the Population Council, a nonprofit organization based in New York that encourages development of new birth control methods. For years, the group sought a pharmaceutical company in the United States willing to produce the drug, until it finally decided to create its own: Danco Laboratories. Finally, in February, after Danco located a plant to produce the pill and conducted all the necessary clinical trials, mifepristone was submitted for FDA approval.
You would think approval of the abortion pill would have come easily by then. After all, the Clinton administration had made it clear that it supported the drug, it had been used almost without incident in Europe for more than 10 years, and an FDA advisory board had already declared the product “safe and effective.” But approval didn’t come easily. Toward the end of the lengthy review process, the FDA tried to impose some rather Byzantine distribution restrictions on the pill.
Those restrictions, which included authorizing distribution only by doctors who were certified to conduct multiple surgical procedures and who worked out of a full-service clinic, would have made the drug almost impossible to get. Proponents argued that it would have driven dissemination of the abortion pill underground. Standing up to the FDA, Danco refused to impose those restrictions, and it received the backing of the American Medical Association and other groups that saw the agency’s requests as unreasonable and unprecedented.
Mifepristone’s supporters attribute this lollygagging by the FDA to the Senate confirmation proceedings of the agency’s commissioner, Dr. Jane Henney, in 1998.
Republican senators stalled Henney’s confirmation because they wanted her absolute assurance that she would not approve the abortion pill. Ultimately, the first woman to lead the agency acquiesced to the pressure, writing a letter to senators in which she vowed, “If I am confirmed as commissioner, I would not solicit a manufacturer for RU-486.”
For pharmaceutical companies, the abortion pill’s long and troubled journey is a cautionary tale. Why invest your company’s resources, public reputation, and political capital on something as mine-laden as contraceptives? “They look at this field and the public debate around this, which is so caught up in the abortion debate, and they say, ‘It’s not worth it,’” observes Kristen Moore, director of the Reproductive Health Technologies Project, a nonprofit organization located in Dupont Circle, that is working to pool money to fund development of new contraceptives. “Are they going to want to have to fight a public image that they are killing babies? It’s not exactly good for business.”
This reasoning, in part, explains why none of the largest drug companies do contraceptive research. In this country, that’s a huge problem. Pharmaceutical companies should be ideally suited to design, develop, and produce drugs and health care products for our market-driven economy. That they stay out of the picture because of fear of getting ensnared in a sticky political debate over abortion is a serious obstacle to the evolution of birth control.
“This field has been bereft of talent for 30 years,” says Lori Heise, founder of the Global Campaign for Sexually Transmitted Infections/HIV Prevention Alternatives for Women. “It’s a real mess. You don’t have science invested in reproductive technologies.”
Conservative politics have also colored the way federal research dollars are allocated. “Government funding isn’t supposed to go toward anything that has to do with terminating a pregnancy,” Gabelnick explains. “The rules on what’s an abortion vary depending on whom you ask. It’s USAID’s policy that anything having to do with post-fertilization would be an abortion.”
In other words, CONRAD, which gets most of its money from the government, doesn’t do research on anything having to do with a fertilized egg. (Grant money from private foundations can be directed toward wider realms of study, naturally, but its uses are contingent on the donor’s specifications.) As a result, CONRAD doesn’t study things like the emergency contraceptive pill. This “morning-after” pill works by using high doses of hormones to make the uterine wall inhospitable to a fertilized egg. It must be taken within 72 hours and differs from the abortion pill in that it prevents a pregnancy by blocking a fertilized egg from implanting itself in the uterus.
Family planning clinicians and counselors say the morning-after pillmarketed only recently in the United Statesis quickly becoming a popular form of contraception. A new version of the pill, called Plan B, is said to have fewer side effects, such as nausea and vomiting, than the old morning-after regimen, which was really nothing more than multiple doses of existing birth control pills. Family planning groups in several states are pushing for pharmacists to be able to distribute the new drug to women who have not seen a doctor first. And Plan B’s manufacturer intends to apply to the FDA for permission to sell the drug over the counter within the next year. But opposition from the anti-abortion activists is already surfacing.
Amy Allina sits in a small conference room under a framed poster that boasts the words “Feminism Lives.” Allina is the director of programs and policy at the National Women’s Health Network, a liberal nonprofit that occupies office space in a building next to the house where President Lincoln died. Unlike many of her colleagues, Allina doesn’t believe that most of the blame for the slow evolution of reproductive technology should be pinned on the anti-abortion movement. She says it’s the fault of the drug makers, whose executives (mostly men, she says) don’t see the benefit or the necessity of developing these products.
“Pharmaceutical companies don’t believe it’s profitable enough,” Allina says. “Even researchers don’t want to go into contraceptive development. It’s a career loser. You won’t get any grant money.”
The facts bear out Allina’s assertion. Whereas Viagra scored $1 billion in sales in its first year on the market, domestic condom sales are a puny $250 million. Meanwhile, combined sales for other do-it-yourself contraceptivesthe diaphragm, spermicides, and the cervical capamount to only $50 million a year. On the other hand, the market for the birth control pill is significant, at $1.5 billion.
Allina suggests that pharmaceutical companies and researchers are intimidated not only by the lack of profit associated with birth control, but also by the daunting legal and financial risks that come with it. Lawsuits arising from a faulty product can crush a drug company’s profit margins, and even the company itself.
Paranoia among drug makers over lawsuits was stoked by the calamitous undoing of the Dalkon Shieldor, strictly speaking, the downfall of a company that widely marketed and distributed a birth control product that resulted in reported health problems in about 100,000 women. A few years after the pill appeared on the market, the intrauterine device, or IUD, began to grow in popularity. The IUD is inserted into a woman’s uterus just above the cervix. Precisely how such devices keep women from getting pregnant is scientifically unclear. But once inserted, they’re remarkably effectivepopulation experts say even more so than the pilland are hassle-free. Plus, they don’t cause the kind of side effects associated with ingesting lab-made hormones. Although no longer popular in the United States today, IUDs are still used by millions of women throughout the world. Two brands of the IUD are currently available in the United States.
The popularity of the IUD suffered immeasurably after A.H. Robbins, a drug company located in Richmond, went belly up. The company began aggressively marketing its Dalkon Shield in 1970. The plastic shield, unlike its T- and S-shaped predecessors, looked like a spindly fish and was advertised as “the most effective contraceptive.” Only four years later, 2.8 million women had been prescribed the product, accounting for almost half of all IUDs sold. Nevertheless, the reported number of problems linked to the device was growing.
By 1975, 10 Dalkon Shield users had died from bleeding and other complications after having miscarriages while the device was in place. Women also complained of irritation and bacterial infections resulting from the shield. That year, the FDA pulled the product from the U.S. market, banning new sales but allowing current users to continue using the device. A year later, Robbins, which was still selling the product overseas, ceased production of the contraceptive.
From there, things really spiraled downward. In 1980, Robbins recommended that remaining shield clients remove the device because long-term use seemed to increase the risk of miscarriage. Four years later, the company offered to pay to remove the device from women who still had it. In 1985, Robbins declared bankruptcy after being besieged by thousands of lawsuits, which cost it more than $450 million altogether. As part of the bankruptcy deal, the company was granted immunity from all future lawsuits. At the same time, several other IUD makers pulled out of the business as liability insurance rates for these devicesand other forms of contraceptionsoared. This state of affairs discouraged other pharmaceutical companies from investigating new contraceptives.
Believing the Dalkon Shield and Norplant experiences are deterring drug makers from pursuing contraceptive research, some family planning advocates favor legislation that would reduce a manufacturer’s responsibility should a birth control product prove toxic. A panel assembled by the U.S. Institute of Medicine and led by Allan Rosenfield, the dean of the Columbia University School of Public Health, published a report in 1996 recommending that Congress pass such a product-liability reform bill, which would insulate contraceptive manufacturers from lawsuits if their products had been approved by the FDA. “It would make a fantastic difference,” gushed Nancy Alexander, who oversees contraceptive development at the National Institutes of Health, in the journal Science in 1996.
Health-insurance policies pose another obstacle to the development of new contraceptives: They make contraceptives less affordable and profitable by failing to cover them. Many health care plans don’t cover contraceptives. But they often do cover abortions, pregnancies, sterilization, and Viagra (at $10 a pill). Strangely enough, the treatments these plans cover are often more expensive than the ones they don’t. Consider that surgical procedures such as sterilizations or abortions are far more costly than, say, something like a prescription for the pill. “These are guys in suits that don’t get it,” says Kristen Moore of the Reproductive Health Technologies Project. “They don’t understand what women need.”
Recently, the D.C. Council tried to change this equation locally by passing a bill to mandate that health insurance providers in the District cover contraception. Maryland and 12 other states have similar laws on the books. Some argued that if insurance companies covered birth control, it would help reduce the number of children in the District living in poverty and reduce the city’s frightening infant mortality rate, which stands at 13 per 1,000 live birthsor twice the national average.
But some religious groups and anti-abortion leaders put on the heat, and Congress threatened to overrule the law unless a conscience clause were added to exempt employers with certain religious traditions, such as Georgetown University. Mayor Anthony A. Williams, who remained silent on the matter, ultimately elected not to sign the bill, effectively vetoing it.
The lab at the Jones Institute of Reproductive Medicine in downtown Norfolk, Va., is knee-deep in sperm. There are sperm inside vials, pipettes, microscopes, petri dishes, plastic cups, and refrigerators. There’s even a virtual school of the little tail-wagging critters swimming across one of the computer screens, like some cute-looking screen saver.
Walking over to one of these screens, Dr. Gustavo Doncel, the lead researcher here, points at an off-color sperm and declares with some excitement: “You see the head of that sperm? It is a bright green. That sperm can’t team up with the egg.”
I’m in this third-floor laboratory, which is run by CONRAD, on a rainy July day to see what this mastermind and his cohorts are up to. To be more exact, I’m here to see what they are cooking up in the area of microbicides, which could one day radically alter sexual behavior. Infused into a gel, a cream, or some other goo, they would be applied inside women’s vaginas and shield people from catching STDs such as AIDS by killing or mitigating dangerous microbes. A viable microbicide would be the first new method by which a couple could have disease-protected sex since the condom. No wonder some have called microbicides the “invisible condom.” Just as spermicides inactivate sperm, microbicides would inactivate STDs. Although none have yet been perfected, there are about 70 potential microbicides in various stages of development.
The Jones Institute is considered by many to be the leader in the field, with three especially promising products in the pipeline. “We are in a position to develop the ideal microbicide,” Doncel boasts. This has been a long and mostly lonely crusade for Doncel. For the last 10 years, he has been searching for a dual microbicide and contraceptiveone that would work as both a sperm- and a disease-killer. When he came to CONRAD, he was the only one at the institute pursuing this technology. Today, the doctor commands a small team of researchers.
From a researcher’s standpoint, brewing a blockbuster microbicide isn’t going to land you on the cover of Time or put you in the running for a Nobel Prize. Not like an HIV vaccine, which is a much easier sell to donors in scientific institutes and foundations. There’s no nonprofit or celebrity banging the drum for the invention of a microbicide. You certainly don’t see people scrambling to pull out their checkbooks as Elizabeth Taylor and Sharon Stone make plaintive cries for a…microbicide.
Even though a microbicide would have a dramatic impact on the spread of HIV, research has been largely lopsided in favor of discovering a vaccine. All the federal money spent on microbicidal development is equal to just 1 percent of what the National Institutes of Health spends on AIDS, much of which goes to treatment research. Yet despite the stacks of money researchers have received, an HIV vaccine isaccording to generous estimatesat least 10 years away. And even if an effective vaccine were available tomorrow, it wouldn’t neutralize other STDs, such as chlamydia or the human papilloma virus.
“Most of the money went to vaccine development,” Doncel says. “But it turns out that HIV is so smart, and it mutates so rapidly. As vaccine research failed, it helped our research. I’m not saying a vaccine will never work. It’s just more of a distant prospect.”
Supporters argue that a viable microbicide has the potential to become a magic bullet as socially significant as the pill. (Last year, for an article about microbicides, New Woman ran this headline on the cover: “The Biggest Breakthrough Since the Pill.”) Put simply, it would be the first form of STD protection that a woman could use at her own discretion. With a condom, a woman must get her partner to agree to use it. Yet men complain that condoms feel uncomfortable or reduce sensation. Some men also have a problem maintaining an erection with a condoma difficulty sex experts believe is fairly common.
The beauty of a dual microbicide is that it would let women decide for themselves when to have safe sex. From what we know of what’s in the works, a woman could apply one of these compounds and her partner might not even notice that they were using protection. Imagine the societal implications of a gel that would permit a teenager to have sex without ever having to plead with her boyfriend to don a rubber, or a cream that would allow a prostitute to have her assignations without ever worrying about gettingor giving someonea disease.
The pressure at the Jones Institute to come up with a viable microbicide is palpable. But what do you expect from a place that just won a massive amount of seed money, at least by contraceptive research standards? In a field starved for cash, doctors here are the beneficiaries of a $25 million grant to further microbicide research. The significance of this money, which was donated by the Bill and Melinda Gates Foundation in July, is enormous: This one check practically doubles the total of all the public and private investments spent on microbicides each year. Although scientists generally calculate that it costs $250 million10 times what Gates is donatingto hatch a new drug, this chunk of change could make a big difference.
Still, some would have been happier had Gates donated all or part of this money elsewhere. “Whether CONRAD is the most appropriate place for this is questionable,” says the Center for Health and Gender Equity’s Gottemoeller. To understand this skepticism, you must understand the lab’s history. The Jones Institute has been an innovator in fertility enhancement. The nation’s first test-tube baby was conceived and delivered here. What’s more, its scientists have mitigated various fetal diseases, such as Tay-Sachs.
So the question is: Can a fertility-focused program such as the Jones Institute be the architect of the best microbicide? The criticism has not been lost on those at the Jones Institute. “The thing is, people don’t realize that the science behind egg fertilization is very similar to fertilization interference,” explains Doncel.
Gottemoeller, among other women’s health advocates, is concerned that CONRAD’s inherent approach to sexuality will limit its ability to design the best microbicide. By virtue of its political and scientific mandate, CONRAD must focus first on a birth control option for women. That means that any microbicide it produces must be dual-purposeinactivating sperm and protecting against sexually transmitted diseases. “We hope to find a single product that will provide both functions,” admits Dr. Susan Ballagh, a clinical researcher at the Jones Institute.
But evidence suggests there is the potential to create a microbicide that would slay sexually transmitted diseases but not harm sperm. Ruling out a microbicide that would allow women to get pregnant at the same time they are having safe sexas CONRAD is doing in its researchcould be short-sighted. If invented, such a microbicide would be particularly groundbreaking in places like sub-Saharan Africa, where rates of HIV infection are the world’s highest and cultural pressures to have children are substantial. Currently, no contraceptive allows for this kind of safe sex. One that does just might reduce AIDS cases drastically.
Another worry is that Gabelnick and his crew have been prevented from investigating products that would also deal with less common sexual behaviors. CONRAD is concerned only with straight, birds-and-bees sexual activity. But men and womennot to mention men and men and women and womenhave sex in various ways. Just because a microbicide may work in the vagina doesn’t mean it will work in the rectum, which is, biologically speaking, a very different environment. When I ask Dr. David Archer, CONRAD’s director of clinical research, if the three microbicides they are toiling over might work for couples having anal sex, I’m given an uncannily long-winded response, as if I’m asking a fascinatingly academic and highly impractical question.
“It’s not been identified as a priority for us,” Archer says finally. “We’re working to develop vaginal microbicidal and viricidal products.”
This attitude is troublesome. A microbicide that didn’t afford homosexuals protection would be a rather egregious oversight in the war against AIDS. Not only is this approach biased, but recent research shows that bisexuals with multiple partners are an important factor in spreading viruses throughout the straight community. And, of course, some straight couples have anal sex, too.
“A lot of women come in and say they’ve had anal sex,” says Lori Peters, a clinician at the Planned Parenthood center in Northeast. “Anal sex is common abroad. I’ve seen many foreign patients who have anal sex. And there are patients who have anal sex to protect their virginity.”
At the XIII Annual International AIDS Conference, in Durban, South Africa, researchers made a shocking announcement. On Wednesday, July 12, the very same day that the Gates Foundation announced that it was handing CONRAD the cash to devise alternatives to the condom, the No. 1 microbicide candidate, nonoxynol-9, was ruled out of the running. This leading spermicide, used worldwide as a lubricant on condoms and in contraceptive gels, foams, and films, likely does nothing to prevent the spread of AIDS, researchers announced.
Taking the podium, Dr. Lut van Damme of the Institute of Tropical Medicine in Antwerp, Belgium, declared to an unsuspecting audience, “This may be the end of nonoxynol-9 as a potential microbicide.”
But what was even more alarming about the nonoxynol-9 research study, which was conducted with 1,000 prostitutes in Africa and Thailand by a company hoping to market nonoxynol-9 as a microbicide, was that chronic users of the compound developed sores and abrasions inside the vagina. That means, scientists fear, that this spermicide may actually be helping to perpetuate the spread of AIDS.
“It was very depressing,” says CONRAD’s Ballagh. “We were developing vehicles for nonoxynol-9 products to reduce the transmission of diseases. Our research agenda has been altered dramatically by the Durban announcement.”
Tellingly, the discovery of nonoxynol-9’s adverse effects came almost by accident. Although the spermicide has been used for more than 60 years, it has never been tested rigorously. That’s because nonoxynol-9 never had to meet FDA approval; it was on the market before the agency was created and was thus grandfathered. The FDA required the new study only because a company wanted to label nonoxynol-9 as a microbicidea new claim for which there was no proof or precedent.
Coincidentally, on the same day that the Gates donation was made and the nonoxynol-9 study was released, a public hearing was convened by the FDA on another contraceptive, the Today sponge, whose new manufacturer, Allendale Pharmaceuticals, wants to begin selling the device once again. The sponge was yanked from the market in 1995 after the FDA deemed its production plant substandard. Rather than bring the facility up to code, which would have required modernizing the plant’s sanitizing equipment, the company, Whitehall-Robbins Healthcare, shut the place down. The company said that it wasn’t worth the costeven though the sponge, when it was on the market, was the top-selling over-the-counter birth control product in the country.
The sponge, though, was granted a second life of sorts when it was featured prominently during an episode of Seinfeld. In the show, the character Elaine hears that the sponge has been discontinued and runs around town buying as many boxes of the precious devices as she can. She then grills prospective sex partners to determine if they are “sponge-worthy.”
Largely because of the publicity generated by Seinfeld, Allendale bought the rights to the Today sponge and now has a plant ready for production. Nevertheless, the FDA has been slow in reviewing the company’s application, canceling two visits to the plant in the last year. Now, news of the nonoxynol-9 study isn’t likely to help things along, because the sponge works by releasing high doses of the spermicide.
The number of HIV cases in the U.S. is once again on the rise. That has a lot to do with the “AIDS cocktail,” the new combination drug therapy that allows people to live rather normally with the virus for long periods: Many consider the epidemic over and the problem entirely manageable. This is a dangerous attitude to have. For one thing, AIDS is still a terminal disease. And it’s not clear what the effects of living with the HIV virus over the long term may be. Might HIV mutate and overcome the therapies offered by the AIDS cocktail, rendering the disease even more insidious?
As it stands, HIV is terrifying already. Dr. Philip Starks of the University of California, Berkeley, recently suggested that HIV may make men horny, because it appears to increase production of testosterone during early stages of infection. Though testosterone decreases as the disease sets in, the crafty virus may have actually found a mechanism to increase its own spread.
Yet our attempts at slowing the spread of the disease are woefully underfunded and anemic, hamstrung by political and monetary concerns. How complicated is it really to devise an effective microbicide? Is the science behind microbicides really so elusive? Researchers don’t seem to think so. Some compare microbicides to the dozens of over-the-counter anti-bacterial soaps and germ-killing gels readily available in any drug store. If we can find something that paralyzes germs on the hands, can it be all that daunting to create a microbicide that would similarly safeguard both the vagina and rectum?
Experts are hopeful. They estimate that the first microbicide will be available as early as 2004. It sounds good.
That is, until you remember that in 1982 we were told we’d have 30 new contraceptives at our disposal by now. And we’re still waiting. CP
Art accompanying story in the printed newspaper is not available in this archive: Photographs by Charles Steck.